Research ethics process policy

Introduction

We are fully committed to advancing high-quality academic research and ensuring that all research activities undertaken by University employees, or on University premises, are done in a way that safeguards the dignity, rights, health, safety, freedom of expression, and privacy of those involved. This commitment extends to participants, researchers, students, and third parties. To facilitate this, we have developed this policy which is to be applied alongside the Code of Good Research Practice and other associated policies, guidance, and processes.

This Policy will be routinely reviewed every three years unless earlier revision is required due to a major change in legislation, regulations, guidance or University processes.

We welcome feedback on the content of this document. Anyone with comments or suggestions regarding the Policy is invited to submit them to Research and Knowledge Exchange: RKE@sunderland.ac.uk(opens in new tab)

Policy statement

We are committed to providing a rigorous and independent ethical review process that is proportionate to the potential risk. The University Research Ethics Committee (REC) has overarching responsibility for research ethics policy, guidance, and processes at the University. REC operates as a strategic committee with derogated authority from the University’s Research and Innovation Committee (RIC). REC provides operational oversight to Faculty Research Ethics Sub-Committees (FRECs) that have devolved responsibility for servicing ethical reviews of research projects.

Three FRECs are established that reflect the University’s academic structure:

Health Sciences and Wellbeing FREC
Education, Society, and Creative Industries FREC
Business and Technology FREC

Applications for ethical review that originate from the University of Sunderland London and Hong Kong campuses, as well as TNE providers are serviced and overseen by the most appropriate FREC as determined by discipline/subject area.

Research ethics process

We recognise that in many cases an independent ethical review will not be necessary. However, all researchers are required to consider and mitigate the ethical risks associated with their proposed work.

We operate a tiered ethical review process with the level of assessment proportionate to the potential ethical risk (see Appendices, Appendix A-D):

Tier 1 – Proportionate review: Involves a formal assessment of the ethical implications and risks of a research project to initially determine whether or not the proposed research project triggers any of the Criteria for FREC review. If none of the Criteria for FREC review are triggered, then the assessor must confirm that the proposed research project complies with the relevant institutional policies, local guidelines and policies, and any regulatory requirements. If one or more of the Criteria for FREC review are triggered, the application will be escalated for a Tier 2 review. This level of review requires an initial compliance check followed by assessment by a single independent reviewer.
Tier 2 – Full FREC review: A formal independent review (assessment and consideration) of the ethical implications and risks of the proposed research for projects that do not meet the criteria for proportionate FREC review. This level of review requires an initial compliance check followed by an assessment by a minimum of two independent reviewers.
Tier 3 – REC review: A formal independent review (assessment and consideration) of the ethical implications and risks of the proposed research for complex projects, requiring University sponsorship, or those that pose a significant security, legal, or reputational risk to the University.

Research that raises ethical risks should be logged using the online research ethics system before any research procedures have commenced. This system uses a filter process to determine what information and type of ethical review and approvals are required.

Where FRECs consider that they are unable to provide the level of necessary review they will, in the first instance, normally be expected to refer the case to REC. We expect such occurrences to be rare and that FRECs in their constitution and procedures, should meet the standards necessary to enable them to provide an ethical opinion for all forms of research in their field.

Appeals to research ethics decisions

A researcher may appeal decisions and outcomes following a research ethics review on the following grounds:

That there existed material circumstances relating directly to the case of which the reviewing committee was not aware
That procedural irregularities occurred in the review process, which were of such a nature as to cause reasonable doubt as to whether the reviewers would have reached the same conclusion had the irregularities not occurred
That there is demonstrable evidence of prejudice, bias, or inadequate review

If the investigating party are of the view that an appeal does not fall within any of the grounds specified above, they shall dismiss the complaint and inform the complainant accordingly. Dissatisfaction with the decision is not sufficient grounds for appeal.

If a researcher wishes to appeal against decisions and outcomes received from a FREC or REC they should notify the relevant Chair within 10 working days of the date the outcome is sent via the online research ethics system. In the first instance, the appeal should be raised informally as most issues can be resolved and misunderstandings clarified.

Appeals made after 10 working days from the date the outcome is sent will not be considered and the original decision will be upheld. If significant new information concerning the project comes to light after this date, the researcher should approach the FREC Chair who will determine whether an investigation into the matter is justified.

If the issue is not resolved following communication with the FREC Chair, or if deemed unsuitable for discussion with the FREC Chair, researchers may appeal or request the case to be escalated to REC. Appeals and escalation requests should be submitted in writing to the REC Chair. Appeals against a REC decision or outcome should also be submitted to the REC Chair. If the case is unsuitable to be handled by the REC Chair, an independent investigator of equivalent seniority will be appointed to investigate the matter.

Written appeals should include:

The title of the research proposal, application number, and name of the lead investigator or supervisor, if appropriate
The name of the FREC to which it was submitted and the date of the decision to be appealed
The reason for the appeal with adequate explanation and justification of the grounds for appeal

The research ethics application together with the written appeal will be considered by REC and the addition of co-opt experts if deemed necessary. REC may request information from University office holders, or others as appropriate to facilitate a thorough investigation. The researcher and the FREC that made the initial decision may also be required to provide additional information. In addition, REC will exercise powers to ensure that any institutional obligations and/or relevant contractual obligations to research funding bodies and partner institutions are met, which may include notifying them of the appeal and its outcome.

In any case that involves allegations of misconduct, in accordance with the University’s established procedures, the REC Chair will notify relevant office holders and refer for investigation under the appropriate misconduct procedures.

REC will deal with requests for appeal with all reasonable expedition. A preliminary timeline to outcome will be communicated to relevant parties, however, researchers should be aware that complex cases, or cases that require obtaining information from experts, University office holders, or others, can impact timelines. Any delays to the process will be communicated at the earliest opportunity.

The decision of REC is final and no further appeals will be considered. Once the final decision has been reached this will be communicated to the relevant FREC Chair and the applicants in writing. A copy of all correspondence will be sent to the relevant FREC for audit purposes.

Scope of FREC review

The primary purpose of the research ethics process is to determine whether the application meets the required University ethical and governance standards, mitigates risks (to participants, researchers, and the University), and complies with statutory, legal, or professional requirements as appropriate. A researcher checklist for the review of ethics applications is provided in Appendix E, which outlines the general issues which ethics reviewers may consider when reviewing an application.

All research carried out at the University must comply with relevant legal, regulatory, and professional requirements and standards, and researchers who are unsure whether such requirements apply to their projects should seek advice. Governance checks of the project documents are an important part of the ethics review process. The submission of poor-quality applications significantly increases the administrative burden of research ethics assessment and impacts the ability to deliver outcomes in an efficient and timely manner. FRECs may choose to implement an initial triage stage to check that applications meet the basic requirements for consideration before review, as agreed locally.

The research ethics process is not a scientific (or other) peer review process, however, FRECs may decide to add an element of scientific review into the review process as per discipline/subject norms or requirements for professional bodies. For undergraduate and postgraduate research projects a scientific (or other) review (i.e., research design, sample size, etc.) should be assumed to have been undertaken and approved by the student’s academic supervisor. Reviewers may provide constructive scientific feedback, as advice rather than a condition for favourable ethical opinion, however, particularly poor applications (i.e., lacking scientific quality, or incomplete) that present ethical risks that could otherwise be mitigated, or prevent a rigorous review, will be rejected outright.

The research ethics process is not a health and safety assessment exercise. However, FRECs should seek assurances from researchers that, where appropriate, a health and safety assessment has been undertaken and such assessment meets the requirements of the Health & Safety Executive (HSE) to ensure risks have been appropriately assessed, mitigated, and recorded. The University requirement is for all risk assessments to be submitted to the risk assessment portal for review by the H&S team and ordinarily this would be the responsibility of the lead investigator or supervisor; further information is outlined in the University’s Risk Assessment procedure and templates webpages (login required)(opens in new tab).

FRECs are not expected to provide legal or policy reviews, nor is the process a proofreading service. Reviewers may decide to reject an application to be resubmitted, should there be substantial typographical errors that affect the integrity of the paperwork, make the application difficult to interpret or properly assess; the suitability and readability of ‘participant-facing’ documentation should be scrutinised carefully to ensure that study materials given to participants are understandable and accurately describe the study procedures and requirements of research participation.

All research involving human participants, human tissue, or personal data is subject to independent ethical review proportionate to the potential risk. Further information is provided in the University’s Guidance on the Ethics of Research Involving Human Participants and Personal Data.pdf(opens in new tab). Stakeholder/user involvement activity which involves collecting opinions rather than study data, generally, does not require an independent ethical review.

For social research involving human participants, researchers should also consult the ESRC’s Framework for Research Ethics; note that compliance with this framework is compulsory for ESRC-funded research. For psychology-based projects, researchers are required to consult and comply with the British Psychological Societies Code of Ethics and Conduct.

Research that requires review by an external body, such as the Health Research Authority (HRA)(opens in new tab) or Ministry of Defence Research Ethics Committee (MODREC)(opens in new tab), should be identified and referred to that body as early as possible in the review process. Applications should be made concurrently through the University’s online research ethics system for review by REC before submission and the request for electronic authorisations.

Most research involving NHS patients, staff, or facilities falls within the Research Governance Framework for Health and Social Care(opens in new tab) and requires Health Research Authority(opens in new tab) (HRA) approval. Some other types of research also require HRA approval for legal and policy reasons, details of which are provided on the HRA website(opens in new tab). Further information is provided in the University’s Guidance on Research Requiring HRA Approval.pdf(opens in new tab).

Research that involves the removal, storage, and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells – must also comply with the Human Tissue Act. Researchers undertaking such work should understand their responsibilities under this legislation and comply with the relevant University's research ethics and governance policies and guidance.

The University does not undertake any experimentation on live animals or house live animals on its premises. It does, however, engage in animal experimentation through collaborations that are undertaken off-site, and, uses animal tissues, cells and fluids on its premises for research purposes. Researchers involved in work that requires the use of animals should do so only as part of regulated research programmes that are of the highest quality and where there are no alternatives. All such work should be carried out under licenses issued by the Home Secretary, and researchers should ensure that any animal work that they are involved in conforms to the principles of reduction, refinement, and replacement. Further, researchers should ensure that any animal work they are involved in has engaged in all reasonable steps to minimise the number of animals used, and, that any procedures, care routines, and husbandry maximise welfare. Researchers engaged in work involving the use of animals in research are required to understand and comply with the University’s Guidance on the Use of Animals in Research.pdf(opens in new tab).

Applying for amendments or extension to research studies

Amendment to research projects cannot be implemented until the relevant approvals are in place, except in the case of urgent safety measures. There are two types of amendments:

- The safety or physical or mental integrity of participants
- The scientific value of the research
- The conduct of the management of the research
- The quality or safety of any investigational produce used
Substantial amendments: defined as any change to the terms of the protocol or any other supporting documentation that is likely to affect to a significant degree:
Non-substantial amendments: defined as minor changes to the protocol or other study documentation that do not meet the criteria for substantial amendment.

Applications seeking minor amendments or an extension to projects that have previously received a favourable opinion and remain largely unchanged (i.e. no substantial amendments to the study design or processes such as correcting errors, minor clarifications, logistical arrangements for storing or transporting samples, or study end date) may be approved by Chairs action.

Amendments to existing projects that have previously received a favourable ethical opinion that propose substantial changes to the original design, methodology, study procedures, or study documentation require re-review.

Research projects which have previously received a favourable ethical opinion but have not started within a year of the opinion require re-review.

Amendments to research projects that have obtained approval from external bodies (for example, the HRA) and from which the University of Sunderland acts as Sponsor, should be submitted for review to the University before the amendment is submitted to the external body.

Further guidance and examples of amendment types are provided in the Amendments to Research Projects Guidance.

Areas of responsibility

We expect the highest standards of research integrity from the researchers it supports. This includes, but is not limited to, people who conduct research: as an employee; as a member of staff on a joint clinical or honorary contract; as a visiting or emeritus member of staff; as an independent contractor or consultant; as a student, and, irrespective of: the sources of their funding; their area of research; their experience of research; whether they are lone scholars or members of a research team; where the research is to be conducted. It is the responsibility of all researchers and staff supporting research to conduct their research in accordance with this policy, the University’s Code on Good Research Practice, other University policies, guidelines, and processes governing research ethics, as well as all applicable legal, regulatory, legislation or frameworks.

It is the responsibility of supervisors of students or lead investigators (as appropriate) undertaking research to ensure that their students become familiar with this policy and any accompanying guidance.

It is the responsibility of Faculty Deans and their nominees as well as FREC Chairs to ensure that their members of staff, students, and other researchers with privileged access to the University’s premises and facilities, are aware of this policy and to ensure the effective implementation of the ethical review process through their respective FREC.

It is the responsibility of researchers to ensure that all appropriate permissions, approvals, and licenses are in place before the research starts and that they are renewed or updated as necessary throughout the duration of a research project. researchers must not begin or undertake any research procedures (including the identification of potential participants) until a favourable ethical opinion has been obtained.

FRECs are responsible for ensuring that proposals referred to them receive valid, sufficiently comprehensive, rigorous, independent, and timely ethical reviews and outcomes. FRECs may also advise, where appropriate, on the wider ethical issues raised by research projects and their potential outcomes (for example dissemination, data use and archiving), and provide recommendations for improving the scientific quality or potential benefit to research participants.

Researchers are required to report any major protocol deviations or adverse events and resulting action to the FREC that issued a favourable ethical opinion, or if appropriate to REC. All such reports are formally considered by FRECs/REC, along with remedial actions including stopping or auditing the project. REC reserves delegated executive authority to investigate and exercise powers to halt the research or withdraw a favourable ethical opinion. Further information is provided within the University’s Guidance for Reporting an Incident in Research.pdf(opens in new tab).

As a condition of gaining University ethical approval or obtaining University sponsorship for research, researchers are required to cooperate with any outcomes of the monitoring and audit of research projects. If researchers become aware of a need for monitoring and audit where it is not already scheduled, they are required to report that need to their respective FREC, or where appropriate REC. Researchers should consider any requirements for monitoring and auditing at an early stage in the design of a project and ensure that research projects comply with all external monitoring and audit requirements.

All individuals have a responsibility to report any concerns about research projects or the conduct of research staff or students at the University. Complaints or expressions of concern about research projects at the University should be made directly to REC. The University welcomes approaches from whistleblowers with information concerning research ethics, and staff are protected under the University’s Whistleblowing policy. Further information is provided in the University’s Guidance on Making a Complaint About a Research Project.pdf(opens in new tab).

REC has overall responsibility for the implementation of this policy. It will also offer advice on best practices in research ethics. REC reports to RIC termly and will recommend any changes that are considered necessary in light of experience.

We will normally accept evidence of approval by another institution in lieu of internal review, provided it is demonstrated that comparable standards have been applied. Research outside the UK will require review within the University, irrespective of whether ethical approval has been previously granted by another institution. Care should be taken with international research as legislative and cultural imperatives vary widely and compliance is the responsibility of the researcher.

Recording, reporting, monitoring, and audit

FRECs are responsible for monitoring research that has received a favourable ethical opinion and are required to provide a qualitative summary of live and completed projects for the reporting period to REC on an annual basis. As such, researchers should keep clear and accurate records of the procedures followed and the approvals granted, including records of interim and final results; this is a requirement for demonstrating good research practice, and to ensure effective reporting, monitoring, and auditing processes.

FRECs are required to conduct an annual audit of live and completed studies to ensure that research activities are being carried out in accordance with good practice, legal and ethical requirements and the procedures described in the original application and any conditions as stipulated when issuing a favourable ethical opinion. It is expected that a random selection studies that received a favourable ethical opinion in the previous year will be audited. FRECs will establish their own local protocols for conducting audits, however, the volume of studies audited should be proportionate to the number, type, and complexity of applications received. Further, FRECs should ensure that any audit complies with RECs guidelines and is able to generate the required information to complete RECs reporting template.

Evaluation (including course evaluation, service evaluation, or teaching evaluation), market research, research involving interviews with participants or subjects deemed to be within their professional competence, audit of data, secondary data analysis, and systematic reviews will not ordinarily require ethical review provided that the following criteria are met:

The data is completely anonymous with no personal information being collected
The data is not considered to be sensitive or confidential in nature
The issues being researched are not likely to upset or disturb participants
Vulnerable or dependent groups are not included
There is no risk of possible disclosures or reporting obligations
The subject matter of interviews is limited to topics that are strictly within the professional competence of the participants
Explicit written consent has been obtained from the data controller to access the data
Written evidence is available that confirms the data will be used for a purpose which falls within the remit of the original consent provided by data subjects

An ethical review is required in the following circumstances, where research involves:

The collection or use of person-identifiable or special-category data
The collection or use of data which is classed as sensitive or confidential
The use of audio/video recordings or photographs
Vulnerable groups
The ingestion or administration (by whatever means of delivery) of any substance by participants
Any invasive/semi-invasive procedure or the administration of drugs.
The physical testing of participants or the use of medical devices
The use of psychological tests or interventions
Privileged access to clinical or personal records
Access to potential volunteers on the basis of them being, or having been, patients
Invitation to volunteers to divulge facts about themselves that they would not wish the investigator to allow to become known to other persons
Any form of physical risk, distress, embarrassment, anxiety, stress, fatigue, or inconvenience to the participant or researcher
Any form of adverse effect on the personal, social, or economic wellbeing of the participant or researcher
Social sensitive topics
Uncovering or likely to uncover illegal or potentially harmful activities

For research projects to qualify for proportionate FREC review they must meet all of the mandatory criteria:

Participants and consent

Does not involve children under the age of 16 or other vulnerable groups, including adults unable to give informed consent
Does not involve prisoners or young offenders
Does not involve police, probation services, or those involved in the criminal justice system
Does not involve a coercive recruitment strategy, or a recruitment strategy that is likely to be experienced as coercive by participants, including where a power dynamic between the researcher/participants or the gatekeeper/participants would be present
Does not require participants to take part in the research project without their knowledge and/or consent at the time
Does not involve deception or withholding information from participants irrespective of post-procedure briefings
Does not involve activities that could be interpreted as or lead to the potential exploitation of participants
Does not involve offering participants incentives that may unduly influence their decisions to participate. FRECs should define this in line with acceptable practices in their field

Data collection and experimental procedures

Involves procedures that risk an adverse effect on participants’ well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness), or economic well-being (e.g. employment, employability, professional standing)
Does not involve procedures where the probability and magnitude of inconvenience or discomfort anticipated are greater and beyond those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
Does not involve the administration of medicines, drugs, placebos, foodstuffs (including supplements), or common substances used to invoke physiological or psychological sensations
Does not involve invasive procedures or the new collection or donation of human tissue from a living person or the recently deceased as defined by the Human Tissue Authority (HTA)
Does not involve activities that are likely to lead to incidental findings or disclosures
Does not involve activities that potentially compromise the safety/wellbeing of the researcher that are not already mitigated through Health and Safety processes
Does not involve data collection outside of the UK (except at the University of Sunderland international campuses)
Does not involve activities requiring travel to countries/regions against the advice of the British Foreign Commonwealth Office
Does not involve research conducted outside of normal working hours
Does not involve research activities in the homes of participants
Does not involve conducting observations in private (non-public) spaces
Does not involve the collection or access of audio, video recording, photographs or quotations where individuals may be identified (beyond those sources that are in the public domain and are being used in their intended context)
Does not involve accessing records and/or the collection of personal data, concerning identifiable individuals as defined by the data protection legislation
Does not involve the linking or sharing of personal data, special category data (sensitive data) or confidential information beyond the initial consent given
Does not involve procedures likely to be deemed offensive, distressing, or deeply personal/sensitive for the target group; may include surveys and questionnaire-only research designs
Does not involve conducting observations of non-ordinary, non-sensitive behaviours

Other criteria

Does not involve research carried out by third parties wishing to recruit University of Sunderland staff and/or students as participants; it may be appropriate that the FRECs ratify the approval from the third party whereby their research ethics code of practice is sufficiently robust as the University of Sunderland’s
Any other criteria or scrutiny measures as deemed appropriate by the FREC in line with discipline/subject norms and requirements of their professional bodies. In such cases, local guidelines including subject-relevant examples should be produced
Note that in regard to risk assessments, a residual risk rating of 10 is classified as High Risk, and 17 or above is considered Very High Risk and required further mitigation measures before being undertaken

Amendments and extensions

Applications seeking minor amendments or an extension to projects that have previously received a favourable opinion via proportionate FREC review and remain largely unchanged (for example, no substantial amendments to the study design or processes such as correcting errors, minor clarifications, logistical arrangements for storing or transporting samples, or study end date) may be approved by Chairs action
Amendments to existing projects that have previously received a favourable ethical opinion via proportionate FREC review, that propose substantial changes to the original design, methodology, study procedures, or study documentation (for example participant information sheets, questionnaires, letters of invitation) require re-review
Research projects which have previously received a favourable ethical opinion via proportionate FREC review but have not started within a year of the opinion require re-review

FRECs must undertake a REC review for any research project involving one or more of the criteria:

Participants and consent

Involves children under the age of 16 or other vulnerable groups, including adults unable to give informed consent
Involves prisoners or young offenders
Involves police, probation services, or those involved in the criminal justice system
Involves a coercive recruitment strategy, or a recruitment strategy that is likely to be experienced as coercive by participants, including where a power dynamic between the researcher/participants or the gatekeeper/participants would be present
Involves participants taking part in the research project without their knowledge and/or consent at the time
Involves deception or withholding information from participants irrespective of post-procedure briefings
Involves activities that could be interpreted as or lead to the potential exploitation of participants
Involves offering participants incentives that may unduly influence their decisions to participate. FRECs should define this in line with acceptable practices in their field

Data collection and experimental procedures

Involves procedures that risk an adverse effect on participants’ well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness), or economic well-being (e.g. employment, employability, professional standing)
Involves procedures where the probability and magnitude of inconvenience or discomfort anticipated are greater and beyond those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
Does not involve the administration of medicines, drugs, placebos, foodstuffs (including supplements), or common substances used to invoke physiological or psychological sensations
Involves invasive procedures or the new collection or donation of human tissue from a living person or the recently deceased as defined by the Human Tissue Authority (HTA)
Involves activities that are likely to lead to incidental findings or disclosures
Involves activities that potentially compromise the safety/wellbeing of the researcher and are not already mitigated through Health and Safety processes
Involves data collection outside of the UK (except at the University of Sunderland international campuses)
Involves activities that require travel to countries/regions against the advice of the British Foreign Commonwealth Office
Involves research conducted outside of normal working hours
Involves research activities in the homes of participants
Involves conducting observations in private (non-public) spaces
Involves the collection or access of audio, video recording, photographs or quotations where individuals may be identified (beyond those sources that are in the public domain and are being used in their intended context)
Involves accessing records and/or the collection of personal data, concerning identifiable individuals as defined by the data protection legislation; If research is limited to the secondary use of previously collected, identifiable data from outside the EEA:
- A material transfer agreement must be in place between the data controller and the University of Sunderland. A copy must be appended to the application, or confirmation in writing that this is currently being drafted
- Written evidence should be available that confirm any analysis to be performed falls within the consent of the data subjects (e.g. that the data can be used for future research)
Involves the linking or sharing of personal data, special category data (sensitive data) or confidential information beyond the initial consent given
Involves procedures likely to be deemed offensive, distressing, or deeply personal/sensitive for the target group; may include surveys and questionnaire-only research designs
Involves conducting observations of non-ordinary, non-sensitive behaviours

Other criteria

Research projects carried out by third parties wishing to recruit University of Sunderland staff and/or students as participants; it may be appropriate that the FRECs ratify the approval from the third party where the third party’s research ethics code of practice is sufficiently robust as the University of Sunderland’s (i.e. another UK HE institution)
Any other criteria or scrutiny measures as deemed appropriate by the FREC in line with discipline/subject norms and requirements of their professional bodies. In such cases, local guidelines including subject-relevant examples should be produced
Note that in regard to risk assessments, a residual risk rating of 10 is classified as High Risk, and 17 or above is considered Very High Risk and required further mitigation measures before being undertaken

Amendments and extensions

Applications seeking minor amendments or an extension to projects that have previously received a favourable opinion via full FREC review and remain largely unchanged (i.e. no substantial amendments to the study design or processes such as correcting errors, minor clarifications, logistical arrangements for storing or transporting samples, or study end date) may be approved by Chairs action
Amendments to existing projects that have previously received a favourable ethical opinion via full FREC review, that propose substantial changes to the original design, methodology, study procedures, or study documentation (for example participant information sheets, questionnaires, letters of invitation) require re-review
Research projects which have previously received a favourable ethical opinion via full FREC review but have not started within a year of the opinion require re-review

FRECs should, where possible and appropriate, implement local standard operational procedures as relevant to the subject/discipline to mitigate the risks associated with some of the FREC triggers and hence reduce the level of review required for similar research projects able to adopt these standard operational procedures (for example, if there are many applications from undergraduate and postgraduate students addressing the same triggers).

This is a tool to guide researchers and research ethics reviewers to use when assessing a research ethics application. All the information included should be understandable by non-specialists and avoid the use of complex technical terms. While applications are assessed by ethics reviewers, others may do so as well to ensure that the research complies with ethical principles. These include institutions, sponsors, regulatory authorities, journal editors, and publishers.

General considerations	Fully met	Partially met	Inadequate	Comments
Is the description of the project understandable?
Are the scientific end points clear?
Are the inclusion and exclusion criteria clear?
Has the research been adequately planned so it will be carried out in a timely manner?
If relevant, have gatekeeper or other permissions been obtained?
Are the sampling frame and the number of participants specified and justified?
If relevant, does the research design appropriately consider issues of participant mental capacity?
Is the recruitment process clearly described?
Has the potential for coercive practices been adequately addressed or mitigated?
Is the information given to participants accurate and clear, enabling an informed decision to participate?
Have potential participants received adequate time to assess the information about the involvement?
Is it clearly stated that participation is voluntary and there will be no adverse consequences of refusal?
Does the consent-seeking process respect cultural and local norms, while adhering to ethical standards?
Are the process and time point(s) for withdrawal from the project detailed?
Are rights and restrictions to request the destruction of already collected data explicitly stated?
If relevant, is the use of deception justified, and have the associated risks been addressed or mitigated?
Is there suitable provision for debriefing participants?
Does the research adequately detail and justify any inducements, rewards, or compensation to participants?
Is there detail of provision for benefit sharing and dissemination?
Are there suitable procedures to assess risk and manage emergencies, incidental findings or disclosure?
Is the duration and security of all personal and research specified and within recognised guidelines?
Do processes for de-identification, data-sharing, and publication adequately protect confidentiality?
If relevant, does the research design adequately address or mitigate risk associated with stigmatisation?
Is it clear how participants will access the final study report/findings, or justify non-disclosure?
Does the management or the research comply with international, national and institutional guidelines?

Participant information (PIS) and recruitment materials	Fully met	Partially met	Inadequate or missing	Comments
Are all recruitment materials included?
Are the PIS title and text comprehensible and suitable for the study population(s)?
Does the PIS clearly explain the purpose and rationale of the study in understandable lay language?
Does the PIS clearly explain the study procedures in understandable lay language?
Does the PIS clearly explain what will happen when the study finishes and how to access the findings?
Does the PIS clearly explain any inducements, rewards, compensation for participation?
Does the PIS address limits of confidentiality in the event of disclosure (for example, safeguarding, Prevent)?
Are confidentiality, de-identification, and security procedures for data access clearly explained?
Is it clear how long data or samples will be retained and by who and how?
Does the PIS explain the study publication policy (including relevant maintenance of anonymity)?
Does it include sufficient details about data sharing and refer to the data protection legislation?
Does it provide sufficient detail of how research findings will be shared with participants?
Does it specify a named study team contact for further information?
Does it include the University's process for reporting concerns?
Does it confirm ethical approval has been obtained and state the name of the application and committee?

Consent form

The following guidance should be carefully evaluated in relation to the cultural and local norms and expectations of participant groups to determine the most appropriate mean of seeking and recording consent. Consideration should be given to consent renewal where participation is extended.

Consent forms should have separate clauses for which consent to specific elements of participant can be recorded as well as overall consent. Consent forms for individual participant groups should be included, and assent forms, where applicable.

Consent form	Fully met	Partially met	Inadequate or missing	Comments
The participant has read and understood the participant information sheet or other mode of informing and has been able to ask questions about the research and have them satisfactorily answered.
Participation is voluntary, with no negative consequences for refusal.
Participants can withdraw from the research and up to what time point without justification to the research team, and what will happen to the data collected up to that point.
Consent has been obtained for storage and destruction of data. The duration of storage and by who and how should be specified.
Where relevant, consent has been obtained for data sharing.
Prospective consent has been obtained for all anticipated further studies, i.e., consent for future use of data in other ethically approved studies.

Adapted from the UKRIO Researcher Checklist of Ethics Applications for Research with Human Beings.

Policy review

Effective date: July 2024

Last revised date: July 2024

Approved by: University Research Ethics Committee (REC), 4 December 2024

Date of next review: July 2027

Owner: University Research Ethics Committee (REC)

Scope and audience: All

Research ethics process policy

Contents+

Introduction

Policy statement

Research ethics process

Appeals to research ethics decisions

Scope of FREC review

Applying for amendments or extension to research studies

Areas of responsibility

Recording, reporting, monitoring, and audit

Appendix A: Criteria for ethical review+

Appendix B: Criteria for proportionate review (Tier 1)+

Appendix C: Criteria for FREC review (Tier 2)+

Appendix D: Criteria for escalation to REC+

Appendix E: Checklist for ethics application for research with involving humans+

Policy review