biobanks need to provide responsible “custodianship” of the tissues and data that they collect, maintain, and share. Biobanks—private and public—commonly have a variety of committees and governance structures to address operational and ethical issues, including access to data and samples by secondary researchers (Eiseman et al., 2003; ISBER, 2008; NCI, 2011). Core issues addressed in discussions of biobank ethics include consent and withdrawal of consent, as well as protection of privacy and confidentiality.

Several well-recognized challenges regarding informed consent to research involve archival biospecimens. Even when recontact and consent or reconsent are possible because the individual sources are still alive, requesting consent for already archived materials can be prohibitively expensive; further, the act of contacting a source for consent can itself be regarded as an invasion of the privacy or, at the least an unwelcome intrusion, especially for persons who were unaware that their or their family’s tissue was used for research (Bathe and McGuire, 2009). When comprehensive collections of material have been assembled—such as specimens from all patients with a particular diagnosis or a common exposure—having to obtain consent for research use may introduce a selection bias if some of those contacted decline to consent. The use of archival tissues requires a balance between the possibility of suboptimal consent and the use of valuable resources. Figure 3-2 illustrates Bathe and McGuire’s suggested framework for using archived tissue samples derived from clinical care.

Bathe and McGuire suggest reconsent if research presents greater than minimal risk; even if the research presents only minimal risk, they call for reconsent if it is practicable. Only if research presents minimal risk and reconsent is impracticable do they indicate that research should be allowed with a waiver of consent. They go on (Bathe and McGuire, 2009, pp. 714–715) to identify a set of guiding principles for making such decisions, including the following:

  • The primary objective of the ethics committee is to balance benefits of research against risks of harm.
  • Privacy risks need to be assessed; but if risks are minimal and reconsent is impracticable, informed consent may be waived.
  • Risks are minimal if samples or data are in databases restricted to “bona fide researchers,” data-access requests are reviewed for merit and ethics standards, the proposed research is consistent with any existing consent, and the research is not “stigmatizing or sensitive.”
  • Impracticability of recontact should be judged by such factors as availability of contact information, probability of the subject’s being alive, harm in recontact, and time or expense of recontact.
  • If privacy risks are greater than minimal, reconsent should be required.


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