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An Introduction to the Ethics Review Procedure

An Introduction to the Ethics Review Procedure. Lindsay Unwin: Research & Innovation Services, UREC Secretary. Routes for ethics approval. University ethics review procedure (administered in each academic department) Alternative ethics review procedure (other HEIs/organisations)

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An Introduction to the Ethics Review Procedure

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

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

  3. University Procedure Remit: • Research project(investigationto 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. Alternative Procedure Remit: • Research conducted outside UK; or • Research led by another UK university/research organisation BUT: • The other procedure must be judged to be sufficiently robust by the UREC; if in doubt, apply University procedure

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

  6. NHS Procedure • 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 Remit: • 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; • Department 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 Low risk Potentially high risk Supervisor Supervisor review Ethics administrator 2 reviewers (usu. supervisor +1) Student Ethics administrator Ethics administrator Lead reviewer Student

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

  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. Is participant information appropriate for audience (no jargon, abbreviations etc)? Have I provided enough information (in lay language)? Issues for applicants to consider What risks does the project pose & how will they be managed? How will I seek informed consent? Does the project require special ethical consideration e.g. vulnerable people or sensitive topics? 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 researchershould 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: • Any risk that confidentiality may not be maintained (eg disclosure of criminal activity); • Who will have access to data; • The purpose for which the data is to be used

  21. Key points to take away • Each research project should be consideredon 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 tothink through potential ethical challenges; • An ethically robust research project may stillencounter unexpected ethical challenges; • Conducting research involving participants isnot an exact science-nor is the ethics review process Put yourself in the participant’s shoes....

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

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