Most discussion of the ethical challenges raised by the growth of research biobanks relies on the assumption that the only ethically relevant interests are those that concern risks to subjects'welfare or well-being. Once materials have been collected, and any further risks have been reduced to near-zero by de-identification, it follows that no further protection of the interests of research subjects is required. For this reason, the Office of Human Research Protections has determined that research on de-identified material in biobanks is exempt from the authority of US Federal research regulations. Ethically, this is a highly questionable assumption, since people have a variety of other interests or concerns about the kinds of research that might use their material. These """"""""non-welfare"""""""" interests have been the subject of very little empirical research or ethical analysis. The proposed study will remedy this by developing, implementing, and evaluating methods to answer these questions: 1. What is the nature, frequency, distribution, and strength of public attitudes toward non-welfare interests that might be affected by uses of de-identified archived biological samples? 2. What is the ethical weight of those interests in designing policies for the collection and use of biological samples for future research? 3. What is the appropriateness of various models for protecting or accommodating such interests? Methods will include a factorial survey designed to evaluate the effect of selected non-welfare interests on subjects'willingness to give a blanket consent to future uses of biological materials;evaluation of the ethical weight of such interests using various ethical frameworks, such as theories of complicity and group harm;and a systematic evaluation of the suitability of various methods for protecting or accommodating the non-welfare interests of research subjects, which will extend well beyond reliance on informed consent as the primary form of ethical protection.
Research using archived biological samples collected in """"""""biobanks,"""""""" especially when these are anonymized or de-identified, may often pose no risks to the welfare of those who contributed their samples -- but welfare interests are not the only kind of stake that individuals may have in the uses of their samples. Too little is known about the """"""""non-welfare interests"""""""" contributors might have, and how they should shape the ethical protections appropriate to research using biological samples. This study will determine how much these sorts of interests matter to people, and how such interests should be accommodated by biobank policies.
| Tomlinson, Tom; Kaplowitz, Stan A; Faulkner, Meghan (2014) Do people care what's done with their biobanked samples? IRB 36:8-15 |
