Withdrawing from a biobank brings special challenges
Consent must spell out limitations
The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a large cohort study is a very different matter from withdrawing from a clinical trial. Because of the technology involved, it may not be possible to completely remove one's information from the research.
However, there's a consensus among researchers in this field that a strong right to withdraw still exists, says Timothy Caulfield, LLM, FRSC, a professor of biotechnology law and research director of the Health Law Institute at the University of Alberta in Edmonton, Alberta.
"I just did a survey of all the policy documents around the world for biobanking and large cohort studies," Caulfield says. "The right to withdraw endures, despite all the practical challenges associated with that and it should endure right up until the point where it can't be operationalized in a realistic way."
He says there has been a lot of discussion about how to preserve the right in a time of fast moving technology. A person who no longer wishes to participate in a biobank can ask that his or her tissue sample be destroyed, but that's only the beginning of the process.
"A lot of scholars have noted that that's a little bit of a smokescreen because it's not really the sample, the actual physical tissue that's important, but the personal information that it represents," Caulfield says. "Once you participate in a research project and information about you has been generated, information that's been aggregated and distributed, it becomes really difficult to pull it back."
He says a more complete withdrawal from a biobank also would include no further generation of information from the sample and most importantly, the severing of any linkages between the data already generated and information about the subject.
"A lot of biobanks and cohort studies that are emerging now are really about tying together various streams of information — health information, genetic information, socioeconomic information. So what you can do with a withdrawal is sever all those ties."
Because a biobank itself is not a single study but a research platform for a variety of studies, Caulfield says it's important to keep study participants informed about the research being conducted, so that they can choose to withdraw if they are uncomfortable with the type of research being done through the biobank.
"There has to be that ability to continually inform research participants of the kind of research that's going on, through research updates," he says. "That's the huge challenge around biobanks — at the consent stage, you cannot inform the research participants of all the potential research projects that are going to happen. We just don't know at the beginning."
He says consent forms need to be clear about the limitations on withdrawal.
"Where it becomes challenging is explaining in a digestible manner, the limits of that right as a result of the nature of that research," Caulfield says. "Once information is distributed, it's very difficult to pull it back in. The consent form has to be frank about that, because some people might not feel comfortable with that reality."
He says some ethicists argue that a protocol should be structured in a way that maximizes the ability of subjects to withdraw more completely from a biobank. For example, linkages to personal information actually could be maintained longer in the process, so that when a person wants to withdraw, the information can be more easily traced and removed. But Caulfield notes that such an approach would raise its own ethical issues related to privacy.
"The counterargument is that if the research participant is aware of the limits to the right to withdraw and goes in fully informed, you don't have that obligation," he says.
The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a large cohort study is a very different matter from withdrawing from a clinical trial. Because of the technology involved, it may not be possible to completely remove one's information from the research.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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