Changes Affecting Procedures for Applications to NHS Research Ethics Committees from 1 April 2002 

INTERIM ARRANGEMENTS FROM 1 APRIL 2002 - 1 OCTOBER 2002

- As of April 2002, 'Health Authorities' in England refers to the new, larger Health Authorities.

- As the principal researcher you should apply in the first instance to the LREC for the locality in which you are based, as you would have previously.

- If that LREC is unable to handle the application within a reasonable time (e.g. if it does not have any spaces left on its next meeting's agenda, or if you have just missed a deadline), you may now apply to any other LREC in that same Health Authority. You should discuss this with the administrator of the LREC to which you first applied.

- A favourable opinion on the ethics of the research proposal from just one LREC in the Health Authority will be sufficient to cover the whole of that Health Authority for NHS research ethics review. You do not need a further full ethical review of the protocol from any other LREC within that same Health Authority.

- Once you have a favourable ethical opinion from one LREC, you will still need to apply to the other relevant LRECs within the same Health Authority for review of locality issues only using the new "Health Authority Locality form" (available from HA locality form). These locality issues are listed in GAfREC para 8.8. The LREC adminstrators will be able to advise you about local arrangements for obtaining this approval. You should report that approval of locality issues to the LREC who gave ethical approval for the research proposal.

- It is essential that permission of the host Trust or or other NHS organisation is also obtained before any research begins.
 

Visit Corec website for further details: www.corec.org.uk/Interim.htm
 

1) GMC has issued new guidance on clinical research: "Research: The Role and Responsibilities of Doctors" is available from the GMC (www.gmc-uk.org or tel 020 7915 3507). 

1) Application form updated to include annual and final report forms. In accordance with ICH/GCP Guidelines (soon to be incorporated into an EU Directive and in time UK law) Investigators are required to submit a progress report once a year until completion of the study when the final report form needs to be returned.

2) Due to forthcoming increase in REC membership the Committee now requires 20 photocopies of applications to be submitted along with the original.

3) The REPORT OF A REVIEW OF THE RESEARCH FRAMEWORK IN NORTH STAFFORDSHIRE HOSPITAL NHS TRUST is now available. 

It examines the way that protocols surrounding clinical practice and research operated at North Staffordshire Hospital. In particular it highlights some of the issues and difficulties around consent to treatment and consent to participation in research. It examines in detail the protocols that existed at the time of the events that led to the review and in particular at the way they were used in relation to the work conducted by Professor Southall.

Full report available at: http://www.doh.gov.uk/wmro/northstaffs.htm
 

24-3-99

MREC applications will now be reviewed by a Sub-Committee. This means that only 3 photocopies, plus the original signed application, need be sent to the Secretary. 

>NB: All applications should be accompanied by a letter from the local investigator's Head of Department stating that the department are aware of the proposed research and that they are satisfied with the investigator's qualifications/suitability for conducting this research.

There are no formal deadlines for MREC applications as sent for review upon receipt. Applicants should be informed of the sub-Committee's decision within 15 working days of submission.

MREC Homepage

3-2-99

IMPORTANT - Due to the closure of Westway Graphics tthe REC now requires that all applications for ethical approval (except MREC applications) are accompanied by 18 photocopies. This is in addition to the requirement for all submissions to be accompanied by an electronic version on disk or sent via e-mail.

Only one original copy of amended re-submissions that have been previously "approved in principle" by the Committee need be returned (in addition to the amended electronic version).

NB: Until further notice all electronic submissions must be accompanied by 18 photocopies of the application/supporting documents due to the closure of Westway Graphics. We apologise for this inconvenience and hope to reinstitute the option of applying solely in an electronic format in the near future.