John Oates
Andrew Rawnsley
Birgit Whitman
Plan
 The background to the Framework
 The structure of the Framework
 How the Framework might be implemented
in institutions
John Oates
Open University and AREC Council
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
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1:
2:
Standard Operating Procedures Framework (NRES/OHRP)
Self-assessment tool
Principles of governance arrangements
Independence
Ensuring that conflicts of interest specific to universities are mitigated by
sufficient external or impartial scrutiny and/or involvement
Competence
Ensuring that membership of committees is informed by relevant
expertise and decision making is consistent and coherent
Facilitation
Ensuring that procedures are administered efficiently and effectively,
balancing duties of care with enabling and support of ethical research
and innovation
Openness
Ensuring that decisions taken by RECs are open to public scrutiny and
responsibilities discharged consistently
Principles of governance arrangements
Independence
 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 arrangements
Competence
 Does 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
Facilitation
 What 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
Openness
 Research 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
Best practice
(required)
(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
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 plan
 Prepare 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 plan
Evaluation 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!