A single sample can yield a lot of information, but many are advocating for a change in the framework of informed consent for biomedical research to protect patients from surprises about where that information shows up.
Consent forms for research face a variety of issues, according to a story in Nature this week, including confusing or ambiguous wording, promises of anonymity that cannot always be upheld, and varying policies of opting in or out. Lawyers and ethicists say these inconsistencies put patients at risk of having their information used in ways they didn’t anticipate, such as gene patents arising from studies of Parkinson’s disease, or the 2010 case of a tribe of Native Americans in Arizona who thought they were participating in a diabetes study, but later found their genetic information had been used to study mental illnesses and population origin, calling into question their personal beliefs.
The swath of information that can be gained also calls into question what participants should be told about the results. Discovering predispositions to certain diseases is not something every participant—or every parent—wants to know. But restricting consent to the study of one disease prohibits pools of data that can be used to study a broader range of issues.
While some companies tackle this by scrambling data to create anonymity, advocacy groups raise concerns about how little control research participants have over their own data. Keeping the door open on large biomedical data sets may rely on new frameworks that build trust with the participants, while allowing broad research on the data, as recently discussed by Krishanu Saha and J. Benjamin Hurlbut in an opinion on The Scientist’s website.