Personalized medicine and research biobanking: From traditional to new informed consent generating a need for participatory governance [BOOK CHAPTER]
Personalized Medicine in the Making, 8 March 2022; pp 249-267 [Springer]
Emerging personalized medicine necessitates the collection, storage and processing of an increasing number and type of human biological samples and associated data within research biobanks throughout the world, materials and data which will be used in future large-scale health-related studies. Hence, ethical concerns regarding biobanks have increased. Here, issues pertaining to autonomy and privacy will be considered, as well the related debate mainly focused on whether or not maintaining the informed consent model used in traditional health research sufficiently guarantees the dignity and rights of subjects, while at the same time serving as a good tool to obtain an appropriate balance between the research subjects’ interests and the public interest. The present paper aims to illustrate the evolutionary path of ethical reflection in this regard towards new models of informed consent, such as broad consent, dynamic consent, and meta consent. At the same time, this path generates the need for new types of governance that take into account the necessity of involving subjects in the decision-making process, especially in light of advancements in data mining and big data technologies.
Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent
T.J. Kasperbauer, Colin Halverson, Abigail Garcia, Karen K. Schmidt, Peter H. Schwartz
Ethics & Human Research, 22 December 2021
Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent. The interviews revealed that while biobank enrollees thought the information on the knowledge test was important, they did not think that performance on the test should affect whether individuals are permitted to enroll in a biobank. Three main themes emerged from the interviews: helping others by contributing to research is more important than understanding consent forms, less understanding is required because biobank-based research is low risk, and only a small amount of information in the consent form is really essential. These perspectives should be considered in discussing the ethics and governance of biobank consent processes.
Harmonising the human biobanking consent process: an Irish experience
Lydia O’Sullivan, Tomás Carroll, Niamh Clarke, Sarah Cooper, Ann Cullen, Laura Gorman, Billy McCann, Blánaid Mee, Nicola Miller, Verena Murphy, Máiréad Murray, Jackie O’Leary, Sharon O’Toole, Emma Snapes, Suzanne Bracken
HRB Open Research, 17 September 2021; 4(96)
Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by documentation in the form of Participant Information Leaflets and Informed Consent Forms (PILs/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation (GDPR) and the related Irish Health Research Regulation (HRR) presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, GDPR/HRR-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.
Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting
T.J. Kasperbauer, Amy Waltz, Brenda Hudson, Bridget Hawryluk, Courtney Moore, Karen Schmidt,
Peter H. Schwartz
Academic Medicine, 14 September 2021
Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues—and the key practical and ethical considerations for each issue—that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.
The value of consent for biobanking
News & Views
Elizabeth Bromley, Dmitry Khodyakov
Nature Human Behaviour, 23 August 2021
Biobanks facilitate large-scale tests of hypotheses that may advance health, but whether biobanking participants adequately comprehend the potential uses of their data should concern researchers and the public. Consent matters because it provides a singular safeguard and a participatory mechanism to influence science’s production of new forms of power…
Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes
Christian M. Simon, Kai Wang, Laura A. Shinkunas, Daniel T. Stein, Paul Meissner, Maureen Smith, Rebecca Pentz, David W. Klein
Journal of Empirical Research on Human Research Ethics, 19 August 2021
Some individuals’ understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.
Vulnerabilities of Cancer Patients and Their Effects on Informed Consent for Biobanking
Mason Kyle, Diana Cortez, Blaze Carbonell, Edgar Masmila, Alfredo Molinolo, and Sharmeela Kaushal
Biopreservation and Biobanking, 4 August 2021
The biorepository (BR) at the Moores Cancer Center (MCC) of the University of California, San Diego is a College of American Pathologists (CAP)-accredited biobanking core that performs informed patient consent, tissue collection, characterisation, storage, and distributiom under Institutional Review Board (IRB)-approved protocol. The informed consent process is the key element that allows the BR to procure and distribute human biospecimens and associated patient information for research…
Thinking about the idea of consent in data science genomics: How ‘informed’ is it?
Jennifer Greenwood, Andrew Crowden
Nursing Philosophy, 12 May 2021
In this paper we argue that ‘informed’ consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance-theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants’ decision to consent. We do not prescribe a standard, formal approach to decision-making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front-line of genomic science.
Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding
J. Kasperbauer, Karen K. Schmidt, Ariane Thomas, Susan M. Perkins, Peter H. Schwartz
American Journal of Bioethics, 4 December 2020
Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an “integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions.
We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants.
Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records.
Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.
Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent
Indrakusuma, S. Kalkman, M. J. W. Koelemay, R. Balm & D. L. Willems
Science and Engineering Ethics, 13 October 2020
Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)—an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent.