Application Number 1: Flagging | |
August 2003 | Application to MREC |
October 2003 | Approval received from MREC of flagging activities only subject to PIAG approval. MREC states that written consent must be obtained for medical records review under the Data Protection Act 1998, and that Section 60 would not override this obligation |
November 2003 | Application to PIAG for permission to flag men |
December 2003* | PIAG requests further information on institutional policies, and states that PIAG can consider an application for medical records review without written consent |
April 2004* | Approval received from PIAG for flagging men |
Application Number 2: Medical records review | |
June 2004 | Application to MREC, for medical records review |
August 2004 | Approval received from MREC subject to PIAG approval |
Application to PIAG, for medical records review | |
September 2004* | PIAG requests further justification for not seeking consent |
December 2004* | PIAG invite principal investigators to attend next meeting |
March 2005* | Principal investigators attend PIAG meeting |
PIAG reject application for medical records review | |
June 2005* | PIAG reject Cancer ResearchUK appeal for “opt-out” consent |
September 2005 | Application to MREC, medical records review with consent |
October 2005 | MREC request further information |
November 2005 | MREC approve medical records review with consent |
Application Number 3: Deceased men | |
January 2006 | Application to PIAG regarding men who die before consent can be sought |
March 2006 | PIAG approve access to medical records without consent when a man has died prior to being approached, but with conditions |
MREC, Multi-centre Research Ethics Committee; PIAG, Patient Information Advisory Group
*PIAG meeting minutes are available at (last accessed 30 October 2007): http://www.advisorybodies.doh.gov.uk/piag/Meetings.htm.