1. 8 th November 2007 Research: ethics and research governance Rossana Dowsett Research and Regional Development Division [Pre Award Support] University of Sussex

2. Research ethics and research governance Overview  Definitions  Legal framework  Funders’ requirements  Systems: research ethics committees  Special Issues  The future…

3. Research ethics and research governance Definitions 1. Research Ethics  Protecting the rights, dignity, and safety of research subjects / participants 2. Research Governance  Standards, management & monitoring of research  Sanctions: research misconduct

4. Research ethics Ethical issues: human participants  The research subject’s welfare  Vulnerable groups  Equitable distribution of benefits and burdens  Informed consent  Confidentiality and privacy  And more…

5. Research ethics Ethics: the legal framework Human subjects/participants  Data Protection Acts  Human Tissue Act (April 2006)  Other regulatory requirements Other  Animals (Scientific Procedures) Act o3 Rs (reduction, replacement, refinement)

6. Research ethics Ethics in practice Patients (NHS / Medical) - NRES  requires approval from NHS Local Research Ethics Committee (LREC) Other humans (e.g. Social Science research)  usually requires ethical approval e.g. University RECs Animals (usually H&S committee)  Home Office licence required

7. Research ethics Result  Fire fighting  Ad hoc Codes of Practice…  External regulation and governance of good practice in research  Sponsors introduce guidelines and new terms & conditions based on principles of good practice

8. Research ethics and… The Wellcome Trust  Guidelines  Integrity  Openness  Guidance from professional bodies  Leadership and cooperation  Supervision  Training  Use of primary data/samples  Ethical practice  Publication practice  Requirement  formal written procedures for the investigation of allegations of misconduct

9. Research ethics ESRC Research Ethics Framework  Launched July 2005, implementation January 2006  A “benchmark” for all social science research  All grant applications must adhere  Compliance to be monitored by institutional RECs  Sanctions: individual and institutional  A minimum set of enforceable standards…

10. Research ethics ESRC: ten minimum requirements  Ethical issues always addressed in the research proposal  Expedited review  Approval by a research ethics committee required  Procedures for institutional monitoring in place  Complaints procedure should be in place  Arrangements should be made for research students  Additional costs are FECable  Arrangements for multi-funder and multi-performer projects  Avoiding duplication of submission  Legal and data requirements must be met

11. Research governance Research Governance - what is it?  Sets standards for Good Practice in Research including:  Management and monitoring of research  Mechanisms to deal with Conflicts of Interest  Mechanisms to investigate Research Misconduct: complaints, appeals, sanctions

12. Research governance Research Governance – who and how? Department of Health  Research Governance Framework for health and social care ( RGF ) DEFRA/FSA/BBSRC/NERC  Joint Code of Practice: Quality Assurance in Research

13. Research: research governance DoH RGF I  Launched in 2001, implemented in 2004  Affects research undertaken in or by the DH/NHS  Social care agencies (health and social care systems)  All research requires a sponsor : not necessarily the funder…

14. Research: research governance DoH RGF II  Arrangements to define and communicate clear quality standards  Delivery mechanisms to ensure these standards are met  Arrangements to monitor quality and assess adherence to standards quality

15. Research governance Quality Assurance in Research  Joint Code of Practice DEFRA/FSA/ BBSRC/NERC  Implemented June 2004  Quality of research process (QP)  Improve public confidence  Reduce risk of incorrect findings  Formal systems to be audited by independent third parties – has this happened?

16. Research governance DEFRA - Joint Code of Practice  Responsibilities  Competence of personnel  Project Planning  Quality control  Health & Safety  Handling of samples and materials  Facilities and equipment  Documentation of procedures and method  Research / work records

17. Research ethics and research governance Accountability and Transparency Research Ethics Committe e Sponsors USA example Professional standards of conduct Public confidence Legislation

18. Research: ethics and research governance A typical committee structure (Sussex…) University Research Governance Committee Deans & Directors Lay members School Research Governance Committees

19. Research: ethics and research governance REC Responsibilities…  Consider ethical implications of all research involving human participants carried out at the University  To receive from members of academic staff proposals for experiments, investigations and procedures and to allow, refer back or disallow such proposals, specifying where necessary any conditions  Make available application forms, guidelines and background documentation  Advise on effective preparation of applications

20. Research: ethics and research governance For each proposal/project…  The proposed study is scientifically valid and justifiable in terms of its possible benefits compared with any inconvenience or harm  Adequate steps have been taken so that physical or psychological harm does not occur  That confidentiality of all personal and medical information is ensured and privacy maintained  Consent is valid (informed) and given without any form of duress

21. Research: ethics and research governance Other considerations  Indemnity insurance  Children and consent (Gillick competent child)  Protection of those undertaking the research (risk analysis)  NHS patients/data/organs/tissue – LREC approval  Training: staff and research students  Frequency of meetings  Transparency  Monitoring  REC structure…

22. Research ethics: School review Checklist:  Formal review required?  Consult checklist (School and/or Code of Practice list)  Consult School Designated Officer for advice  Follow School procedures for submitting project for ethical review  Certificate of Approval (conditions?)  Ongoing review / monitoring?

23. Research: ethics and research governance Special issues  Keeping up to date/raising awareness  Training  Compliance with Terms & Conditions  Checks for internal approvals  Variations in policy and practice  Ongoing monitoring  Independence  Resource

24. Ethics and research governance The future - which way?  Beyond self-regulation  Compliance monitoring?  Quality monitoring?  Process monitoring?  The US experience (Office of Research Integrity)…

25. Summary: ethics and research governance require…  Ethical approval of research involving human participants  Ethical approval of research using animals  Staff : roles, and responsibilities  Monitoring of research  Management of conflicts of interest  System for investigating allegations of misconduct Thank you…