whether obtaining consent to the research use of human biological materials in a research or clinical setting, and whether the consent is new or renewed, efforts should be made to be as explicit as possible about the uses to which the material might be put and whether it is possible that the research might be conducted in such a way that the individual could be identified…. The current debate about the appropriate use of millions of stored specimens endures because of the uncertain nature of past consents. Investigators and others who collected and stored human biological materials now have the opportunity to correct past inadequacies by obtaining more specific and clearly understood informed consent.
It also specifically addressed research use of pre-existing samples—those obtained before the implementation of its recommendations—urging (p. 64) that
general releases for research given in conjunction with a clinical or surgical procedure must not be presumed to cover all types of research over an indefinite period of time. Investigators and IRBs should review existing consent documents to determine whether the subjects anticipated and agreed to participate in the type of research proposed. If the existing documents are inadequate and consent cannot be waived, the investigator must obtain informed consent from the subjects for the current research or in appropriate circumstances have the identifiers stripped so that samples are unlinked. [emphasis added]
The NBAC noted that research on identified samples is human-subjects research and ordinarily requires consent and that “seeking this consent demonstrates respect for the person’s right to choose whether to cooperate with the scientific enterprise, and it permits individuals to protect themselves against unwanted or risky invasions of privacy” (p. 66). The NBAC’s reasoning suggests that unless consent to research use is waived under applicable regulations, ethical research use of tissue, materials, and data that carry identifiers requires either informed consent for the contemplated work or deidentification.
A substantial literature over the last decade argues for recognizing a biorepository duty of responsible custodianship, a concept introduced earlier in this chapter. The National Cancer Institute, for example, in its 2011 Best Practices for Biospecimen Resources (updating its 2007 Best Practices) stresses that “responsible custodianship requires careful planning and transparent policies to ensure the long-term physical quality of the biospecimens, the privacy of human research participants, the confidentiality of associated data, and the appropriate use of biospecimens and data” (NCI, 2011, p. 31). The best practices formulated by the International Society for Biological and Environmental Repositories (ISBER, 2008) maintain that