Docket Management
Docket: 01N-0322 - Institutional Review Boards
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Dr. Howard Mann Date/Time 2002-05-19 13:50:29
Organization University of Utah
Category Individual

Comments for FDA General
Questions
1. General Comments FDA. Comments concerning Docket 01N-0322. Institutional Review Boards IRB approval decisions concerning clinical trials should be readily accessible to other IRBs, and the public in general. There is no justification for confidentiality with respect to IRB decisions -- research is a public health endeavor, and IRBs should be be held fully accountable for their final decisions. The availability of the Internet readily permits public dissemination of IRB decisions as follows: Who should make these disclosures? Disclosure of IRB decisions concerning applications for research should not be directly dependent on reporting obligations imposed on investigators or sponsors. Instead, disclosure should be accomplished as follows: 1. The issuance of an IND or IDE for purposes of a clinical trial should be contingent on trial registration at ClinicalTrials.gov, or an equivalent international trial register. (Indeed, IRBs should require trial registration for all clinical trials [1,2]) 2. The Web page for the trial at Clinicaltrials.gov should include a hyperlinked publicly-accessible section wherein the approval actions of IRBs is itemized. This page should contain a link to an electronic submission form to be used by IRBs reporting their approval or disapproval decisions as described in 3. below. IRB applications for reseach should contain a section wherein the URL to this page must be provided by the research sponsor. 3. A new regulation should stipulate that an IRB must record its approval or disapproval decision concerning each applicable application for research by means of the electronic submission process. In practice, the IRB's administrative staff will complete this process at the time the letter of notification concerning the committee's decision is formulated for transmittal to the applicable Principal Investigator. Fulfillment of this reporting requirement is subject to verification during the process of FDA inspection of IRBs. What information should be disclosed? The electronic submission form to be used by IRBs should require the reporting (and public accessibility) of, at least, the following information: 1. The name of the reporting IRB 2. The date of the final approval or disapproval decision 3. The nature of the decision : Approval or Disapproval 4. When the decision is one of disapproval, the reporting IRB must provide details concerning its decision in each of the following categories [3]: a. Social and scientific value b. Scientific validity c. Fair subject selection d. Favorable risk-benefit ratio e. Informed consent process f. Trial monitoring plan g. Other Reporting in each one of these seven categories should be limited to a specified number of words. If the decision is one of disapproval, the prior (uncensored) information should be publicly accessible through a hyperlinked document. How significant is the problem of IRB shopping ? We do not know. Institution of the process described above would preclude the suppression of unfavorable reviews. The process would make the results of prior IRB reviews readily available to all IRBs, at the time of initial and continuing review of clinical research protocols. Potential trial participants, and the public in general, will benefit from access to this information. My comments reflect my personal views on this issue, and not that of the University of Utah. Sincerely, Howard Mann, M.D. References [1] Tonks A. Registering clinical trials. BMJ 1999; 319:1565-1568 [2] ASSERT. A Standard for the Scientific and Ethical Review of trials. http://www.assert-statement.org [3] Emanuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-2711




EC -3