After working as a data scientist in melanoma research for 6 years, I’ve come to appreciate the need for biobanking specimens, especially when studying rare diseases. The team I worked with at Yale would have never been able to collect the 150 specimens and blood samples needed to produce a large scale melanoma exome resequencing study without a concerted effort from physicians, patients, and biobankers to gather enough samples.
Melanoma is a moderately rare disease, but it has a number of even rarer subtypes, like acral, ocular, and mucosal melanomas which are genetically very different than the relatively more common form. This is further complicated by the process of getting patients to consent to using their samples in research, but I think there’s an opportunity here if we are simply willing to ask.
Ask and Ye Shall Receive (an Answer)
Rather than try to provide a stronger review system and increase the levels of implicit trust, many researchers are advocating collecting more explicit, narrowly focused consent documents that keep patients in the loop. This is argued from a concern about reducing paternalism in the researcher/patient relationship:
Up until now, a ‘broad consent’ model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance.
— “Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?”, Kristin Solum Steinsbekk, Bjørn Kåre Myskja, and Berge Solberg
An alternative is called Dynamic Consent, where the patient gets to determine what uses their samples can be put. Since patients would be informed of each use, and consent to the specifics of the experiment, it can potentially simplify privacy issues, since specific uses can be linked to their known risks. Similarly, while some research institutions may be uncomfortable with allowing for-profit companies to work with their banked samples, or possibly even selling the samples to help support ongoing research, the actual patients themselves may have different opinions about those uses. A dynamic consent framework would allow patients to indicate what they consider acceptable and unacceptable. Given the right consent frameworks around them, biomaterial contributions could be seen as the philanthropic gift to an institution or research program they are.
Privacy is Not Everything
Finally, while patient privacy is important to support and enable by default, it may impede research more than even the patients intend. A number of organizations and companies like Cancer Commons and PatientsLikeMe are attempting to figure out what levels of privacy patients actually want to have, which may be more conducive to research than broad-based assumptions about what an expert panel may consider appropriate protections of their data. In this sort of model, Institutional Review Boards (IRBs) would, rather than determining for the patient that a particular use is appropriate, instead ensure that the known risks for any given use or combination of uses are known to some reasonable degree, and that there aren’t any outstanding ethical questions about that use. That would create a true partnership between patients and researchers, where the patient can actually make decisions of consent based on genuinely informed opinions.
This article is an updated response to a previous one. What other obstacles or challenges do you see facing consent in biobanking? Do you know of any solutions to them? We'd love to hear your opinions! Let us know in the comment section below.