Research with Stored Biologic Samples

As information about activation of genes and expression of proteins in cancer tissues becomes more central to oncology, use of stored biologic samples has become an ever more important aspect of clinical oncology research. Over the past decade or so there has been great controversy about when and under what conditions it is ethical to conduct research with stored biologic samples. In 1995, the ELSI-DOE Working Group suggested that all research with stored biologic samples be reviewed by an IRB and that, to show respect for persons, consent should be obtained to use the sample even if not strictly required by the federal research regulations.82 Subsequently, other groups have advanced other positions. The American Society of Human Genetics argues recontact for consent is unnecessary for research using previously stored samples, provided the risks are minimal.83

In addition to the disagreements about whether consent should be obtained at all, there are disagreements about what individuals should have to consent to. The National Action Plan on Breast Cancer recommends asking individuals to consent to future research on the disease being studied and separately to consent to research on other diseases.84 The National Bioethics Advisory Commission (NBAC) argues that individuals should be offered six choices, including allowing individuals to authorize future research on the same disease, but requiring recontact for consent for research on other diseases.85

This disagreement has produced uncertainty about what the ethical requirements are and worries that research is being stymied. Regarding samples to be prospectively collected, the ethical principle of respect for persons suggests that consent should be obtained. However, there is a further question of what the person should consent to. Respect for persons alone does not determine how many or which choices individuals should be asked to consent to. For these issues, we need empirical data revealing which choices individuals find as expressions of respect. Similarly, for previously collected samples that lack consent, the question is, what procedures demonstrate respect for persons. Given these questions, empirical research is essential to determining when and how to obtain consent for research with stored samples.

Although the available data are limited, they indicate that research participants are willing to have their biologic samples used for all kinds of research (Table 9.5).86-89 Indeed, these data suggest multiple questions on the consent form are unnecessary. Based on these data, it has been suggested that it is sufficient to prospectively ask research subjects to consent to any type of research with their stored biologic sample.86 It has also been suggested that previously collected clinical samples can be used in research when anonymized, based on presumed consent with an opt-out when feasible.

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