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Primary Care Research governance post-1st April 2013

PCRN WMS is providing reassurance to GP teams taking part in research within our area that the research governance arrangements of PCRN-supported research studies will continue to be managed locally in accordance with the discussion paper issued by the Department of Health ‘Determining arrangements for supporting research in primary and community care’[1].

All studies that the PCRN offers to primary care teams are on the National Institute for Health Research (NIHR) Portfolio. The portfolio comprises of studies which are well-planned, peer reviewed, high-quality, and have a clear relevance to the NHS. In addition each study has approval from a Research Ethics Committee (REC) and until now has had local approval from a PCT.

NHS Permissions that have already been issued by a PCT remain valid; there is no requirement for further review or approval of these studies. However, from April 1st, agreement by an Independent Contractor to participate in a research study will constitute NHS Permission.

These changes should not significantly alter the experience for researchers and GP practices participating in Portfolio research; therefore please do continue to conduct research in accordance with current best practice and regulatory guidance. The West Midlands (South) CLRN will continue to assess and quality assure each study against a range of research governance criteria, including checks on Financial Management, Sponsorship, Study Documentation, and other applicable laws, regulations and guidelines. In addition to the research governance assurance provided by West Midlands (South) CLRN, the study will also be reviewed by the local PCRN study group; a multidisciplinary group which includes GPs and other experienced research staff.

West Midlands (South) CLRN and PCRN will continue to work closely to ensure a high quality local research agenda, and as further guidance becomes available, we will continue to keep all research-active primary care teams updated.

If you have any further queries regarding the above, or if you are approached by any other organisations requesting your participation in research, please contact Sue Elwell, Research Manager, on s.elwell@warwick.ac.uk or by phone 02476 575 854


Mon 08 Jul 2013, 13:31 | Tags: Hot Topics