What are the ethical considerations regarding use of tissues originally submitted for clinical use for research and can this be accomplished within current accepted guidelines for clinical research?

As Chapter 3 notes, the policy landscape governing research on clinically collected specimens that are assembled in a biorepository and then made available for research use is in transition. The Department of Health and Human Services (HHS) Office for Human Research Protections has determined that deidentified specimens and data collected for clinical care can be used for research without patient consent because such work is not considered research on human subjects (HHS, 2008). Furthermore, the Common Rule has exempted studies using “existing data, documents, records, pathological specimens, or diagnostic specimens … if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.”12 When research is undertaken on clinically derived materials after the death of the source individual, it is not research on a “human subject” (who under the Common Rule must be a living person) and so does not require consent although Health Insurance Portability and Accountability Act (HIPAA) privacy rules, Federal Privacy Act (5 U.S.C. § 552a), and some state-specific restrictions still apply in such circumstances.13 Should a study using stored specimens be subject to the Common Rule, the institutional review board (IRB) reviewing the proposal may waive the requirement of informed consent if it finds that the research poses minimal risk to the source individuals and that it would be impracticable to recontact them for permission to use their stored specimens or data in research (Miller and Emanuel, 2008; Rhodes et al., 2011).

This approach to research on stored specimens and data, however, is being reconsidered by policy makers. Increasing capabilities for reidentification of genetic material (Homer et al., 2008; McGuire and Gibbs, 2006) have raised concerns about the adequacy of deidentification measures. Emerging public opinion also suggests that research to which a source did not consent can be a source of concern even when material is deidentified (Hull et al., 2008; Kaufman et al., 2009; Lemke et al., 2010; Trinidad et al., 2011). Legal challenges to research use of clinically derived material

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12The usual citation for the Common Rule is to the version published by the Department of Health and Human Services (HHS) because the Office for Human Research Protections (OHRP) in HHS is the lead agency for the Common Rule. The quoted exemption appears at 45 CFR § 46.101(b)(4) in the HHS regulations; the same provision appears in the Department of Defense (DoD) regulations at 32 CFR § 219.101(b)(4).

13Washington State, for example, defines deceased persons as human subjects (RCW 70.02.140; 1991).



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