1. An Introduction to the Ethics Review Procedure Lindsay Unwin: Research & Innovation Services, UREC Secretary

2. Routes for ethics approval 1.University ethics review procedure 1.University ethics review procedure (administered in each academic department) 2.Alternative ethics review procedure 2.Alternative ethics review procedure (other HEIs/organisations) 3.Administrative research ethics review procedure 4.NHS ethics review procedure/Social Care Research Ethics Committee 4.NHS ethics review procedure/Social Care Research Ethics Committee (IRAS)

3. University Procedure Remit: Research project (investigation to gain knowledge & understanding) Involves human participants or personal data Is led by this University Takes place within the UK Research involving NHS staff or NHS premises

4. Remit: Research conducted outside UK; or Research led by another UK university/research organisationBUT: if in doubt, apply University procedureThe other procedure must be judged to be sufficiently robust by the UREC; if in doubt, apply University procedure Alternative Procedure

5. Administrative Procedure Research undertaken in administrative departments Reviewed by central UREC Student Services has its own procedure

6. NHS Procedure Remit: Patients & users of the NHS (current or previous) Relatives or carers of NHS patients Access to data, organs, other bodily material of past or present NHS patients Foetal material & IVF involving NHS patients Recently dead in NHS premises NRES provide comprehensive guidance on the types of research that require NHS review

7. Social Care Research Ethics Committee (SCREC) Apply via NRES (as per NHS procedure) Remit: Staff-led social care research projects in which some or all of the human participants are adults who lack the capacity to consent for themselves;Staff-led social care research projects in which some or all of the human participants are adults who lack the capacity to consent for themselves; Department of Health-funded staff-led social care research projects in which the human participants are adultsDepartment of Health-funded staff-led social care research projects in which the human participants are adults

8. University ethics review procedure

9. How to apply ? Staff: Find relevant ethics application (dept. website/Ethics Administrator/online system) Fill in application Submit to Ethics Administrator Receive decision within 2 weeks *Can also do generic applications (single application for several similar student projects)

10. How to apply ? Postgraduate research students: Find relevant ethics application (dept. website/Ethics Administrator) Fill in application Submit to supervisor for sign-off Submit to Ethics Administrator Receive decision within 2 weeks

11. How to apply ? Undergraduate/postgraduate-taught students: Supervisor should help identify relevant ethics application Fill in application in consultation with supervisor Submit to supervisor Supervisor decides on risk level Low risk: supervisor reviews and gives decision High risk: supervisor submits to Ethics Administrator for review by 2 people: receive decision within 2 weeks

12. FOR ALL APPLICANTS: MAY NEED TO REVISE AND RESUBMIT SO ALLOW TIME FOR THIS PROCESS!

13. What happens once I’ve submitted my application*? Ethics Administrator identifies reviewers: - Staff/PGR projects – 3 (not including supervisor for PGRs) - Potentially high risk UG/PGT projects – 2 (usually supervisor +1) (Potentially low risk UG/PGT projects – supervisor reviews) Reviewers provide comments and decision ‘Lead reviewer’ forms a consolidated response Ethics Administrator confirms decision to applicant *SPECIFIC ARRANGEMENTS VARY BY DEPARTMENT

14. Review process for UG/PGT Student Ethics administrator 2 reviewers (usu. supervisor +1) Lead reviewer Ethics administrator Student Supervisor Low risk Supervisor review Potentially high risk Student Ethics administrator

15. Review process for PGR/staff Researcher Ethics administrator 3 reviewers (not inc. supervisor) Lead reviewer Ethics administrator If PGR - supervisor sign off Researcher Ethics administrator

16. Outcomes of review procedure Approval = GO AHEAD! Approval with suggested amendments = GO AHEAD BUT CONSIDER SUGGESTIONS Approval with compulsory amendments = MAKE CHANGES AND RE-SUBMIT Approval with suggested and compulsory amendments = MAKE CHANGES AND RE-SUBMIT + CONSIDER SUGGESTIONS Not approved = BACK TO DRAWING BOARD

17. Issues for applicants to consider Have I provided enough information (in lay language)? What risks does the project pose & how will they be managed? Is participant information appropriate for audience (no jargon, abbreviations etc)? Does the project require special ethical consideration e.g. vulnerable people or sensitive topics? How will I seek informed consent? How will I protect participant’s confidentiality/ anonymity? How will I ensure participant safety and well-being?

18. Principles: Safety and Well-being Consideration must be given to potential for harm/distress Steps should be taken to minimise harm/distress (e.g. informing participants of possibility; providing help/support after participation) In some research (e.g. clinical trials), the researcher may need to knowingly cause harm BUT possible harm should be outweighed by the potential benefits Participants should be informed of procedures for contacting researcher if problems arise Safety/well-being of researcher should also be considered

19. Principles: Informed consent Participants should be fully informed about reasons/method and be able to ask questions/reflect – INFORMATION SHEET? Participants should give free and voluntary consent, and not be coerced Consent should ideally be in writing or witnessed oral consent instead, although this may not always be appropriate – CONSENT FORM? Must have right to refuse to participate or withdraw Need consent for data to be used for secondary analysis; Special consideration should be given to projects where informed consent will not be sought

20. Principles: Anonymity, Confidentiality & Data Protection Must comply with Data Protection Act 1998 Participants’ identities should not be disclosed without prior consent; data should be anonymised where possible Access to data that could identify individuals should be restricted to lead researcher(s) unless there is agreement from the research participants Participants should be informed of: 1.Any risk that confidentiality may not be maintained (eg disclosure of criminal activity); 2.Who will have access to data; 3.The purpose for which the data is to be used

21. Key points to take away Each research project should be considered on a case by case basis but there are key principles; Ethics review is about heightening risk awareness – not about preventing ‘potentially high risk’ research; Ethical review is about encouraging researchers to think through potential ethical challenges; An ethically robust research project may still encounter unexpected ethical challenges; Conducting research involving participants is not an exact science-nor is the ethics review process Put yourself in the participant’s shoes....

22. Further Guidance Lindsay Unwin/Peggy Haughton (Research & Innovation Services) l.v.unwin@sheffield.ac.uk p.haughton@sheffield.ac.uk www.sheffield.ac.uk/ethics