Many want consent options in biobanking
Many want consent options in biobanking
Some want total control over every study
Biobanks pose a daunting challenge to the very idea of informed consent – how can potential subjects to give consent for research done on their biological samples when there is no way to tell them all the potential studies that could result from their participation?
Developers of biobanks have taken different approaches to solving this problem, but there has been little research about the type of consent the public finds acceptable for participation in a biobank.
Juli Murphy, MS, project manager for Johns Hopkins University's Genetics and Public Policy Center in Washington, DC, was part of a team that set out to take the pulse of the public on this issue, first through a series of focus groups and then an online survey of more than 8,000 participants.
Results from the study were published in a recent issue of the American Journal of Public Health.1 Murphy says they showed that while 48% of those surveyed were willing to give broad consent at the time of enrollment for whatever studies might be done with their samples, another 42% wanted to be contacted for consent each time their samples were sought for a particular study.
While acknowledging that it would be impracticable for a biobank to actually seek consent each time samples were used, Murphy says the results of the study show that a sizeable group of potential participants sees their participation in a biobank as more than a one-time donation.
"The desire to give consent each time reflects the fact that people want to be active participants in biobanks," she says. "I think some biobanks need to consider that in terms of ways they can stay in contact and consult with or inform people who want to volunteer.
"I think it's a call for additional interaction with the study in terms of designing a protocol that would allow people to have ongoing input."
Focus groups discuss NIH proposal
In this study, Murphy's group asked about attitudes regarding a national genomic biobank proposed by the National Institutes of Health and other federal health agencies.
They began with 16 focus groups in six U.S. locations. Each group viewed a short video about the proposed NIH biobank, and then discussed a wide range of issues about the proposal, including preferred forms of consent.
Although the groups were asked about two primary forms of consent – broad "blanket" consent and individual consents for each study – another suggestion emerged in the focus groups. Many participants suggested a "menu" consent that would list possible diseases or research topics and allow participants to check off the ones they would agree to.
In discussions, participants themselves offered the pros and cons of each approach:
- Blanket consent – Supporters of this approach said it would be simpler and require fewer contacts. "If I agree to do the study, I'm going to agree to just give my information and be done with it," one participant said. But others worried that they might find some research being done with their samples to be objectionable.
- Individual consents – Focus group participants who favored this approach said it would give them control over the use of their samples and would help them feel respected and involved. Some said that learning about the various studies as they came up would help keep them informed about the uses of samples. But concerns were raised about the burden on both researchers and on participants who potentially could field many requests. Some participants felt that requiring consent for each study might make it difficult to conduct research.
- Menu consent – Proponents of this approach thought it struck a balance between too much and too little control over the use of their samples. But others thought it might potentially limit research in areas such as mental illness that were sensitive or controversial.
Armed with these discussions, Murphy's group drafted an online survey testing the various approaches.
"What we saw was a split between people saying 'I want to sign once' versus the people who say 'I want to sign with every study that comes along using my samples and information,'" Murphy says. "I was actually surprised we didn't see more people wanting the menu consent that we heard a lot about in the focus groups."
Among the survey participants, black and Hispanic respondents were significantly less willing to give blanket consent for the use of their samples.
Murphy says it's unclear exactly what was driving those who wanted individual consents.
"There may be some lack of trust here or a desire to have more of an ongoing relationship with the study and be more of a partner in the study rather than someone who is just enrolled and forgotten about," she says.
Her group is continuing to research this topic, looking at how it's tied to other biobanking issues such as privacy and data sharing. They're also examining how the recent passage of the Genetic Information Non-Discrimination Act may alter participants' views about consent, perhaps by lessening concerns related to genetic testing.
'Contract' vs. consent
In their ongoing research, Murphy's group is looking closely at one unexpected finding that came up repeatedly during focus groups. Participants would use the word "contract" to describe the agreement they felt should be offered to biobank participants. Although it's unclear exactly what they meant, Murphy says participants seemed to favor a binding agreement between researchers and participants, with potential recourse for participants if researchers didn't follow through on their promises regarding the use of the samples.
In the survey, 94% of respondents stated that if they participated in a study a "contract signed by researchers and participants" would be at least somewhat important to them.
"We're trying to pick it apart – are they referring to the word 'contract' interchangeably with (informed consent), or is there something very different that the word 'contract' brings to it, in terms of their relationship with the study?" she says. "Because it popped up in every location where we did focus groups. We would say 'consent' and they'd say they wanted a contract."
As researchers continue to examine the attitudes of potential biobank participants, Murphy says current biobank developers and IRBs should be mindful of this strong current among many participants to want a more ongoing role in studies.
"Realistically a biobank of this size is not going to be able to ask you consent for every possible study using your samples and information," Murphy says. "But biobanks need to consider those who want to be active participants in terms of making it a successful research vehicle."
Reference
- Murphy J, Scott J, Kaufman D, et al. Public Perspectives on informed consent for biobanking. Am J Public Health 2009 Dec;99(12):2128-34.
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