June 11, 2004

Dear Colleagues:

I am writing to address a recurring issue that has been identified by the JHM IRBs and WIRB in their review of human subjects research applications. There has been an explosion of interest in studying blood and tissue specimens associated with specific diseases and with disease and aging processes. This is an exciting field of research and conduct of such studies will bring great advances in care and treatment. As exciting as the research is, however, it is imperative that investigators collect specimens under IRB approved protocols and conduct future research on existing specimens in a protocol that the IRB has approved and is HIPAA compliant.

The JHM IRBs and WIRB have seen an increase in the number of applications that appear to involve collection and storage of blood or tissue for future unspecific research, but where the application neglects to provide adequate information to allow the IRB to judge the appropriateness of the future research. Often, a consent form references collection or storage of specimens, but the protocol lacks a description of the plans to study the specimens, how long they will be stored, and whether there are limits to future testing that would be done on the material. The flip side is found in applications that provide appropriate detail in the protocol about collection and storage of specimens for future research, but the consent form lacks this information.

I wish to remind you that both the protocol and the consent form must explain procedures for future study of blood and tissue specimens when this activity is part of the project. Please review your applications before submission to make sure that the protocol and consent forms are consistent in this area. In addition, under HIPAA requirements, future research involving stored specimens may not proceed without the subject's privacy authorization for the future research (approved at Hopkins by the IRB) or a waiver by the IRB of that subject's authorization for the future research.

If you have any questions about this topic, please contact staff in the Office of Human Subjects Research or a member of the JHM IRBs for assistance.

Sincerely,

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