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 Association for Research Ethics