Broad consent for biobanks is best – provided it is also deep

Abstract

Background As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. Main text In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. Conclusion We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

Knowledge, perceptions and attitude of Egyptian physicians towards biobanking issues

“…These include, among others, specific consent (specific for a single research project), dynamic consent (using technology to allow participants to choose between broad consent or to approve a single study at a time), and tiered consent (where the participant allows some uses of the samples only and renewal of consent is needed for other studies [ 10 , 47 , 49 ]. A broad consent form that contains adequate details is regarded as a suitable model of consent for use in biobanks [ 50 ]. Broad consent should detail the nature of the biobank and types of samples and data to be collected [ 32 , 51 – 53 ].…”

Recommendations for the development of Egyptian human biobanking ethical guidelines

“…As noted in the literature, this can be challenging if collected samples may be used for future and as yet unspecified research. This process may be even more challenging if future research use involves the generation and/or sharing of genomic data 14 , 28 .…”

“…A broad consent mechanism covering these aspects is considered adequate to meet the informational needs of a prospective donor/participant, and is recognized to be acceptable for use by biobanks in the guidelines that we analyzed. This should be complemented by a robust ethics governance system, which usually includes a REC or institutional review board (IRB) where ethical requirements are concerned 7 , 10 , 12 , 13 , 28 . RECs/IRBs oversee biobanking activities to ensure that the process meet these specifications 13 .…”

Researcher Knowledge, Attitudes, and Communication Practices for Genomic Data Sharing

“…Proponents of such dynamic consent models have argued that broad consent can be viewed as ethically problematic (Budin-Ljøsne et al, 2017; Kanelloupoulou et al, 2011; Steinsbekk et al, 2013). An ethical analysis by Mikkelsen et al (2019) suggests that, when compared to other models of informed consent, a modified form of broad consent may be ideal. These modifications would include a continuous ethical review to evaluate whether proposed research falls within the scope of the broad consent.…”

“…These modifications would include a continuous ethical review to evaluate whether proposed research falls within the scope of the broad consent. Mikkelsen also recommends continuous provision of information to participants (Mikkelsen et al, 2019). Still, Majumder et al (2019) reported that while most researchers are in favor of expanding the role of participants beyond one-time, broad consent, they also raise concerns about the amount of this would require on the part of the researchers.…”