Guidance published on informing study participants about findings with potential health implications
Press release / Published: 31 March 2014
The Wellcome Trust and Medical Research Council (MRC) today launch a framework to help researchers design and implement a policy on feeding back findings that arise during a study which have potential health implications for individual participants.
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 during a genome-wide association study looking for genetic risk factors for diabetes, researchers might find that a participant is at an elevated risk of developing Alzheimer's disease.
Whether and how these 'health-related 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 Wellcome Trust and the MRC 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 of the Public Health Agency, Northern Ireland.
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."
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."
Under the framework, 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.
"If our volunteers didn't hear anything, they would just assume that everything was fine"
Several years ago, Alan Jackson, Professor of Radiology at the University of Manchester, volunteered for a magnetic resonance scan as part of his team's research to develop new imaging technology. The scan was to change his life: it showed that he had an enlargement of the aorta known as an aortic aneurysm. The risk of complications from surgery for an aneurysm can be significant, but if the aneurysm grows bigger than 5 cm, surgery is essential; Professor Jackson's measured 4.9 cm.
Unusually, the aneurysm has stabilised and has not grown further. Instead of surgery, Professor Jackson manages his condition through a combination of anti-hypertension medication and lifestyle changes: he is no longer able to scuba dive, a hobby he misses. For a time, he could not fly to the US because he was unable to receive medical insurance. "I became known as the academic who never goes to conferences," he says.
Professor Jackson is a firm believer that researchers need to have policies in place for feeding back health-related findings to study volunteers. This is based not just on his own story, but on years of experience of running studies. Now, his research group will not allow volunteers to take part in a study unless they are willing to have any health-related findings fed back to their GPs and understand the potential implications of a positive finding.
"It is not uncommon for people to volunteer for trials because they want the peace of mind that, say, their frequent headaches are nothing to be concerned about, yet are afraid to visit their GPs," he explains. "We need policies in place for these people: if they didn't hear anything, they would just assume everything was fine when in fact they could be living with a serious - but potentially manageable - medical condition."