June 19, 2003

Dear Colleagues:

During the last several months, the Office of Human Subjects Research (OHSR) has been undergoing a comprehensive evaluation by the Organizational Development and Diversity group at Homewood. One of our major goals in undergoing this review has been to improve the efficiency of human subject research review by the Johns Hopkins Medicine IRBs (JHM IRBs) in order to serve better faculty, research staff, and research participants.

Based on the recommendations of the external consultants, we are reorganizing OHSR to separate the compliance functions from the operations of the office. Effective July 1, 2003, Barbara Starklauf's title will change to Assistant Dean for Human Subjects Research Compliance. In this new role, she will advise the JHM IRBs chairs and members concerning federal and state regulations pertaining to research. She will also build a program that will facilitate researchers' ability to comply with such regulations. Barbara will facilitate communication with the FDA, OHRP and other regulatory organizations. She will report to me and to the general counsels of Johns Hopkins Medicine and the University. During a national search to fill this position, it became obvious that no one could match Barbara's knowledge of the regulations and their application at our institution.

Responsibility for the operations of OHSR will be assumed on July 1, 2003 by the new Director of OHSR, Judith Carrithers. Judith is an attorney who was in private practice in Washington, D.C. and Honolulu. She has been a consultant to an institutional review board in Maryland for several years and also served as a community member on that board. She has managed several not-for-profit organizations and holds a master's degree in public administration. During the last year she has been a regulatory advisor and consent form specialist with JHM IRB 5 where she has demonstrated impressive maturity and leadership skills. In her new role, Judith will report to me and will assure that all operational process and procedures are appropriately managed and carried out effectively.

We are delighted that we were able to attract persons of Barbara's and Judith's caliber to these important positions. Please join me in wishing Barbara and Judith much success in their new roles. All of us in OHSR look forward to working with them as we continue our improvement of the human subject research oversight process.

Sincerely,

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