1. Introducing Research Ethics: Policy and Procedure www.shef.ac.uk/ethics

2. What is Research Ethics? Ethical review aims to protect welfare, dignity and rights of participants in research. It considers the rights of the research participants and the obligations of the researcher. ‘Unimpeachable ethics are at the heart of the research process, across all of our disciplines’ Keith Burnett Safety and Wellbeing of all participants (including the researcher) Principles of Informed consent Anonymity, confidentiality and data protection Researchers then have the obligation to ensure that their research is conducted with honesty; integrity; minimal risk to participants and themselves and cultural sensitivity

3. Ethics and TUOS www.shef.ac.uk/ethics General Principles and Statements Ethics Approval Procedure Research Ethics Policy Notes Specialist Research Ethics Guidance Papers Other Guidance and Advice www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/general-principles www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/papers www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/universityprocedure2 www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/guidance

4. When is ethics approval required? All research projects involving human participants, personal data or human tissue. Policy Overview What is Research? ‘All investigation undertaken to acquire knowledge and understanding’ (RAE, 2008) - Work of educational value designed to improve understanding of the research process - administrative research (for example within Professional Services) It does not include: - Routine audit and evaluation - Routine testing and analysis of materials, components, processes etc. It includes:

5. Policy Overview Where can approval be gained from? University of Sheffield ethics review procedure NHS ethics review procedure/ Social care research ethics committee An alternative ethics review procedure - Research led by another UK University/ research organisation - Research conducted outside the UK (These procedures must have been judged to be sufficiently robust by the University Research Ethics Committee (UREC)) DoH Governance Arrangements for Research Ethics committees: www.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133 993.pdf Legislative Requirements for Ethical Review: www.nres.nhs.uk/applications/approval-requirements/ethical-review- requirements/requirements-for-ethical-review-under-legislation/ Generally applicable for research involving NHS patients (inc. data) or Social Care users:

6. How does the University Ethics approval process work? www.shef.ac.uk/ris/other/committees/ethicscommittee Procedures - promote awareness and understanding - annually monitoring departmental review arrangements - accrediting and reviewing departmental review arrangements - providing guidance in cases of uncertainty - making decisions on cases that cannot be resolved by ethics review panels - hearing appeals against decisions made by departmental ethics review panels - reviewing applications when necessary due to funding requirements University Research Ethics Committee (UREC) Provides oversight to the process and monitors its implementation.

7. Process of ethical review devolved to Departments (excluding where required by funders or for contentious applications) www.shef.ac.uk/polopoly_fs/1.365132!/file/Principal-Ethics-Contacts.pdf www.shef.ac.uk/polopoly_fs/1.361915!/file/Ethics-Administrators-2014.pdf Procedures How does the University Ethics approval process work? To support this each department has a Principal Ethics Contact (responsible for communicating the policy and any changes that occur) and an Ethics Administrator (responsible for the day-to-day administration of the procedure). These contact details can be found at: Each department also has a pool of ethics reviewers who conduct the majority of ethical reviews and maintain their own webpages giving the details of their departmental Research Ethics review processes Departmental Devolution

8. Procedures Departmental Ethics Review procedures: - Staff led projects and supervised PGR projects - Potentially low risk UG/ PGT - Potentially high risk UG/ PGT - Generic Applications - ESRC funded and some social care research - Contentious applications www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval- procedure/review-procedure Types of Application

9. Possible outcomes of the Procedures: - Approval - Approval with suggested amendments - Approval with compulsory amendments - Approval with suggested and compulsory amendments - Not approved - No decision – referred to Departmental Ethics Panel and then UREC www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval- procedure/review-procedure/possible-project-outcomes Procedures

10. Postgraduate research (PGR) / Staff applications: www.sheffield.ac.uk/ris/other/gov- ethics/ethicspolicy/approval- procedure/review-procedure/how-is- review-carried-out

11. Procedures Undergraduate/ Postgraduate (taught) applications: LOW RISK HIGH RISK www.sheffield.ac.uk/ris/other/gov- ethics/ethicspolicy/approval-procedure/review- procedure/distinct-research-projects

12. Procedures Staff application for UG/ PG (taught) applications: GENERIC http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review- procedure/generic-research-projects

13. Considerations www.shef.ac.uk/polopoly_fs/1.221498!/file/ABriefStudentGuideToResearchEthics.pd f www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further- guidance/universityprocedure2/reviewers

14. Considerations Safety and Wellbeing (Ethics Policy Note 3): 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 www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/safety-well-being

15. Considerations Informed Consent (Ethics Policy Note 2) Consent should be gained using language and actions appropriate to those taking part in the study Participants should be fully informed about reasons/method and be able to ask questions/reflect 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 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 is not being obtained www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/consent

16. Considerations Anonymity, confidentiality and data protection (Ethics Policy Note 4): 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 www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/confidentiality- anonymity-data-protection

17. Other procedures Is ethics the only approval needed?

18. Departmental Contacts Departmental Ethics Contact Departmental Ethics Administrator Departmental Ethics pages www.shef.ac.uk/polopoly_fs/1.365132!/file/Principal-Ethics-Contacts.pdf www.shef.ac.uk/polopoly_fs/1.361915!/file/Ethics-Administrators-2014.pdf

19. Further Information www.shef.ac.uk/ethics UREC Secretary Peggy Haughton p.haughton@sheffield.ac.uk 0114 22 21433 UREC Minute Secretary Catherine Wynn c.wynn@sheffield.ac.uk 0114 22 21400 “Thinking is NOT Optional”