PRIM&R 2013 Advancing Ethical Research conference report: Who is responsible for the body?

By Lauren A. Taylor, Coordinator for Health and Religion in the Global Context, Harvard Divinity School and co-author of The American Health Care Paradox: Why Spending More Is Getting Us Less(PublicAffairs, 2013).

Who is responsible for the stewardship of the body? What about the body’s tissue? Or its blood? While many people suggest that each individual owns their own bodies, these questions can become considerably more complicated when viewed through the lens of a bio-banking effort. When blood and tissues are “inside” or “part of” our body, it may appear clear, but once removed from the larger whole, the question of ownership can become substantially more challenging. One of Wednesday’s pre-conference programs explored these issues in considerable depth, featuring perspectives from a range of relevant actors.

Several key tensions emerged as fundamental to understanding the complexity of bio-banking. The first was a tension between a conception of the body as we classically think of a body – a vehicle for personhood – and a disintegrated body part – which may hold less cultural significance. Practically speaking, this tension manifests itself in a variety of legal questions concerning the status of tissue samples, tumor cells or blood samples. Do individuals forever retain the rights to these parts of themselves? Can someone reasonably donate their bodies to science, and under what conditions? When they aim to do so, is such a donation most appropriately made to an individual scientist or the research funder? One panelist who spoke on the basis of their legal background responded by outlining several instances of case law in which these question were tackled, including cases decided on the premise of property and tax law, and emphasized how differently these matters can be taken up by varying state courts.

An additional tension of note emerged around the role of a bio-banker as researcher, clinician and grant recipient. The following dilemma was posed to the group: If in the process of analyzing a set of samples donated to a bio-bank, a researcher finds that some portion of these samples contains genetic anomalies that predispose the donors to significant health risks, is there an obligation on the part of the researcher to inform the donor of the finding? In response, faculty highlighted the need for clarity in the informed consent process around the purposes of research and expectation of clinical, diagnostic treatment.  (As an aside, several critiqued what they saw as a widespread over-valuation of DNA testing results, which can only determine increased risk but are touted as detecting disease.) On a practical note, one panelist who had run bio-banks in the past, explained that returning positive genetic testing results to all research subjects would be a nearly impossible from both a practical and financial standpoint, given the size of most bio-banks. This panelist noted that it is important to keep primary and secondary goals clear in one’s mind while engaging in this work, and the primary goal is research.

Finally, the panel evoked a timely tension between the desire to protect patient confidentiality and advance research in a timely manner. As many will be aware, the challenges in safeguarding patient confidentiality are growing in the face of increasing interest and availability of genetic sequencing. In light of the unique sequence we each can claim, some experts have argued that there can no longer be such a thing, or soon will be no such thing, as truly de-identified data. And yet, much of medicine is now expressing interest in uncovering genetic roots or predilections to a wide range of conditions under study. Therefore, a key question becomes: does a bio-banker have a responsibility to try to re-identify a purportedly de-identified sample in order to get revised consent from an individual for genetic testing? And, once that identity has been relinked to a sample, should a file then be maintained over the long term, so that further consents can be sought as new research methods are developed? In response to this discussion, the panel described a range of consent processes, and emphasized that the patient and researcher will increasingly need to be seen as in partnership with one another.

The program closed on a note of optimism regarding the scientific promise of bio-banks. The fact that these entities represent a major institution in the future of science was unquestioned by panelists and participants. Rather, the group focused the entirely of its energy on the identification of new areas of concern and need for updates policies and procedures. Ultimately, most agreed that extracting maximum, responsible benefit will rely on a high degree of attentiveness to the complex institutional and technological realities faced by bio-banks and a commitment to flexibility in terms of our conceptions of what key terms may come to mean over time.

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