Biobanks and the Return of Research Results: Out with the Old and In with the New?

- The Journal of Law, Medicine & Ethics
Author/s: -Zawati, Ma'n H -Rioux, Amelie
Journal: The Journal of Law, Medicine & Ethics
Year: 2011
Volume: 39
Issue: 4
Pages: 614-620
Start Page: 614
Abstract:

In 2009, Time magazine named “biobanks” as one of the 10 ideas changing the world. (1) These organized collections of human biological material and associated data (2) have been identified as “vital research tools in the drive to uncover the consequences of human health and disease.”(3) Since their inception, however, biobanks have faced Ethical and legal challenges. (4) Whether these pertain to informed consent, access by researchers, commercialization, confidentiality, or governance, biobanks must continue to address jurisdictional matters, operational difficulties, and normative frameworks that strive to stay abreast of current scientific innovation. (5) Yet, with some biobanks now having completed their recruitment objectives (6) and with research currently being performed on their data and samples, one topic has become the lotus of ongoing debates: the return of research results to participants.

One of the driving forces behind the continued presence of discussion on this issue is the use of innovative technologies, (7) such as next-generation sequencing and the noticeable advancement in “omics” practices. (8) As one author indicates, “deciding how to deal with genomic research results has become increasingly pressing as technologies for genome-wide analysis have become readily available.” (9)

That being said, while the traditional debate centered around whether or not biobanks should return research results, emerging discussions have raised numerous issues that are more focused on the modalities of any eventual return, and this, especially in light of the advances in data production and analysis by researchers using these biobank infrastructures. Part I first reviews the current practices undertaken by various biobanks with regard to the return of research results. This section focuses on population biobanks, since they present interesting dimensions not often covered in the literature. Then, while focusing more specifically on the return of individual research results, this article analyzes both the literature as well as ethical and legal norms surrounding the return of research results in biobanks at large in Part II, as well as the thorny and emergent discussions surrounding this topic in Part III.

However, before embarking on any analysis, it is important to clarify terminology and to exclude issues tangential to discussions on the return of research results in the particular context of biobanks. First of all, biobanking studies generally offer three different types of “communication”: (1) initial feedback upon assessment and lab analysis prior to storage; (2) general results (also known as aggregate); and (3) individual research results. The first type of communication is very common in many biobanks. (10) Feedback is usually provided immediately, (11) sent later by mail, (12) or sent to the physician unless the participant refuses, (13) The feedback covers the results of measurements that include blood pressure, lung function, bone density, height, weight, and estimated amount of fat. (14) When abnormal measurements at recruitment are observed, the personnel will encourage participants to contact a physician. (15) Moreover, biobanks that perform lab analyses ofbiological material prior to storage can provide these as a matter of course. (16) Most importantly, the caveats attached to this initial feedback of measurements and lab analyses serve to avoid the therapeutic misconception that the assessment is equivalent to a medical check-up. (17) Regarding our analysis, we argue that this specific type of communication cannot be described as research results, since no actual research is undertaken at this stage.

Secondly, we posit that the issue where research reveals vital, life-threatening information that poses an immediate danger to the participants or to family members is distinct from the debate surrounding the return of research results in biobanking generally and depends on the ambit of the duty to rescue those in peril in different jurisdictions. The reason for this exclusion is that the obligatory nature of such disclosure may be (or not) legally or ethically mandated. Using these cases as examples can skew the debate on the return of research results, since many researchers in various jurisdictions cannot ignore such an obligation irrespective of the nature of their biobank.

Finally, often flanking the return of research results are “incidental findings” or discoveries “concerning an individual research participant that [have] potential health or reproductive importance and [are] discovered in the course of conducting research but [are] beyond the aires of the study.” (18) Although having similar return modalities, (19) these findings will also be excluded from our analysis, as we do not consider them as “research results” per se due to their incongruity with the objectives of the studies they unexpectedly arise in.