June 2, 2005

Dear Colleagues:

As you know, we are in the process of having our institution accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). In March we underwent a comprehensive, rigorous multiday site visit and, on May 1, received the official site visit report. We worked with AAHRPP to make our policies and procedures consistent with their standards and submitted our response on May 31.

The response to the site visit required changes throughout our process of research oversight and administration. For example, AAHRPP indicated that our review system is geared to DHHS regulations and gives short shrift to research that falls under FDA regulations. Many of the changes in forms and procedures were made to bolster this aspect of our process. The response will be reviewed by their Council at the end of June, and we are hopeful that the Council will take a positive action at that time.

Over the summer, we will hold meetings to explain the new forms and processes. We think that the changes are logical. We will do our best to explain the rationale for the changes and to make the instructions as clear as possible. As in the past, we will depend on feedback from faculty and staff to guide us.

AAHRPP accreditation would mean that we have passed a very high standard and is well worth the time and effort that it entails. Thank you in advance for your cooperation and assistance with this project.

Sincerely,

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