Informed consent

What kind of informed consent should be required for medical study participants? Is a one-time consent sufficient, or should volunteers be given multiple opportunities to opt out of studies? This question is particularly important for people donating genetic samples and/or information that might later be used in unexpected ways. Bioethicists led by Susan Brown Trinidad from the University of Washington have been tackling this issue.

There are two main questions that the panel attempted to address. First, does consent to provide a genetic sample to one group of researchers give that group implied or explicit permission to give that sample to anyone else who may want it? Today, laboratories are pooling genetic information to an unprecedented extent. Many studies rely on large pools of information, and often the original sample collectors could not have predicted how the data would one day be used.

Second, should the biospecimen donators be informed of each study or usage to which their data is put so that they can choose to opt out at any point? Should they perhaps get a yearly summary? For example, 'in 2011, your tissue sample was used in a cancer study, a geneology study, and for suturing practice.' Needless to say, this would require an enormous database and may not even be feasible. Researchers not only don’t know but in many cases are forbidden to know the personal information about the origins of their samples.

When participants in a bioethics study were asked about their preferences, 90% of them were willing to supply tissue and genetic samples to research biobanks. They were divided almost evenly about whether a one-time consent would be sufficient or if they preferred to re-consent to each new usage.

Gathering large pools of biological and genetic data can only benefit the public. Doing so without trampling individual rights is an even worthier goal.