ESRC Framework Research Ethics (FRE)

Professor Ann Buchanan, Chair of FRE Committee

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.

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.

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

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.

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.

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.

 

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’:

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

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

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

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

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.

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

Key changes: Types of review All ESRC research must 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.

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.

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.

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:

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.

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

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?

Young carers of AIDS’ parents in South Africa : Lucie Cluver (Ex ESRC student currently funded by ESRC)

What happens when a parent gets sick ?

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.

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?

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.

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

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

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