September 17, 2004

Partners Human Research Protection Program applies for accreditation

Clinical research at the MGH, BWH and Partners has a long history of meeting the highest ethical and professional standards and of adhering to all legal regulations that protect individuals participating in clinical research studies.

Compliance with these standards requires the attention and effort of many professionals and departments within Partners and the MGH, including clinical researchers, research nurses, grants and contracts negotiators and administrators, the Partners Institutional Review Board (IRB) and its staff and MGH administration. Together, these entities constitute the Human Research Protection Program (HRPP).
Recent public and political scrutiny of the conduct and oversight of clinical research has resulted in the development of human research accreditation programs to ensure that standards are being met. Although accreditation currently is voluntary, it provides an opportunity to assess and, if necessary, strengthen these kinds of programs.

The MGH, BWH and Partners are taking advantage of this opportunity and are jointly applying for accreditation as the Partners Human Research Protection Program. The accrediting entity selected is the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

The accreditation process has two steps. The first was a rigorous self-assessment, which has been completed and submitted to the AAHRPP for review. The second step will be a site visit scheduled for Oct. 5 to 7. During the site visit, AAHRPP evaluators will meet with representatives of all areas of the Partners HRPP — including investigators, IRB members and staff, research administrators, grants and contracts personnel, and Partners administration and leadership.

To help prepare for the site visit, the Partners Human Research Committee will be sending frequent educational briefs to the research community as reminders of specific policies. These also are being posted on the Partners Human Research Committee website at http://healthcare.partners.org/phsirb/home.htm.

For more information about this accreditation process, send an e-mail to Pearl O'Rourke, MD, of Partners Research Management at porourke@partners.org or Rosalyn Gray, also of Partners Research Management, at rgray1@partners.org.