Ethical Review Form for reviewers

This form can be used by REAG reviewers to help them to review a research ethics application. It is intended to raise the main issues that should be considered and help the reviewer to assess whether the applicant has addressed them satisfactorily.

Reviewers’ responses to the form can be used by REAG coordinators to compile the response to the applicant.

Study title/reference:

Checklist document:

Does the study require review by an external REC?
i.e.: SECTION IV(A) – are any questions ticked ‘yes’?
  • participants or their relatives recruited from the NHS or social care
  • involves human tissue samples
  • involves participants who may not have capacity to consent
  • social care study funded by the Department of Health
  • health-related research involving prisoners
  • clinical trial involving a non-CE Marked medical device or a medical device used outside its CE Mark
  • clinical trial of an investigational medicinal product or medical device
If ‘yes’ to any of these, applicant should be directed to the Research Ethics & Governance Officer for assistance with an application to an external research ethics committee (e.g. and NHS REC).
Comments:

Full application document:

Risks and ethical issues:
  • Are inclusion and exclusion criteria appropriate?
­Appropriate selection of research participants so that risks and benefits of research participation are shared equitably
  • Is there accurate description of potential risks and burdens for participants in participant information?
  • Is the risk: benefit ratio reasonable?
­Potential risks should be proportionate to the level of expected benefits
  • Are there suitable plans to mitigate potential risks as far as possible?
  • Is it possible that participants may disclose information about abuse or unreported criminal activity that may require action?
­Are suitable plans in place to deal with this should it occur(e.g. breach of confidentiality)?
  • Is researcher safety adequately considered?
  • Suitability of the applicant and supporting staff
­Are additional training or DBS checks required?
Comments:
Recruitment and informed consent:
  • Fully informed consent must be in place for researcher access to identifiable personal information
­This includes for identification of potential participants
  • Is participant information sufficient for potential participants to understand what participation will involve?
­Is the language used clear and understandable to the participants being recruited?
  • Is the researcher planning not to gain fully informed consent from participants?
­Is this justified? The researcher must demonstrate that it is not possible to carry out the research if consent is sought and that participants will not be harmed or upset by their covert inclusion
­Plans for subsequent debrief and withdrawal must be appropriate.
Comments:
Confidentiality:
  • Are researcher plans for ensuring confidentiality of personal data adequate?
­Where and how and for how long will data be stored?
­Who will have access?
  • If it is planned that participants remain identifiable, is this justified?
­Participants should be at no risk of harm from remaining identifiable and this must be with their fully informed consent.
Comments:
Incentives and payments:
  • Are any incentives appropriate?
­Travel expenses/compensation for time in the form of vouchers are acceptable. Any payments must not be at a level considered coercive for the particular participant population
  • Are there any conflicts of interest?
­For example, does the researcher work at the organisation from which participants will be drawn and are there potential risks for coercion? Are these appropriately mitigated?
Comments:
Publication and dissemination:
  • Plans for publication/dissemination must maximise the potential benefits of the research
­Efforts should be made to inform participants, and others who might benefit, of the findings
  • Do publication plans take account of safeguarding participants’ confidentiality?
­For example, publication of direct quotes.
Comments:
Children:
  • If it is planned to involve children has the researcher demonstrated that it is not possible to carry out the research involving only adults?
  • Are plans to inform and seek consent from a person with parental responsibility suitable?
  • Are plans to ensure child participant assent appropriate?

Comments:
Participants unable to consent for themselves:
  • Does the participant population include people who may be unable to consent for themselves? (e.g. very elderly people/people with dementia/people with severe learning disabilities/people temporarily incapacitated through drugs or alcohol). Are plans to screen these people out suitable?
­If it is intended to recruit people who cannot consent for themselves review by an NHS REC is required (see p1 above).
Comments:
Suitability of supporting documentation:
  • e.g. participant information sheet; consent form; interview schedules; questionnaires; recruitment advertising, etc.
­suitable format; grammar; spelling
­version numbers and dates
­claims of potential benefits not exaggerated.
Comments:
Other general comments:
  • e.g. missing information; typographical errors, etc.

Comments:
OUTCOME OF REVIEW
Please tick
A / Approved / ☐ /
B / Minor amendments required(typographical and formatting errors)
Amendments to be approved by School REAG Rep / ☐ /
C / Major amendments required (minor to major alterations in specific areas of the application)
Amendments to be submitted to the Faculty REAG for approval / ☐ /
D / Resubmission required (major alterations that require a thorough redraft to the application)
Resubmission to be submitted to the Faculty REAG for approval / ☐ /

IN ALL INSTANCES, PLEASE RETURN THIS FORM TO THE FACULTIES SUPPORT OFFICE SO THAT THE OUTCOME CAN BE RELAYED TO THE RESEARCHER – THANK YOU

1

Adapted for FSO/30.11.16