RE: 01N-0322From: Gemmel, David - HMHP [David_Gemmel@HMIS.ORG] Sent: Tuesday, March 26, 2002 10:19 AM To: 'fdadockets@oc.fda.gov' Subject: RE: 01N-0322 RE: IRBS: Requiring Sponsors and Investigators to Inform IRBs if any prior IRB Reviews As a human subjects administrator for Humility of Mary Health Partners, I am writing to oppose additional disclosure of IRB reviews. My opposition is based upon my experience with IRB functions over the past decade at two community teaching hospitals. I am personally aware of only one case of IRB "shopping". In this instance, patient safety was NOT an issue. Rather, a Roman Catholic IRB member strenuously objected to language in an informed consent document on medically acceptable method of birth control. The study sponsor was unwilling to modify the informed consent, and the physician used a noninstitutional review board (Western IRB) so that patients could be enrolled in his private practice (outside of the Catholic hospital). While I object to IRB "shopping" when issues of patient safety are concerned, I can appreciate both the desire for this physician to offer experimental therapies to patients, the need for patients to avoid pregnancy while on such regimens, as well as the institutional commitment to ethical values and mission. Since many study sponsors use Western IRB and other noninstitutional review boards (NIRBs) and our hospital requires local IRB review, I am unsure if the proposed requirements are workable. In multicenter trials, local physician PIs would be unaware of company sponsored reviews, other trial study sites and other, nonlocal IRB reviews. NIRBs review many of the same protocols that our IRB reviews. Other IRBs (those registered and with FWA) may also have reviewed a protocol. For these reasons I am unsure who would receive this information and what information would be disclosed. Likewise, I am unsure how our local IRB would disclose to other IRBs. I am also concerned that knowledge of disclosure may discourage frank, open discussion by IRB members. Before adoption of disclosure requirements, I propose a study of IRBs and their members, sponsors and PIs to determine the extent of IRB "shopping". I would be happy to lead such an effort, serve as a member of the study team or serve as a peer reviewer of the project. Regulations and agency policy, if needed, should be based on objective data. Regards, David J. Gemmel Director of Research Humility of Mary Health Partners St. Elizabeth Health Center 1044 Belmont Avenue Youngstown, OH 44501 phone: 330-480-3610 fax: 330-480-2962 pager: 330-613-0372 email: david_gemmel@hmis.org CONFIDENTIALITY NOTICE: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.