A Framework of Policies and Procedures for University Research Ethics Committees

1. A Framework of Policies and Procedures for University Research Ethics Committees John Oates Andrew Rawnsley Birgit Whitman

2. Plan • The background to the Framework • The structure of the Framework • How the Framework might be implemented in institutions

3. The background to the Framework John Oates Open University and AREC Council

4. The structure of the Framework Andrew Rawnsley Research Governance & Training Manager Teesside University

5. Framework structure • Statement of general ethical principles, references • Principles of governance arrangements • Independence • Competency • Facilitation • Openness • Governance within the Framework • Implementing the Principles in the ethical review process • Model Standard Operating Procedures • Appendices • 1: Standard Operating Procedures Framework (NRES/OHRP) • 2: Self-assessment tool

6. Principles of governance arrangements Independence Ensuring that conflicts of interest specific to universities are mitigated by sufficient external or impartial scrutiny and/or involvement Competence Ensuring that membership of committees is informed by relevant expertise and decision making is consistent and coherent Facilitation Ensuring that procedures are administered efficiently and effectively, balancing duties of care with enabling and support of ethical research and innovation Openness Ensuring that decisions taken by RECs are open to public scrutiny and responsibilities discharged consistently

7. Principles of governance arrangements Independence • ensuring that URECs include members from a wide range of disciplines; • ensuring that URECs have members from outside the faculty or other academic unit covered by the committee; • providing a constitution which grants each UREC the freedom to make ethics judgementsbut that also makes it accountable; • including ‘lay’ or external members in URECs; • having an overarching policy committee which may or may not undertake ethics review itself, but which sets consistent standards and has authority to intervene when necessary.

8. Principles of governance arrangements Competence • Does the UREC have comprehensive standard operating procedures so that ethics opinions are reached consistently and fairly? • Do ethical review applications require details that provide all the information that a competent REC needs to have in order to make sound and coherent decisions? • Do UREC members get compensationwhich demonstrate that the university has a sustainable commitment to competent ethics review? • Does the university provide systematic training for UREC members?

9. Principles of governance arrangements Facilitation • What is the degree of devolution for responsibility in making ethics decision? Are decisions taken at the local or central level? • What checks and balances might be put in place to manage the balance between ethical duties and support of research activity? • How does the UREC and the university ensure that researchers are trained, in ethical issues and in the policies and mechanics of review? • How does the UREC deal with ensuring timely and proportional review? Are different levels of risk handled efficiently? How are delays in response to application minimised?

10. Principles of governance arrangements Openness • Research should be subject to rigorous peer review not normally open to public scrutiny before the results are published, so how is transparency to be achieved? • A researcher should be allowed to respond to any criticism or ethics review without the threat of having his or her career tarnished by adverse publicity, so how does a UREC ensure that this is avoided? • How can the institution ensure openness whilst preserving intellectual property rights where due? • Are the research governance arrangements for the university clearly available to both internal and external parties? • What reporting lines are in place and with whom does the responsibility for reporting lie?

11. Governance within the Framework • decisions on individual projects must be respected • no member should be subject to pressure from interested parties • no negative opinion should be overturned, except by another duly appointed UREC • a positive opinion should be overturned only because of an issue outside the purview of the original UREC or facts not brought to the attention of that UREC • there should be an appeals procedure, which allows reference to another UREC • researchers who fail to refer relevant projects for ethics review, who deliberately act against the requirements of a UREC, or who treat those requirements contemptuously should be liable to investigation for research misconduct

12. Implementing the Principles in the ethical review process Basic standards (required) Best practice (recommended) 1. Policy document (required) a Terms of Reference for REC (required) b Job descriptions for REC members (recommended) 2. Training and development of REC members (required) 3. Standard Operating Procedures (recommended) 4. Other procedures and guidelines (recommended)

13. Model Standard Operating Procedures • The role of a Research Ethics Committee • The constitution of a Research Ethics Committee • Applications • Fast-tracking ethics review and devolved review • Monitoring

14. How the Framework might be implemented in institutions Birgit Whitman Head of Research Governance University of Bristol

15. Internal implementation plan Pilot phase • Introduce the framework to the Research Ethics Community - Strategic level - Operational level • Undertake a mapping exercise in one of the Research Ethics Committees (REC) - identify volunteer for pilot • Identify issues for clarification and training needs

16. Internal implementation plan • Prepare template compliance statement for University wide sections of the framework • Arrange training of Research Ethics Officers and administrators via AREC • Provide hands on support • Roll out to all REC for self-assessment

17. Internal implementation planEvaluation phase • Collect responses and prepare position paper with gap analysis to identify common themes. • Prepare action plan • Feed into system policy development • Consider independent review with colleagues from the AREC community • Redo self-assessment every 3 years

18. Go for it!