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Report (OEI-01-11-00520)

Biospecimen Research: Meeting Basic Human Subjects Protection Requirements and Communicating Informational Risks

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A biobank is a repository of biospecimens-and, in some cases, associated personally identifiable information (PII) and personal health information-to be used for research purposes. This research must comply with Federal regulations governing human subjects research. An institutional review board (IRB) must review and approve the research, and the principal investigator (PI) must obtain informed consent from all potential subjects unless the IRB waives the requirement for informed consent. In addition, informational risks (i.e., risks related to PII or personal health information), such as a breach of privacy, are magnified because of the long-term electronic storage of the subjects' PII and the potential for the biospecimens to be used in research not specified at the time of collection. Researchers and bioethicists have identified human subjects' potential loss of privacy and confidentiality as a challenge to research that involves biospecimens.


We reviewed 71 studies at 32 institutions that met our inclusion criteria. We assessed relevant informed consent documents and IRB documents for compliance with certain requirements for human subjects protections, as well as additional measures contained in these documents to address informational risks. We also surveyed PIs and IRBs from the institutions that conducted the research.


Informed consent documents for biospecimen research contained required information on human subjects protections, but varied in their substance and form. IRBs met basic requirements for membership and continuing review. Some IRBs and PIs took steps to address the informational risks of collecting biospecimens and storing them for future research. IRBs and PIs identified challenges in conducting and overseeing research involving biospecimens, such as determining how much information to share with human subjects, determining how biospecimens should be stored for future use, and dealing with the slow pace of change for regulations governing this type of research.


We recommend that the Office for Human Research Protections (OHRP) provide a forum to IRBs and PIs for discussing informational risks to human subjects. OHRP concurred with our recommendation.

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