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UK's MRC, Wellcome Trust Offer Guidance for Handling Health-related Findings in Research

NEW YORK (GenomeWeb News) – The UK's two major biomedical science funding entities, the Wellcome Trust and the Medical Research Council, have published a new guidance to help research organizations develop policies for handling health-related findings (HRFs) that may arise among their study participants.

This framework requires that researchers and ethics boards develop policies that let individual participants know whether or not health-related findings will be returned to them, Wellcome Trust and MRC said today.

Members of the international biomedical research community have recently begun to consider how to ethically deal with health-related findings that arise during the course of research that could be important or useful to study participants, particularly from projects involving genome-wide association studies and advanced imaging technologies. These kinds of research projects could turn up information and findings, whether incidental or in as an intended part of a study, about genetic variants or disease risk factors that could be useful to participants, who may choose to get screened for diseases or make lifestyle choices to address their risk.

The UK and MRC said the policies that researchers develop must be "clearly articulated," and it must be included in the consent process when participants are brought into a study. Researchers should be able to explain the reasoning behind their policies to participants. In cases where study organizers plan to provide individual data and feedback back to participants, they must develop some "practical feedback pathway that is adequately resourced" for relaying the information to individuals.

The framework 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.

The Wellcome Trust and MRC document offers a range of points that researchers should consider in drafting their health-related findings policies, such as how likely HRFs are to occur in a study; how the benefits of knowing a finding weigh against the possible harms; what the commonly accepted best practices are; what the logistical challenges are in getting information to study volunteers; and how to ensure that when other researchers use data from one study that they will comply with the consent agreements.

According to the framework, consent agreements should cover whether or not HRFs will be returned, how that feedback will be provided, whether healthcare providers will be involved in the return of results, and whether or not participants will be able to choose which feedback they receive, if any.

"There can be no 'one size fits all' policy on whether to feed back information to study participants," MRC Chief Executive John Savill said in a statement."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," Savill said.

The Wellcome Trust and MRC's framework arrives not long after the US government issued similar recommendations, although that report stopped short of proposing requirements. In December the Presidential Commission for the Study of Bioethical Issues proposed in a report that methods for handling incidental findings should be developed and researched by a range of stakeholders and professional organizations. The White House report recommended that in any of the situations in which incidental findings may arise, they should be anticipated and the entities discovering them should communicate with study participants, patients, and consumers about the possibility that such findings are possible.

Questions about how to handle HRFs or incidental findings in the clinical setting have been at the center of an ongoing discussion among ethicists and groups representing healthcare practitioners. The American College of Medical Genetics and Genomics has been at the forefront of the issue, and has generated much debate with its proposal that a list of important genetic variants should be screened for and the results should be relayed to patients' physicians.

The UK's new framework is supported by other UK government and non-profit groups, including Cancer Research UK, the Association of Medical Research Charities, the British Heart Foundation, the Economic and Social Research Council, and others.