The working group was established in May 2003 jointly by the Directors of R&D in England, Northern Ireland, Scotland and Wales, under the chairmanship of Professor Len Doyal. The remit of the group is to provide advice on how ethical review of student research might best be undertaken, within the remit of the wider Research Governance Frameworks.
The group consists of members from throughout the UK, and was drawn from varying professions in the academic community and the NHS, as well as from the ethics community. Professor Doyal has also carried out extensive informal discussions with other interested parties. The membership is listed in Annex A of the draft proposal.
The document below sets out an analysis and a preliminary draft proposal to establish Student Project Ethics Committees (SPECs) which would review those proposals that currently are or should be submitted to NHS Research Ethics Committees (RECs), but which are undertaken by students primarily for educational purposes. Such projects may occur in both undergraduate and postgraduate programmes.
The working group considers that the draft proposal protects the rights, safety, dignity and well-being of the potential research participants while recognising the educational and practical needs of the student population and the university and Higher Education sector.
The Chair of the working group would welcome comments on this draft proposal by Monday 15th March 2004. Comments should be sent by e-mail to Dr Janet Wisely at COREC: janet.wisely@corec.org.uk. The working group will consider the comments received and then make its recommendations.
The Ethical Governance and Regulation of Student Projects: a Proposal
COREC
27th January 2004
Standard NHS REC application form (page updated 30/03/04)
Guidance for applicants (revised 27/04/04)
Phase I Clinical Trials notice to applicants (issued 21/04/04)
How to get a EudraCT number (issued 15/04/04)
Patient information sheet and consent form guidelines
Central Allocation System for MREC applications
Frequently asked questions (page updated 16/03/04)
Standard operating procedures (added 01/03/04)
Governance arrangements (GAfREC)
RED: Research Ethics Database (added 01/03/04)