literature review ethics application

Ethical review application

If your research involves human participants, their data or samples, then ethical review and approval is mandatory and must be obtained  before  starting your research. This page describes how to submit an application for ethical review and what to expect along the way. 

Researchers should consult the guidance on ethical issues  for more on what to consider when planning research and completing an application form.

There are ethical review application form - exemplars (PDF) available for reference when completing the free-text fields in the application form and there is also  training (online and face to face) available for applicants. 

Those making the following types of applications should follow the link for additional information:

• collaborative application  (if you are collaborating with another School or organisation)
• amendment and extension applications  (if you already have ethical approval but your plans have changed or you need to extend the approval period)
• teaching module application  (if you are a module coordinator)
• human tissue and cell line related application (if your research uses human tissue or cell lines)

Applications for ethics review can only be for a specific research project or study and applications for 'umbrella', 'blanket' or generic approval (aside from teaching module approval) will not be reviewed.

For research involving the NHS

If your research involves the NHS you should also visit the Research involving the NHS page .

For research involving children

You should seek the advice of the Child Panel Representative before submitting your application - please email Dr Barbara Dritschel ( [email protected] ). There are template participant documents for children and letters to schools/parents and guardians . You may require PVG/DBS approval, check the guidance on the additional documents page.

What projects require ethical review and approval

All research involving human participants, their data or samples, requires ethical review and approval before the research starts. This includes observation-based research and research using social media . 

The term 'research' refers to a process of investigation leading to new insights.

Applications for ethics approval must be for a specific study or project that is time-limited, clearly defined in scope or aims, and where the data, participants and methods used are specified. The only exception to this is teaching module approval. 

Exemptions from ethical approval

The following types of work do not require ethical approval:

• Service evaluation . This is work to monitor, improve or test a service being delivered, where a 'service provider' (or someone acting on their behalf) collects information from a 'service user'. For example, a module coordinator seeking feedback on a module from their students, or an employer seeking feedback on its support activities from its staff.
• Audit . This is work to ascertain whether an activity was undertaken as it should have been.
• Research involving only deceased subjects. If the subjects are deceased, and the information collected will not contain sensitive information about the living, then ethical approval is not normally required. However, research involving the use of health and census information that is less than 100 years old does require ethical approval. 
• The review includes analysis of the underpinning raw data or of a dataset attached to a publication (for which researchers should follow the guidance on using secondary data ).
• The review will raise ethical issues such as around social profiling, data management issues such as managing sensitive personal data, or access issues that are best addressed by completion of the ethical review process.  

If you are unsure whether your project is research or one of the above, contact your School ethics committee  for guidance.

Other application scenarios

Blanket or generic applications.

Applications for the following will not be accepted:

• ‘Blanket or ‘umbrella’ approval to cover several projects or studies, a lab or research group’s activities, or an ongoing programme of research.
• Generic approval where researchers will pick from several potential methods, topics, or participant groups, including where these are vague or not specified.
• Approval to cover only the use of a specific research method, technique, or piece of equipment.
• Open-ended iterative sequences of experiments or similar

This does not preclude applications for a single project with multiple experimental arms, participant groups, or methods if:

• The project has a well-defined focus such as a specific research question or aim.
• The ethical issues associated with each element of the study are accounted for.
• The study’s elements, their timing, and their relationship to each other and the overall study end point and outcomes are clearly specified, defined, and justified.

Keep these points in mind when amending an existing ethical approval - your SEC may require you to submit a full application. All approvals must be renewed with a full application after five years. See the guidance on amendments and extensions .

Multi-phase, long-term and open-ended research

In large studies with multiple phases or long-term/open-ended research programmes each phase or ‘chunk’ of activity should be submitted for review as a separate application. This ensures the application’s records and documents, including any subsequent amendments, are clear and manageable. Applications can be made as each phase or activity arises (sequentially) or at the same time (in parallel).

Student researchers and student projects

Students sometimes assist on a project or study led by a member of staff which already has ethics approval, using the data or outcomes in an assessed piece of work – in these cases the staff research lead must ensure:

• The project is, or remains, in line with the guidance on this page
• Students are included in, or added to, the ethics approval
• Research participants, if any, are aware of how their data will be used.

PhD (and often Honours and Masters dissertation) research, as a piece of ‘independent research’, will normally require its own ethics approval.

Autonomous student projects

Students undertaking an autonomous research project (an independent self-led project which is not carried out as part of a course, assessed work, or University-affiliated programme such as a Laidlaw Scholarship) may wish to seek advice or obtain an ethics opinion from a University ethics committee.

To request this, the student must identify an academic member of staff to voluntarily ‘sponsor’ the ethics application.

The sponsor should:

• Provide advice on the application and project.
• Check that adequate processes are in place to ensure the ethical conduct of the project.
• Determine if their School’s SEC has capacity to review the application.

If appropriate, an ethics application can then be submitted to the sponsor’s SEC.

The SEC may, at their discretion, review the application and provide feedback, recommendations, and issue an opinion on the ethics of the project, such as reporting a favourable outcome.

This does not constitute University ‘ethics approval’, endorsement or affiliation and should not be represented as such, for example in participant information or by using University branding.

Student researchers in this scenario should also ensure they are familiar with data protection legislation and how this applies to their project, given it does not come under the remit of the University.

Why ethical review and approval is required

Ethical review is a peer-review process to help researchers fulfil their personal responsibility to act in accordance with the University’s Principles of Good Research Conduct (Policy)  and fully account for ethical issues related to research involving humans . This minimises risk to the project, the researcher, the participants and the University.

Failure to obtain and adhere to ethical approvals is defined as research misconduct .

Who should complete the application

The lead researcher, whether that is a member of staff or student, should complete the ethical review application form (Word) . For student projects, supervisors must check and countersign the application form. Failure to do so may delay approval.

The form should name all researchers associated with the project so that ethical approval covers everyone involved.

The same applies to an ethical amendment application.

Which documents to complete

More detail is available on the template documents  page.

All applications should normally include:

• ethical review application form (Word)
• participant information sheet (PIS) (Word)
• consent form (Word) .

You may also need to include copies or drafts of:

• participant advertisement (Word) : when an advert (electronic or hardcopy) will be used to recruit participants 
• participant debrief (Word) : when participants may need referral to support services or additional information about the purpose of a project following completion
• surveys or questionnaires: when using surveys or questionnaires to collect data, append copies to the application - for online surveys or questionnaires , append screenshots of the initial and final pages, and the list of questions. 
• interview or focus group schedules or topic guides: when using interviews or focus groups to collect data, append copies to the application

Depending on the nature of your research project, there are other additional documents related to policies and procedures outwith the ethical approval process, which may need to be obtained prior to research commencing and might need to be appended to your application.

Some School ethics committees (SECs) require their own forms to be submitted alongside the ethical application form. For more information, contact your  SEC . 

Research involving child participants

If the research involves child participants or is taking place in educational establishments (schools) you should include the appropriate documents:

• Letter to schools: when research is within an educational establishment. There is an initial letter to school - agreement in principle (Word) and a follow-up letter to school - study commencing (Word)
• letter to parent or guardian (Word) : when research is with child participants
• Age-appropriate documents : when research is with child participants. There are age-appropriate versions of the template PIS and consent forms (on the templates page under 'PIS and consent for child participants').

Where to submit your application

Following the completion of the form, most Schools require that you email it to your School ethics committee  (SEC), however you should check with your SEC if they have specific instructions for submission.

You should submit your application as far in advance of needing to start research as possible to ensure it can be reviewed in time for your project.

Take care in completing your application form - application forms which are poorly completed, incomplete or unsigned will be returned and may delay approval. Student applications should be checked and countersigned by their supervisor.

If your research will involve child participants you should seek guidance from the Child Panel Representative (Dr Barbara Dritschel, email  [email protected] ) before submitting the application to your SEC.  

Researchers from the Schools of Geography and Sustainable Development, Medicine and Psychology and Neuroscience may send their applications directly to their SEC as usual.

The review process

After you submit your fully completed and signed ethical review application, it is reviewed by your  School ethics committee (SEC). You can be invited to attend a meeting.  

Standard and proportionate review

• Proportionate review - this means that it can be reviewed and approved by a single SEC member without being taken to a full SEC meeting
• Standard review - this means that it will be reviewed by three SEC members or taken to a full SEC meeting 

Filter criteria and why they are used

The criteria are detailed in the filter form at the start of the  ethical review application form (Word)

Research which is complex or that brings more substantial ethical considerations can be valuable and rewarding. However, it is important to consider whether the research is appropriate given the potential participants, nature of the project, experience of the researcher, and circumstances. Projects meeting the filter criteria undergo standard review processes to ensure these aspects are fully considered, while more straightforward projects can often undergo a 'lighter touch' proportionate review. 

If an application reviewed under the proportionate review route is found to involve substantial ethical considerations it may be escalated into the standard review route for consideration by the SEC in full. 

Developing a standardised protocol for research that is complex or which brings substantial ethical considerations

Researchers, research groups or Schools that frequently conduct research projects that would normally come under the standard review route can choose to develop a proposal with a protocol or 'standard operating procedure' (SOP) that puts in place a standardised approach that mitigates the ethical issues. 

If approved, this means any subsequent research projects which strictly follow that protocol or procedure can be reviewed through the proportionate review route.

Protocols or SOPs should be submitted to the  School ethics committee  for approval in principle. The SEC will then seek final sign off from the  University Teaching and Research Ethics Committee . 

Review process and outcomes

All SECs aim to give their decision on applications as soon as possible, though exact timings vary.

The SEC can make three decisions following review:

• Immediate approval : the SEC decides that your application meets the requisite standard and is approved. This is rare because, as a peer-review process, revisions (even if minor) are often requested. 
• Requires revisions : the SEC has identified a need for you to make revisions to your application. Make the required revisions, explicitly highlighting them in the application form, and resubmit the application as instructed by your SEC. Substantial revisions may need to be reviewed at a SEC meeting. 
• Escalation to the University Teaching and Research Ethics committee (UTREC) : sensitive or complex ethical applications may need to be referred to UTREC for further guidance and approval. For most SECs, applications involving child participants must be escalated to UTREC.

If the SEC escalates your application to UTREC review and approval might take longer. If you anticipate that your project will require review by UTREC, please make sure that you submit your application to the SEC in good time so as not to delay the start of your project. Once reviewed at UTREC (at a meeting of the committee), you should be informed within three days of their decision. For information on UTREC and their meetings, refer to the UTREC web page .

How to complain 

If you have evidence that your application has not been properly processed by the SEC, please refer to the guidance on concerns and complaints .

Addressing a request for revisions

If the outcome of your ethical application has been a request for revisions, the SEC may be concerned with two areas:

• Statutory : the committee cannot approve anything that does not meet statutory requirements. For example, if the proposed project fails to comply with data protection legislation. 
• Discretionary : the committee exercises judgment over ethical issues. For example, it may judge that the project entails risk out of proportion to the benefits it may bring or that the researcher has not adequately considered (or detailed in the application form) the ethical issues arising from the proposed research.

Using the committee’s comments, you should revise your application and address any issues. There is guidance available on the ethical issues to consider when planning your research or completing the application form. 

When resubmitting your application, make sure to explicitly highlight where you have dealt with the committee’s concerns. 

If you are unsure about how to revise or resubmit your application, contact your SEC .

Once your application is approved

You must wait for confirmation of approval from your SEC before you can start your research. This is normally in the form of an approval code, issued in a formal letter. Approval is valid for five years.

Once you have received approval, if your research changes and no longer reflects that which you described in your original application then you should submit an  amendment application . 

If you need to extend your approval then you should submit an extension application . Ensure you apply or an extension in good time, before your current approval is due to expire. 

If any adverse events occur during your research you should contact your SEC  and any other relevant contacts. 

Writing an Ethics Application

• First Online: 14 November 2019

Cite this chapter

• Gabriel B. Reedy 6 &
• Jill S. Sanko 7  

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Ethical research practice should be the aim of all simulation researchers. However, this intention does not always translate into the successful completion of an ethics application. In this chapter, we discuss considerations for conducting ethical research in simulation, and the relationship between these principles and the requirements for ethical approval. We will also give practical advice about the common requirements of ethics panels and institutional review boards (IRBs), to enable you to proceed as smoothly as possible through the process of gaining ethical approval for your simulation study.

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Collaborative Institutional Training Initiative (CITI) certification. https://about.citiprogram.org/en/homepage/ .

Family Educational Rights and Privacy Act (FERPA). https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html .

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Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Research. https://privacyruleandresearch.nih.gov/clin_research.asp .

Research Ethics Timeline (1939 – present). https://www.niehs.nih.gov/research/resources/bioethics/timeline/index.cfm.

The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html . ∗The Belmont Report is one of the leading publications on the ethics of healthcare research. This report helped to establish the fundamental principles we follow as healthcare researchers including: (a) respect for persons, (b) protection of autonomy, and (c) informed consent.

United Kingdom National Health Service (NHS) Health Research Authority (HRA) Guidance on the General Data Protection Regulation. https://www.hra.nhs.uk/hra-guidance-general-data-protection-regulation/ .

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Reedy, G.B., Sanko, J.S. (2019). Writing an Ethics Application. In: Nestel, D., Hui, J., Kunkler, K., Scerbo, M., Calhoun, A. (eds) Healthcare Simulation Research. Springer, Cham. https://doi.org/10.1007/978-3-030-26837-4_34

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Guide to ethical approval

• Related content
• Peer review
• Justin Nowell , specialist registrar, London Deanery
• 1 Department of Cardiothoracic Surgery, St George’s Hospital, London SW17 0QT
• justin.nowell{at}stgeorges.nhs.uk

For research involving patients, whether directly or indirectly, or involving NHS facilities, the ethical review process is mandatory. Justin Nowell takes you through it

Why read about ethics?

During their career journey many health professionals do a formal period of research. You may wish to improve your personal portfolio or raise the profile of a new department. Or are you thinking about pursuing research in the NHS? If so, you need to think carefully about ethics. As a chief investigator, whether you are a general practitioner or a nurse, a physiotherapist or a professor of medicine, the process is identical. It would be wise to plan your ethics application early, well before your proposed start date. The requirement for ethical approval applies not only to interventions like clinical trials but also to a range of other activities such as questionnaires, case note reviews, telephone surveys, and collecting samples or data. Many people find the process of applying for NHS ethical approval intimidating. A galaxy of red tape is guaranteed to dampen enthusiasm even in the most ardent researchers, however brilliant their ideas. Some knowledge of the application and review process can help ease this burden. Advance preparation may also save you a lot of wasted time.

Do I need ethical approval?

Traditionally, medical students are taught that the cornerstones of good ethics comprise beneficence, non-maleficence, autonomy, justice, dignity, and truthfulness. Therefore activities that damage these six principles undermine ethics. It is not always clear how to translate such lofty ideals into improving research. The General Medical Council advises that research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and for improving the health of the population as a whole. GMC guidance 1 requires that if you are involved in designing, organising, or doing research you must:

Put the protection of the participants’ interests first

Act with honesty and integrity

Follow the appropriate national research governance guidelines and the guidance in Research: The role and responsibilities of doctors . 2

Ethical review from the appropriate NHS research ethics committee is required for any research involving:

Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient’s or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions

Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above

Access to data, organs, or other bodily material of past and present NHS patients

Fetal material and in vitro fertilisation involving NHS patients

Those who have died recently in NHS premises

The use of, or potential access to, NHS premises or facilities

NHS staff recruited as research participants by virtue of their professional role

Healthy volunteers, if done on NHS premises.

Application form

Obtaining ethical approval is divided into national and local stages. The first task is to complete an application form. This has recently changed from the National Research Ethics Service form to a new Integrated Research Application System. 3 This is much more than just a form; it is an integrated dataset designed to fulfil the requirements of a number of review bodies. Detailed guidance notes are included in the form, but completion is time consuming, so save completed sections as you go and return later.

The aim of the ethics review process is to protect participants and promote good quality research. With this in mind, there are some searching questions to answer. There are four parts A-D and some additional forms. Part A comprises the generic and core information. Answers to part A automatically generate appropriate header sections and datasets for the remainder of the application. Part A has 78 questions, although not all questions will need to be answered and the form sieve will automatically reflect this. Resist the temptation to cut and paste large sections of your protocol—it will be obvious at the review meeting if you do. You are asked to write a comprehensive lay summary and it is worth paying special attention to this task. Since 1 May 2008 lay summaries have been published, and this will soon be extended to include summary ethical opinions. 4

Part B, comprising 25 questions, asks specifically about the product or device to be tested, tissue collection, and information security measures. Part C contains an overview of all research sites. Part D is the declarations section. There are also Research Tissue Bank and Medicines and Healthcare products Regulatory Agency forms to complete if relevant.

Applicant’s checklist

After completing the application form you must complete an applicant’s checklist. The checklist specifies supporting documents to be attached, including patient information sheets, consent forms, sometimes a letter from a statistician, and investigator and subinvestigator CVs. Online guidance is available on the format of protocols and other documents, but if you are unsure ask someone experienced; patient advisory groups are helpful in drafting documents designed to inform patients.

There is no prohibition on asking individual members of your local research ethics committee for advice; several of them are likely to be local health professionals. Probably the most valuable advice is to remember to identify all documents with a date and version number.

Where to apply

If you are unsure, the National Research Ethics Service website 4 contains a list of all local research ethics office contacts, which will be able to advise where to submit and how to book a review slot. Usually this will be via your local research ethics committee. The website also contains the standard operating procedures for ethics committees.

Provided the applicant’s checklist is complete, a reference number is issued, and the forms are locked, printed, and signed. If you do make a mistake you can ring the National Research Ethics Service helpline and they can unlock the form. Deliver signed hard copy forms with supporting documents to the designated research ethics committee office. Local research ethics committees consider around five to 10 studies a month. If they are fully booked you may be asked to return for submission the following month. There is no waiting list system for the research ethics committee —it is first come, first served. If time is tight, you could opt at this stage to submit to another research ethics committee within the same domain (area served by the same strategic health authority). Check local arrangements for submission carefully, because procedures may vary slightly. In some NHS trusts the research and development department wants to scrutinise the application before submission.

Once the application form and checklist have been approved you will receive a letter from the research ethics committee stating that the application is validated and giving a date for review. Ethics committees must provide an opinion within 60 days of validating an application.

Site specific information

The final online forms are the site specific information forms, which are submitted once the application is validated. The form has two purposes: one is to obtain NHS permission (a universal requirement) and the other is to request site specific assessment. Some types of study, such as questionnaires and surveys, are designated site specific assessment exempt. For most studies, however, once ethical approval is obtained local site specific assessment approval is required using the form. This is designed to ensure that individual sites have appropriate local resources to support the study safely.

The committee has a maximum of 18 members and one third of these are lay members. The investigator will receive an invitation to the meeting, and although attendance is not compulsory, it is advisable. The committee will consider the application for up to half an hour and then call in the investigator to answer questions. If you do attend, it will expedite the process as you may be able to clarify points raised by individual research ethics committee members.

Notification of decision

After the review meeting you will be informed of the committee’s provisional opinion, subject to certain conditions or any further information that is required. If the committee has serious concerns, complete resubmission may be requested. The committee will confirm their decision in writing within 10 days.

Request for further information

The committee may request further information or revision of documents before granting a final favourable ethical opinion. You will also be reminded that further consents may be required (site specific approval for other sites, research and development, Medicines and Healthcare products Regulatory Agency) before the study can begin.

Final approval and beyond

The research ethics committee will confirm the final ethical opinion in writing. Subsequent amendments to the study protocol must be formally notified to the committee. You are obliged to start your research within 12 months of a favourable ethical review. You must provide safety and progress reports as specified. You should also notify the committee when your study ends.

Complete the online application form

Complete the applicant’s checklist

Decide where to apply and book a review slot

Make your submission

Validation and review date

Complete site specific information form

Review meeting and provisional ethical opinion

Request for further written information

Final ethical opinion

After approval

Competing interests: None declared.

• ↵ General Medical Council. Good medical practice . London: GMC, 2006 .
• ↵ General Medical Council. Research: The role and responsibilities of doctors. London: GMC, 2002 .
• ↵ Integrated Research Application System. www.myresearchproject.org.uk .
• ↵ National Research Ethics Service. www.nres.npsa.nhs.uk .

IOE - Faculty of Education and Society

Student ethics application guidance

A step-by-step guide to filling out a research ethics application as an IOE student.

At IOE, UCL's Faculty of Education and Society, all research projects by staff, student or visitors that collect or use data from human participants are subject to an ethics review before the project starts (this may include secondary data analysis and systematic reviews). It is your responsibility to ensure that ethics approval is gained prior to the start of any fieldwork. 

Your application will be reviewed by your supervisor and another member of your advisory committee (PhD/MPhil/MRes/EdD) or another member of the course team (MA/UG/all other qualifications). They will add their comments and decision to your application form. 

The Research Ethics Committee (REC) reviews all ethics applications from staff and visitors. The REC will only review a student’s application if the research involves particularly complicated or sensitive ethical issues, or is referred by the supervisor. The committee includes representatives from each department at the IOE as well as external and student members.

All applications should be written in terms that can be understood by a lay person, including giving explanations of any abbreviations or acronyms used. 

Should your application be referred to the REC and the relevant questions/sections are not completed, your application will be returned to you to complete before it is reviewed by the committee. Where particular ethical issues are not addressed adequately the committee may request further information. This can lengthen the time it takes to get ethical approval. 

The form should be completed in Microsoft Word. Text boxes will expand.

This guidance will help you complete your ethics application form section by section. If you would like any further support please contact your Department Graduate Tutor .

Further information can be found on our IOE Research Ethics Committee website .

This section provides the Research Ethics Committee reviewers and IOE’s administrators with all the background details of your project to ensure it is considered by the right members of staff. 

If you are receiving any funding for your research, include details here. If you do have funding this is normally confirmed for a project before the ethics review process, unless you choose to request an earlier review, or a specific funder requires an earlier review. If there is more than one funder please state here.

Reviewers will be able to consider whether the funding source presents any ethical concerns. In addition, different funders may have different ethical review requirements for you to consider.

The project’s start date may precede ethical approval, however no fieldwork should begin until approval has been received. 

Ethical approval will cover your research as outlined in the application form for the duration you state. 

Country fieldwork will be conducted in

If you are conducting your research abroad you will need to give details here and provide further information later in the form under Research Methods Summary (section 2) and Ethical Issues (section 8). It is important that you discuss working abroad with your supervisor as early as possible. Please note that not all travel will be authorised by the IOE. 

If you are travelling overseas you must fill out UCL’s travel insurance form  and send it to the named contact in UCL Insurance.

Please check the Foreign and Commonwealth Office (FCO) website for travel advice and confirm the status they give to the country you intend to travel to. If you are planning to visit a country or city where the FCO advises against all travel the IOE will not normally sanction your travel.

If the FCO advises against all but essential travel, you must discuss this with your supervisor and provide written justification of your travel plans. Alongside this insurance form you must supply a detailed account of how the risks associated with your travel are going to be mitigated. 

There is further information regarding field work risk assessment on UCL's Off-site Working guidance. However, as section 8 of the ethics form already covers this you are not required to complete the full risk assessment form the UCL Safety team provides.

External research ethics committees

If the proposal has gone through another rigorous ethics review process, it does not need to be reviewed again by the IOE’s Research Ethics Committee. 

This is most likely to occur when your research project has been reviewed through the NHS system ( Integrated Research Application System ) or another university’s ethics review process (where they are the lead investigators). If this is the case, please provide information about any external ethical approval you have received for our records. If your project has been reviewed elsewhere you do not need to complete Sections 2-8. 

You will need to send a copy of the ethics approval notice to your supervisor and local administrator.

Research requiring external ethical approval

Not all research at the IOE can be ethically approved by the Research Ethics Committee; some must be ethically reviewed by other specialist ethics committees. 

• Research involving NHS patients, service uses (those using NHS services) and NHS premises must be ethically approved by the NHS Research Ethics Service (RES). Please note the following exceptions : research involving NHS or social care staff recruited as research participants by virtue of their professional role does not usually require NHS ethical approval and so should be submitted to the IOE’s Research Ethics Committee. Research activities defined by NRES as not requiring ethics review within the NRES processes include audit and service evaluation. 
• Under the Mental Capacity Act 2005 (MCA 2005) , any research that proposes to involve the recruitment of participants aged 16 and above who lack capacity to consent to take part in the research or who later lose capacity during the research must have ethical approval by a recognised appropriate body such as the Social Care Research Ethics Committee or certain National Research Ethics Service Research Ethics Committees. 
• Social research funded by the Department of Health and therefore requiring review by the Social Care Research Ethics Committee (SCREC) . 
• Research which involves human participants, and which is funded or sponsored by the Ministry of Defence (MOD) must secure approval from the MOD Research Ethics Committee (MODREC) . 
• Research that involves prisons, youth offending or probation services requires approval through the National Offender Management Service (NOMS) or NHS committee.   

In this section you will need to enable the reviewers to fully comprehend the scope of your research project. This should include clear information on the aims and any supporting research, the rationale and justification for the research, the study design (including data collection and methods of analysis) as well as a justification for all of the research methods to be used and the topics/questions presented to participants. In order to assist the reviewers in understanding the project, ensure that your explanation is written in lay language and that any acronyms or abbreviations are clearly explained. 

Please ensure you tick all of the methods that will be used in your research and follow the directions for which section to complete next. This information enables the reviewers to consider the extent of the ethical issues that may arise depending on methods. 

You should attach a copy of the questionnaires or interview schedules you will be using.

Most research projects at IOE are likely to have human participants, but not all. For example, if a literature review is a project in its own right (rather than one component of a wider project) there may be no human participants. 

For research where there are participants, please ensure that you tick all relevant boxes. Research participants are those from whom you are collecting data (i.e. through questionnaires, interviews, focus groups or observation) as well as those whose personal data may be used (including for secondary analysis) and participants in action research. Not all research will involve direct interaction with participants. 

Research involving children

Ensure that you are clear on the ages of the children involved and provide more detailed information in sections 2 and 8. 

Research involving adults

Describe them briefly (e.g. teachers, parents, adult learners, patients) and provide more information under sections 2 and 8. 

Research involving unknown participants

If you do not yet know who the participants will be, tick the ‘unknown’ box and explain clearly why this is.

Research involving vulnerable participants

If you intend to conduct research with vulnerable participants (such as those in care, children, people in custody, participants with mental health difficulties) this should be covered in the ethical issues section.  

Some projects may collect or encounter security-sensitive research material. This may be more likely if your project is within any of the following categories: 

• Commissioned by the military; 
• Commissioned under a European Union (or other) security programme; 
• Involve the acquisition of security clearances; 
• Concerns terrorist or extreme groups. 

If your project will involve security-sensitive material, please provide further details in Section 8 Ethical Issues. Once your application has been received, you will be asked to provide more information and you may be required to follow specific data storage and other practices.

A systematic review is a literature review that asks one or more specific research questions. It uses systematic and explicit research methods to review relevant research in relation to these research questions. 

In a systematic review, the findings of existing research studies themselves become raw data for analysis and interpretation. These data usually come from reports and information that are already in the public domain, for example published theses, papers and other publications. 

Systematic reviews are often considered to have a low risk of potential harm. The following points might be helpful in judging this for your own project: 

Systematic reviews are often conducted alongside some form of consultation

If you intend to collect new data from people alongside your review of the literature, such as by the use of focus groups, you should consider the ethical concerns that could arise, e.g. if you plan to report what individual people say, and you should complete the rest of the application form with this in mind. 

Will you be contacting the original research team?

If you require clarification on certain matters and decide to contact the original research team you should consider what issues may arise from this. Will this only be clarification or will new data be obtained? Is there the potential for a breach of participant confidentiality? 

Further information

• Systematic reviews that are not collecting any new data or analysing secondary data are not required to complete the ethical issues section (Section 8 Ethical issues). This light touch approach is appropriate where the potential for risk of harm to participants and others affected by the research is minimal.

Secondary data analysis is eligible for light touch review if the following criteria are met:

• the appropriate permissions have been gained;
• the data have been or will be anonymised;
• ‘technical and organisational measures’ to ensure that they process only the personal data necessary for the research purposes, in particular ensuring compliance with the principle of data minimisation, e.g. the use of pseudonymisation, are put in place
• the processing is not carried out of the purposes of measures or decisions with respect to a data subject (except in the context of ‘approved medical research’); and
• the processing is not likely to cause substantial damage or distress to an individual;
• the analysis is within the remit the data was collected for. 

This light touch approach is appropriate where the potential for risk of harm to participants and others affected by the research is minimal. Approval of these applications is confirmed by the Chair or Deputy of the Research Ethics Committee.

A full review is necessary where the data are:

• sensitive or may infringe an individual’s privacy; 
• ‘special category personal data’ under data protection legislation;
• at individual level; and
• to be linked to an individual or identification is reasonably likely.

Special category personal data mean personal data consisting of information relating to:

• data which reveals racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership;
• data concerning health (the physical or mental health of a person, including the provision of health care services);
• data concerning sex life or sexual orientation; or
• genetic or biometric data processed to uniquely identify a natural person. Note: Collecting and using special category personal data requires a further basis (meaning a specific justification) under GDPR Article 9(2) and the Data Protection Act 2018.

UCL’s view is that the most appropriate legal basis to rely upon when processing ‘special category personal data’ for research purposes is Article 9(2)(j), i.e. where the processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.

Reliance on this condition requires UCL to ensure that the processing meets the public interest test and ‘appropriate safeguards’ are in place. These ‘appropriate safeguards’ include:

• using ‘technical and organisational measures’ to ensure data minimisation, e.g. pseudonymisation;
• using anonymised data where possible;
• not processing in ways that are likely to cause substantial damage or distress to individuals;
• not supporting measures or decisions with respect to individuals; and
• having the assurance that research ethics committee approval is in place where needed.

In this section you will need to explain how data will be stored and managed both during and after the research, as well as who will have access to the data. This must be provided so that UCL can register all projects that are collecting or using data from human participants. The registration process for students is managed by the Data Protection team at UCL ( [email protected] ). The Research Development Administrator will liaise with the team on your behalf.

The questions in section 7f ask you to confirm that you have appropriate organisation and technical measures in place to ensure security for the data you are using in compliance with data protection legislation. 

You are advised to refer to UCL’s Data Protection Policy  and Information Security Policy  when answering this question.

In addition, the Information Commissioner’s Office (ICO) has a very helpful, plain English guide to GDPR ( The Guide to Data Protection ) that breaks down each principle and provides examples.

Data security and sharing

Please ensure that you address the following in relation to all hard copy and electronic data:

• How and where will the data be stored both during and after the research? 
• How will you ensure the safety and security of the data?
• How will you prevent accidental disclosure – e.g. by encryption of data on laptops, not taking printed confidential materials out of premises, storing files in locked cabinets in locked rooms?
• Who will have access to the data both during and after the study? This includes, for example, transcribers. 
• Will you be collecting ‘special category’ data as defined by data protection legislation (see secondary data analysis section above)? What steps have you taken to ensure that only special category personal data which is necessary to the research is collected? 
• How long will such data be kept for? Please clarify what data will be destroyed, when and how, as well as what data will be retained. 
• If data are to be retained, please clarify for what purpose, such as for further analysis and/or archiving.

General data security guidance

Antivirus software.

All devices that have access to the internet can be targeted by hackers and malware programmes, therefore it is important that all devices used have antivirus software installed. It is important to ensure that this is regularly updated. It is advisable to also ensure the firewall on your device is turned on for additional protection.

Personal computers

Many people use personal devices such as home computers and laptops for work purposes and it is important to ensure that the data on these devices are secure. The device should be password protected and if others have access to the device, such as other family members, it is best practice to create different users so that only you have access to the data. You should also consider password protecting those files.

Personal devices can be stolen or lost and so it is good practice to only store what is necessary on them.  If you no longer need data then this should be removed. In addition, if you decide to sell or gift your laptop for example, you should ensure that all data has been wiped from the device. Deleting files is not enough as it is possible to still recover the data so you should look at wiping software to ensure that no data remains. 

Wifi and public internet access

Though your personal device such as a laptop may have antivirus software to protect it you should be careful on how you access the internet. For example, wifi available in cafes and other stores are likely to be targeted and so it is advised that you do not use these options. Private password protected wifi options are best. 

Never use public computers such as internet cafes or those available in other stores or airports to access data as these systems are not secure and could easily leave the data open to attack from viruses or use by others.

More information 

Please visit the UCL Information Security Group for further guidance on all security issues.   

In this section consider the issues that may arise in this research and how you will manage them. Please ensure your answer to this section is written in terms understandable to a lay person.

To assist you, a list of issues that you may need to consider has been included in the application form at the start of the section. This list is not exhaustive, nor will every issue apply to every project. It is intended to help you think about things which may happen, and to help Research Ethics Committee members to review your proposal.

When completing the application form, certain answers/sections specifically asked you to address the issues raised in Ethical Issues section. Please ensure that all of these are addressed there.

Participants and recruitment

• Who you intend to collect data from and how
• Who the potential participants are and how you will identify them
• How you will approach potential participants
• Any approvals / necessary permissions (such as from gatekeepers) and how these will be managed

If you are planning to carry out research in regulated Education environments such as schools, or if your research will bring you into contact with children and young people (under the age of 18), or adults classed as vulnerable, you will need to have a Disclosure and Barring Service (DBS) check before you start. The DBS was previously known as the Criminal Records Bureau (CRB). If you do not already hold a current DBS check, and have not registered with the DBS update service, you will need to obtain one through UCL. 

• Further information can be found in UCL DBS Checks and Criminal Convictions Policy

Online MPhil/PhD International Students: Guidance on Applying for Criminal Records Check 

Informed consent

• How will you inform participants about the research and gain their informed consent to participate? 
• If you do not intend to gain informed consent, please explain why.
• How will you inform children about the research? Have you ensured that the consent form is easy to understand for children of this age?
• You are requested to attach copies of information leaflets etc. which you intend to use – if you do not intend to use information leaflets, please explain why not. 
• How will you document participants’ consent? 
• Will you need to get consent from participants on more than one occasion, or only at the outset of the project? 
• Have you gained consent for future use of data?

Observation

Observation is a method which raises a variety of ethical issues depending on the individual nature of the research and observation. One of the more prominent issues is whether you as the researchers will seek consent (from gatekeepers and/or individuals) for the observation, though the possible issues that could arise go beyond issues of consent.

Best practice is that informed consent should be obtained from all participants in advance of the observation. However, it is recognised that there may be occasions when this is not feasible or appropriate.  As the researcher you should ask yourself why, in such circumstances, it is not appropriate to seek informed consent from participants. One possible example could be that the observation is taking place in a public space and it is not possible to obtain consent from all those being observed.

Even where it may not be possible to seek consent, this does not preclude you as the researcher informing those involved that observation is taking place. Could you place signs in the area to let people know that observational research is taking place, or if the research is taking place in a specific company, could you arrange for an email to all staff to inform them ahead of time about the observation?

This would allow those who do not wish to be included to either avoid the area or to inform you as researcher that they do not wish to be included.  

Covert research

There may be situations where it is not appropriate to inform participants either in full or at all about the study as it may either affect the behaviour of participants and/or make it impossible to collect the data. In which case, is it possible to seek consent for the use of the data after it has been collected? For example, in psychological experiments you may need to have an element of deception in order to test the hypothesis, and so after the data has been collected it would be expected that you would debrief participants; explaining the deception and reasons for it and then seek their consent again based on this new information.

The ESRC Framework for Research Ethics (Updated January 2015, page 31-2) states that:

“ “Covert research may be undertaken when it may provide unique forms of evidence that are crucial to the research objectives and methodology or where overt observation might alter the phenomenon being studied. The broad principle should be that covert research should not be undertaken lightly or routinely. It is only justified if important issues are being addressed and if matters of social significance which cannot be uncovered in other ways are likely to be discovered. Normally, social scientists should ensure that research participants are aware of and consent to arrangements made with regard to the management and security of data, the preservation of anonymity, and any risk that might arise during or beyond the project itself, and how these might be minimised or avoided. Disciplinary professional ethics codes may be helpful here.  Where the research design is such that valid consent cannot be obtained from participants before data is gathered, REC review of the protocol should take place at the highest level. Wherever practically possible participants should be fully debriefed about the true aims and objectives of the research and given the opportunity to withdraw their data from the study (e.g. experimental studies involving deception). Researchers should also ensure they have received the relevant permission from gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to undertake research on public sector property.” 

Studies such as these must apply to the Research Ethics Committee for ethical approval, including studies conducted by students. 

Opt-in/opt-out sampling

When seeking to recruit participants the most often used approach is opt-in sampling. This means that following receipt of information about the research (such as information sheets/letters) the potential participants take an active step in agreeing to participate. This is often in the form of returning signed consent forms or completed questionnaires, for example: 

Opt-in sampling

• Information sheets sent to potential participants
• Signed consent form/completed questionnaire(s) returned to researcher
• Individual included in research as participant
• No response received, returned unsigned or incomplete
• Individual not included in the research

Using this approach, if you need to seek additional approval from parents/carers or gatekeepers such as schools, you need to wait until this permission has been given before approaching individuals/collecting data. An example process for this is below.

• Information sheets sent to parent(s) or carer(s) or child
• Parent/carer returns signed consent form
• Consent form discussed with child
• Child agrees to take part in the research
• Data collection begins
• Parent/carer does not return signed consent form or returns unsigned
• Child is not included in the research

Opt-out sampling

Another method that is used is opt-out sampling, whereby information is sent to all potential participants and gatekeepers/parents as above, but researchers deem participants to have agreed to take part unless they specifically state otherwise.  

• Information sheet sent to potential participants
• No response received
• Individual contacts researcher to refuse
• Individual not included in research as participant

A further example of the process for studies involving children using the opt-out method for parental consent is below.

• Information sheets sent to parent/s or carer and child
• No response received from parent/carer
• Child agrees to take part in the research
• Child is included in research as participant
• Parent/carer contacts researcher to refuse permission for their child to be included
• Child not included in the research

Choosing opt-in or opt-out

It is recognised that using the opt-in sampling method can lead to lower response rates and potentially a less representative sample of participants, such as those in the harder to reach areas. It can be for such reasons that a researcher may choose to adopt an opt-out approach instead.  

Both methods are accepted by ethics committees, and the researcher will need to decide which the most appropriate method for their particular research is. If you choose to use opt-out sampling, the reason for doing so would need to be explained in the ethics application. 

Many committees will prefer the use of opt-in as one of the principles of informed consent is that participants must participant willingly and without coercion (see the ESRC Framework for Research Ethics ) and using opt-in sampling helps to demonstrate this with the active step participants and gatekeepers need to take in order to show their agreement to participate. Those that do not take that step are simply excluded from the study as their consent has not been given. In addition, if participants do not wish to take part they do not need to take an active step in order to do this, they can simply not respond. On the other hand, opt-out requires individuals to actively refuse to participate, which some may feel unable to so and may feel some pressure to participate. 

For example, are potential participants being asked to indicate their refusal to participate as a group (and so publically indicating their refusal), or through an organisation they are working for or seeking services from? Consider also the relationship of the gatekeepers and whether their involvement could lead to possible participants feeling pressured to accept. There are, by its very nature, more ethical implications to be considered for opt-out sampling than opt-in and these would need to be addressed in the ethics application.

The decision to use opt-in or opt-out consent should be made on the basis of appropriateness for your study. In both cases all relevant parties must still be provided with clear and detailed information regarding the study, as would normally be expected in ensuring informed consent. The differences lie in the process for taking or assuming consent.

Research with children

• See  Research with Children: Guidance on Data Protection Issues

Benefits of the research

• Who will benefit from this research? 
• How will participants benefit, now or in the future?
• Who else might benefit, now or in the future?
• Will you offer participants financial incentives (e.g. shopping vouchers, entry in a prize draw) to take part in the research? If so, how much will you offer and how will you ensure that the payment does not unduly influence their decision to take part and their responses to your questions?
• Will you offer to meet participants’ expenses (e.g. travel costs, child care costs) to take part in the research? 

Risks of the research

• Please address any risks that may arise for participants as a result of participation, and how these will be managed. ‘Risks’ includes physical, mental and emotional risks, including distress. 
• Where sensitive topics/events that are likely to cause distress are part of data collection, please clarify the experience of the researcher/s concerned in managing these.
• Clarify whether there are any risks for the researchers, such as working alone in a hazardous place, and describe how these will be addressed. 
• Are there risks to anyone else?

Anonymised data, pseudonymised data and disclosure

• What personal data will be anonymised and how will this be done? 
• Will personal data be pseudonymised?
• What level of anonymity or confidentiality will you promise the participants and how will this be guaranteed?
• Is the nature of the research (such as topics to be discussed) likely to divulge information that could necessitate disclosure to other parties, for instance issues relating to child protection? If so, clarify the possible foreseen issues and describe how these will be addressed and how participants will be informed of the potential for disclosure.

Post research

• Who will you inform about the findings of the research, and how? 
• Will you tell participants about the results? If so how will this be done?

Research outside the UK

• If the work involves data collection outside the UK, are there any special issues arising because of the country/ies where the work takes place? Issues might include different values and traditions which affect approaches to gaining informed consent, and making arrangements for speakers of other languages.
• Are there additional permissions/authorisations that need to be obtained? This includes any local ethical approvals.
• If research is to be conducted abroad please check the Foreign and Commonwealth Office  and UCL's International Travel Policy & Procedures for full details on the processes to be followed, including completing and submitting a full risk assessment form.

Please note, that not all travel will be authorised by IOE.

Use this section to set out any further information relating to your project you wish to have considered by the reviewers.

You are required to attach all necessary supporting documents to your application, in particular copies of any external ethical approval (if applicable) and recruitment documents such as information sheets and consent forms. If these are not available please state the reason. 

Please note that attachments relating to the recruitment of participants (where the research involves participants) are essential for review and so applications submitted without these may not be reviewed until they have been submitted. 

Specific guidance on writing information sheets and consent forms is available on the IOE's Research Ethics student pages , but in summary they should:

• cover all aspects of the research;
• be clear and comprehensible (including translations if applicable);
• include contact details for the researcher;
• clearly state that participants can withdraw at any time, without reason and without any impact on   them;
• be clear about what will happen to their data if they decide to withdraw;
• be provided to participants in advance to give them sufficient time to consider all the information before giving their consent.

Finally, you will need to sign and date the declaration to confirm that:

• this information is correct to the best of your knowledge;
• this is a full description of the ethical issues that may arise in the course of this project; and
• you have read, understood and will abide by the chosen set of guidelines.    

Code of ethics

State which code will govern the project. You do not have to be a member of the society in question to follow its ethics code. A project team may be multidisciplinary and have members who personally follow different codes: you must decide which code will apply for this project and record that on the form. 

Please submit your completed ethics form and attachments to your supervisor for review.

Ethics Review

Your application will be reviewed by your supervisor and another member of your advisory committee (PhD/MPhil/MRes/EdD) or another member of the course team (all other qualifications). They will add their comments and decision to your application form. 

The three types of decisions that could be made are as follows:

The reviewers are satisfied that all ethical issues have been addressed.

Referred back to applicant/approved subject to the following measures

Further information or amendments will be requested before approval can be issued. This may also include major changes to the research design if these are considered necessary. Students should address these urgently and submit their response with any supporting documentation as soon as possible. This is then resubmitted for further consideration by the reviewers.

Referred to the Research Ethics Committee (REC) for review

Student projects can be referred to the Research Ethics Committee for ethical review if they involve particularly complicated or sensitive ethical issues, and this is felt to be necessary by the supervisor. Examples of ethical issues that may require referral to the REC can be found on the ethics pages of the IOE Research Ethics Committee website.

After Approval 

You are responsible for the ethical conduct of your research and should notify the reviewers if any of the following occur:

• A complaint of any kind from any person involved or affected by your research. These may include parents/carers, gatekeepers, junior researchers and also members of the group being researched who may be adversely affected by the research reports.
• Changes in the research design, instruments, setting or participants.
• Any other events during the course of the research which give rise to ethical concerns.

Please note that changes to the design of your project can raise new ethical issues and as such require review. 

The Research Development Administrator should also be informed either by yourself or your supervisor of any complaint:  [email protected]

IOE doctoral students

All completed and approved ethics applications should be sent to the Centre for Doctoral Education for processing - [email protected] .

• Research article
• Open access
• Published: 30 April 2021

A scoping review of the literature featuring research ethics and research integrity cases

• Anna Catharina Vieira Armond   ORCID: orcid.org/0000-0002-7121-5354 1 ,
• Bert Gordijn 2 ,
• Jonathan Lewis 2 ,
• Mohammad Hosseini 2 ,
• János Kristóf Bodnár 1 ,
• Soren Holm 3 , 4 &
• Péter Kakuk 5  

BMC Medical Ethics volume  22 , Article number:  50 ( 2021 ) Cite this article

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Metrics details

The areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.

The search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.

A total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).

Conclusions

Case descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors.

Peer Review reports

There has been an increase in academic interest in research ethics (RE) and research integrity (RI) over the past decade. This is due, among other reasons, to the changing research environment with new and complex technologies, increased pressure to publish, greater competition in grant applications, increased university-industry collaborative programs, and growth in international collaborations [ 1 ]. In addition, part of the academic interest in RE and RI is due to highly publicized cases of misconduct [ 2 ].

There is a growing body of published RE and RI cases, which may contribute to public attitudes regarding both science and scientists [ 3 ]. Different approaches have been used in order to analyze RE and RI cases. Studies focusing on ORI files (Office of Research Integrity) [ 2 ], retracted papers [ 4 ], quantitative surveys [ 5 ], data audits [ 6 ], and media coverage [ 3 ] have been conducted to understand the context, causes, and consequences of these cases.

Analyses of RE and RI cases often influence policies on responsible conduct of research [ 1 ]. Moreover, details about cases facilitate a broader understanding of issues related to RE and RI and can drive interventions to address them. Currently, there are no comprehensive studies that have collected and evaluated the RE and RI cases available in the academic literature. This review has been developed by members of the EnTIRE consortium to generate information on the cases that will be made available on the Embassy of Good Science platform ( www.embassy.science ). Two separate analyses have been conducted. The first analysis uses identified research articles to explore how the literature presents cases of RE and RI, in relation to the year of publication, country, article genre, and violation involved. The second analysis uses the cases extracted from the literature in order to characterize the cases and analyze them concerning the violations involved, sanctions, and field of science.

This scoping review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and PRISMA Extension for Scoping Reviews (PRISMA-ScR). The full protocol was pre-registered and it is available at https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bde92120&appId=PPGMS .

Eligibility

Articles with non-fictional case(s) involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework, were included. Cases unrelated to scientific activities, research institutions, academic or industrial research and publication were excluded. Articles that did not contain a substantial description of the case were also excluded.

A normative framework consists of explicit rules, formulated in laws, regulations, codes, and guidelines, as well as implicit rules, which structure local research practices and influence the application of explicitly formulated rules. Therefore, if a case involves a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework, then it does so on the basis of explicit and/or implicit rules governing RE and RI practice.

Search strategy

A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without any language or date restrictions. Two parallel searches were performed with two sets of medical subject heading (MeSH) terms, one for RE and another for RI. The parallel searches generated two sets of data thereby enabling us to analyze and further investigate the overlaps in, differences in, and evolution of, the representation of RE and RI cases in the academic literature. The terms used in the first search were: (("research ethics") AND (violation OR unethical OR misconduct)). The terms used in the parallel search were: (("research integrity") AND (violation OR unethical OR misconduct)). The search strategy’s validity was tested in a pilot search, in which different keyword combinations and search strings were used, and the abstracts of the first hundred hits in each database were read (Additional file 1 ).

After searching the databases with these two search strings, the titles and abstracts of extracted items were read by three contributors independently (ACVA, PK, and KB). Articles that could potentially meet the inclusion criteria were identified. After independent reading, the three contributors compared their results to determine which studies were to be included in the next stage. In case of a disagreement, items were reassessed in order to reach a consensus. Subsequently, qualified items were read in full.

Data extraction

Data extraction processes were divided by three assessors (ACVA, PK and KB). Each list of extracted data generated by one assessor was cross-checked by the other two. In case of any inconsistencies, the case was reassessed to reach a consensus. The following categories were employed to analyze the data of each extracted item (where available): (I) author(s); (II) title; (III) year of publication; (IV) country (according to the first author's affiliation); (V) article genre; (VI) year of the case; (VII) country in which the case took place; (VIII) institution(s) and person(s) involved; (IX) field of science (FOS-OECD classification)[ 7 ]; (X) types of violation (see below); (XI) case description; and (XII) consequences for persons or institutions involved in the case.

Two sets of data were created after the data extraction process. One set was used for the analysis of articles and their representation in the literature, and the other set was created for the analysis of cases. In the set for the analysis of articles, all eligible items, including duplicate cases (cases found in more than one paper, e.g. Hwang case, Baltimore case) were included. The aim was to understand the historical aspects of violations reported in the literature as well as the paper genre in which cases are described and discussed. For this set, the variables of the year of publication (III); country (IV); article genre (V); and types of violation (X) were analyzed.

For the analysis of cases, all duplicated cases and cases that did not contain enough information about particularities to differentiate them from others (e.g. names of the people or institutions involved, country, date) were excluded. In this set, prominent cases (i.e. those found in more than one paper) were listed only once, generating a set containing solely unique cases. These additional exclusion criteria were applied to avoid multiple representations of cases. For the analysis of cases, the variables: (VI) year of the case; (VII) country in which the case took place; (VIII) institution(s) and person(s) involved; (IX) field of science (FOS-OECD classification); (X) types of violation; (XI) case details; and (XII) consequences for persons or institutions involved in the case were considered.

Article genre classification

We used ten categories to capture the differences in genre. We included a case description in a “news” genre if a case was published in the news section of a scientific journal or newspaper. Although we have not developed a search strategy for newspaper articles, some of them (e.g. New York Times) are indexed in scientific databases such as Pubmed. The same method was used to allocate case descriptions to “editorial”, “commentary”, “misconduct notice”, “retraction notice”, “review”, “letter” or “book review”. We applied the “case analysis” genre if a case description included a normative analysis of the case. The “educational” genre was used when a case description was incorporated to illustrate RE and RI guidelines or institutional policies.

Categorization of violations

For the extraction process, we used the articles’ own terminology when describing violations/ethical issues involved in the event (e.g. plagiarism, falsification, ghost authorship, conflict of interest, etc.) to tag each article. In case the terminology was incompatible with the case description, other categories were added to the original terminology for the same case. Subsequently, the resulting list of terms was standardized using the list of major and minor misbehaviors developed by Bouter and colleagues [ 8 ]. This list consists of 60 items classified into four categories: Study design, data collection, reporting, and collaboration issues. (Additional file 2 ).

Systematic search

A total of 11,641 records were identified through the RE search and 3078 in the RI search. The results of the parallel searches were combined and the duplicates removed. The remaining 10,556 records were screened, and at this stage, 9750 items were excluded because they did not fulfill the inclusion criteria. 806 items were selected for full-text reading. Subsequently, 388 articles were included in the qualitative synthesis (Fig.  1 ).

Flow diagram

Of the 388 articles, 157 were only identified via the RE search, 87 exclusively via the RI search, and 144 were identified via both search strategies. The eligible articles contained 500 case descriptions, which were used for the analysis of the publications articles analysis. 256 case descriptions discussed the same 50 cases. The Hwang case was the most frequently described case, discussed in 27 articles. Furthermore, the top 10 most described cases were found in 132 articles (Table 1 ).

For the analysis of cases, 206 (41.2% of the case descriptions) duplicates were excluded, and 56 (11.2%) cases were excluded for not providing enough information to distinguish them from other cases, resulting in 238 eligible cases.

Analysis of the articles

The categories used to classify the violations include those that pertain to the different kinds of scientific misconduct (falsification, fabrication, plagiarism), detrimental research practices (authorship issues, duplication, peer-review, errors in experimental design, and mentoring), and “other misconduct” (according to the definitions from the National Academies of Sciences and Medicine, [ 1 ]). Each case could involve more than one type of violation. The majority of cases presented more than one violation or ethical issue, with a mean of 1.56 violations per case. Figure  2 presents the frequency of each violation tagged to the articles. Falsification and fabrication were the most frequently tagged violations. The violations accounted respectively for 29.1% and 30.0% of the number of taggings (n = 780), and they were involved in 46.8% and 45.4% of the articles (n = 500 case descriptions). Problems with informed consent represented 9.1% of the number of taggings and 14% of the articles, followed by patient safety (6.7% and 10.4%) and plagiarism (5.4% and 8.4%). Detrimental research practices, such as authorship issues, duplication, peer-review, errors in experimental design, mentoring, and self-citation were mentioned cumulatively in 7.0% of the articles.

Tagged violations from the article analysis

Analysis of the cases

Figure  3 presents the frequency and percentage of each violation found in the cases. Each case could include more than one item from the list. The 238 cases were tagged 305 times, with a mean of 1.28 items per case. Fabrication and falsification were the most frequently tagged violations (44.9%), involved in 57.7% of the cases (n = 238). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%) and involved in 20.2% of the cases. Patient safety issues were the third most frequently tagged violations (11.1%), involved in 14.3% of the cases, followed by plagiarism (6.9% and 8.8%). The list of major and minor misbehaviors [ 8 ] classifies the items into study design, data collection, reporting, and collaboration issues. Our results show that 56.0% of the tagged violations involved issues in reporting, 16.4% in data collection, 15.1% involved collaboration issues, and 12.5% in the study design. The items in the original list that were not listed in the results were not involved in any case collected.

Major and minor misbehavior items from the analysis of cases

Article genre

The articles were mostly classified into “news” (33.0%), followed by “case analysis” (20.9%), “editorial” (12.1%), “commentary” (10.8%), “misconduct notice” (10.3%), “retraction notice” (6.4%), “letter” (3.6%), “educational paper” (1.3%), “review” (1%), and “book review” (0.3%) (Fig.  4 ). The articles classified into “news” and “case analysis” included predominantly prominent cases. Items classified into “news” often explored all the investigation findings step by step for the associated cases as the case progressed through investigations, and this might explain its high prevalence. The case analyses included mainly normative assessments of prominent cases. The misconduct and retraction notices included the largest number of unique cases, although a relatively large portion of the retraction and misconduct records could not be included because of insufficient case details. The articles classified into “editorial”, “commentary” and “letter” also included unique cases.

Article genre of included articles

Article analysis

The dates of the eligible articles range from 1983 to 2018 with notable peaks between 1990 and 1996, most probably associated with the Gallo [ 9 ] and Imanishi-Kari cases [ 10 ], and around 2005 with the Hwang [ 11 ], Wakefield [ 12 ], and CNEP trial cases [ 13 ] (Fig.  5 ). The trend line shows an increase in the number of articles over the years.

Frequency of articles according to the year of publication

Case analysis

The dates of included cases range from 1798 to 2016. Two cases occurred before 1910, one in 1798 and the other in 1845. Figure  6 shows the number of cases per year from 1910. An increase in the curve started in the early 1980s, reaching the highest frequency in 2004 with 13 cases.

Frequency of cases per year

Geographical distribution

The first analysis concerned the authors’ affiliation and the corresponding author’s address. Where the article contained more than one country in the affiliation list, only the first author’s location was considered. Eighty-one articles were excluded because the authors’ affiliations were not available, and 307 articles were included in the analysis. The articles originated from 26 different countries (Additional file 3 ). Most of the articles emanated from the USA and the UK (61.9% and 14.3% of articles, respectively), followed by Canada (4.9%), Australia (3.3%), China (1.6%), Japan (1.6%), Korea (1.3%), and New Zealand (1.3%). Some of the most discussed cases occurred in the USA; the Imanishi-Kari, Gallo, and Schön cases [ 9 , 10 ]. Intensely discussed cases are also associated with Canada (Fisher/Poisson and Olivieri cases), the UK (Wakefield and CNEP trial cases), South Korea (Hwang case), and Japan (RIKEN case) [ 12 , 14 ]. In terms of percentages, North America and Europe stand out in the number of articles (Fig.  7 ).

Percentage of articles and cases by continent

The case analysis involved the location where the case took place, taking into account the institutions involved in the case. For cases involving more than one country, all the countries were considered. Three cases were excluded from the analysis due to insufficient information. In the case analysis, 40 countries were involved in 235 different cases (Additional file 4 ). Our findings show that most of the reported cases occurred in the USA and the United Kingdom (59.6% and 9.8% of cases, respectively). In addition, a number of cases occurred in Canada (6.0%), Japan (5.5%), China (2.1%), and Germany (2.1%). In terms of percentages, North America and Europe stand out in the number of cases (Fig.  7 ). To enable comparison, we have additionally collected the number of published documents according to country distribution, available on SCImago Journal & Country Rank [ 16 ]. The numbers correspond to the documents published from 1996 to 2019. The USA occupies the first place in the number of documents, with 21.9%, followed by China (11.1%), UK (6.3%), Germany (5.5%), and Japan (4.9%).

Field of science

The cases were classified according to the field of science. Four cases (1.7%) could not be classified due to insufficient information. Where information was available, 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities (Fig.  8 ). Additionally, we have retrieved the number of published documents according to scientific field distribution, available on SCImago [ 16 ]. Of the total number of scientific publications, 41.5% are related to natural sciences, 22% to engineering, 25.1% to health and medical sciences, 7.8% to social sciences, 1.9% to agricultural sciences, and 1.7% to the humanities.

Field of science from the analysis of cases

This variable aimed to collect information on possible consequences and sanctions imposed by funding agencies, scientific journals and/or institutions. 97 cases could not be classified due to insufficient information. 141 cases were included. Each case could potentially include more than one outcome. Most of cases (45.4%) involved paper retraction, followed by exclusion from funding applications (35.5%). (Table 2 ).

RE and RI cases have been increasingly discussed publicly, affecting public attitudes towards scientists and raising awareness about ethical issues, violations, and their wider consequences [ 5 ]. Different approaches have been applied in order to quantify and address research misbehaviors [ 5 , 17 , 18 , 19 ]. However, most cases are investigated confidentially and the findings remain undisclosed even after the investigation [ 19 , 20 ]. Therefore, the study aimed to collect the RE and RI cases available in the scientific literature, understand how the cases are discussed, and identify the potential of case descriptions to raise awareness on RE and RI.

We collected and analyzed 500 detailed case descriptions from 388 articles and our results show that they mostly relate to extensively discussed and notorious cases. Approximately half of all included cases was mentioned in at least two different articles, and the top ten most commonly mentioned cases were discussed in 132 articles.

The prominence of certain cases in the literature, based on the number of duplicated cases we found (e.g. Hwang case), can be explained by the type of article in which cases are discussed and the type of violation involved in the case. In the article genre analysis, 33% of the cases were described in the news section of scientific publications. Our findings show that almost all article genres discuss those cases that are new and in vogue. Once the case appears in the public domain, it is intensely discussed in the media and by scientists, and some prominent cases have been discussed for more than 20 years (Table 1 ). Misconduct and retraction notices were exceptions in the article genre analysis, as they presented mostly unique cases. The misconduct notices were mainly found on the NIH repository, which is indexed in the searched databases. Some federal funding agencies like NIH usually publicize investigation findings associated with the research they fund. The results derived from the NIH repository also explains the large proportion of articles from the US (61.9%). However, in some cases, only a few details are provided about the case. For cases that have not received federal funding and have not been reported to federal authorities, the investigation is conducted by local institutions. In such instances, the reporting of findings depends on each institution’s policy and willingness to disclose information [ 21 ]. The other exception involves retraction notices. Despite the existence of ethical guidelines [ 22 ], there is no uniform and a common approach to how a journal should report a retraction. The Retraction Watch website suggests two lists of information that should be included in a retraction notice to satisfy the minimum and optimum requirements [ 22 , 23 ]. As well as disclosing the reason for the retraction and information regarding the retraction process, optimal notices should include: (I) the date when the journal was first alerted to potential problems; (II) details regarding institutional investigations and associated outcomes; (III) the effects on other papers published by the same authors; (IV) statements about more recent replications only if and when these have been validated by a third party; (V) details regarding the journal’s sanctions; and (VI) details regarding any lawsuits that have been filed regarding the case. The lack of transparency and information in retraction notices was also noted in studies that collected and evaluated retractions [ 24 ]. According to Resnik and Dinse [ 25 ], retractions notices related to cases of misconduct tend to avoid naming the specific violation involved in the case. This study found that only 32.8% of the notices identify the actual problem, such as fabrication, falsification, and plagiarism, and 58.8% reported the case as replication failure, loss of data, or error. Potential explanations for euphemisms and vague claims in retraction notices authored by editors could pertain to the possibility of legal actions from the authors, honest or self-reported errors, and lack of resources to conduct thorough investigations. In addition, the lack of transparency can also be explained by the conflicts of interests of the article’s author(s), since the notices are often written by the authors of the retracted article.

The analysis of violations/ethical issues shows the dominance of fabrication and falsification cases and explains the high prevalence of prominent cases. Non-adherence to laws and regulations (REC approval, informed consent, and data protection) was the second most prevalent issue, followed by patient safety, plagiarism, and conflicts of interest. The prevalence of the five most tagged violations in the case analysis was higher than the prevalence found in the analysis of articles that involved the same violations. The only exceptions are fabrication and falsification cases, which represented 45% of the tagged violations in the analysis of cases, and 59.1% in the article analysis. This disproportion shows a predilection for the publication of discussions related to fabrication and falsification when compared to other serious violations. Complex cases involving these types of violations make good headlines and this follows a custom pattern of writing about cases that catch the public and media’s attention [ 26 ]. The way cases of RE and RI violations are explored in the literature gives a sense that only a few scientists are “the bad apples” and they are usually discovered, investigated, and sanctioned accordingly. This implies that the integrity of science, in general, remains relatively untouched by these violations. However, studies on misconduct determinants show that scientific misconduct is a systemic problem, which involves not only individual factors, but structural and institutional factors as well, and that a combined effort is necessary to change this scenario [ 27 , 28 ].

Analysis of cases

A notable increase in RE and RI cases occurred in the 1990s, with a gradual increase until approximately 2006. This result is in agreement with studies that evaluated paper retractions [ 24 , 29 ]. Although our study did not focus only on retractions, the trend is similar. This increase in cases should not be attributed only to the increase in the number of publications, since studies that evaluated retractions show that the percentage of retraction due to fraud has increased almost ten times since 1975, compared to the total number of articles. Our results also show a gradual reduction in the number of cases from 2011 and a greater drop in 2015. However, this reduction should be considered cautiously because many investigations take years to complete and have their findings disclosed. ORI has shown that from 2001 to 2010 the investigation of their cases took an average of 20.48 months with a maximum investigation time of more than 9 years [ 24 ].

The countries from which most cases were reported were the USA (59.6%), the UK (9.8%), Canada (6.0%), Japan (5.5%), and China (2.1%). When analyzed by continent, the highest percentage of cases took place in North America, followed by Europe, Asia, Oceania, Latin America, and Africa. The predominance of cases from the USA is predictable, since the country publishes more scientific articles than any other country, with 21.8% of the total documents, according to SCImago [ 16 ]. However, the same interpretation does not apply to China, which occupies the second position in the ranking, with 11.2%. These differences in the geographical distribution were also found in a study that collected published research on research integrity [ 30 ]. The results found by Aubert Bonn and Pinxten (2019) show that studies in the United States accounted for more than half of the sample collected, and although China is one of the leaders in scientific publications, it represented only 0.7% of the sample. Our findings can also be explained by the search strategy that included only keywords in English. Since the majority of RE and RI cases are investigated and have their findings locally disclosed, the employment of English keywords and terms in the search strategy is a limitation. Moreover, our findings do not allow us to draw inferences regarding the incidence or prevalence of misconduct around the world. Instead, it shows where there is a culture of publicly disclosing information and openly discussing RE and RI cases in English documents.

Scientific field analysis

The results show that 80.8% of reported cases occurred in the medical and health sciences whilst only 1.3% occurred in the humanities. This disciplinary difference has also been observed in studies on research integrity climates. A study conducted by Haven and colleagues, [ 28 ] associated seven subscales of research climate with the disciplinary field. The subscales included: (1) Responsible Conduct of Research (RCR) resources, (2) regulatory quality, (3) integrity norms, (4) integrity socialization, (5) supervisor/supervisee relations, (6) (lack of) integrity inhibitors, and (7) expectations. The results, based on the seven subscale scores, show that researchers from the humanities and social sciences have the lowest perception of the RI climate. By contrast, the natural sciences expressed the highest perception of the RI climate, followed by the biomedical sciences. There are also significant differences in the depth and extent of the regulatory environments of different disciplines (e.g. the existence of laws, codes of conduct, policies, relevant ethics committees, or authorities). These findings corroborate our results, as those areas of science most familiar with RI tend to explore the subject further, and, consequently, are more likely to publish case details. Although the volume of published research in each research area also influences the number of cases, the predominance of medical and health sciences cases is not aligned with the trends regarding the volume of published research. According to SCImago Journal & Country Rank [ 16 ], natural sciences occupy the first place in the number of publications (41,5%), followed by the medical and health sciences (25,1%), engineering (22%), social sciences (7,8%), and the humanities (1,7%). Moreover, biomedical journals are overrepresented in the top scientific journals by IF ranking, and these journals usually have clear policies for research misconduct. High-impact journals are more likely to have higher visibility and scrutiny, and consequently, more likely to have been the subject of misconduct investigations. Additionally, the most well-known general medical journals, including NEJM, The Lancet, and the BMJ, employ journalists to write their news sections. Since these journals have the resources to produce extensive news sections, it is, therefore, more likely that medical cases will be discussed.

Violations analysis

In the analysis of violations, the cases were categorized into major and minor misbehaviors. Most cases involved data fabrication and falsification, followed by cases involving non-adherence to laws and regulations, patient safety, plagiarism, and conflicts of interest. When classified by categories, 12.5% of the tagged violations involved issues in the study design, 16.4% in data collection, 56.0% in reporting, and 15.1% involved collaboration issues. Approximately 80% of the tagged violations involved serious research misbehaviors, based on the ranking of research misbehaviors proposed by Bouter and colleagues. However, as demonstrated in a meta-analysis by Fanelli (2009), most self-declared cases involve questionable research practices. In the meta-analysis, 33.7% of scientists admitted questionable research practices, and 72% admitted when asked about the behavior of colleagues. This finding contrasts with an admission rate of 1.97% and 14.12% for cases involving fabrication, falsification, and plagiarism. However, Fanelli’s meta-analysis does not include data about research misbehaviors in its wider sense but focuses on behaviors that bias research results (i.e. fabrication and falsification, intentional non-publication of results, biased methodology, misleading reporting). In our study, the majority of cases involved FFP (66.4%). Overrepresentation of some types of violations, and underrepresentation of others, might lead to misguided efforts, as cases that receive intense publicity eventually influence policies relating to scientific misconduct and RI [ 20 ].

Sanctions analysis

The five most prevalent outcomes were paper retraction, followed by exclusion from funding applications, exclusion from service or position, dismissal and suspension, and paper correction. This result is similar to that found by Redman and Merz [ 31 ], who collected data from misconduct cases provided by the ORI. Moreover, their results show that fabrication and falsification cases are 8.8 times more likely than others to receive funding exclusions. Such cases also received, on average, 0.6 more sanctions per case. Punishments for misconduct remain under discussion, ranging from the criminalization of more serious forms of misconduct [ 32 ] to social punishments, such as those recently introduced by China [ 33 ]. The most common sanction identified by our analysis—paper retraction—is consistent with the most prevalent types of violation, that is, falsification and fabrication.

Publicizing scientific misconduct

The lack of publicly available summaries of misconduct investigations makes it difficult to share experiences and evaluate the effectiveness of policies and training programs. Publicizing scientific misconduct can have serious consequences and creates a stigma around those involved in the case. For instance, publicized allegations can damage the reputation of the accused even when they are later exonerated [ 21 ]. Thus, for published cases, it is the responsibility of the authors and editors to determine whether the name(s) of those involved should be disclosed. On the one hand, it is envisaged that disclosing the name(s) of those involved will encourage others in the community to foster good standards. On the other hand, it is suggested that someone who has made a mistake should have the right to a chance to defend his/her reputation. Regardless of whether a person's name is left out or disclosed, case reports have an important educational function and can help guide RE- and RI-related policies [ 34 ]. A recent paper published by Gunsalus [ 35 ] proposes a three-part approach to strengthen transparency in misconduct investigations. The first part consists of a checklist [ 36 ]. The second suggests that an external peer reviewer should be involved in investigative reporting. The third part calls for the publication of the peer reviewer’s findings.

Limitations

One of the possible limitations of our study may be our search strategy. Although we have conducted pilot searches and sensitivity tests to reach the most feasible and precise search strategy, we cannot exclude the possibility of having missed important cases. Furthermore, the use of English keywords was another limitation of our search. Since most investigations are performed locally and published in local repositories, our search only allowed us to access cases from English-speaking countries or discussed in academic publications written in English. Additionally, it is important to note that the published cases are not representative of all instances of misconduct, since most of them are never discovered, and when discovered, not all are fully investigated or have their findings published. It is also important to note that the lack of information from the extracted case descriptions is a limitation that affects the interpretation of our results. In our review, only 25 retraction notices contained sufficient information that allowed us to include them in our analysis in conformance with the inclusion criteria. Although our search strategy was not focused specifically on retraction and misconduct notices, we believe that if sufficiently detailed information was available in such notices, the search strategy would have identified them.

Case descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields when compared with the volume of publications produced by each field. Moreover, published cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of ethical issues for RE and RI. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations and ethical issues, and recently emerging forms of misbehaviors.

Availability of data and materials

This review has been developed by members of the EnTIRE project in order to generate information on the cases that will be made available on the Embassy of Good Science platform ( www.embassy.science ). The dataset supporting the conclusions of this article is available in the Open Science Framework (OSF) repository in https://osf.io/3xatj/?view_only=313a0477ab554b7489ee52d3046398b9 .

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Acknowledgements

The authors wish to thank the EnTIRE research group. The EnTIRE project (Mapping Normative Frameworks for Ethics and Integrity of Research) aims to create an online platform that makes RE+RI information easily accessible to the research community. The EnTIRE Consortium is composed by VU Medical Center, Amsterdam, gesinn. It Gmbh & Co Kg, KU Leuven, University of Split School of Medicine, Dublin City University, Central European University, University of Oslo, University of Manchester, European Network of Research Ethics Committees.

EnTIRE project (Mapping Normative Frameworks for Ethics and Integrity of Research) has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement N 741782. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Department of Behavioural Sciences, Faculty of Medicine, University of Debrecen, Móricz Zsigmond krt. 22. III. Apartman Diákszálló, Debrecen, 4032, Hungary

Anna Catharina Vieira Armond & János Kristóf Bodnár

Institute of Ethics, School of Theology, Philosophy and Music, Dublin City University, Dublin, Ireland

Bert Gordijn, Jonathan Lewis & Mohammad Hosseini

Centre for Social Ethics and Policy, School of Law, University of Manchester, Manchester, UK

Center for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway

Center for Ethics and Law in Biomedicine, Central European University, Budapest, Hungary

Péter Kakuk

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All authors (ACVA, BG, JL, MH, JKB, SH and PK) developed the idea for the article. ACVA, PK, JKB performed the literature search and data analysis, ACVA and PK produced the draft, and all authors critically revised it. All authors have read and approved the manuscript.

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Correspondence to Anna Catharina Vieira Armond .

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Supplementary Information

Additional file 1.

. Pilot search and search strategy.

Additional file 2

. List of Major and minor misbehavior items (Developed by Bouter LM, Tijdink J, Axelsen N, Martinson BC, ter Riet G. Ranking major and minor research misbehaviors: results from a survey among participants of four World Conferences on Research Integrity. Research integrity and peer review. 2016;1(1):17. https://doi.org/10.1186/s41073-016-0024-5 ).

Additional file 3

. Table containing the number and percentage of countries included in the analysis of articles.

Additional file 4

. Table containing the number and percentage of countries included in the analysis of the cases.

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Armond, A.C.V., Gordijn, B., Lewis, J. et al. A scoping review of the literature featuring research ethics and research integrity cases. BMC Med Ethics 22 , 50 (2021). https://doi.org/10.1186/s12910-021-00620-8

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DOI : https://doi.org/10.1186/s12910-021-00620-8

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Example Documents

Each project is different and so the documentation required for different projects is different too.  Below you will find some examples of study documentation, which you may use as a guide when producing your own.

General Tips

• Use simple words and sentences.
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• For guidance on writing a good lay summary, see VoiceNorth's short video:  Bitesize Training - How to Write a Good Lay Summar y. 

Ethics Application Forms

At Newcastle University, researchers must complete an ethics application form, before any research commences, either by:

• completing the University Online Ethics Form  or
• by completing the HRA IRAS form  (if NHS/HSC Research Ethics Committee approval required)*

*Note, if you are unsure whether your study requires NHS/HSC REC approval, you should complete the University Online Ethics Form first, which will notify you accordingly if NHS/HSC REC approval is needed.

Ethics application forms will ask the researcher for key information about the research project, including:

• Principal Investigator contact details
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• Proposed project start and end dates
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• Additional details, as applicable  

The information provided should be written for a lay audience, and supporting documentation should be attached with the application form (e.g. information sheets, consent forms, data management plans and other relevant research materials, including for example research questionnaires, recruitment materials). 

Below are examples of ethics application forms:

1.  Example Ethics Form - Cyber Bullying [PDF: 122KB]

2.  Example Ethics Form - Student Project [WORD: 50KB]

3.  Example Ethics Form - Food & Nutrition [PDF: 496KB]

4.  Example Ethics Form - Sexual Health [PDF: 201KB]

Participant Information Sheets (PIS)

The Participant Information Sheet (PIS) provides participants with sufficient information about the research study to allow them to make an appropriate (fully informed) decision about taking part. For further information, please see the Human Participation - Informing Participants section.

‌ Example Information Sheet

Consent Forms

On receiving the information about the research study (typically through a Participant Information Sheet), the participant should be allowed time to consider whether or not to take part.  If they wish to take part, typically participants will sign a Consent Form.  For further information, please refer to the section on Human Participation - Acquiring Voluntary Consent  and the University's Informed Consent Guidelines .

The University has also developed an Example Consent Form that can be downloaded and adapted to the research project.

Data Management Plans

A research data management plan outlines how a researcher will collect, use and store data, during and after the research study.  For further information, please see the Data - Governance considerations for research data .

DMPOnline provides access to example Data Management Plans.  The online tool can also be used to develop Data Management Plans that meet different funder requirements.   

Further guidance is available through the University's  Research Data Service (RDS) .

Privacy Notice

A Privacy Notice sets out how personal information will be processed in accordance with the UK General Data Protection Regulation (GDPR).  Participants in a research project should be provided with a Privacy Notice alongside a Participant Information Sheet (PIS), and have the opportunity to ask questions before they sign a Consent Form .  

To support researchers, the University has created a template form that can be downloaded and adapted to the project:

Template Privacy Notice for research

If you wish to recommend any changes to the information above, or have any example documents that may help other researchers, please contact  [email protected] . 

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Access the online ethics review application tool and advice on how to complete the application.

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Submitting an application for research ethics review

This online application fully replaces all previous online (Level 1) and/or paper (Levels 2 and 3) research ethics review applications.

On the online application page, you will find:

· A video overview of the online research ethics review application (Research Ethics, Integrity & Governance Application).

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The Participant Information Sheet (PIS) and Participant Consent Form (PCF)

CAHSS-approved English-language Participant Information Sheets and Participant Consent Forms, can be found together with the Research Ethics, Integrity & Governance Application . 

Templates in Arabic, Chinese, French, German and Spanish

CAHSS-approved templates for the Participant Information Sheets (PIS) and Participant Consent Forms (PCF) are available in various languages for use by researchers in LLC. T he Research Ethics Committee would like to thank Cameron Cross, Emma Fuertes Pablo, Dr Karin Bosshard, Dr Luan Duo, and Phil Hermina for their contributions to translating these documents.

Note 1: Please submit only English-language versions of the PIS and PCF with your Research Ethics, Integrity and Governance application. Reviewers are not responsible for reviewing documentation in languages other than English. 

Note 2: The PCF should not be filled in by participants before a favourable ethical opinion has been secured. Therefore, please submit a blank PCF with your REIG Application. 

Note 3: If the nature of your project means that you need to use a Participant Information Sheet, please see instructions below. 

In the section, ‘If you would like to discuss this study with someone independent of the study please contact’ please adhere to the following: 

Undergraduate and taught postgraduate students should insert the contact details of their Course Organiser or Programme Director. 

MScR and PhD students should insert the contact details of the Departmental Director of Research (DDoR). In cases where the student is being supervised by the DDoR, then the student should insert the contact details of the Departmental Postgraduate Research Director (DPGRD). 

Staff should insert the contact details of the Departmental Director of Research. In cases where the DDoR is conducting the research, the contact details of the Line Manager or Head of Department should be used. 

In the section, ‘If you wish to make a complaint about the study, please contact:’ please use the following contact: 

Research Governance Team ( [email protected] ) 

Please read before drafting and submitting your ethics application for review 

1: begin your application well in advance of your project start date, making sure you adhere to the llc submission deadline of a minimum of: .

4 weeks before the commencement of any project or funding application deadline which does not involve human participants 

8 weeks before the commencement of any project or funding application deadline which involves human participants 

All new research projects (and not only those involving human participants, personal or sensitive data, and/or human tissue), regardless of whether they are funded or not, should go through research ethics review before they commence. Any new ethical issues which arise during the course of the research should be addressed via further ethics review in a timely manner. This applies to both staff and students. The ethics review process is not a ‘rubber-stamp’ exercise and in rare instances for some proposed research projects can take a considerable amount of time. Please consider: 

· Reviewers endeavour to process applications in a timely manner, but it is not uncommon for reviewers to request further information or clarification on specific aspects of the application. This takes time. 

· In cases where a project involves novel or new research methods, or where the project raises complex ethical issues, it may be necessary for reviewers to seek guidance from other colleagues in LLC, the College Research Ethics Committee (CREC), or other schools and colleges in the University. For some ethically-complex projects, it may even be necessary to approach experts in other institutions or organisations. This can take a considerable amount of time. 

· There are certain times of the year when reviewers may be dealing with multiple applications and may not be able to process them as quickly as usual. 

2: Ensure you have completed the mandatory training in advance of working on your application 

Access to the online Research Ethics, Integrity & Governance Application, which serves as the vehicle for research ethics review, is dependent on you having completed some mandatory training on research ethics and General Data Protection Regulation (GDPR) and Data Protection. 

Whilst completing your application:

3: be proactive in thinking through and identifying potential ethical issues in your project..

Highlight and explain these in the application, and make sure you explain how you propose to address them, avoid them, or mitigate them as you carry out your research. 

The main purpose of the research ethics review process is to ensure that you, the researcher, have thought through the ethical implications of your research and to propose ways in which you will overcome ethical challenges. This may require reading around your methods or approach, or discussing these with colleagues or supervisors, so that you are aware of the key ethical issues your project raises. Concealing potential ethical issues in your application is unethical. 

4: Answer all questions as fully as you can and make sure that you answer all the questions as requested 

There are multiple question sets in the application and it may be tempting to answer these with instructions such as ‘see above,’ ‘see description of research project/study,’ etc. This slows down the review process and often leads to the applicant not answering the questions properly (resulting in delays to your application because reviewers will seek further information from you or an unfavourable opinion due to insufficient information).

5: Provide references to, or engage with any relevant ethics policies, ethics guidelines or secondary literature relevant to your research 

Practices, approaches and expectations vary across disciplines and subject areas, and it is your job as the applicant to justify the approach you are taking to your project in the research ethics review application, especially when you are working with sensitive data or using novel (or even controversial) methods. It helps reviewers enormously if you can justify your project in the wider context of your field/discipline/methods on the basis of specific ethics policies or guidelines, or published research relevant to your project. 

6: Explain your approach, processes and procedures clearly at all points 

Although reviewers will have knowledge of different research fields, disciplines and methodologies, you need to bear in mind that they might not be familiar with the particular intricacies of your project.

7: Make sure your description of research project/study actually describes in sufficient detail what your project is about and how you will go about generating/collecting data and utilising it 

All research ethics review applications must include a description of research project/study (maximum 500 words). Lifting a 500-word excerpt from a research, funding or dissertation proposal might be the easy thing to do at the time, but is no use to the reviewers if it doesn’t provide a systematic overview of your project approach and methods. 

8: Make sure you include all relevant documents with the application 

One of the most common reviewer requests is for documentation which should have been included with the application but which has not (such as a Participant Information Sheet (PIS), Participant Consent Form (PCF)) and/or a Travel or Fieldwork Risk Assessment. 

9: Check for consistency in dates, timelines, and other basic project information across all your application materials 

A common error in research ethics review applications is a lack of consistency across the online application form and documentation (such as the Participant Information Sheet (PIS) and Participant Consent Form (PCF)). 

10: Please do not rely solely on the automated email response from the REIG Application system for the outcome of ethics review.

You MUST read reviewer comments to ensure that you will carry out your research in an ethically viable manner. For an explanation of the outcomes of ethics review, please refer to “What are the possible outcomes of ethics review?”

After submitting your application

11: respond to any reviewer requests or queries in a timely manner .

It is your responsibility as a researcher (whether a member of staff or a student) to see that your application goes through the process to completion. As a matter of policy, reviewers will not chase up requests for further information. 

If requested, please adhere to the Instructions for RE-SUBMISSIONS. 

12: If you submit or re-submit an application and you do not hear back from a reviewer within 15 working days, chase it up by emailing  [email protected] . 

It is your responsibility as a researcher (whether a member of staff or a student) to see that your application goes through the process to completion and that you secure a favourable opinion before beginning your research. Sometimes, however, technology fails or things go wrong due to human error and you may not receive a response within the expected timescale, so please chase it up. 

Research Ethics, Integrity & Governance Application – A Rough Guide

A scoping review of the literature featuring research ethics and research integrity cases

Affiliations.

• 1 Department of Behavioural Sciences, Faculty of Medicine, University of Debrecen, Móricz Zsigmond krt. 22. III. Apartman Diákszálló, Debrecen, 4032, Hungary. [email protected].
• 2 Institute of Ethics, School of Theology, Philosophy and Music, Dublin City University, Dublin, Ireland.
• 3 Department of Behavioural Sciences, Faculty of Medicine, University of Debrecen, Móricz Zsigmond krt. 22. III. Apartman Diákszálló, Debrecen, 4032, Hungary.
• 4 Centre for Social Ethics and Policy, School of Law, University of Manchester, Manchester, UK.
• 5 Center for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway.
• 6 Center for Ethics and Law in Biomedicine, Central European University, Budapest, Hungary.
• PMID: 33931043
• PMCID: PMC8086087
• DOI: 10.1186/s12910-021-00620-8

Background: The areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.

Methods: The search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.

Results: A total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).

Conclusions: Case descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors.

Keywords: Cases; Research ethics; Research integrity; Review; Scientific misconduct.

Publication types

• Research Support, Non-U.S. Gov't
• Biomedical Research*
• Ethics, Research
• Organizations
• Scientific Misconduct*

Grants and funding

• N 741782/Horizon 2020