Research Involving Coded Private Information and Biological Specimens

Specimen collections, whether they are described as "banks" or not, are many and varied. They cover the spectrum from individual clinicians' research specimen collections, often gathered with no specific project in mind; to institutional "Tissue Banks" such as Cancer Centers' Shared Resource banks; to multi center, industry-sponsored drug trials which usually collect at least some blood or tissue for unspecified future research.

Principal Investigators must submit their protocols to the IRB even if the Investigator believes their studies are exempt.

Principal Investigators should adopt procedures to anonymize samples to the extent practicable consistent with the research goals. Such procedures can minimize risks to subjects and related ethical concerns, expedite review, and facilitate research.

In order to facilitate scientific research, development of a system of specimen collection and distribution has been recommended which will enable patients to donate tissue and researchers to have tissue that is coded but, when necessary for research, will allow specimens to be linked, through an intermediary, to outcome data such as those available through a registry system. The IRB requires review of such proposals with informed consent required to be obtained.

The consent document must also specify potential for economic gain. The Institutional Review Board may determine, on an individual basis, that a waiver of informed consent is appropriate. To obtain a waiver, Investigators should provide documentation that consent was obtained at the time the specimen was obtained in the clinical setting (standard U of U surgical consent document or other document which was utilized). The Protocol must include a discussion of the risk associated with uses of the tissues and the chance of improper release of confidential information. Coded specimens (that facilitate research and best protect the privacy and confidentiality of tissue donors) require a prohibition against reporting individual results to either the don or or his/her physician. Rare exceptions to this rule will be examined with extreme scrutiny.

Disclosure of Information: Identifiable results may not be disclosed to the subject or anyone else except in compliance with an approved protocol for contacting subjects and/or family members. Information about results may be released to subjects when IRB criteria for clinical application of results are met, (i.e., the claimed association between marker or gene and disease is generally accepted by the medical community). Information about results may be released to the subject's family members or others if, and only if, the subject gives written permission.

With the criteria present here, including initial informed consent, distribution of coded samples and coded follow up information by a tissue/specimen bank trustee, and the almost-total prohibition against return of results, the IRB believes that this system involves risks comparable to those found in daily life, and thus presents minimal risk to subjects.