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Telling research participants about health related findings

31 Mar 2014

The Medical Research Council and Wellcome Trust have launched a framework (PDF, 421KB) to help researchers design and implement a policy on feeding back findings that arise during the course of a study which have a potential health implication for the individual participant.

In the course of a study involving human participants, it is possible that researchers may make a finding that has potential health or reproductive implications for an individual participant. For example, during a brain imaging study, researchers might identify a brain tumour, or a genome-wide association study looking for genetic risk factors for diabetes might show that a participant is at an elevated risk of developing Alzheimer’s disease.

Whether and how these ‘health-related findings’ (sometimes called ‘incidental findings’) should be fed back to the participant is currently subject to intense debate. Given the lack of evidence and consensus on how such findings should be handled, the MRC and the Wellcome Trust worked with the Health Research Authority to develop a framework to help researchers and research ethics committees identify and consider the relevant issues around feedback in a study. The framework is also supported by the Association of Medical Research Charities, the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, and the Health & Social Care R&D Division, Public Health Agency, Northern Ireland.

Sir John Savill, Chief Executive of the MRC, adds:

“There can be no ‘one size fits all’ policy on whether to feed back information to study participants. Research contexts vary widely and so the balance of public and individual harms and benefit must be assessed on a study-by-study basis. We need further empirical evidence before we know the best approach to take but in the meantime it is important that researchers consider these issues carefully.”

Dr Jeremy Farrar, Director of the Wellcome Trust, says:

“As we involve more and more people in medical research and our ability to identify disease markers increases significantly, it is inevitable that we will often see cases where findings could have potential health implications for individuals. We need a public discussion about where and how it is appropriate to feed this information back to participants.”

Under the framework, the researchers will be required to have a policy that indicates whether or not health-related findings will be fed back to individuals. Such a policy must be clearly articulated and researchers must be able to demonstrate the reasoning behind it. Information on the study policy must be included in the consent process. In cases where the policy is to provide individual feedback, the researchers must develop a practical feedback pathway that is adequately resourced.

The framework itself includes points for researchers to consider when deciding whether individual feedback is appropriate and what information should be included in the consent process, as well as points to consider in designing feedback pathways where appropriate, and hypothetical case studies showing possible approaches in different settings.

Here’s a commentary on the subject, co-authored by Professor John Savill, which appeared in the Lancet.

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