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

摘要

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.