A Framework of Policies and Procedures for University Research Ethics Committees

John OatesAndrew Rawnsley

Birgit Whitman

Plan

The background to the Framework

The structure of the Framework

How the Framework might be implemented in institutions

The background to the Framework

John Oates

Open University and AREC Council

The structure of the Framework

Andrew Rawnsley

Research Governance & Training Manager Teesside University

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

Principles of governance arrangementsIndependenceEnsuring that conflicts of interest specific to universities are mitigated by sufficient external or impartial scrutiny and/or involvement

CompetenceEnsuring that membership of committees is informed by relevant expertise and decision making is consistent and coherent

FacilitationEnsuring that procedures are administered efficiently and effectively, balancing duties of care with enabling and support of ethical research and innovation

OpennessEnsuring that decisions taken by RECs are open to public scrutiny and responsibilities discharged consistently

Principles of governance arrangementsIndependence 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 judgements but 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.

Principles of governance arrangementsCompetenceDoes 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 compensation which demonstrate that the university has a sustainable commitment to competent ethics review?

Does the university provide systematic training for UREC members?

Principles of governance arrangements

FacilitationWhat 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?

Principles of governance arrangements

OpennessResearch 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?

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

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)

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

How the Framework might be implemented

in institutions

Birgit Whitman

Head of Research Governance University of Bristol

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

Internal implementation planPrepare 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

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

Go for it!