Research Ethics Framework
APPENDIX A – RESEARCH ETHICS REVIEW CHECKLIST
An example of a checklist that could be used in a UK university to determine the level of risk of harm entailed in a proposed study.
This checklist should be completed for every research project that involves human participants. It is used to identify whether a full application for ethics approval needs to be submitted. If a full application is required, Form XX should be used.
Before completing this form, please refer to the University Code of Practice on Ethical Standards for Research Involving Human Participants. The principal investigator or, where the principal investigator is a student, the supervisor, is responsible for exercising appropriate professional judgement in this review.
This checklist must be completed before potential participants are approached to take part in any research.
Section I: Project Details
Section II: Applicant Details
Section III: For Students Only
Section IV: Research Checklist
Please answer each question by ticking the appropriate box:
YES/NO
1. Does the study involve participants who are particularly vulnerable or unable to give informed consent? (e.g. children, people with learning disabilities, your own students)
2. Will the study require the co-operation of a gatekeeper for initial access to the groups or individuals to be recruited? (e.g. students at school, members of self-help group, residents of nursing home)
3. Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (e.g. covert observation of people in non-public places)
4. Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use)?
5. Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study participants or will the study involve invasive, intrusive or potentially harmful procedures of any kind?
6. Will blood or tissue samples be obtained from participants?
7. Is pain or more than mild discomfort likely to result from the study?
8. Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life?
9. Will the study involve prolonged or repetitive testing?
10. Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?
11. Will the study involve recruitment of patients or staff through the NHS?
Research Ethics Framework (REF)
If you have answered ‘no’ to all questions, send the completed and signed form E1/SS to your Department’s representative on the School Research and Consultancy Committee, for their records.
Undergraduate and MA students should retain a copy of the form and submit it with their research report or dissertation
(bound in at the beginning).Work that is submitted without the appropriate ethics form will be returned unassessed. MPhil/PhD students should submit a copy to the Research Degrees Board with their application for Registration, and forward a copy to the [designated] Research Ethics Officer. Members of staff should send a copy to the [designated] Research Ethics Officer.
If you have answered ‘yes’ to any of the questions in Section IV, you will need to describe more fully how you plan to deal with the ethical issues raised by your research. This does not mean that you cannot do the research, only that your proposal will need to be approved by the Research Ethics Committee.
You will need to submit your plans for addressing the ethical issues raised by your proposal using the ethics approval application form E2/SS, which should be sent to the Department/School Research Ethics Officer. Form E2/SS can be obtained from the Department/School web site.
If you answered ‘yes’ to question 11, you will also have to submit an application to the appropriate external health authority ethics committee, after you have received approval from the School Research Ethics Officer. For research conducted in *****shire, applications to the Applied and Qualitative Research Ethics Committee must be signed by the [designated] Faculty/School/Department Research Ethics Officer before they are submitted. Information on how to obtain this form is also available on the School web site.
Please note that it is your responsibility to follow the University’s Code of Practice on Ethical Standards and any relevant academic or professional guidelines in the conduct of your study.
This includes providing appropriate information sheets and consent forms, and ensuring confidentiality in the storage and use of data. Any significant change in the question, design or conduct over the course of the research should be notified to the School Research Ethics Officer and may require a new application for ethics approval.
Signed
Date
Principal Investigator
Supervisor or module leader (where appropriate)
Signed
Date