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.
Research participant understanding and engagement in an institutional, self‐consent biobank model
Andrew Schmanski, Emily Roberts, Marilyn Coors, Stephen J. Wicks, Jaron Arbet, Rachel Weber, Kristy Crooks, Kathleen C. Barnes, Matthew R. G. Taylor
Journal of Genetic Counselling, 20 September 2020
The number of institutional and governmental biobanks and the target enrollment sizes of modern biobanks are increasing, affording more opportunities for the public to participate in biobanking efforts. In parallel with these expansions are pressures to increase the efficiency of obtaining informed consent using shorter consent forms that cover a broader scope of research and increasingly include provisions for return of research or clinical genetic test results to participants. Given these changes, how well these participants understand genetics, their level of understanding of what they are consenting to, and their wishes to engage longitudinally and receive biobank results are not well understood. We surveyed participants in a large, medical system‐based biobank who had enrolled through a two‐page, self‐consent process about their baseline knowledge of genetics, understanding and recall of the consent process, wishes for future contact and engagement, and level of interest in receiving clinical genetic testing results. A total of 856 consented persons participated in the survey (67% women; 67% white). Participants’ general reported genetics knowledge was relatively high (mean 11.60 of 15 questions answered correctly) as was recall of key elements from the two‐page consent form. Overall participant enthusiasm for future contact by the biobank and for receiving clinical genetic testing results was high. The use of a two‐page, self‐consent process in a large, institutional biobank resulted in high levels of consent recall and enthusiasm for future ongoing engagement and receipt of genetic testing results by participants.
Enabling data sovereignty for patients through digital consent enforcement
Arno Appenzeller, Ewald Rode profile imageEwald Rode, Erik Krempel profile imageErik Krempel, Jürgen Beyerer profile imageJürgen Beyerer
PETRA ’20: Proceedings of the 13th ACM International Conference on PErvasive Technologies Related to Assistive Environments, June 2020; 33 pp 1-4
Digital medical data offers an opportunity to improve medical diagnosis and caregiving. While a single doctor might not have enough patients to spot significant factors, data becomes much more evaluable once different doctors combine their data. Data evaluation across multiple data sources will be more practical with the increasing level of digitalization. While the potential benefits of a broad data analysis are enormous, there is a huge potential privacy impact for patients. To cope with legal regulations, for example the European General Data Protection Regulation (GDPR) and to give patients more control over the usage of their data, new tools are needed. Digital distributed patient records need a mechanism to manage a digital declaration of consent. There are some concepts how to digitize medical consent, but still there is no complete workflow that automatically evaluates and enforces consent for the usage of personal medical data. In this paper we will present a continuous digital consent enforcement workflow. Patients can define a detailed declaration of consent for their medical data and researchers can request data through a dedicated interface that enforces that consent. We show the feasibility of this workflow by presenting a prototype implementation and evaluating the system against defined requirements for informed consent.
Modelling Consent in the Time of COVID-19
Bartha Maria Knoppers, Michael J S Beauvais, Yann Joly, Ma’n H Zawati, Simon Rousseau, Michaël Chassé, Vincent Mooser
Journal of Law and the Biosciences, 8 May 2020
Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patient, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.
Developing model biobanking consent language: what matters to prospective participants?
Laura M. Beskow, Catherine M. Hammack-Aviran, Kathleen M. Brelsford
BMC Medical Research Methodology, 15 May 2020; 20(119)
Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation.
We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions.
Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful.
These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.
Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent
Joel E. Pacyna, Jennifer B. McCormick, Janet E. Olson, Erin M. Winkler, Josh T. Bublitz, Matthew A. Hathcock & Richard R. Sharp
European Journal of Human Genetics, 23 April 2020
Dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation. Although the argument for dynamic consent has been made on theoretical grounds, empirical studies evaluating the potential utility of dynamic consent are needed to enhance deliberations about the merits of dynamic consent. Few studies have assessed such considerations as whether donor preferences may change over time or if participants would use a dynamic consent mechanism to modify preferences when they change. We administered a 66-item survey to participants in a large DNA biobank. The survey sought to gauge the stability of donor preferences specified at the time of biobank enrollment, specifically the stability of donors’ preference regarding posthumous availability of biospecimens to next-of-kin. We received 1164 completed surveys for a response rate of 72%. Forty percent of respondents indicated a preference regarding sample availability on the survey (T2) that was inconsistent with the preference they had expressed when they enrolled in the biobank (T1). Most (94%) individuals with inconsistent preferences regarding sample availability had initially restricted sample availability at T1 but were comfortable with broader availability when asked at the time of the survey (T2). Our findings demonstrate that preferences regarding sample use expressed at the time of enrollment in a DNA biobank may not be reliable indicators of donor preferences over time. These findings lend empirical support to the case for a dynamic consent model in which biobank participants are approached over time to clarify their views regarding sample use.
From Subjective To Objective Informed Consent In Healthcare : Biobanks In Focus [CONFERENCE PAPER]
Syeda Amna Sohail, Faiza Allah Bukhsh
Alice & Eve 2020: Celebration of Women in Computer Science – University of Twente, 24 January 2020 – 24 January 2020; Enschede, Netherlands
Healthcare data has long been handled as per the national\local legislative and organizational prerequisites of the healthcare providers across the EU. This inculcates that the healthcare providers goals/objectives substantially dictated the data handling paths of the patients. Where the former could be starkly different from that of the patients/data subjects. Recently, healthcare stakeholders, for patients optimal value care, embedded the idea of Informed Consent (IC) at the onset of data collection. To transform the former, subjective way of data handling by healthcare providers into an objective pan European data handling procedure, the EU introduced General Data Protection Regulation, GDPR. Post GDPR, the EU legitimized patients IC as an integral part at the onset of patients information value care. Now IC, entails patients explicit, well informed , specific, free choice for his/her healthcare data collection and processing, demonstrated in an easily accessible and understandable manner with patients having the right of erasure at any point of data processing (GDPR, article 7). This poses limitations, specifically against scientific research, when applied in biobanks and bio-repositories. Limitations range from Biobanks data collection to data anonymization or/and pseudonymization to the data storage and sharing. In each phase of data handling, the issues and their respective solutions are discussed. Solution lies in defining the public/vital and legitimate interests and in incorporating the broad-open ended informed consent. This is vital for better health outcomes of the patients and the society at large. Regulatory and legislative authorities at the EU and national level must unite to resolve these issues.
Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis
Soo Jung Hong, Bettina Drake, Melody Goodman, Kimberly A. Kaphingst
Journal of Genetic Counselling, 28 January 2020
In this study, we investigated how patients’ self‐reported health information efficacy, relationship with health providers, and cancer history are associated with their preferences for informed consent and need for control over biobank biospecimens. We recruited 358 women aged 40 and older (56% African American; 44% European American) and analyzed the data using multivariable regression models. Results show that African American participants’ health information efficacy was significantly and negatively associated with their need for control over biospecimens and preference for a study‐specific model. European American participants’ dependency on doctors was a significant and negative predictor of their preference for a study‐specific model. Several significant interaction effects, which varied across races, were found with regard to health information efficacy, personal cancer history, need for control, and preference for a study‐specific model. The study findings suggest it is important to consider health information efficacy, relationship with providers, and need for control when developing large diverse biobanks.