the research form

Informed Consent and Consent Forms for Research Participants

Informed consent is a communication process by which researchers reach agreement with people about whether they wish to participate in research. Confusing informed consent with a signed consent form may violate the ethical intent of informed consent, which is to communicate clearly and respectfully, to foster trust, comprehension, and good decision making, and to ensure that participation is voluntary.

Consent forms are often written in “legalese” and are long, complex, and often inappropriate to the culture or language of the potential subject, insulting, and virtually impossible for most people to comprehend. They convey to some the impression that signing such a formal-looking document commits them to participation. Among subjects who willingly sign documents, most sign the consent form without reading it.

How has this come to pass? Early concern with ethics of human research was about biomedical research and focused on the necessity of obtaining informed consent. Over the decades, the elements of informed consent have grown in number, as has the idea that informed consent is a form that is to be signed by the subject. According to the Federal Regulation of Human Research 46.117(a):

Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.

However, many researchers and the Institutional Review Boards that govern their research fail to recognize that 46.117(c) provides for a waiver of signed consent forms:

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern, or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

The reason for obtaining a signed consent form has always been much more to protect the researcher and the institution than to serve the interests of the research subject. In case the subject claims later that consent was inadequate or omitted, the researcher can counter by showing the form. Recently, the Office of Human Research Protection has imposed highly publicized and costly sanctions against a few research institutions. Understandably, IRBs and research administrators consider it in their self-interest to make highly conservative decisions. Since IRBs must take steps to justify waiving documentation of informed consent by deeming the research to be minimal risk, many consider it safer not to do so, fearing that such an action might leave them open to questions by the OHRP. Thus, the reason for obtaining a signed consent form is typically to protect the institution, not the subject. Researchers, science, institutions, subjects, and IRBs would all be better off if they made intelligent interpretations of the requirements of the Common Rule.

The Social and Behavioral Sciences Working Group has made various recommendations based on the Common Rule, designed to guide social and behavioral researchers and IRBs out of such conundrums. The authors, both members of the Working Group, developed recommendations concerning informed consent, some of which are summarized here:

1. Informed consent should take the form of an open, easily understood communication process. Typically, this means a friendly verbal exchange between researcher and subject, with a written summary of the information for the subject to keep, as appropriate. (The copy for the subject to keep would be inappropriate if the written record of the subject’s participation could be damaging to the subject, as when the research is about domestic violence, or illegal behavior). Both the verbal and written discussion should be brief, and simply phrased at such a level that all of the subjects can understand it.

2. Subjects must receive enough easily understood, accurate information to judge whether the risk or inconvenience involved is at a level they can accept. The responsibility rests with the investigator to describe any risks accurately and understandably. There are many kinds of minor or everyday risks or inconveniences that most persons would gladly undertake if it were their choice to do so, but which they would not wish to have imposed upon them unilaterally. However, some may make a rational decision that the experience would be too stressful, risky, or unpleasant for some idiosyncratic reason that applies to them and not to other subjects.

3. Especially when the research procedure is long and complex, the researcher must make it quite clear that the subject is free to ask questions at any time. Informed consent, as a conversation (not a form), needs to be available throughout the research, as subjects do not necessarily develop questions or concerns about their participation until they are well into the research experience. For example, a discussion of confidentiality may not capture subjects’ attention or comprehension until they are asked some quite personal questions in the ensuing research experience.

4. When subjects can readily refuse to participate by hanging up the phone or tossing out a mailed survey, the informed consent can be extremely brief (a sentence or two). Courtesy and professionalism require that the identity of the researcher and research institution be mentioned, along with the nature and purpose of the research. However, if there are no risks, benefits, or confidentiality issues involved, these topics and the right to refuse to participate need not be mentioned, as such details would be gratuitous and might decrease participation by implying greater risk that actually exists. If the researcher has any connection with the institution at which the subjects receive health care or other essential services, it is necessary to mention the right of the research subject to refuse or withdraw without prejudice. Such rights may be honored implicitly by making it clear that you are asking their permission to involve them as research subjects.

5. Verbal informed consent need not be detailed and written consent is not appropriate when the research is not concerned with sensitive personal information and when subjects are peers or superiors of the researcher.

6. The cultural norms and life-styles of subjects should be considered when deciding how to approach informed consent. For example, research on homeless injection drug users should probably be preceded by a several week-long process of “hanging out” and talking with them. The resulting informal communication will raise issues they wish to discuss with the researcher. The conditions under which the research is conducted can then be negotiated orally between the researcher and the community members, as appropriate. Written documents and signed forms would expose subjects to risk of arrest and serve no redeeming purpose.

7. A wide range of media are appropriate for administering informed consent. Video tapes, brochures, group discussions, web sites, community newsletters, and the “grape vine” can be more appropriate ways of communicating with potential subjects than the potentially confusing formal consent forms that often are used.

8. When written or signed consent places subjects at risk, it must be waived. There are times when the written record is the only evidence that the subject has participated in a study in which there is acknowledgement or appearance of situations that would place the subject at risk.

9. When it is important to have some record of the informed consent but when written or signed consent would place the subject at risk or be difficult for the subject to read, one useful procedure is to have a trusted colleague witness the verbal consent.

10. Community consultation, or meeting with community leaders of the potential subjects, is a useful way to plan research that is likely to raise sensitive questions among those to be studied and members of their community. This is not a substitute for individual informed consent, but often clears the way for potential subjects to be ready to decide whether to participate.

11. In certain circumstances, persons are not in a position to decide whether to consent until immediately after their participation, e.g., in brief sidewalk interviews, which persons are likely to welcome.

12. Some research cannot validly be conducted if all details are disclosed at the outset. The alternatives to outright deception of subjects are to a) obtain permission to provide only a description of what the subject will experience, with an agreement that the full details of the study will be disclosed afterward; b) obtain permission to engage in concealment or deception with the understanding that pilot research has shown that peers of the subject do not find such concealment or deception objectionable and that a full explanation will follow their participation, c) explain that the subject might be enrolled in one of several possible conditions and to gain permission to disclose in which of these the subject was actually enrolled after his or her participation is completed.

Author’s Note: The Social and Behavioral Sciences Working Group (formerly a part of the National Human Research Protections Advisory Council but now an independent body) chaired by Felice Levine helped to develop these ideas.

Reference Melton, G., Levine, R. J., Koocher, G., Rosethal, R., & Thompson, W. (1988). Community Consultation in Socially Sensitive Research: Lessons from Clinical Trials on Treatments for AIDS. American Psychologist , 43, 573-581.

APS regularly opens certain online articles for discussion on our website. Effective February 2021, you must be a logged-in APS member to post comments. By posting a comment, you agree to our Community Guidelines and the display of your profile information, including your name and affiliation. Any opinions, findings, conclusions, or recommendations present in article comments are those of the writers and do not necessarily reflect the views of APS or the article’s author. For more information, please see our Community Guidelines .

Please login with your APS account to comment.

About the Authors

Joan Sieber is professor of psychology at California State University, Hayward. She received her bachelor's, master's, and doctorate from the University of Delaware. Robert J. Levine is professor of medicine and co-chair of the interdisciplinary bioethics project at Yale University. He is also the founding editor of IRB: A Review of Human Subjects Research.

Student Notebook: Finding Your Path in Psychology

Feeling unsure or overwhelmed as an early-career psychology student? Second-year graduate student Mariel Barnett shares advice to quell uncertainties.

Matching Psychology Training to Job Market Realities

APS President Wendy Wood discusses how graduate programs can change the habit of focusing on academic-career preparation.

Scientists Propose Upgrades to Research-Methods Education for Psychology Students 

Many undergraduate psychology courses fail to ensure students fully understand research design and analysis. An international team of psychological scientists have recommended some systemic steps to remedy that shortcoming.

Privacy Overview

• Find My GCO
• IACUC applications (Cayuse Animal Management System)
• IBC Applications (eMUA)
• IRB Applications (RASS-IRB) External
• Institutional Profile & DUNS
• Rates and budgets
• Report external interests (COI)
• Join List Servs
• Ask EHS External
• Research Development Services
• Cornell Data Services External
• Find Your Next Funding Opportunity
• Travel Registry External
• RASS (Formerly Form 10 and NFA) External
• International research activities External
• Register for Federal and Non-Federal Systems
• Disclose Foreign Collaborations and Support
• Web Financials (WebFin2) External
• PI Dashboard External
• Research metrics & executive dashboards
• Research Financials (formerly RA Dashboard) External
• Subawards in a Proposal
• Proposal Development, Review, and Submission
• Planning for Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Budgets, Costs, and Rates
• Collaborate with Weill Cornell Medicine
• Award Negotiation and Finalization
• Travel and International Activities
• Project Finances
• Project Modifications
• Research Project Staffing
• Get Confidential Info, Data, Equipment, or Materials
• Managing Subawards
• Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Project Closeout Financials
• Project Closeout
• End a Project Early
• Protecting an Invention, Creation, Discovery
• Entrepreneurial and Startup Company Resources
• Gateway to Partnership Program
• Engaging with Industry
• Responsible Conduct of Research (RCR)
• Export Controls

Research with Human Participants

• Research Security
• Work with Live Vertebrate Animals
• Research Safety
• Regulated Biological Materials in Research
• Financial Management
• Conflicts of Interest
•   Search

IRB Informed Consent

UPDATED February 1, 2023

NIH Data Management and Sharing Policy Update: Learn more here . TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols are now required to complete CITI training in human participant research ethics. See details here . For more information about Cornell IRB training requirements, visit the IRB Training webpage .

Informed consent is more than just a form; it is a process that takes place between researcher and participant, forming the basis of ethical research that respects the autonomy of research subjects.

Introduction to Informed Consent

Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete and true information regarding the study. The "informed" in informed consent means the participant has all the information necessary to make a decision. To help new researchers develop a consent process that works, the IRB staff offers a brief video tutorial on the basics of informed consent.

The principle of informed consent applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.

Typically, a "consent form" documents that the informed consent process has taken place. It must contain all the required components of informed consent, as defined in 45 CFR 46.116 , and described below. The consent form must be written in language that is easy for the participant to understand. Avoid technical terms and complex sentences, regardless of your intended audience. When there are different groups or types of participants who may take part in a study, different consent documents may be required for different study populations.

Informed Consent Can Take Various Forms

• Signed informed consent is the gold standard, and what is generally required for research with human participants. This involves presentation of a written document to the prospective participant, including all elements of informed consent. The document is read and signed by the participant and kept as a record by the researcher.

Remember: if you choose a written informed consent process, the research will not be anonymous.  Do not promise anonymity to prospective participants and then ask them to sign a consent form!

• Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. This type of consent process is most common in internet-based research. Participants must still be presented with the consent information - the information a participants needs to know in order to make an educated decision about whether or not to participate. This type of process is be considered a waiver of documentation of informed consent, and must meet certain requirements to be applied to a given study (see IRB SOP #10 ).
• Oral consent occurs when the researcher reads a consent script, and the subject verbally indicates that they agree to participate. Subjects should be given the opportunity to ask questions and, in most cases, provided with an information sheet containing key information about the study, including contact information for the PI. See IRB SOP #10 for more details on how to implement and document an oral consent procedure.
• In research with children , a parent or guardian must typically give their permission (called "parental consent") to allow the child to participate. Also, if the child is mature enough, they will need to give their "assent" to participate. For detailed information, please read the IRB's guidance document on Research Involving Children .

Guidelines for Writing your Informed Consent Document

General advice:.

• Start with an IRB-approved consent form template .
• Headings for paragraphs are helpful and make the form easier to read.
• Use adequate white space so that the form is easy to read. Avoid fine print.

1. Provide a clear, concise explanation of the purposes of the research including the name of the study (the IRB can waive under certain specific circumstances if appropriate).

• Replace any technical terms with ordinary language, and use simple, clear phrasing. Avoid unnecessarily long or wordy paragraphs.

2. Explain what will be happening to the participant during the study and indicate participant's time commitment for each component.

• Be clear about what the participant will be asked to do, not vaguely say, "You might be asked to," state "You will be asked."  The participant needs to understand what the experiment involves in order to decide whether they want to participate.
• Write in the second person "You" -- for example: "You are invited to participate in a research project..., " "You will be asked to..."
• Do not make coercive statements such as "you understand that ...," "you have been told that...

3. Describe the frequent and/or important risks, side effects or discomforts of the study procedures (e.g., even though it is not considered a risky procedure, a needle stick to draw blood creates discomfort).

• If it appears that there are no real risks to participation, state, "We do not anticipate any risks to you participating other than those encountered in daily life." See our Sample Consent Form . 

4. Describe any direct or indirect benefit from participating.

• Learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are NOT direct benefits. Gifts and extra credit are considered compensation or incentives.
• Learning about how research is conducted, gaining some knowledge of a particular subject, or enjoying a game played during the research, may be indirect benefits.

5. State that the participant's involvement is voluntary, the participant may refuse to participate before the study begins, discontinue at any time, or skip any questions that may make him/her feel uncomfortable, with no penalty to him/her, and no effect on the compensation earned before withdrawing, or academic standing or record.

• If completing the entire study is required for compensation, make this clear. Likewise, if there are minimum requirements to be met to earn compensation, state this clearly.
• If partial compensation or pro-rated compensation will be given, please make clear how the amount of compensation will be determined.

6. State that the participant is allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study. See required contact information in #11 below.

7. describe how participant's confidentiality will be protected., 8. describe what will be done with the data once the study is completed, including identifiable information..

• Include any plans to share either identifiable or de-identified data with other researchers, or to publish in journals or present at conferences.

9. Indicate that recording devices, audio or visual, are being used (when applicable).

• If identifiable images or videos will be used for any purpose other than analysis of data, please make this clear and make sure the participant indicates permission for these uses (see below).
• Describe what will be done with the any video or audio tapes upon the completion of the study (destroyed, erased, archived, etc.), and when (after transcription,3 years, 5 years, etc.).
• If being audio/video recorded is required to participate in the study, please make this clear on the consent form. Whether this is required is up to the PI, but if so it should be clear for the participant.
• If recording is optional, provide a separate signature line on the consent form for the participant to agree to be video/audio taped or photographed. For example:

Please sign below if you are willing to have this interview recorded on tape (specify audio or video). You may still participate in this study if you are not willing to have the interview recorded. I am willing to have this interview recorded on tape: Signed: ______________ Date: __________

10. Indicate that the participant shall receive a copy of the signed and dated consent form.

11. provide the name(s) of the investigator(s) and contact information., 12. indicate that the participant may contact the institutional review board (irb) with any concerns or complaints..

• Include our email address ([email protected]), phone (607-255- 5138), and website . 
• Concerns may also be reported anonymous through EthicsPoint online at www.hotline.cornell.edu or by calling toll free 1-866-293-3077. Ethicspoint is an independent organization that serves as a liaison between the University and the person bringing the complaint so that anonymity can be ensured.

13. Include at the bottom of the form: "This consent form will be kept by the researcher for at least three years beyond the end of the study and was approved by the IRB on [date]."

Remember, if the participant is under the age of 18, parental/guardian consent is required. This includes college and university students under the age of 18, unless the IRB approves a request for waiver of parental consent (at their discretion). If the participant is 7-17 years old, child assent is also required.

Research Involving Deception

• You will need to explain the deception and the reason for it to the participant as soon as the study is completed. Deception (including incomplete disclosure) is a technique that is sometimes used in social and behavioral research, in order to avoid response bias or for other valid scientific reasons. However, deception conflicts the subject's ability to make a fully informed decision about whether or not to participate in the research. To mitigate this concern, debriefing is a n essential part of the consent process whenever a study involves deception.
• Once a participant has been debriefed, it is almost always appropriate to offer them the opportunity to withdraw their consent to participate. A template for creating a debrief can be found here: Sample Debriefing Statement.

Cornell Guidance on Informed Consent

Informed Consent Options, Processes, and Documentation

Informed Consent - Research Involving Children

Informed Consent - Research Involving Normal, Healthy Participants

Informed Consent - Research Involving Cornell Students

Informed Consent - Research Involving Prisoners

Parent/Guardian Permission for Studies Involving Children

Guidance for Protocols Involving Oral Consent

Informed Consent 101 Video

IRB Consent Form Templates

About the irb committee, irb announcements & newsletters, irb covid-19 faqs, submit or manage your irb protocol, irb training, irb considerations: human participant data, data sets and internet research, irb biomedical research, irb considerations for international research, irb considerations for clinical trials.

• Skip to main content
• Skip to FDA Search
• Skip to in this section menu
• Skip to footer links

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food and Drug Administration

•   Search
•   Menu
• For Patients
• Clinical Trials: What Patients Need to Know

Informed Consent for Clinical Trials

On this page you will find information on:

What is Informed Consent

Before enrolling in a clinical trial, the following information must be given to each potential research subject

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document

A potential research subject must have an opportunity to

Informed consent may not include language that

To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with: 

adequate information to allow for an informed decision about participation in the clinical investigation.

facilitating the potential participant's understanding of the information.

an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.

obtaining the potential participant's voluntary agreement to participate.

continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. ( 21 CFR 50.20 .) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

What is Informed Consent? 

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find.   Clinical trials are used to answer questions such as: 

Are new medical products safe enough to outweigh the risks related to the underlying condition?,

How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),

How effective is the medical product  at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to “study” new medical products in people.  It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient. 

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

may not benefit from the clinical trial,

may be exposed to unknown risks,

are entering into a study that may be very different from the standard medical practices that they currently know 

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

what will be done to them,

how the protocol (plan of research) works,

what risks or discomforts they may experience,

participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process.  Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. 

A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document,  but does require certain basic elements of consent be included.

Before enrolling in a clinical trial, the following information must be given to each potential research subject:

A statement explaining that the study involves research.

An explanation of the purposes of the research.

The expected length of time for participation.

A description of all the procedures that will be completed during enrollment on the clinical trial.

Information about all experimental procedures the will be completed during the clinical trial.

A description of any predictable risks.

Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.

Any possible benefits that may be expected from the research.

Information about any alternative procedures or treatment (if any) that might benefit the research subject.

A statement describing:

the confidentiality of information collected during the clinical trial,

how records that identify the subject will be kept

the possibility that the FDA may inspect the records.

For research involving more than minimal risk information including

an explanation as to whether any compensation or medical treatments are available if injury occurs,

what they consist of, or

where more information may be found.

questions about the research,

research subjects' rights,

injury related to the clinical trial.

Research subject participation is voluntary,

Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,

Research subjects may choose to stop participation in the clinical trial at any time without  losing benefits for which they are entitled.

Contact information will be provided for answers to :

A statement that:

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document:

A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).

Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).

Added costs to the research subject that may result from participating in the trial.

The consequence of leaving a trial before it is completed (e.g. if the research and procedures  require a slow and organized end of participation).

A statement that important findings discovered during the clinical trial will be provided to the research subject.

The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

read the consent document,

ask questions about anything they do not understand. 

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.

An investigator should only get consent from a potential research subject if:

enough time was given to the research subject to consider whether or not to participate

the investigator has not persuaded or influenced the potential research subject.

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

the research subject is made to ignore or appear to ignore any of the research subject's legal rights,

releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary.  You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully.  Ask questions about any information you don’t understand or find confusing.

Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

• eResearch IRB NextGen Project
• Class Assignments & IRB Approval
• Operations Manual (OM)
• Authorization Agreement Process
• ORCR Policies and Procedures
• Self-Assessment Tools
• Resources and Web Links
• Single IRB-of-Record (sIRB) Process
• Certificate of Confidentiality Process
• HRPP Education Resources
• How to Register a Clinical Trial
• Maintaining and Updating ClinicalTrial.gov Records
• How to Report Clinical Trial Results
• Research Study Participation - FAQ
• International Research
• Coordinated Services & Practices (CSP)
• Collaborative Research: IRB-HSBS sIRB Process
• Data Security Guidelines
• Research Incentive Guidelines
• Routine fMRI Study Guidelines
• IRB-HSBS Website Directory and Guidance
• Waivers of Informed Consent Guidelines
• IRB Review Process
• IRB Amendment Process
• Continuing Review Process
• Incident Reporting (AE/ORIO)
• IRB Repository Application
• IRB-HSBS Education
• Newsletter Archive

You are here

• Human Subjects
• IRB Health Sciences and Behavioral Sciences (HSBS)

Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

Informed consent guidance.

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Informed Consent Templates (2018 Common Rule)

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

Other Templates

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/10/24

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Brief protocol for exempt research including data management and security questionnaire

Child Assent and Parental Permission

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Child assent 12-14

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

Informed Consent

This guide provides:

• General guidance on preparing the informed consent process
• A description and explanation of the basic components of informed consent
• Four sample consent processes

You could also refer to the full list of the required  Elements of Informed Consent .

General Guidance

• Write scripts as if you were engaging in a conversation with potential participants. Refer to yourself as "I" or “we” and to the participant as "you."
• Use  lay language  at the appropriate reading or comprehension level.  Do not use jargon or academic language.
• Ensure that your consent processes are culturally appropriate.
• Prepare scripts and documents for all steps involved in securing informed consent. This may include recruitment messages, scripts, and flyers as well as the informed consent scripts or forms.
• If you have multiple participant populations, clearly mark the consent materials for each population.
• If appropriate, create scripts and documents to secure permission to conduct research from other parties such as community leaders, school principals, and others who serve as gatekeepers to the research site.
• If you will share data, either with other researchers or as a requirement of publication or funding, participants must be informed.
• Include the Protocol ID# on each consent process to help participants identify the study in case they need to reach you or contact the IRB with any questions.

The collection of biospecimens, such as saliva samples, includes  additional components  not listed in this guidance document. Contact IRB staff if you are collecting biospecimens.

Basic Components of Consent

When preparing consent documents, you should:

1.  Introduce yourself and invite people to participate in your research.

Inform participants that you are a researcher from Duke University. A “statement of research” is a required component of informed consent. There are several ways to do this. For example, you can use words like "research” or “study” or statements like “I am looking into” or “I am interested in learning more about." It is important to convey to your participants that you are doing an investigation.

Include a subheading titled “Key Information” early in the consent form. If you will use an oral consent process, you can introduce the consent form with something like, “Here’s what you need to know.”

2.  Describe the purpose of your research.

You do not have to reveal your hypothesis, but your participants should have a general idea of what the study is about. A simple, straightforward purpose statement will suffice. If including a purpose statement in the consent may invalidate the science, the requirement to include a purpose statement can be waived. However, the description of procedures (see #3 below) should be detailed and comprehensive.

When the study uses deception, consent processes cannot include false statements. A detailed description of procedures (see #3 below) should be provided.

3.  Explain what participants will be asked to do and how long each task or activity will take.

Describe all the research activities participants will be asked to do. If you will ask participants to complete surveys or respond to an interview, describe the nature and scope of the questions.

If your study includes many tasks or is completed over multiple sessions, bulleted lists may be useful.

Always inform participants of the expected duration of participation.

4.  Describe any foreseeable risks.

It is important for participants to know if there are any risks in the study. If there are no foreseeable risks, it is not necessary to say so. If you prefer to make a statement, you could say, “There are no anticipated risks of harm as a result of participating in the study,” or “There are no foreseeable risks of harm in this study.”

Risks related to research procedure or the research topic need to be described, such as nausea from perceptual tasks or distress from personal questions or questions about illegal behavior. An  explanation  about how you will manage the risks also needs to be provided.  

5.  Describe anticipated benefits to the participants, if any.

Individual participants seldom benefit directly from participation. If there are no direct benefits, it is not necessary to say so. If you prefer to make a statement, you can tell participants what you hope to learn through your research. (Please Note: Compensation is not a benefit. For compensation, see #8 below.)

6.  Describe confidentiality procedures, if needed.

Participants should know how their information will be used in your research.

If you are collecting and retaining individually identifiable information that, if inadvertently disclosed, could pose risk of harm to participants, the informed consent process must include the measures you are taking to protect information they have shared with you. Simply informing participants that their “participation is confidential” or that their “information will be protection” is not sufficient. Refer to the  Confidentiality Guide .

A simple explanation of how you will store and report data would be sufficient if 1) you are not collecting individually identifiable information about participants, or 2)  if the individually identifiable data you collect would not pose risk of harm to participants if inadvertently disclosed

It can be confusing to describe elaborate data protection procedures for data that pose no risk of harm.

If participants are willing to be identified and/or have quotes attributed to them, explain how the process will work.

You also need to inform participants whether their data, in identified or de-identified form, will be made public, shared with other researchers as a requirement of publication or funding, or used for future research purposes.

If you have to collect identifiable information in order to compensate participants, you cannot tell them that you will not collect their names.

7.  Describe voluntariness.

Inform participants that the decision to take part in your research is completely up to them. Consent is an ongoing process so people can choose not to answer questions, not take part in activities, and they can withdraw from the study for any reason. Participants should be informed if there are tasks that must be completed so they can decide beforehand if they want to be in the study.

8.  Describe compensation you will provide, if any.

Compensation  can include monetary (cash, gift cards) and/or non-monetary (gifts, course credit) payments.

Explain under what conditions participants will receive partial or no payment. (If you plan to give participants a small token or gift, it is not necessary to tell them during the consent process.)

It is unnecessary to inform participants that they will not be compensated for being in the study, unless you think participants would expect to receive something.

Compensation is not a requirement; you are not obligated to compensate your participants. (Note: Compensation is not a direct benefit for study participation.)

Some department or unit accounting processes require researchers to collect additional information about their participants, for example, email addresses for electronic Amazon gift cards, mailing addresses, and/or social security numbers. The informed consent process should explain these conditions for compensation. Please check with your department or unit.

9.  Give potential participants an opportunity to ask questions about your research.

Research participants have the right to ask questions about the research before, during, and after participation.

10.  Provide contact information.

Provide participants with contact information for you and other individuals who can answer questions about the study. If you are using an oral consent script, you may want to provide participants with a card listing the contact information.

If appropriate, also include contact information for people who can address questions about participants’ rights or concerns. This is usually, but not always, the Campus IRB office.

If your participants do not have the resources to make contact outside the US or if there are language barriers, it is unreasonable to provide an IRB contact. In some instances, you may rely on an in-country contact to respond to questions about participants’ rights. This could be someone in your hosting organization or an on-site collaborator.

If review by an ethics committee in the country where the research is taking place is required, that committee should be the contact for questions about participants' rights.

Include the Campus IRB protocol ID number, and ask participants identify the study by the Protocol ID# in any communication with the researchers, Campus IRB, or in-country contact.

Below we have provided examples of how four different researchers incorporated the components of informed consent into their consent processes. Note that each researcher carried out a different type of study.

These are only samples and not intended to be duplicated for all consent processes.

Sample A. An undergraduate student asking other undergraduate students to complete an in-person survey.

Sample b. a graduate student conducting in-person interviews with community members., sample c. a graduate student doing an online study on mturk., sample d. a faculty member doing an informal interview as part of an ethnography..

Campus IRB Guides

Understanding Informed Consent Forms

The informed consent form puts you in control of your health decisions and protects your rights.

Before you join a cancer research study, you’ll receive an informed consent form to review, ask questions about, and sign. The form covers a description of the study’s purpose, procedures and safety measures researchers will follow, and what is expected of study participants. 

The form is part of the informed consent process. This process protects your rights. It also gives you control over your choice to take part in research.

Federal law requires that researchers give the informed consent form to potential participants. You will have a chance to ask questions about information you read in the form. Once you understand the study, you can choose if you want to sign the consent form and take part.

Getting comfortable with informed consent forms

Understanding a consent form is an important part of the informed consent process. All informed consent forms are different. But most forms will have the same kinds of information about the study divided into sections.  

Overview of study This section tells you: 

• what question researchers are hoping to answer with the study 
• the main potential risks and benefits of taking part in the study 
• your responsibilities as a participant  



The overview also describes the choices you have if you do not take part in the study. And it explains the reasons you might leave the study early. This section also lets you know that taking part is voluntary and you may leave the study at any time.

Study design This section describes:

• each study group
• what each group will be asked to do, including tests and procedures you will have and drugs you will take
• how many people will be in each group
• how long the study will last

Risks and benefits This section describes:

• all known potential risks and benefits of taking part in the study 
• the most common side effects
• how the study will help doctors learn about your disease

Cost This section explains the costs of taking part in a study. Insurance and the study sponsor should cover some expenses. But you might have others, such as the cost of travel to the trial site. Learn more about who pays for clinical trials .

Safety and Clinical Trials

Explore the many safety measures in place to help keep you safe during a trial or study.

Your rights This section covers your rights:

• if you are injured because of the study or neglect 
• to privacy when it comes to sharing your medical information 
• to leave the study at any time

How to get more information on the study This section provides ways to:

• learn more about the study
• learn more about your rights as a participant
• reach the study team

Signature As with most legal documents, informed consent forms require a signature. But it’s important to remember that you are not signing away your rights or binding yourself to the study. You may still leave the study at any time. If a participant is under 18 years of age, read about the children’s assent process . 

Sample informed consent form

Read a sample consent form to become familiar with the content and sections. Note: this form is for informational purposes only and does not represent a real study. Your form may have other sections, and may present the information in a different way.

Tips for reading informed consent forms

Amy Rose oversees the day-to-day operations of clinical research, including the informed consent process for potential research participants. She is the associate director in Clinical Research Services at University of Pittsburgh Medical Center Hillman Cancer Center.

If you are thinking about taking part in a clinical trial, Amy suggests that you: 

• Bring a friend or relative to the appointment when your study team discusses the study and informed consent form. 
• Take the form home . Read it in a comfortable place, take notes, and jot down questions for your doctor or study team. “You can highlight things and write down questions right on the consent form,” Amy said.  
• Ask a close friend or spouse to read the form so you can discuss it with them. Have them take notes too, and compare your understanding. Reviewing it with your primary care provider can also be helpful, Amy said. 
• Don’t be afraid to ask questions . Amy said she and other medical professionals don’t always realize when they aren’t explaining things clearly. They may be in a rush or too steeped in the language of medicine. 
• You can decide not to take part before or after you sign the form. “We always tell people their participation is completely voluntary,” Amy said. “You do not have to continue just because you sign this consent today.” 

The informed consent process does not end when you sign a form and decide to take part. Your doctor and study team will keep you updated about the study so you can continue to make informed decisions. 

Have questions about informed consent?

Connect with our cancer information specialists.

Phone: 1-800-4-CANCER   Chat: LiveHelp Email:   [email protected]

Available Monday–Friday 9:00 a.m. to 9:00 p.m. ET.

Yearly paid plans are up to 65% off for the spring sale. Limited time only! 🌸

• Form Builder
• Survey Maker
• AI Form Generator
• AI Survey Tool
• AI Quiz Maker
• Store Builder
• WordPress Plugin

HubSpot CRM

Google Sheets

Google Analytics

Microsoft Excel

• Popular Forms
• Job Application Form Template
• Rental Application Form Template
• Hotel Accommodation Form Template
• Online Registration Form Template
• Employment Application Form Template
• Application Forms
• Booking Forms
• Consent Forms
• Contact Forms
• Donation Forms
• Customer Satisfaction Surveys
• Employee Satisfaction Surveys
• Evaluation Surveys
• Feedback Surveys
• Market Research Surveys
• Personality Quiz Template
• Geography Quiz Template
• Math Quiz Template
• Science Quiz Template
• Vocabulary Quiz Template

Try without registration Quick Start

Read engaging stories, how-to guides, learn about forms.app features.

Inspirational ready-to-use templates for getting started fast and powerful.

Spot-on guides on how to use forms.app and make the most out of it.

See the technical measures we take and learn how we keep your data safe and secure.

• Integrations
• Help Center
• Sign In Sign Up Free
• How to create an online research consent form for your research

Fatih Serdar Çıtak

Collecting data is the backbone of academic research and studies. We can safely say that the data collected determines the results and the accuracy of the academic work. When data collecting is in question, things can get a bit tricky because people in the study may need to divulge personal information.

An online research consent form is essential when collecting personal or private information to use as bulk data in your study in order to state the purposes of the data collection and reassure the people. In this article, we are gonna find out useful information as to how to create an online research consent form and which free tools are at your disposal.

• What is a research consent form?

A research consent form is a document providing the potential participants with the nature and details of a study, informing them of their voluntary involvement. 

It also highlights that they give their consent for sharing the mentioned data and that they reserve their right to withdraw from the study. Furthermore, it ensures that the data shared by the participant and to be used for the research is confidential and will be disclosed to specified parties only. 

• When do you need a research consent form?

A research consent form may be very useful when a study involves human participants. It is the ideal way to prove the participants understand the purpose, risks, and benefits of your study and agree to participate in it of their own accord.

• An academic research
• A study for a commercial campaign
• Surveys/Questionnaires
• Clinical Trials 

You should also bear in mind that this document proves the fact that you followed the right steps and came by the data to support your research without any unethical conduct, helping you avoid any legal problems or accusations you may face in the future.

• Why use an online research consent form?

A research form can be in a printed or online format, depending on the purpose of the study or the author of the document. However, creating and using an online research consent form is more advantageous than a printed form, as online forms: 

• are more accessible to the audience,
• eliminate any printing or mailing costs,
• are more dynamic when editing or revision is needed,
• enable tracking the responses in real-time.

Many useful examples of consent forms are available online. They vary from sample consent forms for research surveys to templates of consent forms for research interviews. You can always create and customize research consent form examples in forms.app, creating your own best consent form format for your research.  

• How can you create a custom consent form for your research?

Every research/study has different parameters and variants, requiring different types of data to be collected. This means the consent form should also be customized to get maximum accuracy and efficiency. An online consent form will facilitate customization with more options in terms of both content and format. Let’s see how to create an online and custom consent form for your research:

1. Choose how you like to start

Choose a template or start from scratch. You can start by customizing the free research consent form template provided by forms.app, enabling you to utilize a great deal of features, i.e., a variety of form fields, conditional logic, and themes for your consent form. 

If you do not want to start from scratch, forms.app has other solutions for you. You can use forms.app AI to create a base for your consent form. Just type what you want to see in your form, and then continue working from there. Everything is easier with AI these days.

Choose a way to start

2. Add questions/fields to get consent

It is up to you to make it an original research consent form for your study by adding different questions/form fields such as cover, logo, text, multiple or drop-down selections, signature field, etc. All this can vary according to the preferences of the persons/institutions collecting different kinds of consent.

Add your questions

3. Customize the form according to your study/research

Your form will look smoother and work better with the colorful themes to dynamic types of questions, various interactive form fields, useful conditions, and custom warning messages , all offered free by forms.app to you! Make sure to customize the template to suit the purposes of your research/study.

Customizing the design of your form

4. Share your form and gather consent

When your form is ready to go after customization, you can share it with the participants of your research/study and start gathering consent to divulge information. You do not have to print it out and distribute though. You can share it via e-mail, send the link out, or even embed it on your website with different options for views.

Share your consent form

• What should be included in a research consent form?

The content of your research consent form should clearly state your purposes for gathering the consent of participants to avoid any kind of legal or academic problems. It should outline the study’s purpose, the potential risks/benefits, assurance of privacy, and the participant’s right to withdraw. You can also check out the guide to consent forms provided by forms.app.

A standard consent form can consist of the following sections:

Things to consider while creating a research consent form

✅Title and details of the study: Write the title of the study alongside the details, such as the duration or participant eligibility. 

✅Purpose of the research: Provide a brief introduction informing on the research/study purpose.

✅Study procedures: You should describe the study procedures in detail and include any risks that may occur during the research/study, as well as the benefits the participants may receive.

✅ Informed consent:   Explain in plain language that the participants are being asked to participate in a study and that they are giving their consent to participate and give out information. You should also indicate that this is a voluntary practice, and the participants can ask questions and seek clarification regarding a matter and have the right to withdraw.

✅Financial compensation (if applicable): To avoid any claims in the future, it should be clarified in the consent form whether the participants are entitled/not entitled to any form of financial compensation.

✅Consent for data processing and use: The participants might want to know how the data obtained by/through them will be used, and it may be an important factor in giving consent. Explain the type of data and how it will be used.

✅Approval and signature: This is a significant part of the form where the participant acknowledges that they read and agree with the statements in the form and approve it by putting their signature.

• 7 Tips to create a better online research consent form

So far,  we have covered how to create and customize a research consent form. It is now easier for you to create and customize a standard online research consent form. However, if you want to be one step ahead, here are 7 tips for creating a better online research consent form that will make your job easier.

Tips to consider while creating research consent forms

1. Use plain language

Use clear and plain language that can easily be understood by your participants. Remember that your participants are not necessarily familiar with the technical terms and procedures of your research.

2. Change how your form looks

You can include images, icons, or visually attractive layouts that promote readability and give out a positive message about your research/study. A good-looking form enhances readability and clarity, ensures comprehension of critical information, and promotes informed consent.

3. Try various form fields

Create your form online with dynamic form fields. Rather than using plain text, you can use clickable checkboxes or include signature fields for the participants to sign. You can always make your consent form more accessible and compatible across various platforms and devices.  

4. Tell your audience about data security

You need to ensure the participants that the security measures are in place to protect their data. You can also indicate that the data is collected, stored, and processed in secure and private platforms.

5. Show progress indicators

Some forms can be long and complicated due to the nature of the research/study. Therefore, you can include progress indicators to show the participants how far they are from completing the consent process. On forms.app, your forms will have progress indicators on default settings. 

6. Ask for feedback

Always leave room for improvement! You can create a field for participants where they can express their opinions and talk about their experiences while filling out your online consent form. It enables researchers to address potential errors and ambiguities and is a good channel for communication with the participants.  

7. Confirmation and response

Last but not least, include a confirmation page affirming that the participant has completed the consent form and no further action is required. You can also enable email notifications to send a copy of the completed consent form to the participants as an e-mail.

In conclusion, consent forms are an important part of research, and you can create an online and customized consent form that is better suited for your purposes by including required sections and better visuality.

In this article, you have seen what should be included in a standard online research consent form and how to be one step ahead by using a dynamic platform enabling various features and following through some handy tips . Now that you have learned everything about online research consent forms, you can visit forms.app and create yours!

• Form Features
• Data Collection

Table of Contents

Related posts.

How to create a marketing research survey (+ free templates)

Yakup Ahenpençe

How to collect electronic signatures with Google Forms

Emre Eltemur

The ultimate guide to a strong B2B sales process (with web forms)

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base
• Starting the research process

A Beginner's Guide to Starting the Research Process

When you have to write a thesis or dissertation , it can be hard to know where to begin, but there are some clear steps you can follow.

The research process often begins with a very broad idea for a topic you’d like to know more about. You do some preliminary research to identify a  problem . After refining your research questions , you can lay out the foundations of your research design , leading to a proposal that outlines your ideas and plans.

This article takes you through the first steps of the research process, helping you narrow down your ideas and build up a strong foundation for your research project.

Table of contents

Step 1: choose your topic, step 2: identify a problem, step 3: formulate research questions, step 4: create a research design, step 5: write a research proposal, other interesting articles.

First you have to come up with some ideas. Your thesis or dissertation topic can start out very broad. Think about the general area or field you’re interested in—maybe you already have specific research interests based on classes you’ve taken, or maybe you had to consider your topic when applying to graduate school and writing a statement of purpose .

Even if you already have a good sense of your topic, you’ll need to read widely to build background knowledge and begin narrowing down your ideas. Conduct an initial literature review to begin gathering relevant sources. As you read, take notes and try to identify problems, questions, debates, contradictions and gaps. Your aim is to narrow down from a broad area of interest to a specific niche.

Make sure to consider the practicalities: the requirements of your programme, the amount of time you have to complete the research, and how difficult it will be to access sources and data on the topic. Before moving onto the next stage, it’s a good idea to discuss the topic with your thesis supervisor.

>>Read more about narrowing down a research topic

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

So you’ve settled on a topic and found a niche—but what exactly will your research investigate, and why does it matter? To give your project focus and purpose, you have to define a research problem .

The problem might be a practical issue—for example, a process or practice that isn’t working well, an area of concern in an organization’s performance, or a difficulty faced by a specific group of people in society.

Alternatively, you might choose to investigate a theoretical problem—for example, an underexplored phenomenon or relationship, a contradiction between different models or theories, or an unresolved debate among scholars.

To put the problem in context and set your objectives, you can write a problem statement . This describes who the problem affects, why research is needed, and how your research project will contribute to solving it.

>>Read more about defining a research problem

Next, based on the problem statement, you need to write one or more research questions . These target exactly what you want to find out. They might focus on describing, comparing, evaluating, or explaining the research problem.

A strong research question should be specific enough that you can answer it thoroughly using appropriate qualitative or quantitative research methods. It should also be complex enough to require in-depth investigation, analysis, and argument. Questions that can be answered with “yes/no” or with easily available facts are not complex enough for a thesis or dissertation.

In some types of research, at this stage you might also have to develop a conceptual framework and testable hypotheses .

>>See research question examples

The research design is a practical framework for answering your research questions. It involves making decisions about the type of data you need, the methods you’ll use to collect and analyze it, and the location and timescale of your research.

There are often many possible paths you can take to answering your questions. The decisions you make will partly be based on your priorities. For example, do you want to determine causes and effects, draw generalizable conclusions, or understand the details of a specific context?

You need to decide whether you will use primary or secondary data and qualitative or quantitative methods . You also need to determine the specific tools, procedures, and materials you’ll use to collect and analyze your data, as well as your criteria for selecting participants or sources.

>>Read more about creating a research design

Finally, after completing these steps, you are ready to complete a research proposal . The proposal outlines the context, relevance, purpose, and plan of your research.

As well as outlining the background, problem statement, and research questions, the proposal should also include a literature review that shows how your project will fit into existing work on the topic. The research design section describes your approach and explains exactly what you will do.

You might have to get the proposal approved by your supervisor before you get started, and it will guide the process of writing your thesis or dissertation.

>>Read more about writing a research proposal

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

Methodology

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

Is this article helpful?

Other students also liked.

• Writing Strong Research Questions | Criteria & Examples

What Is a Research Design | Types, Guide & Examples

• How to Write a Research Proposal | Examples & Templates

More interesting articles

• 10 Research Question Examples to Guide Your Research Project
• How to Choose a Dissertation Topic | 8 Steps to Follow
• How to Define a Research Problem | Ideas & Examples
• How to Write a Problem Statement | Guide & Examples
• Relevance of Your Dissertation Topic | Criteria & Tips
• Research Objectives | Definition & Examples
• What Is a Fishbone Diagram? | Templates & Examples
• What Is Root Cause Analysis? | Definition & Examples

"I thought AI Proofreading was useless but.."

I've been using Scribbr for years now and I know it's a service that won't disappoint. It does a good job spotting mistakes”

• UConn Library
• Research Now
• Get Started
• Forming a Research Question

Get Started — Forming a Research Question

• Reading (and Understanding) Your Assignment
• Background Research
• Initial Searching
• Help & Other Resources
• Research Now Homepage

Writing out your research question will help you articulate (to yourself and others) the direction of your research – what you need to be looking for as you prepare to gather specific information.

Forming the Research Question

Performing Background Research and Initial Searching develops your general area of interest so that you can form a more focused topic.

As you review the information you've found from these steps and the ideas you've encountered, these questions may help you to form a focus for your research:

• What am I trying to accomplish?
• How interested am I in this idea?
• How much time do I have?
• What information and resources are available?

(From Guided Inquiry: Learning in the 21st Century by Carol Kuhlthau, Leslie Maniotes, and Ann Caspari)

Your Research Log helps you to keep track of and think about your research.  Look back through your log and consider: 

What have you found? How does the information and ideas you've encountered fit together?  What themes have emerged ? What important question do you want to develop from the ideas and information you have found? What do you want to explore in more detail? What do you want your research to focus on? 

And - does your research question answer the assignment?

You'll want to make sure that you're not trying to answer too many questions  - think about the time you have available. You'll want to focus on one aspect of your topic.

• Research Questions - The Good and the Not So Good

(Credit: William Badke)

How do I Know if My Topic is Sustainable?

You will not really know if your topic will work until you start searching for information. The information you found while exploring your topic doing background research should give you an idea of whether or not your topic is sustainable.

Test your topic in a few databases by searching for the key concepts or terms. 

• Are you finding too much information? Perhaps your topic is too general . Add a few more terms to your search and explore (for example, you might feel like you're finding too much on "College Students." Looking for information about "Freshmen," though, will give you fewer and more specific results).
• Are you finding too little information? Perhaps your topic is  too specific . Try searching again using broader synonyms for your search terms (for example, you might not find much on the topic "UConn Students." "College Students" will give you more information).

As you develop your research question, you might find that you need to ask a broader or narrower question, depending upon the resources available and the time you have to complete your assignment.

Sometimes it's hard to determine if a topic is too broad or specific. Try checking in with your instructor (who has a good idea of the field of research!) or a librarian (who has a good idea of the available resources!).

• Ask a Librarian Chat with a UConn librarian.

Developing a Research Question

(Credit: Wilfrid Laurier University Library)

Now apply what you've learned! These tools will  help you write out your research question.

• Research Question Generator Worksheet A tool to help you develop your research question.

Test Your Knowledge: Forming a Research Question

• Test your knowledge: Too Broad, Too Narrow Get some practice evaluating a research question.

Does Your Research Question Actually Answer a Question?

Sometimes this is referred to as the "so what" - what makes your project interesting and important.

What makes your question important? What makes your question interesting or exciting? Does your question require anything more of you than just repeating the information you've found? (If you find you're just repeating the information found, you probably don't have a very good question).

• << Previous: Initial Searching
• Next: Help & Other Resources >>
• Last Updated: Mar 27, 2024 3:43 PM
• URL: https://guides.lib.uconn.edu/getstarted

• Skip to main content
• Skip to primary sidebar
• Skip to footer
• QuestionPro

• Solutions Industries Gaming Automotive Sports and events Education Government Travel & Hospitality Financial Services Healthcare Cannabis Technology Use Case NPS+ Communities Audience Contactless surveys Mobile LivePolls Member Experience GDPR Positive People Science 360 Feedback Surveys
• Resources Blog eBooks Survey Templates Case Studies Training Help center

Home Market Research

What is Research: Definition, Methods, Types & Examples

The search for knowledge is closely linked to the object of study; that is, to the reconstruction of the facts that will provide an explanation to an observed event and that at first sight can be considered as a problem. It is very human to seek answers and satisfy our curiosity. Let’s talk about research.

Content Index

What is Research?

What are the characteristics of research.

• Comparative analysis chart

Qualitative methods

Quantitative methods, 8 tips for conducting accurate research.

Research is the careful consideration of study regarding a particular concern or research problem using scientific methods. According to the American sociologist Earl Robert Babbie, “research is a systematic inquiry to describe, explain, predict, and control the observed phenomenon. It involves inductive and deductive methods.”

Inductive methods analyze an observed event, while deductive methods verify the observed event. Inductive approaches are associated with qualitative research , and deductive methods are more commonly associated with quantitative analysis .

Research is conducted with a purpose to:

• Identify potential and new customers
• Understand existing customers
• Set pragmatic goals
• Develop productive market strategies
• Address business challenges
• Put together a business expansion plan
• Identify new business opportunities
• Good research follows a systematic approach to capture accurate data. Researchers need to practice ethics and a code of conduct while making observations or drawing conclusions.
• The analysis is based on logical reasoning and involves both inductive and deductive methods.
• Real-time data and knowledge is derived from actual observations in natural settings.
• There is an in-depth analysis of all data collected so that there are no anomalies associated with it.
• It creates a path for generating new questions. Existing data helps create more research opportunities.
• It is analytical and uses all the available data so that there is no ambiguity in inference.
• Accuracy is one of the most critical aspects of research. The information must be accurate and correct. For example, laboratories provide a controlled environment to collect data. Accuracy is measured in the instruments used, the calibrations of instruments or tools, and the experiment’s final result.

What is the purpose of research?

There are three main purposes:

• Exploratory: As the name suggests, researchers conduct exploratory studies to explore a group of questions. The answers and analytics may not offer a conclusion to the perceived problem. It is undertaken to handle new problem areas that haven’t been explored before. This exploratory data analysis process lays the foundation for more conclusive data collection and analysis.

LEARN ABOUT: Descriptive Analysis

• Descriptive: It focuses on expanding knowledge on current issues through a process of data collection. Descriptive research describe the behavior of a sample population. Only one variable is required to conduct the study. The three primary purposes of descriptive studies are describing, explaining, and validating the findings. For example, a study conducted to know if top-level management leaders in the 21st century possess the moral right to receive a considerable sum of money from the company profit.

LEARN ABOUT: Best Data Collection Tools

• Explanatory: Causal research or explanatory research is conducted to understand the impact of specific changes in existing standard procedures. Running experiments is the most popular form. For example, a study that is conducted to understand the effect of rebranding on customer loyalty.

Here is a comparative analysis chart for a better understanding:

It begins by asking the right questions and choosing an appropriate method to investigate the problem. After collecting answers to your questions, you can analyze the findings or observations to draw reasonable conclusions.

When it comes to customers and market studies, the more thorough your questions, the better the analysis. You get essential insights into brand perception and product needs by thoroughly collecting customer data through surveys and questionnaires . You can use this data to make smart decisions about your marketing strategies to position your business effectively.

To make sense of your study and get insights faster, it helps to use a research repository as a single source of truth in your organization and manage your research data in one centralized data repository .

Types of research methods and Examples

Research methods are broadly classified as Qualitative and Quantitative .

Both methods have distinctive properties and data collection methods.

Qualitative research is a method that collects data using conversational methods, usually open-ended questions . The responses collected are essentially non-numerical. This method helps a researcher understand what participants think and why they think in a particular way.

Types of qualitative methods include:

• One-to-one Interview
• Focus Groups
• Ethnographic studies
• Text Analysis

Quantitative methods deal with numbers and measurable forms . It uses a systematic way of investigating events or data. It answers questions to justify relationships with measurable variables to either explain, predict, or control a phenomenon.

Types of quantitative methods include:

• Survey research
• Descriptive research
• Correlational research

LEARN MORE: Descriptive Research vs Correlational Research

Remember, it is only valuable and useful when it is valid, accurate, and reliable. Incorrect results can lead to customer churn and a decrease in sales.

It is essential to ensure that your data is:

• Valid – founded, logical, rigorous, and impartial.
• Accurate – free of errors and including required details.
• Reliable – other people who investigate in the same way can produce similar results.
• Timely – current and collected within an appropriate time frame.
• Complete – includes all the data you need to support your business decisions.

Gather insights

• Identify the main trends and issues, opportunities, and problems you observe. Write a sentence describing each one.
• Keep track of the frequency with which each of the main findings appears.
• Make a list of your findings from the most common to the least common.
• Evaluate a list of the strengths, weaknesses, opportunities, and threats identified in a SWOT analysis .
• Prepare conclusions and recommendations about your study.
• Act on your strategies
• Look for gaps in the information, and consider doing additional inquiry if necessary
• Plan to review the results and consider efficient methods to analyze and interpret results.

Review your goals before making any conclusions about your study. Remember how the process you have completed and the data you have gathered help answer your questions. Ask yourself if what your analysis revealed facilitates the identification of your conclusions and recommendations.

LEARN MORE ABOUT OUR SOFTWARE         FREE TRIAL

MORE LIKE THIS

The Power of AI in Customer Experience — Tuesday CX Thoughts

Apr 16, 2024

Employee Lifecycle Management Software: Top of 2024

Apr 15, 2024

Top 15 Sentiment Analysis Software That Should Be on Your List

Top 13 A/B Testing Software for Optimizing Your Website

Apr 12, 2024

Other categories

• Academic Research
• Artificial Intelligence
• Assessments
• Brand Awareness
• Case Studies
• Communities
• Consumer Insights
• Customer effort score
• Customer Engagement
• Customer Experience
• Customer Loyalty
• Customer Research
• Customer Satisfaction
• Employee Benefits
• Employee Engagement
• Employee Retention
• Friday Five
• General Data Protection Regulation
• Insights Hub
• Life@QuestionPro
• Market Research
• Mobile diaries
• Mobile Surveys
• New Features
• Online Communities
• Question Types
• Questionnaire
• QuestionPro Products
• Release Notes
• Research Tools and Apps
• Revenue at Risk
• Survey Templates
• Training Tips
• Uncategorized
• Video Learning Series
• What’s Coming Up
• Workforce Intelligence

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Turk J Anaesthesiol Reanim
• v.44(4); 2016 Aug

What is Scientific Research and How Can it be Done?

Scientific researches are studies that should be systematically planned before performing them. In this review, classification and description of scientific studies, planning stage randomisation and bias are explained.

Research conducted for the purpose of contributing towards science by the systematic collection, interpretation and evaluation of data and that, too, in a planned manner is called scientific research: a researcher is the one who conducts this research. The results obtained from a small group through scientific studies are socialised, and new information is revealed with respect to diagnosis, treatment and reliability of applications. The purpose of this review is to provide information about the definition, classification and methodology of scientific research.

Before beginning the scientific research, the researcher should determine the subject, do planning and specify the methodology. In the Declaration of Helsinki, it is stated that ‘the primary purpose of medical researches on volunteers is to understand the reasons, development and effects of diseases and develop protective, diagnostic and therapeutic interventions (method, operation and therapies). Even the best proven interventions should be evaluated continuously by investigations with regard to reliability, effectiveness, efficiency, accessibility and quality’ ( 1 ).

The questions, methods of response to questions and difficulties in scientific research may vary, but the design and structure are generally the same ( 2 ).

Classification of Scientific Research

Scientific research can be classified in several ways. Classification can be made according to the data collection techniques based on causality, relationship with time and the medium through which they are applied.

• Observational
• Experimental
• Descriptive
• Retrospective
• Prospective
• Cross-sectional
• Social descriptive research ( 3 )

Another method is to classify the research according to its descriptive or analytical features. This review is written according to this classification method.

I. Descriptive research

• Case series
• Surveillance studies

II. Analytical research

• Observational studies: cohort, case control and cross- sectional research
• Interventional research: quasi-experimental and clinical research
• Case Report: it is the most common type of descriptive study. It is the examination of a single case having a different quality in the society, e.g. conducting general anaesthesia in a pregnant patient with mucopolysaccharidosis.
• Case Series: it is the description of repetitive cases having common features. For instance; case series involving interscapular pain related to neuraxial labour analgesia. Interestingly, malignant hyperthermia cases are not accepted as case series since they are rarely seen during historical development.
• Surveillance Studies: these are the results obtained from the databases that follow and record a health problem for a certain time, e.g. the surveillance of cross-infections during anaesthesia in the intensive care unit.

Moreover, some studies may be experimental. After the researcher intervenes, the researcher waits for the result, observes and obtains data. Experimental studies are, more often, in the form of clinical trials or laboratory animal trials ( 2 ).

Analytical observational research can be classified as cohort, case-control and cross-sectional studies.

Firstly, the participants are controlled with regard to the disease under investigation. Patients are excluded from the study. Healthy participants are evaluated with regard to the exposure to the effect. Then, the group (cohort) is followed-up for a sufficient period of time with respect to the occurrence of disease, and the progress of disease is studied. The risk of the healthy participants getting sick is considered an incident. In cohort studies, the risk of disease between the groups exposed and not exposed to the effect is calculated and rated. This rate is called relative risk. Relative risk indicates the strength of exposure to the effect on the disease.

Cohort research may be observational and experimental. The follow-up of patients prospectively is called a prospective cohort study . The results are obtained after the research starts. The researcher’s following-up of cohort subjects from a certain point towards the past is called a retrospective cohort study . Prospective cohort studies are more valuable than retrospective cohort studies: this is because in the former, the researcher observes and records the data. The researcher plans the study before the research and determines what data will be used. On the other hand, in retrospective studies, the research is made on recorded data: no new data can be added.

In fact, retrospective and prospective studies are not observational. They determine the relationship between the date on which the researcher has begun the study and the disease development period. The most critical disadvantage of this type of research is that if the follow-up period is long, participants may leave the study at their own behest or due to physical conditions. Cohort studies that begin after exposure and before disease development are called ambidirectional studies . Public healthcare studies generally fall within this group, e.g. lung cancer development in smokers.

• Case-Control Studies: these studies are retrospective cohort studies. They examine the cause and effect relationship from the effect to the cause. The detection or determination of data depends on the information recorded in the past. The researcher has no control over the data ( 2 ).

Cross-sectional studies are advantageous since they can be concluded relatively quickly. It may be difficult to obtain a reliable result from such studies for rare diseases ( 2 ).

Cross-sectional studies are characterised by timing. In such studies, the exposure and result are simultaneously evaluated. While cross-sectional studies are restrictedly used in studies involving anaesthesia (since the process of exposure is limited), they can be used in studies conducted in intensive care units.

• Quasi-Experimental Research: they are conducted in cases in which a quick result is requested and the participants or research areas cannot be randomised, e.g. giving hand-wash training and comparing the frequency of nosocomial infections before and after hand wash.
• Clinical Research: they are prospective studies carried out with a control group for the purpose of comparing the effect and value of an intervention in a clinical case. Clinical study and research have the same meaning. Drugs, invasive interventions, medical devices and operations, diets, physical therapy and diagnostic tools are relevant in this context ( 6 ).

Clinical studies are conducted by a responsible researcher, generally a physician. In the research team, there may be other healthcare staff besides physicians. Clinical studies may be financed by healthcare institutes, drug companies, academic medical centres, volunteer groups, physicians, healthcare service providers and other individuals. They may be conducted in several places including hospitals, universities, physicians’ offices and community clinics based on the researcher’s requirements. The participants are made aware of the duration of the study before their inclusion. Clinical studies should include the evaluation of recommendations (drug, device and surgical) for the treatment of a disease, syndrome or a comparison of one or more applications; finding different ways for recognition of a disease or case and prevention of their recurrence ( 7 ).

Clinical Research

In this review, clinical research is explained in more detail since it is the most valuable study in scientific research.

Clinical research starts with forming a hypothesis. A hypothesis can be defined as a claim put forward about the value of a population parameter based on sampling. There are two types of hypotheses in statistics.

• H 0 hypothesis is called a control or null hypothesis. It is the hypothesis put forward in research, which implies that there is no difference between the groups under consideration. If this hypothesis is rejected at the end of the study, it indicates that a difference exists between the two treatments under consideration.
• H 1 hypothesis is called an alternative hypothesis. It is hypothesised against a null hypothesis, which implies that a difference exists between the groups under consideration. For example, consider the following hypothesis: drug A has an analgesic effect. Control or null hypothesis (H 0 ): there is no difference between drug A and placebo with regard to the analgesic effect. The alternative hypothesis (H 1 ) is applicable if a difference exists between drug A and placebo with regard to the analgesic effect.

The planning phase comes after the determination of a hypothesis. A clinical research plan is called a protocol . In a protocol, the reasons for research, number and qualities of participants, tests to be applied, study duration and what information to be gathered from the participants should be found and conformity criteria should be developed.

The selection of participant groups to be included in the study is important. Inclusion and exclusion criteria of the study for the participants should be determined. Inclusion criteria should be defined in the form of demographic characteristics (age, gender, etc.) of the participant group and the exclusion criteria as the diseases that may influence the study, age ranges, cases involving pregnancy and lactation, continuously used drugs and participants’ cooperation.

The next stage is methodology. Methodology can be grouped under subheadings, namely, the calculation of number of subjects, blinding (masking), randomisation, selection of operation to be applied, use of placebo and criteria for stopping and changing the treatment.

I. Calculation of the Number of Subjects

The entire source from which the data are obtained is called a universe or population . A small group selected from a certain universe based on certain rules and which is accepted to highly represent the universe from which it is selected is called a sample and the characteristics of the population from which the data are collected are called variables. If data is collected from the entire population, such an instance is called a parameter . Conducting a study on the sample rather than the entire population is easier and less costly. Many factors influence the determination of the sample size. Firstly, the type of variable should be determined. Variables are classified as categorical (qualitative, non-numerical) or numerical (quantitative). Individuals in categorical variables are classified according to their characteristics. Categorical variables are indicated as nominal and ordinal (ordered). In nominal variables, the application of a category depends on the researcher’s preference. For instance, a female participant can be considered first and then the male participant, or vice versa. An ordinal (ordered) variable is ordered from small to large or vice versa (e.g. ordering obese patients based on their weights-from the lightest to the heaviest or vice versa). A categorical variable may have more than one characteristic: such variables are called binary or dichotomous (e.g. a participant may be both female and obese).

If the variable has numerical (quantitative) characteristics and these characteristics cannot be categorised, then it is called a numerical variable. Numerical variables are either discrete or continuous. For example, the number of operations with spinal anaesthesia represents a discrete variable. The haemoglobin value or height represents a continuous variable.

Statistical analyses that need to be employed depend on the type of variable. The determination of variables is necessary for selecting the statistical method as well as software in SPSS. While categorical variables are presented as numbers and percentages, numerical variables are represented using measures such as mean and standard deviation. It may be necessary to use mean in categorising some cases such as the following: even though the variable is categorical (qualitative, non-numerical) when Visual Analogue Scale (VAS) is used (since a numerical value is obtained), it is classified as a numerical variable: such variables are averaged.

Clinical research is carried out on the sample and generalised to the population. Accordingly, the number of samples should be correctly determined. Different sample size formulas are used on the basis of the statistical method to be used. When the sample size increases, error probability decreases. The sample size is calculated based on the primary hypothesis. The determination of a sample size before beginning the research specifies the power of the study. Power analysis enables the acquisition of realistic results in the research, and it is used for comparing two or more clinical research methods.

Because of the difference in the formulas used in calculating power analysis and number of samples for clinical research, it facilitates the use of computer programs for making calculations.

It is necessary to know certain parameters in order to calculate the number of samples by power analysis.

• Type-I (α) and type-II (β) error levels
• Difference between groups (d-difference) and effect size (ES)
• Distribution ratio of groups
• Direction of research hypothesis (H1)

a. Type-I (α) and Type-II (β) Error (β) Levels

Two types of errors can be made while accepting or rejecting H 0 hypothesis in a hypothesis test. Type-I error (α) level is the probability of finding a difference at the end of the research when there is no difference between the two applications. In other words, it is the rejection of the hypothesis when H 0 is actually correct and it is known as α error or p value. For instance, when the size is determined, type-I error level is accepted as 0.05 or 0.01.

Another error that can be made during a hypothesis test is a type-II error. It is the acceptance of a wrongly hypothesised H 0 hypothesis. In fact, it is the probability of failing to find a difference when there is a difference between the two applications. The power of a test is the ability of that test to find a difference that actually exists. Therefore, it is related to the type-II error level.

Since the type-II error risk is expressed as β, the power of the test is defined as 1–β. When a type-II error is 0.20, the power of the test is 0.80. Type-I (α) and type-II (β) errors can be intentional. The reason to intentionally make such an error is the necessity to look at the events from the opposite perspective.

b. Difference between Groups and ES

ES is defined as the state in which statistical difference also has clinically significance: ES≥0.5 is desirable. The difference between groups is the absolute difference between the groups compared in clinical research.

c. Allocation Ratio of Groups

The allocation ratio of groups is effective in determining the number of samples. If the number of samples is desired to be determined at the lowest level, the rate should be kept as 1/1.

d. Direction of Hypothesis (H1)

The direction of hypothesis in clinical research may be one-sided or two-sided. While one-sided hypotheses hypothesis test differences in the direction of size, two-sided hypotheses hypothesis test differences without direction. The power of the test in two-sided hypotheses is lower than one-sided hypotheses.

After these four variables are determined, they are entered in the appropriate computer program and the number of samples is calculated. Statistical packaged software programs such as Statistica, NCSS and G-Power may be used for power analysis and calculating the number of samples. When the samples size is calculated, if there is a decrease in α, difference between groups, ES and number of samples, then the standard deviation increases and power decreases. The power in two-sided hypothesis is lower. It is ethically appropriate to consider the determination of sample size, particularly in animal experiments, at the beginning of the study. The phase of the study is also important in the determination of number of subjects to be included in drug studies. Usually, phase-I studies are used to determine the safety profile of a drug or product, and they are generally conducted on a few healthy volunteers. If no unacceptable toxicity is detected during phase-I studies, phase-II studies may be carried out. Phase-II studies are proof-of-concept studies conducted on a larger number (100–500) of volunteer patients. When the effectiveness of the drug or product is evident in phase-II studies, phase-III studies can be initiated. These are randomised, double-blinded, placebo or standard treatment-controlled studies. Volunteer patients are periodically followed-up with respect to the effectiveness and side effects of the drug. It can generally last 1–4 years and is valuable during licensing and releasing the drug to the general market. Then, phase-IV studies begin in which long-term safety is investigated (indication, dose, mode of application, safety, effectiveness, etc.) on thousands of volunteer patients.

II. Blinding (Masking) and Randomisation Methods

When the methodology of clinical research is prepared, precautions should be taken to prevent taking sides. For this reason, techniques such as randomisation and blinding (masking) are used. Comparative studies are the most ideal ones in clinical research.

Blinding Method

A case in which the treatments applied to participants of clinical research should be kept unknown is called the blinding method . If the participant does not know what it receives, it is called a single-blind study; if even the researcher does not know, it is called a double-blind study. When there is a probability of knowing which drug is given in the order of application, when uninformed staff administers the drug, it is called in-house blinding. In case the study drug is known in its pharmaceutical form, a double-dummy blinding test is conducted. Intravenous drug is given to one group and a placebo tablet is given to the comparison group; then, the placebo tablet is given to the group that received the intravenous drug and intravenous drug in addition to placebo tablet is given to the comparison group. In this manner, each group receives both the intravenous and tablet forms of the drug. In case a third party interested in the study is involved and it also does not know about the drug (along with the statistician), it is called third-party blinding.

Randomisation Method

The selection of patients for the study groups should be random. Randomisation methods are used for such selection, which prevent conscious or unconscious manipulations in the selection of patients ( 8 ).

No factor pertaining to the patient should provide preference of one treatment to the other during randomisation. This characteristic is the most important difference separating randomised clinical studies from prospective and synchronous studies with experimental groups. Randomisation strengthens the study design and enables the determination of reliable scientific knowledge ( 2 ).

The easiest method is simple randomisation, e.g. determination of the type of anaesthesia to be administered to a patient by tossing a coin. In this method, when the number of samples is kept high, a balanced distribution is created. When the number of samples is low, there will be an imbalance between the groups. In this case, stratification and blocking have to be added to randomisation. Stratification is the classification of patients one or more times according to prognostic features determined by the researcher and blocking is the selection of a certain number of patients for each stratification process. The number of stratification processes should be determined at the beginning of the study.

As the number of stratification processes increases, performing the study and balancing the groups become difficult. For this reason, stratification characteristics and limitations should be effectively determined at the beginning of the study. It is not mandatory for the stratifications to have equal intervals. Despite all the precautions, an imbalance might occur between the groups before beginning the research. In such circumstances, post-stratification or restandardisation may be conducted according to the prognostic factors.

The main characteristic of applying blinding (masking) and randomisation is the prevention of bias. Therefore, it is worthwhile to comprehensively examine bias at this stage.

Bias and Chicanery

While conducting clinical research, errors can be introduced voluntarily or involuntarily at a number of stages, such as design, population selection, calculating the number of samples, non-compliance with study protocol, data entry and selection of statistical method. Bias is taking sides of individuals in line with their own decisions, views and ideological preferences ( 9 ). In order for an error to lead to bias, it has to be a systematic error. Systematic errors in controlled studies generally cause the results of one group to move in a different direction as compared to the other. It has to be understood that scientific research is generally prone to errors. However, random errors (or, in other words, ‘the luck factor’-in which bias is unintended-do not lead to bias ( 10 ).

Another issue, which is different from bias, is chicanery. It is defined as voluntarily changing the interventions, results and data of patients in an unethical manner or copying data from other studies. Comparatively, bias may not be done consciously.

In case unexpected results or outliers are found while the study is analysed, if possible, such data should be re-included into the study since the complete exclusion of data from a study endangers its reliability. In such a case, evaluation needs to be made with and without outliers. It is insignificant if no difference is found. However, if there is a difference, the results with outliers are re-evaluated. If there is no error, then the outlier is included in the study (as the outlier may be a result). It should be noted that re-evaluation of data in anaesthesiology is not possible.

Statistical evaluation methods should be determined at the design stage so as not to encounter unexpected results in clinical research. The data should be evaluated before the end of the study and without entering into details in research that are time-consuming and involve several samples. This is called an interim analysis . The date of interim analysis should be determined at the beginning of the study. The purpose of making interim analysis is to prevent unnecessary cost and effort since it may be necessary to conclude the research after the interim analysis, e.g. studies in which there is no possibility to validate the hypothesis at the end or the occurrence of different side effects of the drug to be used. The accuracy of the hypothesis and number of samples are compared. Statistical significance levels in interim analysis are very important. If the data level is significant, the hypothesis is validated even if the result turns out to be insignificant after the date of the analysis.

Another important point to be considered is the necessity to conclude the participants’ treatment within the period specified in the study protocol. When the result of the study is achieved earlier and unexpected situations develop, the treatment is concluded earlier. Moreover, the participant may quit the study at its own behest, may die or unpredictable situations (e.g. pregnancy) may develop. The participant can also quit the study whenever it wants, even if the study has not ended ( 7 ).

In case the results of a study are contrary to already known or expected results, the expected quality level of the study suggesting the contradiction may be higher than the studies supporting what is known in that subject. This type of bias is called confirmation bias. The presence of well-known mechanisms and logical inference from them may create problems in the evaluation of data. This is called plausibility bias.

Another type of bias is expectation bias. If a result different from the known results has been achieved and it is against the editor’s will, it can be challenged. Bias may be introduced during the publication of studies, such as publishing only positive results, selection of study results in a way to support a view or prevention of their publication. Some editors may only publish research that extols only the positive results or results that they desire.

Bias may be introduced for advertisement or economic reasons. Economic pressure may be applied on the editor, particularly in the cases of studies involving drugs and new medical devices. This is called commercial bias.

In recent years, before beginning a study, it has been recommended to record it on the Web site www.clinicaltrials.gov for the purpose of facilitating systematic interpretation and analysis in scientific research, informing other researchers, preventing bias, provision of writing in a standard format, enhancing contribution of research results to the general literature and enabling early intervention of an institution for support. This Web site is a service of the US National Institutes of Health.

The last stage in the methodology of clinical studies is the selection of intervention to be conducted. Placebo use assumes an important place in interventions. In Latin, placebo means ‘I will be fine’. In medical literature, it refers to substances that are not curative, do not have active ingredients and have various pharmaceutical forms. Although placebos do not have active drug characteristic, they have shown effective analgesic characteristics, particularly in algology applications; further, its use prevents bias in comparative studies. If a placebo has a positive impact on a participant, it is called the placebo effect ; on the contrary, if it has a negative impact, it is called the nocebo effect . Another type of therapy that can be used in clinical research is sham application. Although a researcher does not cure the patient, the researcher may compare those who receive therapy and undergo sham. It has been seen that sham therapies also exhibit a placebo effect. In particular, sham therapies are used in acupuncture applications ( 11 ). While placebo is a substance, sham is a type of clinical application.

Ethically, the patient has to receive appropriate therapy. For this reason, if its use prevents effective treatment, it causes great problem with regard to patient health and legalities.

Before medical research is conducted with human subjects, predictable risks, drawbacks and benefits must be evaluated for individuals or groups participating in the study. Precautions must be taken for reducing the risk to a minimum level. The risks during the study should be followed, evaluated and recorded by the researcher ( 1 ).

After the methodology for a clinical study is determined, dealing with the ‘Ethics Committee’ forms the next stage. The purpose of the ethics committee is to protect the rights, safety and well-being of volunteers taking part in the clinical research, considering the scientific method and concerns of society. The ethics committee examines the studies presented in time, comprehensively and independently, with regard to ethics and science; in line with the Declaration of Helsinki and following national and international standards concerning ‘Good Clinical Practice’. The method to be followed in the formation of the ethics committee should be developed without any kind of prejudice and to examine the applications with regard to ethics and science within the framework of the ethics committee, Regulation on Clinical Trials and Good Clinical Practice ( www.iku.com ). The necessary documents to be presented to the ethics committee are research protocol, volunteer consent form, budget contract, Declaration of Helsinki, curriculum vitae of researchers, similar or explanatory literature samples, supporting institution approval certificate and patient follow-up form.

Only one sister/brother, mother, father, son/daughter and wife/husband can take charge in the same ethics committee. A rector, vice rector, dean, deputy dean, provincial healthcare director and chief physician cannot be members of the ethics committee.

Members of the ethics committee can work as researchers or coordinators in clinical research. However, during research meetings in which members of the ethics committee are researchers or coordinators, they must leave the session and they cannot sign-off on decisions. If the number of members in the ethics committee for a particular research is so high that it is impossible to take a decision, the clinical research is presented to another ethics committee in the same province. If there is no ethics committee in the same province, an ethics committee in the closest settlement is found.

Thereafter, researchers need to inform the participants using an informed consent form. This form should explain the content of clinical study, potential benefits of the study, alternatives and risks (if any). It should be easy, comprehensible, conforming to spelling rules and written in plain language understandable by the participant.

This form assists the participants in taking a decision regarding participation in the study. It should aim to protect the participants. The participant should be included in the study only after it signs the informed consent form; the participant can quit the study whenever required, even when the study has not ended ( 7 ).

Peer-review: Externally peer-reviewed.

Author Contributions: Concept - C.Ö.Ç., A.D.; Design - C.Ö.Ç.; Supervision - A.D.; Resource - C.Ö.Ç., A.D.; Materials - C.Ö.Ç., A.D.; Analysis and/or Interpretation - C.Ö.Ç., A.D.; Literature Search - C.Ö.Ç.; Writing Manuscript - C.Ö.Ç.; Critical Review - A.D.; Other - C.Ö.Ç., A.D.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study has received no financial support.

• U.S. Locations
• UMGC Europe
• Learn Online
• Find Answers
• 855-655-8682
• Current Students

Online Guide to Writing and Research

The research process, explore more of umgc.

• Online Guide to Writing

Structuring the Research Paper

Formal research structure.

These are the primary purposes for formal research:

enter the discourse, or conversation, of other writers and scholars in your field

learn how others in your field use primary and secondary resources

find and understand raw data and information

For the formal academic research assignment, consider an organizational pattern typically used for primary academic research.  The pattern includes the following: introduction, methods, results, discussion, and conclusions/recommendations.

Usually, research papers flow from the general to the specific and back to the general in their organization. The introduction uses a general-to-specific movement in its organization, establishing the thesis and setting the context for the conversation. The methods and results sections are more detailed and specific, providing support for the generalizations made in the introduction. The discussion section moves toward an increasingly more general discussion of the subject, leading to the conclusions and recommendations, which then generalize the conversation again.

Sections of a Formal Structure

The introduction section.

Many students will find that writing a structured  introduction  gets them started and gives them the focus needed to significantly improve their entire paper. 

Introductions usually have three parts:

presentation of the problem statement, the topic, or the research inquiry

purpose and focus of your paper

summary or overview of the writer’s position or arguments

In the first part of the introduction—the presentation of the problem or the research inquiry—state the problem or express it so that the question is implied. Then, sketch the background on the problem and review the literature on it to give your readers a context that shows them how your research inquiry fits into the conversation currently ongoing in your subject area. 

In the second part of the introduction, state your purpose and focus. Here, you may even present your actual thesis. Sometimes your purpose statement can take the place of the thesis by letting your reader know your intentions. 

The third part of the introduction, the summary or overview of the paper, briefly leads readers through the discussion, forecasting the main ideas and giving readers a blueprint for the paper. 

The following example provides a blueprint for a well-organized introduction.

Example of an Introduction

Entrepreneurial Marketing: The Critical Difference

In an article in the Harvard Business Review, John A. Welsh and Jerry F. White remind us that “a small business is not a little big business.” An entrepreneur is not a multinational conglomerate but a profit-seeking individual. To survive, he must have a different outlook and must apply different principles to his endeavors than does the president of a large or even medium-sized corporation. Not only does the scale of small and big businesses differ, but small businesses also suffer from what the Harvard Business Review article calls “resource poverty.” This is a problem and opportunity that requires an entirely different approach to marketing. Where large ad budgets are not necessary or feasible, where expensive ad production squanders limited capital, where every marketing dollar must do the work of two dollars, if not five dollars or even ten, where a person’s company, capital, and material well-being are all on the line—that is, where guerrilla marketing can save the day and secure the bottom line (Levinson, 1984, p. 9).

By reviewing the introductions to research articles in the discipline in which you are writing your research paper, you can get an idea of what is considered the norm for that discipline. Study several of these before you begin your paper so that you know what may be expected. If you are unsure of the kind of introduction your paper needs, ask your professor for more information.  The introduction is normally written in present tense.

THE METHODS SECTION

The methods section of your research paper should describe in detail what methodology and special materials if any, you used to think through or perform your research. You should include any materials you used or designed for yourself, such as questionnaires or interview questions, to generate data or information for your research paper. You want to include any methodologies that are specific to your particular field of study, such as lab procedures for a lab experiment or data-gathering instruments for field research. The methods section is usually written in the past tense.

THE RESULTS SECTION

How you present the results of your research depends on what kind of research you did, your subject matter, and your readers’ expectations. 

Quantitative information —data that can be measured—can be presented systematically and economically in tables, charts, and graphs. Quantitative information includes quantities and comparisons of sets of data. 

Qualitative information , which includes brief descriptions, explanations, or instructions, can also be presented in prose tables. This kind of descriptive or explanatory information, however, is often presented in essay-like prose or even lists.

There are specific conventions for creating tables, charts, and graphs and organizing the information they contain. In general, you should use them only when you are sure they will enlighten your readers rather than confuse them. In the accompanying explanation and discussion, always refer to the graphic by number and explain specifically what you are referring to; you can also provide a caption for the graphic. The rule of thumb for presenting a graphic is first to introduce it by name, show it, and then interpret it. The results section is usually written in the past tense.

THE DISCUSSION SECTION

Your discussion section should generalize what you have learned from your research. One way to generalize is to explain the consequences or meaning of your results and then make your points that support and refer back to the statements you made in your introduction. Your discussion should be organized so that it relates directly to your thesis. You want to avoid introducing new ideas here or discussing tangential issues not directly related to the exploration and discovery of your thesis. The discussion section, along with the introduction, is usually written in the present tense.

THE CONCLUSIONS AND RECOMMENDATIONS SECTION

Your conclusion ties your research to your thesis, binding together all the main ideas in your thinking and writing. By presenting the logical outcome of your research and thinking, your conclusion answers your research inquiry for your reader. Your conclusions should relate directly to the ideas presented in your introduction section and should not present any new ideas.

You may be asked to present your recommendations separately in your research assignment. If so, you will want to add some elements to your conclusion section. For example, you may be asked to recommend a course of action, make a prediction, propose a solution to a problem, offer a judgment, or speculate on the implications and consequences of your ideas. The conclusions and recommendations section is usually written in the present tense.

Key Takeaways

• For the formal academic research assignment, consider an organizational pattern typically used for primary academic research. 
•  The pattern includes the following: introduction, methods, results, discussion, and conclusions/recommendations.

Mailing Address: 3501 University Blvd. East, Adelphi, MD 20783 This work is licensed under a  Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License . © 2022 UMGC. All links to external sites were verified at the time of publication. UMGC is not responsible for the validity or integrity of information located at external sites.

Table of Contents: Online Guide to Writing

Chapter 1: College Writing

How Does College Writing Differ from Workplace Writing?

What Is College Writing?

Why So Much Emphasis on Writing?

Chapter 2: The Writing Process

Doing Exploratory Research

Getting from Notes to Your Draft

Introduction

Prewriting - Techniques to Get Started - Mining Your Intuition

Prewriting: Targeting Your Audience

Prewriting: Techniques to Get Started

Prewriting: Understanding Your Assignment

Rewriting: Being Your Own Critic

Rewriting: Creating a Revision Strategy

Rewriting: Getting Feedback

Rewriting: The Final Draft

Techniques to Get Started - Outlining

Techniques to Get Started - Using Systematic Techniques

Thesis Statement and Controlling Idea

Writing: Getting from Notes to Your Draft - Freewriting

Writing: Getting from Notes to Your Draft - Summarizing Your Ideas

Writing: Outlining What You Will Write

Chapter 3: Thinking Strategies

A Word About Style, Voice, and Tone

A Word About Style, Voice, and Tone: Style Through Vocabulary and Diction

Critical Strategies and Writing

Critical Strategies and Writing: Analysis

Critical Strategies and Writing: Evaluation

Critical Strategies and Writing: Persuasion

Critical Strategies and Writing: Synthesis

Developing a Paper Using Strategies

Kinds of Assignments You Will Write

Patterns for Presenting Information

Patterns for Presenting Information: Critiques

Patterns for Presenting Information: Discussing Raw Data

Patterns for Presenting Information: General-to-Specific Pattern

Patterns for Presenting Information: Problem-Cause-Solution Pattern

Patterns for Presenting Information: Specific-to-General Pattern

Patterns for Presenting Information: Summaries and Abstracts

Supporting with Research and Examples

Writing Essay Examinations

Writing Essay Examinations: Make Your Answer Relevant and Complete

Writing Essay Examinations: Organize Thinking Before Writing

Writing Essay Examinations: Read and Understand the Question

Chapter 4: The Research Process

Planning and Writing a Research Paper

Planning and Writing a Research Paper: Ask a Research Question

Planning and Writing a Research Paper: Cite Sources

Planning and Writing a Research Paper: Collect Evidence

Planning and Writing a Research Paper: Decide Your Point of View, or Role, for Your Research

Planning and Writing a Research Paper: Draw Conclusions

Planning and Writing a Research Paper: Find a Topic and Get an Overview

Planning and Writing a Research Paper: Manage Your Resources

Planning and Writing a Research Paper: Outline

Planning and Writing a Research Paper: Survey the Literature

Planning and Writing a Research Paper: Work Your Sources into Your Research Writing

Research Resources: Where Are Research Resources Found? - Human Resources

Research Resources: What Are Research Resources?

Research Resources: Where Are Research Resources Found?

Research Resources: Where Are Research Resources Found? - Electronic Resources

Research Resources: Where Are Research Resources Found? - Print Resources

Structuring the Research Paper: Formal Research Structure

Structuring the Research Paper: Informal Research Structure

The Nature of Research

The Research Assignment: How Should Research Sources Be Evaluated?

The Research Assignment: When Is Research Needed?

The Research Assignment: Why Perform Research?

Chapter 5: Academic Integrity

Academic Integrity

Giving Credit to Sources

Giving Credit to Sources: Copyright Laws

Giving Credit to Sources: Documentation

Giving Credit to Sources: Style Guides

Integrating Sources

Practicing Academic Integrity

Practicing Academic Integrity: Keeping Accurate Records

Practicing Academic Integrity: Managing Source Material

Practicing Academic Integrity: Managing Source Material - Paraphrasing Your Source

Practicing Academic Integrity: Managing Source Material - Quoting Your Source

Practicing Academic Integrity: Managing Source Material - Summarizing Your Sources

Types of Documentation

Types of Documentation: Bibliographies and Source Lists

Types of Documentation: Citing World Wide Web Sources

Types of Documentation: In-Text or Parenthetical Citations

Types of Documentation: In-Text or Parenthetical Citations - APA Style

Types of Documentation: In-Text or Parenthetical Citations - CSE/CBE Style

Types of Documentation: In-Text or Parenthetical Citations - Chicago Style

Types of Documentation: In-Text or Parenthetical Citations - MLA Style

Types of Documentation: Note Citations

Chapter 6: Using Library Resources

Finding Library Resources

Chapter 7: Assessing Your Writing

How Is Writing Graded?

How Is Writing Graded?: A General Assessment Tool

The Draft Stage

The Draft Stage: The First Draft

The Draft Stage: The Revision Process and the Final Draft

The Draft Stage: Using Feedback

The Research Stage

Using Assessment to Improve Your Writing

Chapter 8: Other Frequently Assigned Papers

Reviews and Reaction Papers: Article and Book Reviews

Reviews and Reaction Papers: Reaction Papers

Writing Arguments

Writing Arguments: Adapting the Argument Structure

Writing Arguments: Purposes of Argument

Writing Arguments: References to Consult for Writing Arguments

Writing Arguments: Steps to Writing an Argument - Anticipate Active Opposition

Writing Arguments: Steps to Writing an Argument - Determine Your Organization

Writing Arguments: Steps to Writing an Argument - Develop Your Argument

Writing Arguments: Steps to Writing an Argument - Introduce Your Argument

Writing Arguments: Steps to Writing an Argument - State Your Thesis or Proposition

Writing Arguments: Steps to Writing an Argument - Write Your Conclusion

Writing Arguments: Types of Argument

Appendix A: Books to Help Improve Your Writing

Dictionaries

General Style Manuals

Researching on the Internet

Special Style Manuals

Writing Handbooks

Appendix B: Collaborative Writing and Peer Reviewing

Collaborative Writing: Assignments to Accompany the Group Project

Collaborative Writing: Informal Progress Report

Collaborative Writing: Issues to Resolve

Collaborative Writing: Methodology

Collaborative Writing: Peer Evaluation

Collaborative Writing: Tasks of Collaborative Writing Group Members

Collaborative Writing: Writing Plan

General Introduction

Peer Reviewing

Appendix C: Developing an Improvement Plan

Working with Your Instructor’s Comments and Grades

Appendix D: Writing Plan and Project Schedule

Devising a Writing Project Plan and Schedule

Reviewing Your Plan with Others

By using our website you agree to our use of cookies. Learn more about how we use cookies by reading our  Privacy Policy .

• Privacy Policy

Buy Me a Coffee

Home » Research – Types, Methods and Examples

Research – Types, Methods and Examples

Table of Contents

Definition:

Research refers to the process of investigating a particular topic or question in order to discover new information , develop new insights, or confirm or refute existing knowledge. It involves a systematic and rigorous approach to collecting, analyzing, and interpreting data, and requires careful planning and attention to detail.

History of Research

The history of research can be traced back to ancient times when early humans observed and experimented with the natural world around them. Over time, research evolved and became more systematic as people sought to better understand the world and solve problems.

In ancient civilizations such as those in Greece, Egypt, and China, scholars pursued knowledge through observation, experimentation, and the development of theories. They explored various fields, including medicine, astronomy, and mathematics.

During the Middle Ages, research was often conducted by religious scholars who sought to reconcile scientific discoveries with their faith. The Renaissance brought about a renewed interest in science and the scientific method, and the Enlightenment period marked a major shift towards empirical observation and experimentation as the primary means of acquiring knowledge.

The 19th and 20th centuries saw significant advancements in research, with the development of new scientific disciplines and fields such as psychology, sociology, and computer science. Advances in technology and communication also greatly facilitated research efforts.

Today, research is conducted in a wide range of fields and is a critical component of many industries, including healthcare, technology, and academia. The process of research continues to evolve as new methods and technologies emerge, but the fundamental principles of observation, experimentation, and hypothesis testing remain at its core.

Types of Research

Types of Research are as follows:

• Applied Research : This type of research aims to solve practical problems or answer specific questions, often in a real-world context.
• Basic Research : This type of research aims to increase our understanding of a phenomenon or process, often without immediate practical applications.
• Experimental Research : This type of research involves manipulating one or more variables to determine their effects on another variable, while controlling all other variables.
• Descriptive Research : This type of research aims to describe and measure phenomena or characteristics, without attempting to manipulate or control any variables.
• Correlational Research: This type of research examines the relationships between two or more variables, without manipulating any variables.
• Qualitative Research : This type of research focuses on exploring and understanding the meaning and experience of individuals or groups, often through methods such as interviews, focus groups, and observation.
• Quantitative Research : This type of research uses numerical data and statistical analysis to draw conclusions about phenomena or populations.
• Action Research: This type of research is often used in education, healthcare, and other fields, and involves collaborating with practitioners or participants to identify and solve problems in real-world settings.
• Mixed Methods Research : This type of research combines both quantitative and qualitative research methods to gain a more comprehensive understanding of a phenomenon or problem.
• Case Study Research: This type of research involves in-depth examination of a specific individual, group, or situation, often using multiple data sources.
• Longitudinal Research: This type of research follows a group of individuals over an extended period of time, often to study changes in behavior, attitudes, or health outcomes.
• Cross-Sectional Research : This type of research examines a population at a single point in time, often to study differences or similarities among individuals or groups.
• Survey Research: This type of research uses questionnaires or interviews to gather information from a sample of individuals about their attitudes, beliefs, behaviors, or experiences.
• Ethnographic Research : This type of research involves immersion in a cultural group or community to understand their way of life, beliefs, values, and practices.
• Historical Research : This type of research investigates events or phenomena from the past using primary sources, such as archival records, newspapers, and diaries.
• Content Analysis Research : This type of research involves analyzing written, spoken, or visual material to identify patterns, themes, or messages.
• Participatory Research : This type of research involves collaboration between researchers and participants throughout the research process, often to promote empowerment, social justice, or community development.
• Comparative Research: This type of research compares two or more groups or phenomena to identify similarities and differences, often across different countries or cultures.
• Exploratory Research : This type of research is used to gain a preliminary understanding of a topic or phenomenon, often in the absence of prior research or theories.
• Explanatory Research: This type of research aims to identify the causes or reasons behind a particular phenomenon, often through the testing of theories or hypotheses.
• Evaluative Research: This type of research assesses the effectiveness or impact of an intervention, program, or policy, often through the use of outcome measures.
• Simulation Research : This type of research involves creating a model or simulation of a phenomenon or process, often to predict outcomes or test theories.

Data Collection Methods

• Surveys : Surveys are used to collect data from a sample of individuals using questionnaires or interviews. Surveys can be conducted face-to-face, by phone, mail, email, or online.
• Experiments : Experiments involve manipulating one or more variables to measure their effects on another variable, while controlling for other factors. Experiments can be conducted in a laboratory or in a natural setting.
• Case studies : Case studies involve in-depth analysis of a single case, such as an individual, group, organization, or event. Case studies can use a variety of data collection methods, including interviews, observation, and document analysis.
• Observational research : Observational research involves observing and recording the behavior of individuals or groups in a natural setting. Observational research can be conducted covertly or overtly.
• Content analysis : Content analysis involves analyzing written, spoken, or visual material to identify patterns, themes, or messages. Content analysis can be used to study media, social media, or other forms of communication.
• Ethnography : Ethnography involves immersion in a cultural group or community to understand their way of life, beliefs, values, and practices. Ethnographic research can use a range of data collection methods, including observation, interviews, and document analysis.
• Secondary data analysis : Secondary data analysis involves using existing data from sources such as government agencies, research institutions, or commercial organizations. Secondary data can be used to answer research questions, without collecting new data.
• Focus groups: Focus groups involve gathering a small group of people together to discuss a topic or issue. The discussions are usually guided by a moderator who asks questions and encourages discussion.
• Interviews : Interviews involve one-on-one conversations between a researcher and a participant. Interviews can be structured, semi-structured, or unstructured, and can be conducted in person, by phone, or online.
• Document analysis : Document analysis involves collecting and analyzing written documents, such as reports, memos, and emails. Document analysis can be used to study organizational communication, policy documents, and other forms of written material.

Data Analysis Methods

Data Analysis Methods in Research are as follows:

• Descriptive statistics : Descriptive statistics involve summarizing and describing the characteristics of a dataset, such as mean, median, mode, standard deviation, and frequency distributions.
• Inferential statistics: Inferential statistics involve making inferences or predictions about a population based on a sample of data, using methods such as hypothesis testing, confidence intervals, and regression analysis.
• Qualitative analysis: Qualitative analysis involves analyzing non-numerical data, such as text, images, or audio, to identify patterns, themes, or meanings. Qualitative analysis can be used to study subjective experiences, social norms, and cultural practices.
• Content analysis: Content analysis involves analyzing written, spoken, or visual material to identify patterns, themes, or messages. Content analysis can be used to study media, social media, or other forms of communication.
• Grounded theory: Grounded theory involves developing a theory or model based on empirical data, using methods such as constant comparison, memo writing, and theoretical sampling.
• Discourse analysis : Discourse analysis involves analyzing language use, including the structure, function, and meaning of words and phrases, to understand how language reflects and shapes social relationships and power dynamics.
• Network analysis: Network analysis involves analyzing the structure and dynamics of social networks, including the relationships between individuals and groups, to understand social processes and outcomes.

Research Methodology

Research methodology refers to the overall approach and strategy used to conduct a research study. It involves the systematic planning, design, and execution of research to answer specific research questions or test hypotheses. The main components of research methodology include:

• Research design : Research design refers to the overall plan and structure of the study, including the type of study (e.g., observational, experimental), the sampling strategy, and the data collection and analysis methods.
• Sampling strategy: Sampling strategy refers to the method used to select a representative sample of participants or units from the population of interest. The choice of sampling strategy will depend on the research question and the nature of the population being studied.
• Data collection methods : Data collection methods refer to the techniques used to collect data from study participants or sources, such as surveys, interviews, observations, or secondary data sources.
• Data analysis methods: Data analysis methods refer to the techniques used to analyze and interpret the data collected in the study, such as descriptive statistics, inferential statistics, qualitative analysis, or content analysis.
• Ethical considerations: Ethical considerations refer to the principles and guidelines that govern the treatment of human participants or the use of sensitive data in the research study.
• Validity and reliability : Validity and reliability refer to the extent to which the study measures what it is intended to measure and the degree to which the study produces consistent and accurate results.

Applications of Research

Research has a wide range of applications across various fields and industries. Some of the key applications of research include:

• Advancing scientific knowledge : Research plays a critical role in advancing our understanding of the world around us. Through research, scientists are able to discover new knowledge, uncover patterns and relationships, and develop new theories and models.
• Improving healthcare: Research is instrumental in advancing medical knowledge and developing new treatments and therapies. Clinical trials and studies help to identify the effectiveness and safety of new drugs and medical devices, while basic research helps to uncover the underlying causes of diseases and conditions.
• Enhancing education: Research helps to improve the quality of education by identifying effective teaching methods, developing new educational tools and technologies, and assessing the impact of various educational interventions.
• Driving innovation: Research is a key driver of innovation, helping to develop new products, services, and technologies. By conducting research, businesses and organizations can identify new market opportunities, gain a competitive advantage, and improve their operations.
• Informing public policy : Research plays an important role in informing public policy decisions. Policy makers rely on research to develop evidence-based policies that address societal challenges, such as healthcare, education, and environmental issues.
• Understanding human behavior : Research helps us to better understand human behavior, including social, cognitive, and emotional processes. This understanding can be applied in a variety of settings, such as marketing, organizational management, and public policy.

Importance of Research

Research plays a crucial role in advancing human knowledge and understanding in various fields of study. It is the foundation upon which new discoveries, innovations, and technologies are built. Here are some of the key reasons why research is essential:

• Advancing knowledge: Research helps to expand our understanding of the world around us, including the natural world, social structures, and human behavior.
• Problem-solving: Research can help to identify problems, develop solutions, and assess the effectiveness of interventions in various fields, including medicine, engineering, and social sciences.
• Innovation : Research is the driving force behind the development of new technologies, products, and processes. It helps to identify new possibilities and opportunities for improvement.
• Evidence-based decision making: Research provides the evidence needed to make informed decisions in various fields, including policy making, business, and healthcare.
• Education and training : Research provides the foundation for education and training in various fields, helping to prepare individuals for careers and advancing their knowledge.
• Economic growth: Research can drive economic growth by facilitating the development of new technologies and innovations, creating new markets and job opportunities.

When to use Research

Research is typically used when seeking to answer questions or solve problems that require a systematic approach to gathering and analyzing information. Here are some examples of when research may be appropriate:

• To explore a new area of knowledge : Research can be used to investigate a new area of knowledge and gain a better understanding of a topic.
• To identify problems and find solutions: Research can be used to identify problems and develop solutions to address them.
• To evaluate the effectiveness of programs or interventions : Research can be used to evaluate the effectiveness of programs or interventions in various fields, such as healthcare, education, and social services.
• To inform policy decisions: Research can be used to provide evidence to inform policy decisions in areas such as economics, politics, and environmental issues.
• To develop new products or technologies : Research can be used to develop new products or technologies and improve existing ones.
• To understand human behavior : Research can be used to better understand human behavior and social structures, such as in psychology, sociology, and anthropology.

Characteristics of Research

The following are some of the characteristics of research:

• Purpose : Research is conducted to address a specific problem or question and to generate new knowledge or insights.
• Systematic : Research is conducted in a systematic and organized manner, following a set of procedures and guidelines.
• Empirical : Research is based on evidence and data, rather than personal opinion or intuition.
• Objective: Research is conducted with an objective and impartial perspective, avoiding biases and personal beliefs.
• Rigorous : Research involves a rigorous and critical examination of the evidence and data, using reliable and valid methods of data collection and analysis.
• Logical : Research is based on logical and rational thinking, following a well-defined and logical structure.
• Generalizable : Research findings are often generalized to broader populations or contexts, based on a representative sample of the population.
• Replicable : Research is conducted in a way that allows others to replicate the study and obtain similar results.
• Ethical : Research is conducted in an ethical manner, following established ethical guidelines and principles, to ensure the protection of participants’ rights and well-being.
• Cumulative : Research builds on previous studies and contributes to the overall body of knowledge in a particular field.

Advantages of Research

Research has several advantages, including:

• Generates new knowledge: Research is conducted to generate new knowledge and understanding of a particular topic or phenomenon, which can be used to inform policy, practice, and decision-making.
• Provides evidence-based solutions : Research provides evidence-based solutions to problems and issues, which can be used to develop effective interventions and strategies.
• Improves quality : Research can improve the quality of products, services, and programs by identifying areas for improvement and developing solutions to address them.
• Enhances credibility : Research enhances the credibility of an organization or individual by providing evidence to support claims and assertions.
• Enables innovation: Research can lead to innovation by identifying new ideas, approaches, and technologies.
• Informs decision-making : Research provides information that can inform decision-making, helping individuals and organizations make more informed and effective choices.
• Facilitates progress: Research can facilitate progress by identifying challenges and opportunities and developing solutions to address them.
• Enhances understanding: Research can enhance understanding of complex issues and phenomena, helping individuals and organizations navigate challenges and opportunities more effectively.
• Promotes accountability : Research promotes accountability by providing a basis for evaluating the effectiveness of policies, programs, and interventions.
• Fosters collaboration: Research can foster collaboration by bringing together individuals and organizations with diverse perspectives and expertise to address complex issues and problems.

Limitations of Research

Some Limitations of Research are as follows:

• Cost : Research can be expensive, particularly when large-scale studies are required. This can limit the number of studies that can be conducted and the amount of data that can be collected.
• Time : Research can be time-consuming, particularly when longitudinal studies are required. This can limit the speed at which research findings can be generated and disseminated.
• Sample size: The size of the sample used in research can limit the generalizability of the findings to larger populations.
• Bias : Research can be affected by bias, both in the design and implementation of the study, as well as in the analysis and interpretation of the data.
• Ethics : Research can present ethical challenges, particularly when human or animal subjects are involved. This can limit the types of research that can be conducted and the methods that can be used.
• Data quality: The quality of the data collected in research can be affected by a range of factors, including the reliability and validity of the measures used, as well as the accuracy of the data entry and analysis.
• Subjectivity : Research can be subjective, particularly when qualitative methods are used. This can limit the objectivity and reliability of the findings.
• Accessibility : Research findings may not be accessible to all stakeholders, particularly those who are not part of the academic or research community.
• Interpretation : Research findings can be open to interpretation, particularly when the data is complex or contradictory. This can limit the ability of researchers to draw firm conclusions.
• Unforeseen events : Unexpected events, such as changes in the environment or the emergence of new technologies, can limit the relevance and applicability of research findings.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

You may also like

What is Art – Definition, Types, Examples

What is Anthropology – Definition and Overview

What is Literature – Definition, Types, Examples

Economist – Definition, Types, Work Area

Anthropologist – Definition, Types, Work Area

What is History – Definitions, Periods, Methods

NIH RPPR Summary Form (RSF) Updated

Please be informed that our “NIH RPPR Summary Form (RSF)” has been updated!

Sponsored Programs has made a series of changes to the RSF form to better accommodate for PI certifications and disclosures. These changes will assist with the overall review of the RPPR and provide the most accurate information possible.

• PDF NIH RPPR Summary Form (RSF) Updated April 16, 2024

The RSF is an internal form to be completed and submitted to your BU SP Pre-Award Officer when the Annual NIH RPPR has been finalized and routed to SP for final review and submission. The RSF is NOT required for Final NIH Performance Progress Reports or progress reports to other sponsors.

The new version of the RSF will be required for all Annual NIH Research Performance Progress Reports (RPPR) effective June 1, 2024.

Summary of Changes to the RSF

The first major change to the form is a new ‘Principal Investigator: Certifications’ section, which includes

• Certification that all subrecipient report documents have been received as required for any outgoing subcontract agreement; and
• Certification that the project is compliant with the approved Data Management and Sharing Plan (if applicable).

The second major change to the form is within the ‘Principal Investigator: Disclosures’ section.  A new disclosure is included pertaining to foreign subcontractors. Effective January 1, 2024, NIH updated its grant policy guidance for foreign subaward agreements ( NOT-OD-23-182 ). Foreign subrecipients must provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient (Boston University) with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report (RPPR) submission.

Information For...

Prepare & Submit Proposals

Prepare, submit and check status of proposals

•   Letters of Intent and Proposals
•   Demo Site: Prepare Proposals
•   Check Proposal Status

Proposal/ Panel Review

Review proposals, participate in panels

• Proposal Review
• Panelist Functions

Awards & Reporting

Submit project reports, notifications & requests, and supplemental funding requests

•   Project Reports
•      Demo Site: Project Reports (Training)
•   Notifications & Requests
•   Deposit Public Access Publication
•   Award Documents
•   Supplemental Funding Requests (including Career-Life Balance)
•      Demo Site: Supplement Funding    Requests (Training)
•   Continuing Grant Increments Reports

Fellowships & Honorary Awards

Nominate colleagues, apply for awards

• Graduate Research Fellowship Program (GRFP)
• Honorary Awards
•   Manage Reference Letters (Writers)

Manage Financials

View or submit cash requests, reports, and individual banking information

•   Submit or manage payment transactions
•   More about ACM$
•   Program Income Reporting
•   More about Individual Banking

Administration

Manage your account and user roles

•   User Management

NSF Award Highlights

•   Explore Scholarly publications in the NSF Public Access Repository (NSF-PAR)
•   Search awards going back to 1994

Read our research on: Gun Policy | International Conflict | Election 2024

Regions & Countries

9 facts about americans and marijuana.

The use and possession of marijuana is illegal under U.S. federal law, but about three-quarters of states have legalized the drug for medical or recreational purposes. The changing legal landscape has coincided with a decades-long rise in public support for legalization, which a majority of Americans now favor.

Here are nine facts about Americans’ views of and experiences with marijuana, based on Pew Research Center surveys and other sources.

As more states legalize marijuana, Pew Research Center looked at Americans’ opinions on legalization and how these views have changed over time.

Data comes from surveys by the Center,  Gallup , and the  2022 National Survey on Drug Use and Health  from the U.S. Substance Abuse and Mental Health Services Administration. Information about the jurisdictions where marijuana is legal at the state level comes from the  National Organization for the Reform of Marijuana Laws .

More information about the Center surveys cited in the analysis, including the questions asked and their methodologies, can be found at the links in the text.

Around nine-in-ten Americans say marijuana should be legal for medical or recreational use,  according to a January 2024 Pew Research Center survey . An overwhelming majority of U.S. adults (88%) say either that marijuana should be legal for medical use only (32%) or that it should be legal for medical  and  recreational use (57%). Just 11% say the drug should not be legal in any form. These views have held relatively steady over the past five years.

Views on marijuana legalization differ widely by age, political party, and race and ethnicity, the January survey shows.

While small shares across demographic groups say marijuana should not be legal at all, those least likely to favor it for both medical and recreational use include:

• Older adults: 31% of adults ages 75 and older support marijuana legalization for medical and recreational purposes, compared with half of those ages 65 to 74, the next youngest age category. By contrast, 71% of adults under 30 support legalization for both uses.
• Republicans and GOP-leaning independents: 42% of Republicans favor legalizing marijuana for both uses, compared with 72% of Democrats and Democratic leaners. Ideological differences exist as well: Within both parties, those who are more conservative are less likely to support legalization.
• Hispanic and Asian Americans: 45% in each group support legalizing the drug for medical and recreational use. Larger shares of Black (65%) and White (59%) adults hold this view.

Support for marijuana legalization has increased dramatically over the last two decades. In addition to asking specifically about medical and recreational use of the drug, both the Center and Gallup have asked Americans about legalizing marijuana use in a general way. Gallup asked this question most recently, in 2023. That year, 70% of adults expressed support for legalization, more than double the share who said they favored it in 2000.

Half of U.S. adults (50.3%) say they have ever used marijuana, according to the 2022 National Survey on Drug Use and Health . That is a smaller share than the 84.1% who say they have ever consumed alcohol and the 64.8% who have ever used tobacco products or vaped nicotine.

While many Americans say they have used marijuana in their lifetime, far fewer are current users, according to the same survey. In 2022, 23.0% of adults said they had used the drug in the past year, while 15.9% said they had used it in the past month.

While many Americans say legalizing recreational marijuana has economic and criminal justice benefits, views on these and other impacts vary, the Center’s January survey shows.

• Economic benefits: About half of adults (52%) say that legalizing recreational marijuana is good for local economies, while 17% say it is bad. Another 29% say it has no impact.

• Criminal justice system fairness: 42% of Americans say legalizing marijuana for recreational use makes the criminal justice system fairer, compared with 18% who say it makes the system less fair. About four-in-ten (38%) say it has no impact.
• Use of other drugs: 27% say this policy decreases the use of other drugs like heroin, fentanyl and cocaine, and 29% say it increases it. But the largest share (42%) say it has no effect on other drug use.
• Community safety: 21% say recreational legalization makes communities safer and 34% say it makes them less safe. Another 44% say it doesn’t impact safety.

Democrats and adults under 50 are more likely than Republicans and those in older age groups to say legalizing marijuana has positive impacts in each of these areas.

Most Americans support easing penalties for people with marijuana convictions, an October 2021 Center survey found . Two-thirds of adults say they favor releasing people from prison who are being held for marijuana-related offenses only, including 41% who strongly favor this. And 61% support removing or expunging marijuana-related offenses from people’s criminal records.

Younger adults, Democrats and Black Americans are especially likely to support these changes. For instance, 74% of Black adults  favor releasing people from prison  who are being held only for marijuana-related offenses, and just as many favor removing or expunging marijuana-related offenses from criminal records.

Twenty-four states and the District of Columbia have legalized small amounts of marijuana for both medical and recreational use as of March 2024,  according to the  National Organization for the Reform of Marijuana Laws  (NORML), an advocacy group that tracks state-level legislation on the issue. Another 14 states have legalized the drug for medical use only.

Of the remaining 12 states, all allow limited access to products such as CBD oil that contain little to no THC – the main psychoactive substance in cannabis. And 26 states overall have at least partially  decriminalized recreational marijuana use , as has the District of Columbia.

In addition to 24 states and D.C.,  the U.S. Virgin Islands ,  Guam  and  the Northern Mariana Islands  have legalized marijuana for medical and recreational use.

More than half of Americans (54%) live in a state where both recreational and medical marijuana are legal, and 74% live in a state where it’s legal either for both purposes or medical use only, according to a February Center analysis of data from the Census Bureau and other outside sources. This analysis looked at state-level legislation in all 50 states and the District of Columbia.

In 2012, Colorado and Washington became the first states to pass legislation legalizing recreational marijuana.

About eight-in-ten Americans (79%) live in a county with at least one cannabis dispensary, according to the February analysis. There are nearly 15,000 marijuana dispensaries nationwide, and 76% are in states (including D.C.) where recreational use is legal. Another 23% are in medical marijuana-only states, and 1% are in states that have made legal allowances for low-percentage THC or CBD-only products.

The states with the largest number of dispensaries include California, Oklahoma, Florida, Colorado and Michigan.

Note: This is an update of a post originally published April 26, 2021, and updated April 13, 2023.  

Sign up for our weekly newsletter

Fresh data delivered Saturday mornings

Americans overwhelmingly say marijuana should be legal for medical or recreational use

Religious americans are less likely to endorse legal marijuana for recreational use, four-in-ten u.s. drug arrests in 2018 were for marijuana offenses – mostly possession, two-thirds of americans support marijuana legalization, most popular.

About Pew Research Center Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of The Pew Charitable Trusts .

The Ohio State University

• BuckeyeLink
• Search Ohio State

How to Boost Your Resume Without a Summer Internship

Summer internships are one of the most common ways to gain relevant experience, but they certainly aren’t the only. Many students don’t realize that there are still several ways to build your engineering qualifications and strengthen your resume. If you won’t be participating in an internship this summer, it is advantageous to complete at least one alternative experience that you can add to your resume. 

On campus research opportunities are available to undergraduate students both during the semester and over the summer. Even if you don’t think the grad school or research paths align with your long-term career goals, undergraduate research experiences provide you with technical knowledge and hands-on skills. You can also use research lab experience to highlight your problem solving, quick learning, and collaborating abilities.

Micro-Internships and Projects

Companies post micro-internship opportunities when they are looking for help on one specific project. The project’s scope, deadline, and pay may vary. Micro-Internships give students the flexibility of setting their own work schedule/hours. Similar to traditional internships, micro-internships require you to apply technical and soft skills in a professional environment to meet expectations and complete the project on time. You can also learn new skills by engaging in personal projects. Whether it involves software, hardware, or a combination of the two, you can tailor personal projects to meet your specific needs. This type of project highlights your ability to take initiative, use your resources, and work independently.

Online Courses and Certifications

If you’re looking to learn something completely new (like circuits, a coding language, or CAD software) there are a ton of free resources – especially for students! These include Coursera , edX , SolidProfessor , Tinkercad , LinkedIn Learning , and more. There are even complete computer science courses from sources like Harvard University available on YouTube. If you receive certifications, these can be included under the “Qualifications” section of your resume.

Other Work Experience

Non-engineering work experiences bring more value to your resume than you may expect. Working as a restaurant server, grocery store cashier, or summer camp counselor speaks to your interpersonal skills and responsibility. Every company has customers, so who wouldn’t want to hire someone with customer service experience? You may also want to mention working in a fast-paced environment, applying attention to detail, or implementing time management.

Volunteering

Whether or not it is for a STEM-related organization, volunteering showcases causes that are of personal significance to you. This shows some of your personality and can even serve as great conversation starters in an interview. In addition to your transferrable skills, volunteer experiences show that you are a committed leader in your community.

“Don’t follow where the path may lead, go instead where there is no path and leave a trail.” - Ralph Waldo Emerson

Related News

Apr. 16, 2024

From battling pandemics to serving the uninsured, why houston’s health care leadership is more important than ever before, interviews :  apr. 16, 2024 health.

Photo by Robert Seale

Dr. Marc Boom, president and CEO of Houston Methodist, helped lead Houston through the COVID-19 pandemic by prioritizing the public’s accessibility to the COVID-19 vaccine, and he was the first hospital system CEO to introduce an employee COVID-19 vaccine mandate.

Boom will receive the 2024 Stephen L. Klineberg Award for outstanding leadership in health care at the 2024 Kinder Institute Luncheon on May 20. Ticket sales close May 8.

Boom, who has been a Houstonian since he was 14, is still a practicing physician while also leading a hospital system that has over 32,000 employees and had over 2 million outpatient visits in 2023. He has served in his role since 2012.

Houston Methodist is among the best hospitals in the country and tied for No. 1 in Texas according to U.S. News & World Report’s Honor Roll released 2023. It was ranked in 10 specialties, more than any other hospital in Houston, with nine placing in the top 20 and two in the top five.

The Urban Edge interviewed Boom about Houston Methodist’s response to the COVID-19 pandemic, and the current and future state of health care in the Houston area. The interview has been edited for length and clarity.

What made you want to enter the medical profession and how did it bring you to Houston?

I always liked science in grade school. It kept my attention and sparked my curiosity. With a father who was an engineer, I initially thought I might become an engineer, but in high school, I began to pursue medical interests. At first, I thought I’d combine my love of animals with my love of science, so I worked part time at a veterinary clinic. But later, I decided I would prefer to work with patients who could talk to me.

Ultimately, that’s why I chose to be a primary care physician. The long-term relationships with patients — helping them through good times and bad — are what I find most meaningful. Now, having been in the profession for decades, I can say that working in medicine is a sacred calling. We are meant to help others, and that’s what keeps me in this profession.

As for Houston, I consider it home. Both my parents are immigrants from Belgium and moved to the U.S. right after they were married. My dad’s job eventually brought us to Houston when I was 14, and it’s a remarkable city. I graduated from Baylor College of Medicine and did my residency on the East Coast, but I always knew that I wanted to come back.

What measures taken by Houston Methodist during the height of the COVID-19 pandemic are you most proud of?

Houston Methodist is an independent academic medical center, a very unique structure within the field. The advantages of this structure were on full display during the COVID-19 pandemic as we were extremely nimble and effective. For example, we developed a COVID-19 PCR test just a couple of weeks after the virus was discovered in China so that when the first cases hit Houston, we were able to get an answer in a couple of hours when most institutions were sending tests out to get answers in days to a couple of weeks.

We were the first in the world to use convalescent plasma in March 2020. We have sequenced the viral genome of every patient who tested positive, which has allowed us to have one of the largest databases of viral genomes in the world and has enabled our teams to gain valuable insights into the spread of the virus. We administered more monoclonal antibody infusions and more vaccines than any institution in the state of Texas. And, of course, we were the first medical institution to mandate the COVID-19 vaccine for our employees and physicians. It was courageous, and it was the right thing to do to protect our patients.

I am so proud of our Houston Methodist family for pulling together and rallying around this call to get vaccinated. There is no doubt in my mind it saved countless lives. To this day, when I meet hospital executives around the country, they are quick to thank Houston Methodist for leading the way.

Most of all, I’m proud of how we were able to look out for our people. We are fortunate to have a strong balance sheet at Houston Methodist. So, we committed early to no layoffs, no furloughs, no benefit cuts and no pay cuts — aspects that have reinforced our culture. We also invested heavily in support of our heroic employees and physicians who put their personal lives on hold to care for our community.

The pandemic made for a challenging time for the medical profession. What do you think are the best methods to confront burnout and the state of the workforce?

There’s no doubt the pandemic was very challenging for medical professionals. At Houston Methodist, we’ve worked hard to confront burnout. What is most important is connecting people to the passion and purpose we all derive from the sacred privilege of caring for others. When we think in terms of work-life integration rather than work-life balance, which implies that we choose one over the other, we can focus on how best to bring back the joy in medicine. Like everything that has to do with culture, it requires a very purposeful and deliberate approach.

At Houston Methodist, we’re seeing the results with employee engagement at the 96th percentile nationally, significantly reduced turnover and an embracing of many creative solutions, like a virtual nursing program that offers different career options for our nurses while easing some of the workload on those nurses who are at the bedside — all while improving safety and quality. Combatting burnout is not a quick fix, and the best way to confront burnout is to care for the whole employee. We have an entire program to combat burnout and teach resiliency to our physicians. Houston Methodist also has an employee well-being clinic that brings mental health support directly to our employees. It makes a huge difference to know you’re not alone.

Houston is renowned for its world-class Texas Medical Center. However, over 2 million people in the Houston metro area are medically uninsured, according to the U.S. Census Bureau. How would you describe the disconnect?

This is a big issue, one that’s frankly at an existential level for our society. How can we be the wealthiest, most successful country on the planet yet still have so many people uninsured? Why is health care in the United States the envy of the rest of the world, but only if you have access to insurance? I wish we as a hospital system could solve it individually, but this will require a concerted effort that starts with an important societal discussion.

Unfortunately, these conversations are difficult to have in today’s contentious and divided environment. This is why I speak so much about an “and” mentality, one in which diverse individuals with different points of view come together, hammer out compromise and do what’s best for the American people. I firmly believe this is possible in health care.

In the meantime, at Houston Methodist, we focus on what we can impact. We provide hundreds of millions in direct charity care at cost. We provide well over $1 billion in community benefits. Through our Community Benefits Grant Program, Houston Methodist provides uninsured and underinsured patients improved access to health care services, mental health services and financial support. We have partnered with free clinics, federally qualified health centers and other nonprofit agencies in the Greater Houston area for more than 30 years as part of this program. Just this year, we awarded nearly $6.8 million in community grants to 30 local nonprofit organizations. The Community Benefits Grant Program allows us to continue to address crucial community issues, including reducing barriers to accessing primary and preventative care.

What high-level investments are needed for Houston to remain a leader in medicine in the future?

A continued investment in technology, infrastructure and people is a must for Houston to remain a leader in medicine. There is a tremendous opportunity to scale innovative treatments and technologies thanks to the large, diverse clinical base that we have in Houston. And if we continue to work together and work across industries, we will stay a leader in medicine.

A great example is the Ion District , an area in the middle of the city where Houston Methodist and Rice University both have a presence. The Ion gives us the chance to test the latest innovations in health care technology with the bonus of collaborating with experts from across industries, such as aerospace, energy, and oil and gas. That kind of collaboration works in everyone’s favor and positions us to bring treatments and innovations to our patients first.

How can the Houston area be prepared for another pandemic or large-scale public health emergency?

Several years before COVID-19, Houston-area hospitals prepared for an Ebola outbreak in Houston. Fortunately, we didn’t see any patients, but that taught us the importance of preparing for a global infectious disease. We had set up an inpatient isolation unit for Ebola patients. When we started getting our first COVID-19 patients, we used that facility to control infection. Now, we aren’t waiting for the next pandemic; we’re preparing for it. We’re using what we learned from COVID-19 to prepare for how we’ll respond to the next public health emergency.

At Houston Methodist, we expanded and invested a lot of resources into our infectious diseases department. We also still collect data to inform us on how to anticipate and treat future infectious diseases. In the Houston area, it’s about investing in the resources and the people who have the expertise now so that we can mitigate the effects of the next public health emergency.

How does being a practicing physician help you stay connected to those who are seeking care at Houston Methodist?

When I was in business school, I knew I wanted to remain a practicing physician no matter where my career took me. When the administrative side of my work ramped up even further in 2004, I took my active primary care physician practice of more than 1,000 patients and decreased it significantly. Since then, I have had a very small practice with the same patients I’ve been seeing for decades.

Being a practicing physician allows me to use the technologies that our employees and physicians use. For example, when we transitioned to a new health record management system, I had to learn it because I used it for my practice. I order tests, consult with radiologists and do all the things other primary care physicians do. It allows me to see how patients experience care at Houston Methodist in a tangible way. And at Houston Methodist, the patient is the center of everything we do. When I’m caring for a patient, that brings me back to that sentiment.

The 2024 Kinder Institute Luncheon will honor Dr. Marc. L. Boom, president and CEO of Houston Methodist. Findings from the 43rd Kinder Houston Area Survey will also be shared.

Kinder Institute Newsletter

Keep up with the latest research, news and events.

Mailing Address

6100 Main St. MS-208 Houston, TX 77005-1892

[email protected] 713-348-4132 

Subscribe to our e-newsletter

Physical Address

Rice University Kraft Hall 6100 Main Street, Suite 305 Houston, TX 77005-1892

Featured Sponsor

Support the Kinder Institute

• International edition
• Australia edition
• Europe edition

What are the key findings of the NHS gender identity review?

Report by Dr Hilary Cass finds young people being let down by lack of research and evidence on medical interventions

• Thousands of children ‘let down by NHS’
• Review has major implications for mental health services

A review into the NHS’s gender identity services has found that children and young people have been let down by a lack of research and evidence on medical interventions in a debate that has become exceptionally toxic.

Dr Hilary Cass said her report was not about defining “what it means to be trans” or “undermining the validity of trans identities”, but about “how best to help the growing number of children and young people who are looking for support from the NHS in relation to their gender identity”. Here are the review’s key findings.

The evidence

“This is an area of remarkably weak evidence,” Cass writes in the foreword to her 398-page report.

Despite that, she adds: “Results of studies are exaggerated or misrepresented by people on all sides of the debate to support their viewpoint. The reality is that we have no good evidence on the long-term outcomes of interventions to manage gender-related distress.”

When Cass began her inquiry in 2020, the evidence base, especially about puberty blockers and masculinising and feminising cross-sex hormones was “weak”. That was exacerbated by the existence of “a lot of misinformation, easily accessible online, with opposing sides of the debate pointing to research to justify a position, regardless of the quality of the studies.”

Cass commissioned the University of York to undertake systematic reviews of the evidence on key issues, such as puberty blockers. It found that “there continues to be a lack of high-quality evidence in this area”. York academics, as part of their research, tried to document the outcomes seen among the 9,000 young people who the Tavistock and Portman NHS trust’s gender identity development service (Gids) treated between 2009-2020. However, it was “thwarted by a lack of cooperation from [six of England’s seven NHS] adult gender services”.

The new NHS services for these young people must routinely collect evidence of what treatments work, and learn from them to improve clinical practice, the report states.

Cass acknowledges that the discussion around how to care for such young people is polarised, both among health professionals and in wider society. For example, some clinicians believe that most people who present to gender services “will go on to have a long-term trans identity and should be supported to access a medical pathway at an early stage”.

“Others feel that we are medicalising children and young people whose multiple other difficulties are manifesting through gender confusion and gender-related distress. The toxicity of the debate is exceptional,” the report says.

Cass has been criticised for talking both to groups who support gender affirmation – the medical approach – and also those who believe greater caution is needed. Some experienced doctors who have offered different viewpoints have been “dismissed and invalidated”, she says.

“There are few other areas of healthcare where professionals are so afraid to openly discuss their views, where people are vilified on social media and where name-calling echoes the worst bullying behaviour. This must stop.”

The toxicity of debate has made some clinicians fearful of working with these young people.

The Tavistock and Portman NHS Trust

When its Gids service was set up in 1989, it saw fewer than 10 children a year, mainly birth-registered males who had not reached puberty. Most received therapy and only a few hormones from the age of 16.

But in 2011 the UK began trialling the use of puberty blockers, as a result of the emergence of “the Dutch protocol”, which involved using them from early puberty. However, a study undertaken in 2015-16, although not published until 2020, shows “a lack of any positive measurable outcomes”.

“Despite this, from 2014 puberty blockers moved from a research-only protocol to being available in routine clinical practice.” This “adoption of a treatment with uncertain benefits without further scrutiny” helped increase the demand among patients for them, the report finds.

An NHS England review in 2019, which examined the evidence on medical intervention and found evidence of its effectiveness to be “weak”, led to Cass being asked to undertake her review.

Changing patient profile

Referral rates to Gids have rocketed since 2014, but there has also been a shift in the profile of those using services. For centuries transgender people have been predominantly trans females who present in adulthood. Now the vast majority are teenagers who were registered as female at birth.

An audit of discharge notes of Gids patients between 1 April 2018 and 31 December 2022 showed the youngest patient was three, the oldest 18, and 73% were birth-registered females, according to the review, which tries to discover why things have changed so dramatically.

One area it explores is the deterioration in mental health among young people, and the links with social media, which have brought pressures to bear on them that no previous generation has experienced.

“The increase in presentations to gender clinics has to some degree paralleled this deterioration in child and adolescent mental health,” the review says. “Mental health problems have risen in both boys and girls, but have been most striking in girls and young women.”

Youngsters who present with gender identity issues to services may also have depression, anxiety, body dysmorphia, tics and eating disorders, as well as autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Referrals to Gids are also associated with higher than average rates of adverse childhood experiences, the review says.

“There is no single explanation for the increase in prevalence of gender incongruence or the change in case-mix of those being referred to gender services,” the review says, concluding instead that gender incongruence is a result of “a complex interplay between biological, psychological and social factors”.

Transitioning

Young people’s sense of their identity is not always fixed and can evolve over time, Cass says.

“Whilst some young people may feel an urgency to transition, young adults looking back at their younger selves would often advise slowing down,” the report says.

“For some, the best outcome will be transition, whereas others may resolve their distress in other ways. Some may transition and then de/retransition and/or experience regret. The NHS needs to care for all those seeking support.”

Social transitioning

Social transitioning is the process by which individuals make social changes in order to live as a different gender, such as changing name, pronouns, hair or clothing, and it is something that schools in England have been grappling with in recent years.

According to the Cass review, many children and young people attending Gids have already changed their names by deed-poll and attend school in their chosen gender by the time they are seen.

The review says research on the impact of social transition is generally of a poor quality and the findings are contradictory. Some studies suggest that allowing a child to socially transition may improve mental health and social and educational participation.

Others say a child who is allowed to socially transition is more likely to have an altered trajectory, leading to medical intervention, which will have life-long implications, when they might otherwise have desisted.

“Given the weakness of the research in this area there remain many unknowns about the impact of social transition,” the review concludes. “In particular, it is unclear whether it alters the trajectory of gender development, and what short- and longer-term impact this may have on mental health.”

The review recommends that parents should be involved in decision making, unless there are strong grounds to believe this may put a child at risk, and where children are pre-puberty, families should be seen as early as possible by a clinician with relevant experience. It also suggests avoiding premature decisions and considering partial rather than full transitioning as a way of keeping options open.

Future care

The report says that in the future any young person seeking NHS help with gender-related distress should be screened to see if they have any neurodevelopmental conditions, such as autism spectrum disorder, and also given a mental health assessment.

NHS England has already in effect banned the use of puberty blockers because of limited evidence that they work. Cass found that there is “no evidence that puberty blockers buy time to think”, which their advocates have claimed. There is also “concern that they may change the trajectory of psychosexual and gender identity development” as well as pose long-term risks to users’ bone health, the review says.

There is also a lack of evidence to prove that masculinising and feminising hormones improve a young person’s body satisfaction and psychosocial health, and there is concern over the impact on fertility, growth and bone health. There is also no evidence they reduce the risk of suicide in children, as their proponents have claimed.

Lastly, the evidence base showing whether psychosocial interventions – therapy – work for those who do not undergo hormone treatment is “as weak” as for puberty blockers and cross-sex hormones.

All this means that there is “a major gap in our knowledge about how best to support and help the growing population of young people with gender-related distress in the context of complex presentations”.

• Transgender
• Young people

Most viewed

Meet the Institutes

Rice's growing portfolio of research hubs creates new opportunities for collaboration and discovery.

As part of a ramp-up in Rice’s strategic research aspirations in health care sciences and technologies, data science and machine learning, and energy, environment and sustainability, the Office of Research, led by Vice President Ramamoorthy Ramesh, recently launched several new institutes. Meet the distinguished scholars leading these dynamic institutes and learn more about their goals in this roundup of Rice’s growing research portfolio.

An Interdisciplinary Powerhouse

Rice’s Synthetic Biology Institute will create new tools for living systems.

The Medical Experience, Humanized

Rice’s new Medical Humanities Research Institute expands the conversation around health care and disease.

The Right To Clean Water

The new Clean Water Technologies Entrepreneurship and Research Institute (WaTER) focuses on the intersection of water and public health, energy transitions and resilient infrastructure.

A Vibrant Landscape for Exchange

The Rice Advanced Materials Institute builds collaborations on energy, electronics and the environment.

An Impact Amplifier

“Think global, act local” drives the new Rice Sustainability Institute.

Big Steps for Little Ones

Rice360 is helping improve newborn care across Africa.

Wide Open Space 

The Rice Space Institute extends its reach.

Policy and People

Rice’s Baker Institute for Public Policy delivers data-driven research and independent, nonpartisan discourse on critical foreign and domestic issues.

The New Digital Age

Rice’s Ken Kennedy Institute takes on challenges within artificial intelligence.

Nanoscience Branches Out at Rice

The Smalley-Curl Institute has expanded to include quantum science, physics, advanced materials and more.

Local Impact, National Reputation

The Kinder Institute for Urban Research develops solutions to help all Houstonians prosper.

Advancing Religious Pluralism

The Boniuk Institute fosters religious literacy through research and education.

Full Potential

The Doerr Institute for New Leaders looks forward to a new era.