June 2020

How should an investigator initiate a research project using fresh or archival human tissue or specimens from JHM Pathology?

The Department of Pathology at Johns Hopkins Hospital and at JHBMC serves as the guardian of tissues/specimens collected and stored at JHMI.  Investigators may access the archival specimens, or arrange to obtain fresh tissue collected for clinical treatment or diagnostic purposes, with the permission and support of the Department of Pathology Tissue/Specimen Use Committee. When an eIRB application requiring materials from Pathology is submitted, the tissue or specimen requirements should be clearly described in the application and in the eformA or other protocol. The pathology requirements are not always clearly stated or identifiable in studies sponsored by other groups or institutions. It is the JHMI investigator’s responsibility to clearly describe the requirements.

Do all projects involving prospective collection of human tissue/specimens, or involving use of existing archival materials, require review by the Department of Pathology’s Tissue/Specimen Use Committee?

The Tissue/Specimen Use Committee must review all requests for prospective collection of tissue if any portion of that tissue is obtained as part of a clinically indicated treatment or diagnostic process.  The Pathology Department Tissue /Specimen Use Committee must assess independently each investigator request for prospectively collected or for archival tissues or specimens to be used in research, whether or not the project requires JHM IRB review.   

Which Projects Should Be Submitted to the JHM IRB for Review?

Human subjects research projects must be reviewed and approved by one of the JHM IRBs prior to beginning the research. This includes research that may meet the requirement for an exemption from IRB review. The JHM IRB, not the investigator, makes the determination that a project is or is not exempt from JHM IRB review. Any questions about the requirement for submission should be sent to the JHM Office for Human Subject Protection (OHSR) at Human subjects research projects must be reviewed and approved by one of the JHM IRBs prior to beginning the research. This includes research that may meet the requirement for an exemption from IRB review. The JHM IRB, not the investigator, makes the determination that a project is or is not exempt from JHM IRB review. Any questions about the requirement for submission should be sent to the JHM Office for Human Subject Protection (OHSR) at [email protected].

What will the Department of Pathology Look for in a request for tissue/specimen use?

The Tissue/Specimen Use Committee will consider whether it is possible to accommodate the request in terms of personnel, inventory, and process of harvesting, preserving, and storing tissue.  Pathology will review projects involving tissue or specimens obtained only for research purposes. In order to make certain that patient care is not compromised by the proposed tissue or specimen use.

Investigators should note that:

1. The Pathology Department does not release blocks to investigators.  Re-cut slides are available.
2. Re-cut slides on paraffin blocks and frozen tissues from the tumor bank are available.  A small fee is charged per case.  Make certain that funding is available for these services. The fee schedule can be discussed with Carla Rivera Colón at [email protected].
3. Use of tissues taken during operative procedures is strictly regulated.  In most circumstances this tissue should be distributed by Surgical Pathology to avoid compromise of patient care.

What Types of Action Might the Tissue/Specimen Use Committee Take in its Review of a request for tissue/specimen use?

The Tissue/Specimen Use Committee may approve a request, or table it pending further discussion with the investigator.   It will notify investigators of its actions.  It reserves the right to:

1. suggest that a member of the Department of Pathology be assigned to a research project that will be submitted to the JHM IRB, unless a collaborator from this Department has already been designated by the Principal Investigator;
2. determine the distribution of human tissues for research projects to accommodate competing requests;
3. Re-evaluate projects on an annual basis, or earlier, if necessary.

For questions about the Tissue/Specimen Use Committee and its review of applications, please contact: Members of the Pathology Tissue/Specimen Use Committee: Daniel Chan, Ph.D., Barbara Crain, M.D., Ph.D., William Westra, M.D., Lori Sokoll, Ph.D.