Have Research Ethics Committees Got It Wrong? A New Study Looks at What Participants in Medical Research Actually Want

Traditionally, the "gold standard" of informed consent for participation in medical research entails that participants need to consent to every new research study, which means that they need to be contacted and re-consented each time.
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Co-authored by Susan E. Kelly and Barbara Prainsack

Traditionally, the "gold standard" of informed consent for participation in medical research entails that participants need to consent to every new research study, which means that they need to be contacted and re-consented each time. Biomedical research today increasingly involves large international consortia of researchers using large data sets that may be physically located in dispersed locations across the globe. Seeking specific informed consent in these circumstances, particularly for each potential new use of samples or information, is challenging, expensive and often practically impossible. Some institutions thus use so-called "broad consent", by which research participants agree to a range of future uses of their samples and data. This can be particularly helpful in situations where at the time of the initial consent, it is impossible to predict how data and samples will be used in the future. Broad consent has thus been seen as a feasible compromise between individual autonomy and practical feasibility.

But is it a compromise? A study we published in PLOS ONE suggests broad consent may be what many research participants actually prefer. The study, which surveyed over 2,300 unselected research volunteers from a UK twin cohort, found that the majority (58%) of respondents were happy for their DNA and medical information to be used without being re-contacted for additional consent if a different study was carried out on the same disease and by the same researcher. When asked if they would want to be re-consented if a different investigator was to use their DNA to conduct research on the same disease, respondents were only half as likely to give their consent without being re-contacted (31%). These findings are a strong indication that knowing who carries out the study matters to participants, and that their trust in the researcher or research institution carrying out the study influences how much control they want to retain themselves.

We urgently need new forms of consent that take into account both the needs of research and the preferences of participants, that incorporates the protections participants want. This need is increasingly recognised by researchers and patients, as evidenced by the development of such experimental models as 'portable consent', enable people who want to participate in research to donate data for unspecified research purposes. While ethicists have debated these points extensively, there has been limited research on what participants want and value most in consenting to donate samples and information for research.

From the TwinsUK study discussed above, it appears that volunteers view their participation in research as part of belonging or contributing to something, of being in a relationship with the researchers. It is not that individual consent doesn't matter -- it does -- but that the priorities and perceived needs of participants may not be best served by the current gold standard of ensuring detailed individual controls for every research participant at every stage. Frameworks such as solidarity-based database governance, or the principled proportionate governance approach, for example, represent a move away from research ethics committees' obsession with individual autonomy. They bring us a step closer to facilitating the use of health information for public benefit, with safeguards in place to minimise harm to participants. These solutions do not give priority to public benefit at the cost of individual wellbeing; in fact they mandate that participants are treated more equally to researchers than they are now (e.g. by being given access to their own data). They make the important point that individual wellbeing and public benefit are not a zero sum game. Both can win. The only loser here would be research ethics committees holding on to a principle that worked well in an bygone age of smaller scale studies carried out in a fragmented manner, but that in today's world of data linkage and global collaborative datasets are outdated and harmful.

Susan E. Kelly is Associate Professor at Sociology, Philosophy and Anthropology at the University of Exeter.

Barbara Prainsack is Professor at the Department of Social Science, Health & Medicine at King's College London. Follow her on Twitter: https://twitter.com/Wutbuergerin

Tim D Spector is Professor of Genetic Epidemiology and Author, King's College London

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