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AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret...
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![Page 1: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/1.jpg)
Association for Research Ethics
AfRE Standard Operating Procedures for University
Research Ethics Committees
Overview Prof Margaret Rees AfRE Chair 8
September 2015
![Page 2: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/2.jpg)
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
![Page 3: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/3.jpg)
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
![Page 4: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/4.jpg)
Association for Research Ethics
The committee and meetings
Procedures should be set down to cover:• constitutional matters: committees and
subcommittees• business procedures• documentation • minutes
![Page 5: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/5.jpg)
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
![Page 6: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/6.jpg)
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
![Page 7: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/7.jpg)
Association for Research Ethics
Amendments
• Definition of minor or substantial amendments
• Mechanisms for dealing with substantial amendments: full committee or executive committee
![Page 8: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/8.jpg)
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
![Page 9: AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.](https://reader036.fdocuments.in/reader036/viewer/2022082821/5697bfd31a28abf838cac684/html5/thumbnails/9.jpg)
Association for Research Ethics
Other issues
• Appeals• Duration of approval• Progress reports• Safety measures• Final reports