by László M. Szabó, Esq., director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
More than six months after the 2013 Advancing Ethical Research (AER) Conference, members of the PRIM&R Blog Squad are still benefiting from the experiences they had in Boston. With the opening of registration for the 2014 AER Conference around the corner, we’re pleased to share a few of their reflections.
In November of last year, I attended a panel at the 2013 AER Conference titled, Innovations in Genomics and Biobanking, and more than six months later I still find myself thinking about it. During the session, the panelists discussed how research involving the use of biospecimens is on the rise, but best practices around the collection, storage, and identification of the samples and their donors remain lacking. Considering that such research has long been a foundation of medical advancement, but has also given rise to important lessons about the protection of research subjects (take for example the case of Henrietta Lacks), this fact is worrisome.
Biomedical research tends to promote the creation of biospecimen repositories for intra- or inter-institutional use. The process for creating such repositories is relatively clear cut; the planned purpose is conveyed to the subjects in a consent document, which outlines the use of their specimens. Then, following the consent process, samples are collected and stored with appropriate protections and used for the research purposes described to subjects.
In reality, however, biospecimen research does not always occur on such a straightforward trajectory. The reasons for deviations from the planned use are diverse: funding runs out and institutions face the burden of shouldering the costs of storage; research hypotheses don't bear out; there are new developments in scientific techniques or understanding. A change in the planned use of biospecimens can lead to a situation in which the purposes for which a donor’s consent was given no longer matches what the researcher does with the sample, thus undermining the integrity of the informed consent, and therefore the validity of the consent itself. To prevent such situations from occurring, IRBs should ensure that some flexibility is built into consent forms in order to facilitate unforeseen uses of biospecimens and to convey to subjects that, with the development of science, the proposed uses may shift over time.
When conveying the purposes for which biospecimens are being collected, however, it is imperative to find a balance between the specific and the general. One way to address this tension is to ask subjects for permission to use the biospecimens not only for the explicit purpose being outlined, but also unforeseen (and related) purposes in the future. Such a method would enable subjects to opt-in for unforeseen and related uses of their specimens, or, alternatively, indicate that they would only like their specimens used for the explicit purposes identified in the consent form.
Appropriately describing unforeseen and related uses in such a way that makes consent meaningful requires an intellectual stroll through a land of gray. To help navigate this terrain, the sharing of best practices is essential. In reviewing the tools being used by institutions throughout the country, we can begin to develop a sense of the practices that work well.
PRIM&R members can access examples of these tools submitted by their peers in PRIM&R’s Knowledge Center:
- Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories
- Consent Form Sample Template: Identifiable Specimens
- Research Tissue Banks/Repositories Policy
- Repository Consent Template
Share your organization’s best practices on this topic or another by contacting Avery Avrakotos, education and policy manager, by email or by phone (617.423.4112, ext. 130).