IRB Accreditations

January 13, 2005

Dear Colleagues:

I am writing to inform you about the latest developments in the IRB review process at JHM. We have completed three and a half years of rebuilding the human subjects review system to improve protections afforded to individuals who volunteer to join research projects here and to make the IRB review process more responsive and effective for faculty who wish to conduct human subjects research.

As a result of the modifications in the system, we were able to submit an application to the Association for the Accreditation of Human Research Protections Programs (AAHRPP), seeking recognition of the positive changes we have made since the OHRP shutdown in 2001. President Brody and Dean Miller strongly support the accreditation process, and we join the ranks of other peer institutions who have sought accreditation.

I am pleased to inform you that the application we submitted was accepted and a site visit is scheduled for March 28, 29, 30, and 31. Due to the logistics of scheduling the visit, all IRB meetings will be cancelled for the week of March 28th. IRB staff will work with researchers and their staff to try to avoid significant disruption in the review process caused by canceling meetings for one week. The site visitors will select researchers, research coordinators, and IRB members and staff that they wish to interview as part of this process, and we will not be allowed to preselect individuals. Once decisions are sent to us by the site team, we will begin notifying individuals if they have been selected for interviews. The schedule will be coordinated by Barbara Starklauf, Assistant Dean for Human Subjects Research Compliance and her staff, and we will schedule meetings with the selected individuals to review the process that will be followed by the interviewers.

I am very proud of the efforts made by faculty and staff to reach the point that accreditation is possible. Through your hard work and cooperation I am confident that the site visit will be a success.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation