IRBIS does NOT generate these documents with application-specific information.
Concise Summary examples can be found here .
Guidance on the use of plain language in consent forms:
There are a few additional forms that are not provided online and may be accessed below. As needed, these should be completed and uploaded to your IRB application.
COVID-19 Related Forms:
Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).
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.
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.
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 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 .
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.
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.
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/
The informed consent document should succinctly describe the research as it has been presented in the IRB application.
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.
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.
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.
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 4/17/24
(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
(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.
Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]
This template includes key information that you should provide to get consent from people participating in your research interviews or focus groups. Before you use this template, check out the getting consent guide for more information.
I ….............................................................(name), being over the age of 18 years, hereby consent to participate as requested in the [focus group/interview] for the research project held on …………………………………… (date).
Name, Role – Organisation
Email and phone number
Participant’s signature: ………………………………………
Date: ……………………………………………………………………
Date of birth: ………………………………………………………
General consent form to participate in research (DOC)
Two stage project consent form (DOC)
Parent permission form for research with child (DOC)
Child assent form (DOC)
Multiple consent form including audio-recording and quotations (DOC)
Photo and video consent form (DOC)
Video-recording consent form (DOC)
Re-contact agreement form (DOC)
Post-debriefing consent form (DOC)
Need to interview someone for research or journalistic purposes? Optimize your research or reporting process with our informed consent form for an interview. Designed for interviewees to grant permission to use their data, this simple consent form for interview is perfect for qualitative research or journalistic reports. This template is designed for a research interview with audio recording, but it can be easily adapted for other cases.
Key features of the Consent Form for Research Interview:
Make this consent form sample for an interview your own and start using it today! Simply add this template to your account, customize it to fit your needs, and start leveraging its benefits immediately. With AidaForm, you can create professional digital consent forms in minutes – no design or coding knowledge needed!
What is an interview consent form.
An interview consent form is a legal document that informs participants about the interview process and obtains their voluntary consent to participate prior to the interview. It empowers participants to make informed choices about their participation by outlining the interview purpose, data handling, rights and withdrawal option. It is often required for academic research (for dissertations) and for professional interviews (for journalism).
Clearly explain the interview’s purpose, scope and key details for participants in plain language, avoiding jargon and complex terms. Emphasize that participation is voluntary and individuals can withdraw at any time. Use clear headings, formatting and bullet points for easy navigation.
Customize your form in 4 simple steps:
Get started with a template . Click “Use This Template” to add the consent form to your AidaForm account. If you don’t have one yet, that’s ok. It takes minutes to create an account with AidaForm.
Customize form fields . Use our drag-and-drop editor to swap out pre-written text, add extra fields and pick a design that matches your brand. Think of it as giving your consent form a modern upgrade!
Add checkboxes . Make signing a breeze for clients by adding digital checkboxes and a signature field. This streamlines smooth consent collection without any hassle. Remember to consult a lawyer to ensure your disclaimer texts comply with local regulations.
Publish your form . Ready to launch your form? Toggle the “Publish” button and it’s live! Let people know by adding the form to your website.
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Home > All Tools > Informed Consent Form Template for Qualitative Studies
Informed consent form template for qualitative studies.
This template is for research interventions that use questionnaires, in-depth interviews or focus group discussions. The form consists of two parts: the information sheet and the consent certificate
Last modified: April 13, 2020
Language: English
Templates for informed consent forms
Notes to researchers
The language used throughout form should be at the level of a local student of class 6th/8th
Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.
The informed consent form consists of two parts: the information sheet and the consent certificate.
Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.
These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.
In these templates:
IMAGES
VIDEO
COMMENTS
University Institutional Review Board. The phone number for the IRB is (212) 678-4105 and the email is [email protected]. Or, you can write to the IRB at Teachers College, Columbia. University, 525 W. 120th Street, New York, NY, 10027, Box 151. Include both the PI's contact information and TC IRB's contact information on every consent form. • I ...
Interview Consent Form School of GeoSciences - Ethics Committee - 2013 1 Here is an outline of the information you should consider including on an 'Interview Consent' form. This template is not prescriptive and it is provided to act only as a guide for your research project requirements. Interview Consent Form Research project title:
Sample Informed Consent Form - ©NCPI. The following is a sample consent form for a research project. It is a research project on faculty life on campus, carried out by the principle investigator (PI) of this project from the fake-named Century University. The interviewer (the investigator) should have the interviewee read this form carefully ...
Double-check that the information in your consent form/forms matches/match the information provided in your research ethics protocol (and funding proposal if applicable). Consent forms should be written at a reading level appropriate for your target audience. Use clear language, avoid acronyms/academic jargon, and explain terms a layperson may ...
Participant Consent FormP. rticipant Consent Form This template is designed primarily for those doing qualitative interviews with adults from non-vulnerable populations and dealing wit. non-sensitive topics.The form would be different in the case of focus groups. r quantitative research. If conducting research with vulnerable populations and ...
se this template if your research is NOT. derally-sponsore. A. D participants are adults.Avoid Common Problems with Consent Forms. Read these tips!1. ustomize this template to reflect the specifics of your study and participan. population.Text in [brackets] represents study-specific information that must be added.A ba.
General Consent Form Templates. Social and Behavioral Research Projects (last updated 03/16/2023) Biomedical Research Projects (last updated 07/18/2022)
If you like, a summary of the results of the study will be sent to you. If you have any other concerns about your rights as a research participant that have not been answered by the investigators, you may contact the Smith College Institutional Review Board at [email protected] or (413) 585-3562.
l study and what the outputs will be}.If you wish to take part in the interview, you need to fill in this consent form. We will ask for your email address so we can contact you regarding an opportunity t. participate in a follow-up interview.During this interview, we will ask you a se. ies of questions related to {explain}. We.
Consent for participation in research interview [name of the project] funded by [name of the sponsor] agree to participate in a research project conducted by Prof. [Name of the Principal Investigator] from the European University Institute (EUI) in Florence, Italy. I have received sufficient information about this research project and ...
A Journey Through Qualitative Research. From Design to Reporting. London: Sage. 1 Consent form for an interview. Example Title of the research: Name of the researchers : Affiliation and address : Phone number and email : Invitation to Participate: I am invited to participate in the research study entitled (title of the
2023-04-10. The following documents are samples. IRBIS does NOT generate these documents with application-specific information. Exempt Research Information Sheet. 2017-10-30. Addendum to provide additional information to subject after original consent. 2024-08-09. SSN Collection for Medicare Recipients. 2017-04-17.
The logo of the Institution must be used on the ICF and not the WHO logo. The informed consent form consists of two parts: the information sheet and the consent certificate. Do not be concerned by the length of this template. It is long only because it contains guidance and explanations which are for you and which you will not include in the ...
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 ...
This is an example of a form you should provide to get consent from people participating in your research interviews or focus groups. Why use it? This template includes key information that you should provide to get consent from people participating in your research interviews or focus groups. ... Interview/Focus group consent form. I ...
This template is a guide to help researchers design study information sheets and consent forms. It has been designed with reference to HRA Participant Information Sheet Preparation Guidance. Sample text is italicised. Alter or delete as required as you produce the draft. Standard required text is underlined.
Contact. Sample consent and permission forms. General consent form to participate in research (DOC) Two stage project consent form (DOC) Parent permission form for research with child (DOC) Child assent form (DOC) Multiple consent form including audio-recording and quotations (DOC) Photo and video consent form (DOC)
Key features of the Consent Form for Research Interview: Secure online storage and easy customization; Mobile-friendly design; Built-in signature field; Ability to save signed forms as PDFs and print them; Make this consent form sample for an interview your own and start using it today! Simply add this template to your account, customize it to ...
The informed consent form should be accompanied by an information sheet that describes: 1. General information about the research and the collected research data • Purpose of the research • Type of research intervention, e.g. questionnaire, interview, etc. • Voluntary nature of participation • Benefits and risks of participating
This template is for research interventions that use questionnaires, in-depth interviews or focus group discussions. The form consists of two parts: the information sheet and the consent certificate. Last modified: April 13, 2020. Language: English.
Please do not write any identifying information on the survey/questionnaire.". Also see the Sample Cover Letter - Studies Involving Mailed Surveys/Questionnaires provided below, which is an optional cover letter that may be used separately or in conjunction with the sample consent form for adults depending on the appropriateness of the situation.
Research Ethics Review Committee (ERC) The Research Ethics Review Committee (ERC) is a 27-member committee established and appointed by the Director-General. Its mandate is to ensure WHO only supports research of the highest ethical standards. The ERC reviews all research projects, involving human participants supported either financially or ...
Research Consent Form. STUDY DETAILS. The purpose of this study is for us to better understand the user experience of our products and services. Your participation in this study will help us modify, develop, or otherwise improve our products and services. This study will consist of a 1-on-1 interview with a member of our research team.