esrc framework research ethics fre

1. ESRC Framework Research Ethics (FRE) Professor Ann Buchanan, Chair of FRE Committee University of Oxford

3. The Challenge: Updating the Framework for Research Ethics My background is as a researcher undertaking research with children and young people in sometimes very sensitive areas. Early on was involved in developing the first guidance for research with children for Barnardo�s in 1990s Since then, we have learnt much about how to undertake research that meets high ethical standards. But we are still learning. The challenge in updating FRE was to continue the push for the development of high ethical standards while at the same time not block research using new innovative methodologies. ESRC need to enforce basic minimum standards but as we learn we need a flexible approach which enables us to overcome new ethical dilemmas in research.

4. Origins of the Framework and Review Framework launched in January 2006 Followed wide consultation over 2 years Designed to address the challenges facing social science research Addresses the core criteria of the dignity, rights and welfare of research participants

5. Key Aspects of Original Framework Research designed, reviewed and undertaken to ensure integrity and quality Staff and subjects must be fully informed about purpose, methods, uses and risks Confidentiality and anonymity must be respected Voluntary basis free from coercion Harm to participants must be avoided Independence of the research must be clear, and conflicts of interest must be explicit

6. The 2009 Review Promised after three years Some issues had arisen in that time (none major) Some significant developments in legislation RCUK Research Integrity (Good Research Conduct) 2008 consultation and its relevance Major developments in ESRC with new funding across disciplines, across research councils, across countries.

7. Conduct of the Review Aim was that the review would be light touch and framework would retain similar structure for familiarity Public consultation January-February 2009 Research organisations (universities, etc. - ROs), Learned Societies and wider public consulted Over 100 responses Reviewed by small review panel chaired by ESRC Council member (Professor Ann Buchanan) in May 2009.

8. The Review Panel Chair: Professor Ann Buchanan, ESRC Council and Oxford University Professor Sheila Peace � Open University Professor John Oates � Open University Professor Graham Crow � University of Southampton Professor William Dutton � University of Oxford Dr Janet Boddy � Institute of Education The Panel was ably assisted by: Michelle Dodson and Mary Day of ESRC. �

9. Some of the Issues raised in the consultation The non-prescriptive approach adopted by the ESRC was generally welcomed. But there was also an awareness of different levels of development in the different Research Organisations. There was a general recognition for the need for minimum standards. Consultees asked for the framework to be made more accessible and to give more information on specific concerns. It was felt that with the rapid pace of new methodologies and new technology were raising new ethical issues. They felt that the FRE should be available on the web: a �living tool�: a place to share approved research ethics protocols and to discuss solutions to new ethical dilemmas.

10. Specific concerns Special concerns

11. Some more of the Issues Raised Risk assessment : more advice and guidance was asked for Co-funded and International research: particular challenges in ensuring ethical best practice More guidance on social care issues in the light of recent / current developments and the role of SCIE (Social Care Institute for Excellence) and SCREC (National Social Care Research Ethics Committee) More guidance on and reference to other bodies with supervisory responsibilities

12. Structure of updated ESRC Framework SUMMARY Principles and Minimum Requirements SECTION 1: The ESRC�s Minimum Requirements SECTION 2: Frequently Asked Questions Relating to the Principles: Assessing Risk, Consent, Vulnerable Groups and the links between Research Governance and Ethics. Appendices

13. Appendices APPENDIX A: Sample REC Initial Checklist, List of Points to Consider for Full Review, UKRIO Checklist APPENDIX B : Flowchart of Review Process APPENDIX C: Key Terms APPENDIX D: Relevant Legislation and Data Requirements; Disciplinary Websites, Useful Links APPENDIX E: Summary of Changes made to the 2005 Framework APPENDIX F: Illustrative Case Studies and Protocols

14. Key Changes New Name: Framework for Research Ethics (FRE)! New Guidance for key legislative changes: e.g. Mental Capacity Act 2005 and links to relevant websites for other legislation. Clear link made between Governance and Ethics- The RCUK Research Conduct and Research Integrity Policy.

15. Reminders and further changes The role of Research Ethics Committees : to facilitate good practice; involve all groups involved in research (funders, institutions, researchers and participants) throughout the life of the research. They should publish a timetable for considering proposals. In FRE it is proposed RECS should feedback comments to researchers; dialogue between RECs and researchers to inform best practice. Institutions encouraged to undertake periodic reviews of research funded by ESRC and record the results ESRC may undertake periodic audits of institutional arrangements to ensure they are operating to at least the minimum standards. RECs should therefore keep records of procedures etc.

16. Key changes: Types of review FRE now clarifies that all ESRC research must go through at least a Light Touch Review as a minimum standard. The focus as a starting point is: risk awareness whilst not being risk averse. Light Touch Review: This may be all that is needed where the potential for risk of harm to participants and others affected by the proposed research is minimal. Use of approved protocols. Many Research Organisations have developed Research ethics protocols for commonly occurring situations. These can speed up the approval process. Where Light Touch Review has confirmed that a research proposal requires a Full Ethics Review this should be carried out by a REC under the same conditions as stated in the original REF. FRE encourages researchers to consider Full Ethics Review if research is carried out in international settings or with international partners. Similarly Elite interviews, internet based research (particularly those involving visual images), data sharing and data archiving may raise issues which should be considered. Ongoing review may be necessary after the start of an award to consider emerging ethical issues. Also during the dissemination process (see later).

17. Further clarification Students: their research should be treated in the same manner as other research. Many projects may only need light touch review but it cannot be assumed that all student research is minimal risk. Doctoral Training Centres and Doctoral Training Units will need to detail their ethics training. International /security. ESRC/DflD is funding an increasing volume of overseas research, some in sensitive areas. Consultation raised issues including risk to researchers and participants which required further guidance. Use of approved research ethics protocols for commonly occurring situations (e.g. normally developing children in school). It is hoped Research Organisations will be willing to publish these on the web. Also anonymised case studies to demonstrate how ethical issues have been overcome. Limits to Confidentiality. The FRE provides clarification on limits to confidentiality when working with vulnerable populations and where it becomes apparent that the vulnerable person/child is at risk of significant harm. Internet and technology: Responses indicated concerns about the vast increase in the use of e-technology: further guidance is given but it is also recognised that this will be a growing area and experience needs to be exchanged.

18. Next Steps Revised Framework for Research Ethics was published on web in January 2010 New web version under preparation (Available later this year) Requirement for New ethics guidance to be incorporated by researchers and RECs next academic year

19. Ethics and Knowledge Exchange Possible areas of concern that raise ethics� issues As far as possible these need to be considered at the start of a project: Data archiving of interviews: may be difficult to anonymise case studies. Has the respondent given permission for their interview to be archived and available to other researchers? Linking and sharing of data: has the respondent given permission for this? Could a person be identified by linking data? May be a particular issue in e-technology and visual images. �Just because you can does not mean that you should� (Prof Dutton) Pressures to demonstrate IMPACT: Note the new requirements by ESRC for research proposals to highlight the potential IMPACT pathways of their research. Also the new requirements in the Framework for Research Ethics (FRE) to demonstrate IMPACT. Could there be risks to researchers, participants or others from demonstrating impact and/or disseminating findings? Knowledge exchange is important. Ethical issues need to be thought through before they happen. May also be necessary to have an ongoing review.

20. For further information: contact ESRC Michelle Dodson, Head of Research Grants, Policy and Development michelle.dodson@esrc.ac.uk telephone 01793 414357 Mary Day, Senior Policy Manager, mary.day@esrc.ac.uk telephone 01793 413078

21. Now over to you! ESRC Framework Research Ethics (FRE)