IRB Confidentiality Statement
Pace University Institutional Review Board
Policy Statement on Confidentiality
It is necessary that the members of the Pace University Institutional Review Board (IRB) function in an atmosphere of mutual trust and respect. We wish to foster honest and direct communication of concerns. It is important that IRB members feel free to share what they think with one another without having to worry that their statements may be repeated elsewhere to people who do not have the benefit of the full context of what is often a lengthy and ongoing discussion. By definition, any attempt to reproduce the content of an IRB conversation will be partial and incomplete, and there is always a risk that the result will be, or seem, inaccurate. That risk is increased by the fact that IRB members often change their minds during the course of our deliberations, leading them to adopt positions quite different from their starting points. Thus, a later report outside of the IRB of what an individual initially said about an issue may be misleading.
Necessary components of the IRB’s work are the review of performance of individuals conducting research and assessment of the qualifications of those proposing research. In addition, periodically the IRB considers nominations for new members. Finally, the IRB also must take account of its responsibilities to sponsors and investigators. While the IRB may be legally bound to treat as confidential only trade secrets and other commercially valuable proprietary information (1), the IRB should dispense information derived from its consideration of proposed protocols with caution and discretion, as a matter of both professionalism and prudence. It is difficult to determine that a particular piece of information clearly falls outside the legally protected category, and every IRB member could be exposed to the risk of litigation and/or liability as a result of a disclosure eventually deemed improper.
In an effort to clarify these interests and concerns, the Pace University IRB has resolved the following:
1. Members of the IRB and staff associated with the IRB and privy to its deliberations agree not to divulge to anyone outside the IRB information learned in the course of their work with the IRB, whether from the review of protocols, adverse reaction or monitoring reports, or during IRB discussions. Copies of IRB minutes and all intra-IRB communications, worksheets, and correspondence with sponsors, investigators, or consultants should be created, transmitted, and maintained in a manner designed to protect their confidentiality. Once the IRB has made a decision with respect to a particular protocol and has communicated that decision to the protocol’s sponsor and/or principal investigator, the fact of that decision may be made public.
2. If an IRB member or associated staff believes that a particular item of information ought to be disclosed, either to specific individuals or to the public at large, that member or staff person should raise the issue with the entire IRB. The IRB may decide that the harm caused by the breach of confidentiality will, in this instance, be outweighed by the important considerations of public interest. In that event the IRB will determine the appropriate timing, audience, and method for disclosure.
3. Under no circumstances will any member of the IRB or its staff purport to attribute particular statements, oral or written, to specific individuals. While it is permissible to describe the various positions expressed, those positions should not be linked to individual proponents or opponents.
4. The IRB may decide, on a case by case basis, that it wishes to communicate the fact that it has received certain information about a particular person to the person involved, so as to enable that individual to provide additional or different information. In that event, every effort will be made to avoid revealing the source of the information in question. The fact that disclosure of the information will necessarily reveal the identity of its source, however, will not in and of itself bar disclosure if the IRB believes such disclosure to be appropriate and fair. Again, the IRB will determine the timing, circumstances, and method for disclosure of such information.
(1) It is possible for a sponsor or investigator harmed by disclosure of non-public information provided to the IRB to seek redress under New York State law for claims such as prima facie tort, intentional interference with economic advantage, and injurious falsehood or defamation, even though the information involved did not qualify technically as a trade secret.