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ESRC Framework Research Ethics (FRE)

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

  2. In this talk: • I will outline the challenges of the task • I will summarise the conduct of the review • I will highlight the major changes in the new ESRC Framework for Research Ethics. (FRE) • Finally will introduce some case studies for discussion • What I am hoping to do is to start a dialogue. We are all learning.

  3. The Challenge: Updating the Framework for Research Ethics My background: considerable research with children and young people in some very sensitive areas. Involved in the development or original Barnardo’s Guide The challenge 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 we need a flexible approach which enables us to overcome new ethical dilemmas in research.

  4. 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

  5. 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.

  6. 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.

  7. 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 - Southampton • Professor William Dutton – University of Oxford • Dr Janet Boddy – Institute of Education • The Panel was ably assisted by: • Michele Dobson and Mary Day of ESRC.

  8. Some of the Issues raised in the consultation • The non-prescriptive approach generally welcomed. But varying levels of development in the different Research Organisations. • The need for enforcement of minimum standards. • Asked to make Framework make more accessible and to give more information on specific concerns. • New methodologies and new technology were raising new ethical issues. • They felt that the FRE should be available on the web: a ‘living tool’:

  9. Specific concerns • Vulnerable groups: need for greater definition and guidance • Security, Data and Risk: further guidance was needed • Use of technology: more guidance was necessary • Privacy and consent: secondary, video and image evidence in particular needed more guidance, and also for small / elite populations where people might be identifiable

  10. 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

  11. 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

  12. 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

  13. 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.

  14. Reminders and further changes • The role of Research Ethics Committees : • They should publish a timetable for considering proposals. • Feedback comments to researchers; dialogue between RECs and researchers to inform best practice. • Institutions encouraged to undertake periodic reviews of research funded by ESRC • ESRC to undertake periodic audits of institutional arrangements

  15. Key changes: Types of review • All ESRC researchmust go through at least a Light Touch Review. risk awareness whilst not being risk adverse. • Light touch review for projects of minimum risk • Use of approved protocols. To speed up the approval process. • 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). • Ongoing review may be necessary after the start of an award to consider emerging ethical issues.

  16. Further clarification • Student research: treated in the same manner as other research. It cannot be assumed that all student research is minimal risk. • International /security. ESRC/DflD is funding increasing volume of overseas research, some in sensitive areas. Consultation raised issues including risk to researchers and participants • Use of approved research ethics protocols for commonly occurring situations (e.g. normally developing children in school). • 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: 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.

  17. Next Steps • Revised Framework for Research Ethics was published on web in January 2010 • New web version under preparation • Requirement for New ethics guidance to be incorporated by researchers and RECs by next year.

  18. Ethics and Knowledge ExchangePossible 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: • Linking and sharing of data: ‘Just because you can does not mean you should’ • Pressures to demonstrate IMPACT. Could there be risks to researchers, participants or others from demonstrating impact and/or disseminating findings? • Knowledge exchange is important.

  19. Case Study: Evaluation of Creative Relaxation (not ESRC funded) • The Girasol Foundation established in 2006 for the well-being of children and those who work with them. Their vision is to give every child the opportunity to experience their positive potential and to develop resources to deal with the inevitable difficulties which life presents. Cascade programme: train teachers in Creative Relaxation and teachers then train children Centre for Research into Parenting and Children at Oxford responsible for evaluation of pilot project

  20. What were the ethics’ issues? Research with vulnerable group i.e. children But research on ‘typically-developing children’ in school Oxford University has an agreed Research Protocol for ‘Non-invasive methods with typically-developing children in schools. (MSD/IDREC/2005/p.2.1) For the ESRC purposes: this could be a Light Touch Review. This would highlight that the research was with a vulnerable group but that the project was suitable for and would be able to follow the agreed protocol What issues does the protocol cover?

  21. Young carers of AIDS’ parents in South Africa : Lucie Cluver (Ex ESRC student currently funded by ESRC) What happens when a parent gets sick ?

  22. Ethics’ Issues The key issue here was risk awareness – unable to avoid all risks Vulnerable group: interviewing children in a particularly vulnerable situation Vulnerable parents: sick/dying ; stigma of HIV/AIDS International setting: safety risks to children, parents, researchers (research took place in townships with high levels of violence) But also: politically sensitive. Findings presented as attacking Government are unlikely to enter policy This proposal had to go through a full Oxford Ethics Review as ell as Univ. of Cape town; Univ. of Kwa-Zulu, natal; helth Departments and Education Departments of each province.

  23. Young Lives funded Department for International Development (DFID) Young Lives is a long-term international research project investigating the changing nature of childhood poverty in order to: improve understanding of the causes and consequences of childhood poverty and to examine how policies affect children’s well-being inform the development and implementation of policies and practices that will reduce childhood poverty. To do this they are tracking the lives of 12,000 children growing up in four developing countries over 15 years. The study countries – Ethiopia, the state of Andhra Pradesh in India, Peru and Vietnam – were selected to reflect a wide range of cultural, political, geographical and social contexts. What are the ethics’ issues?

  24. Young Lives: ethics’ issues The study raises numerous ethics questions : Research with children Research in a developing countries with international partners Research that is longitudinal, thus requiring sustaining of relationships over time; Research that involves the archiving of collected data. Approach was informed by: • Guidelines from the University of Oxford’s Department of International Development, adapted from the ethical guidelines of the Association of Social Anthropologists of the Commonwealth, and based on the Helsinki guidelines. • Save the Children Child Protection Policy (2003). Ethics approaches in Young Lives were developed collaboratively with the country Process, not a one-off event.

  25. Lessons learnt The need to understand the dynamic nature of communities is crucial in longitudinal research. While broad shared ethics practices are important, these need to be applied with some flexibility Researchers should be aware that they are not going into neutral situations – • Survey and qualitative research teams undergo additional training sessions before each round of fieldwork, and ethics questions are discussed across the study, with the aim of developing a shared understanding of research ethics. • Consent is understood as an ongoing process and is renegotiated at each stage of the study. • To ensure that staff knew what to do should they encounter children they believe may be suffering from abuse or exploitation; we use the child protection protocols developed by Save the Children (2003). Virginia Morrow (2009) The Ethics of Social Research with Children and Families in Young Lives: Practical Experiences, Young Lives Working Paper 53

  26. 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 • Phil Sooben, Director Corporate Strategy, phil.sooben@esrc.ac.uk telephone 01793 413028 • Glyn Davies, Director with special responsibility for research integrity, glyn.davies@esrc.ac.uk telephone 01793 413009

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