Consent Critical to Building Public Support for Biobanks?
Ever-increasing demand for personalised medicine has enhanced the global requirement for biobanks to provide human tissue, body fluids and their derivatives. Between the two distinct types of biobank, those which primarily support healthcare and those which boost clinical research, there are major similarities in terms of the philosophical issues that restrict their everyday activities. In order to ensure sustained viability in the future, these repositories must comply with ethical and regulatory standards, as well as winning the support and trust of the public they so greatly rely on for progress.
Regardless of whether it is blood, saliva or leftover tissue from a surgical procedure, samples collected for future research are frequently linked to personal health information relating to the donor. Researchers who want to make use of these samples face important questions about whether permission is necessary and exactly how consent should be obtained. In a recent study, scientists made a number of observations that suggested communication and trust between biobanks and the public needed to be improved.
A team of University of Iowa (UI) researchers, led by Christian Simon, associate professor of Bioethics and Humanities in the Department of Internal Medicine at the UI College of Medicine, conducted a study to determine people's preferences with respect to informed consent for biobanking. Published ahead of print in the May 2011 online edition of Genetics in Medicine, the project involved more than 750 telephone interviews and seven separate focus groups. Interestingly, the majority of participants had never even heard of a 'biobank' before. But once the concept had been explained to them, most respondents were pleased to lend their support to repositories that could help advance research on disease. Quite unsurprisingly, 95 per cent of the individuals surveyed reacted negatively to the idea of deriving and storing samples without first obtaining permission from the donor.
"This speaks to the premium many people place on being informed and having a choice about participating in research," Professor Simon commented. Next, participants were asked for their preferences on opt-in and opt-out biobanking involvement. "This distinction is important because opt-in consent typically involves more detail, more time and a more active decision on research participation when compared to an opt-out process," he added. In fact, more than two-thirds of people said they would prefer an opt-in consent process.
Professor Simon noted, however, that a "substantial minority" of almost a quarter actually said they would prefer an opt-out process, as it would still provide some level of choice, but involves less time for potential donors and fewer resources for the biobank. These people said they would like to do what they could to help with sample accrual and thus assist scientists in making progress on new therapies and cures.
Later on in the UI study, participants were asked to consider three options as to how their permission might be obtained. Firstly, they could be given a broad description of how their health information and tissue samples might be used in the lab. Secondly, they could be given control over how their data might be used via a menu-type consent form. The third and final option involves the donor being contacted for their permission every time their samples and information are relevant to a study.
"Broad consent was preferred by more people when compared to either the menu or study-specific types of consent," said Professor Simon. "However, if you were to lump together the people who said they preferred the menu and study-specific types of consent on the grounds that both these approaches promote more control over sample use than broad consent, the margin is not so impressive." He noted how some experts suggest the use of more than one approach to consent, allowing for a diversity of preferences, though he recognised the likelihood of this having cost and logistics implications.
Professor Simon concluded: "Biobanks are going to be – just as they already are – dependent on public support and participation. Putting into place an informed consent process that meets formal requirements and standards and that works for people by taking their values and preferences into account is one way that we can reach out and build public support and trust for biobanks."