Association for Research Ethics

AfRE Standard Operating Procedures for University

Research Ethics Committees

Overview Prof Margaret Rees AfRE Chair 8

September 2015

Association for Research Ethics

Purpose

• To meet the obligations of the university’s own research ethics policies

• To have due regard for national and international guidelines

• To set out areas that are outside the scope of URECs

• To set out time lines to deal with applications and amendments

Association for Research Ethics

Applications

• Applications should be made on a prescribed form.

• The application should be made by the Chief Investigator

• Procedures should specify how a form is submitted and what documents are required for a valid application

• A check list of supporting documents is recommended

Association for Research Ethics

The committee and meetings

Procedures should be set down to cover:• constitutional matters: committees and

subcommittees• business procedures• documentation • minutes

Association for Research Ethics

Giving an ethics opinion: options

Decisions available to the committee:• approval• conditional approval• non-mandatory advice• resubmit with revisions• reject• refer to another committee with or without

advice

Association for Research Ethics

Giving an ethics opinion: letters

• Signature of Chair or designated person• Acknowledgement of those present at meeting• Period of validity of ethics approval• Warning about deviating from approved

protocol• Mechanism for amendments• Requirement for continuing review/final report

Association for Research Ethics

Amendments

• Definition of minor or substantial amendments

• Mechanisms for dealing with substantial amendments: full committee or executive committee

Association for Research Ethics

Proportionate or expedited review

Factors to consider• Set criteria for applications• Membership of the committee dealing with

these applications• Mechanism of communication

Association for Research Ethics

Other issues

• Appeals• Duration of approval• Progress reports• Safety measures• Final reports