IRBs and Blood/Tissue Specimens

A recurring issue 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.

Remember 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.

Triage of Research Protocols to WIRB

There are changes in the triage of human subject protocols to WIRB, effective July 1, 2004. As of that date:

• All new federally-funded protocols (whether multicenter or single center) will be reviewed by JHM IRB. As you know, such protocols should be submitted to the IRB when the Principal Investigator has received notification that funding is likely, not before.
• Commercially-funded protocols will continue to be reviewed by WIRB. There are important exceptions to review of commercially-funded protocols by WIRB:
• Protocols that involve gene therapy or for which there is review by the Conflict of Interest Committee will be reviewed by JHM IRB.
  
• Investigator-initiated studies in which the protocol is written by the investigator and the company does not accept responsibility for the protocol will be reviewed by JHM IRB.
  
• Commercially-funded protocols that the investigator believes qualify for an expedited review or waiver of consent may be submitted to the JHM IRB, if the investigator wishes to do so. The investigator should include a cover letter listing the criteria that he/she believes support use of an expedited review process. For guidance see the IRB website (http://irb.jhmi.edu/Guidelines/expeditedreview.html). Regardless of which IRB reviews the application, sole-sponsor commercially-funded studies receiving cash support in excess of $10,000. will be charged an IRB review fee. Please see http://irb.jhmi.edu/GeneralInformation/westirb.html for a list of the IRB review fees.
  

These new procedures apply only to newly submitted protocols. WIRB will conduct continuing review of protocols originally reviewed by WIRB. Our ability to review more protocols at the JHM IRBs reflects the substantial improvement in our processes over the last year. This improvement is due to the hard work of Judith Carrithers, the Director of the Office of Human Subjects Research, and Barbara Starklauf, the Assistant Dean for Human Subjects Research Compliance, and their staff. Please let them know (phone 410-955-3008; email ohsceb@jhmi.edu) if you have any comments or questions.

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