The Human Investigation Committee (HIC) revised the policy on “ Use of Biological Specimens”. During the ongoing process improvement activities, the policy was reevaluated using the guidance from Office of Human Rights Protection (OHRP) on research involving coded private information and human biological specimens. After careful consideration of the guidance, it was determined that the HIC policy should be revised to allow for a broader range of specimen use and more options in IRB review processes.

With the increased use of human biological samples from tissue banks and repositories for research purposes, ethical and regulatory dilemmas exist regarding the distribution and use of these materials in research projects. The implications that this has on individuals and families when these samples are used for genetic research increase the regulatory and ethical burdens. In the previous policy, all genetics research specimens were reviewed by a Full Board review. In the current policy, genetic studies can be reviewed under the exempt or expedited review process, if the study meets the review criteria. The new policy (http://www.hic.wayne.edu/hicpol/BioSpec11_16_05.pdf) contains scenario boxes to help determine the type of IRB review and HIPAA documentation required for specimens research.

Another change in the policy addresses when biological specimens are obtained from a 3rd party. If there is no code on the specimens, this study should qualify for an exemption from IRB review and approval. When using coded specimens, the IRB must determine who has access to the code (identifiers) and whether or not that person is “involved” in the research protocol. If the individual who holds the link to the codes is “involved” in the research project, the protocol is not eligible for exemption from IRB review and approval. The WSU IRBs do not consider the act of solely providing coded specimens to constitute involvement in the conduct of research. When a 3rd party holds the link to the coded specimens is not “involved” in the research protocol, a written agreement between the PI and the individual who maintains the link must be submitted to the IRB as part of their submission for an exemption from IRB review and approval. However, if the 3rd party who provided the samples is the only individual to maintain the link to the codes and has other study responsibilities (i.e. involved in the design, analysis of data, authorship and/or presentations of result), the individual is considered “involved”. In this situation the protocol does not qualify for an exemption from IRB review and approval and the study must be submitted for expedited or full board review.

When doing research on biological specimens the consent form must contain the following information as appropriate to the protocol:

1. A description of planned future use of the specimens. If this is unknown, this should be so stated in the consent document.
2. Procedures that will be used to protect the confidentiality and privacy of any personal identifiers that will be associated with the source of a tissue sample or cell line.
3. Information about the control and ownership of the tissue samples during storage.
4. The participant’s right to withdraw his/her consent at any time either by requesting that the tissue be destroyed or that all personal identifiers be removed.
5. Information about the length of storage.
6. Whether the participant can obtain future access to the stored samples for information that may be of clinical relevance to him/her. Similarly, participants must be told if such information will not be available in the future (e.g. because personal identifiers are to be removed.)
7. How the investigator will handle future third-party access.
8. Information about possible secondary use of the stored tissue, or the possible creation of an immortalized cell line based on the specimen.

There may be situations where a patient or research participant is known to possess biologic materials with unique characteristics thought to have potential commercial value. In this case, if specimens are to be collected for research and the investigator expects that the specimens will be commercialized into a marketable product or sent to a commercial sponsor for research or development, the consent form must state this possibility. HIC policy requires that the consent form stipulate that the participants will not have any financial or proprietary interest in the samples or in any products or processes that may result from research on the samples

The changes to the policy increase the standards for specimens review and improve the consent process. With the increased options for biological specimens IRB review, investigator should have more flexibility to determine the type of IRB review is needed. The consent requirements and recommendations provide more information to the potential participant to truly make an informed decision.

If you have further questions about HIC policies and procedures on, you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu