For Biobanks, Broad Consent is Not Enough
The key to applicable, quality research findings is good data. For medical research, this means maximizing quantity and diversity in participant demographics, whether it be ethnicity or medical history. Enter the biobank. The advent of biobanks allows researchers access to volumes of quality data in an efficient, swift manner. A biobank is a collection of biological materials, this includes but is not limited to, tissues, blood, full genome sequences, and associated health data stored for research purposes. It is, in many ways, the future of research, representing the paradigm of communal engagement and patient-directed public health initiatives.
In 1999, over 300 million biospecimen were stored in biobank repositories.1 This figure has surged since the completion of the human genome project. The last decade alone has given rise to approximately two-thirds of all biobank repositories, many of which reflect diversity in the samples collected and the research fields explored.2 With this explosion in biobanks come unresolved concerns over how biobanks should be regulated.3 How should one’s information remain confidential? Should new medical information found during the study be returned to individual participants? Can we use a participant’s data for an experiment that they did not originally consent to? These questions ultimately tie into the level of autonomy individual participant should be given in research, questions whose answers will have major implications on the efficiency and quality of conducted research studies.
In the United States, policy formation has lagged because the discussions over participant autonomy remain unresolved. The UK Biobank is the paragon of emphasis on efficiency and practicality. The UK Biobank recruited approximately 500,000 participants, from 2006-2010, aged 40-69 to submit saliva, urine, blood, and general health information.4 The biobank is open to researchers across the globe and hopes to be a beacon from which medical advancements in cancer, heart disease, and osteoporosis will arise.4 Aside from its size, the UK Biobank is notable because of its streamline policies regarding informed consent and individual participant information return. The Biobank utilizes broad consent, meaning that all participants agree to the same conditions using an identical form, regardless of what experiments will be conducted on the participant’s samples.5 One size fits all. Participants also accept that they will not receive any health information, other than basic measurements, related to them individually.5 In this way, each participant is relegated to a list of measurements. Potentially life-saving information remains concealed under policy.
The UK biobank cannot be the model for developing biobanks in the U.S because of the utilitarian structure. Specifically, the philosophical underpinnings of practicality and efficiency undermine its medical initiatives. Biobanks require informed consent; however, the “this one size fits all model” that the UK Biobank offers fails to respect the rights of the patient. The concept of ‘general informed consent’ is paradoxical; the more generalized the consent, the less truly informed it is for the participant.6 To be truly informed requires the details and specifics of what participant data will be used for that this broad consent process surely lacks. Participants are asked to agree to “long-term storage and use of my blood and urine samples for health-related purposes.”5 This stipulation is almost insultingly vague, surely stripping away at the researcher-participant relationship. The dearth of detail or specificity is nearing coercion. It will be difficult for a participant to understand the magnitude of their consent and the potential long-term effects of their data donation. How can we expect someone to willingly donate to a process without concrete boundaries?
The reason for the UK Biobank’s ambiguous statement derives from the nature of most biobanks. The institution, at the time of consent, simply does not know what a participant’s information will be used for, and thus cannot provide a more concrete form. If a biobank was forced to outline every potential experiment one’s information could be used for, however, the institution as a whole would slow to a stop. It is not necessary to demand this level of specificity; rather, the biobank should allow participants the option to select for what kinds of experiments they would condone to their data usage.7 For many volunteers, this opt-in process would prove to be no setback, as they would have volunteered to donate their information quite generally. For others wary of where they information may be used, this option provides a sense of security and autonomy while building trust in this philanthropic initiative.
During the consent process, it is made clear that the UK biobank will not return individual participant information, meeting the altruism of the donor with hardened complacence. Participation to biobanks is entirely voluntary and unpaid, a charitable act that puts the individual at some, albeit minimal, risk to privacy infringements and potential life insurance discrimination. While there are only a few reported cases where individuals have been denied coverage, the possibility looms. Biospecimen, in collaboration with experiments and medical data, provide researchers with a vast amount of information, and while most of this information might hold little value to participants, some findings might be life altering. It is important to distinguish the researcher-participant, a generally impersonal affiliation, with the far more intimate, communication-driven clinician-patient relationships; however, I believe that there are times where these boundaries must be smeared for humanitarian reasons. Suppose during a genomics study, a researcher finds an individual who was a predisposition for a very treatable, but quite serious disorder. The individual may show no phenotypic signs at the time of the experiment, but such information provided by the researcher could immensely improve the individual’s quality of life. The UK biobank policy tells us we have no need to interfere, no requirement to report our findings. I believe this decision, to report or not to report, should lie with the individual. We should neither give into this practical apathy, where participants are seen merely as data points, nor should we go about carelessly and casually invading other’s privacy to report potentially inconsequential findings. Instead, potential participants should have the option of deciding for what they would like to be contacted for based on the criteria of actionability and significance. The exact criteria for reporting are not as essential, at this point, as is guaranteeing this option to future participants. Of course, quelling therapeutic misconception, in that potential participants should not involve themselves with research studies with therapeutic intentions, will be important in the recruitment of participants.
Long-term studies using biobanks present immense opportunity for improved medical care. They are a tool for a bright future of research, but biobanks can only be used effectively if we carry with them the ethical advancements and duties instilled in modern researchers procedures. Participants deserve to be viewed as partners, not merely as pawns in conducting research. Only with trust and community-wide understanding will biobanks extend to encompass all demographics. By providing individuals with these options in research, by allowing them to take charge in public health, we incorporate vital fundamentals to a system that could revolutionize the way we improve medicine. Hopefully, the rush for research will be tapered by our moral convictions, not galvanized by our impatience.
Maschke, Karen J. 2015. “Biobanks: DNA and Research.” The Hastings Center. September 17. http://www.thehastingscenter.org/briefingbook/biobanks-dna-and-research/.
“US Sees Boom in Diverse Range of Biobanks, But Regulations Are Lacking.” 2016. GenomeWeb. Accessed October 24. https://www.genomeweb.com/archive/us-sees-boom-diverse-range-biobanks
Henderson, Gail E., R. Jean Cadigan, Teresa P. Edwards, Ian Conlon, Anders G. Nelson, James P. Evans, Arlene M. Davis, Catherine Zimmer, and Bryan J. Weiner. 2013. “Characterizing Biobank Organizations in the U.S.: Results from a National Survey.” Genome Medicine 5: 3. doi:10.1186/gm407.
“Https://www.ukbiobank.ac.uk/about-Biobank-Uk/.” 2016. Accessed October 24. https://www.ukbiobank.ac.uk/about-biobank-uk/.
“Http://www.ukbiobank.ac.uk/resources/.” 2016. Accessed October 24. http://www.ukbiobank.ac.uk/resources/.
Hansson, M G. 2009. “Ethics and Biobanks.” British Journal of Cancer 100 (1): 8–12. doi:10.1038/sj.bjc.6604795.
Beskow, Laura M., Joëlle Y. Friedman, N. Chantelle Hardy, Li Lin, and Kevin P. Weinfurt. 2010. “Developing a Simplified Consent Form for Biobanking.” PLoS ONE 5 (10). doi:10.1371/journal.pone.0013302.