Association for Research Ethics

AfRE Framework of Policies andProcedures for University

Research Ethics Committees

Overview Prof Margaret Rees AfRE Chair 29 July

2015

Association for Research Ethics

Key content

• Principles of research ethics• Principles of governance arrangements• Implementing the principles in the ethical

review process• Model Standard Operating Procedures (SOPs)• Self assessment tool

Association for Research Ethics

Basic principles of ethical research• Autonomy. The participant must normally be as aware as possible of what the

research is for and be free to take part in it without coercion or penalty for not taking part, and also free to withdraw at any time without giving a reason and without a threat of any adverse effect.

• Beneficence. The research must be worthwhile in itself and have beneficial effects that outweigh any risks; it follows that the methodology must be sound so that best results will be yielded.

• Non-maleficence. Any possible harm must be avoided or at least mitigated by robust precautions.

• Confidentiality. Personal data must remain unknown to all but the research team (unless the participant agrees otherwise or in cases where there is an overriding public interest, or where participants wish their voices to be heard and identified).

• Integrity. The researcher must be open about any actual or potential conflicts of interest, and conduct their research in a way that meets recognised standards of research integrity.

Association for Research Ethics

Principles of governance arrangements

• Independence• Competence• Facilitation• Openness

Association for Research Ethics

Governance within the framework: key features

• Independence and integrity of committee decisions• Clear committee structure • Appeals procedures defined• Misconduct procedures for researchers who act

against the requirements of the REC in place• Clear job descriptions for REC administrators

Association for Research Ethics

Implementing the principles in the ethical review process

• Policy document with approach to ethics review, terms of reference of the committee and job descriptions for committee members

• Training and development of committee members• Standard operating procedures• Other procedures and guidelines eg conduct of

meeting, dealing with complaints

Association for Research Ethics

Model standard operating procedures should include

• Role of a REC• Constitution of a REC• Arrangements for dealing with applications,

amendments and appeals• Fat tracking ethics review and devolved review• Monitoring procedures

Association for Research Ethics

Conclusion

• AfRE promotes excellence in the ethics of research in humans through training and education

• The full framework is available @ http://www.arec.org.uk/documents/afre-trustees/12-11-13-framework-complete-2.pdf