Clinically Relevant Findings in Research
Organised by the Wellcome Trust
Wellcome Trust, Gibbs Building, 215 Euston Road, London NW1 2BE, UK
Monday 13 June 2011
What happens when a research team discovers something that has direct significance to the health of an individual involved in their study? Although the discovery of 'health-related findings' can occur in any study involving human participants, the answer to this question is by no means clear.
How to manage such findings is a matter of significant debate within the research community, and one which is increasing with advances in technology, such as whole genome sequencing, making these discoveries much more likely. A finding can be relevant to the research question (a 'pertinent' finding) or completely unrelated (an 'incidental' finding). A pertinent finding might be the identification of a genetic variant that increases a participant's risk for developing breast cancer in a breast cancer study. An incidental finding could be the identification of a potential brain tumour in a magnetic resonance imaging (MRI) scan taken as part of a cognitive research study.
There are no clear UK guidelines to support researchers, and practice varies widely both within and between research disciplines. With this in mind, the Wellcome Trust organised a workshop on 13 June, aiming to explore what should be considered when designing a study involving human participants. The attendees were a diverse group of stakeholders including imaging and genetic researchers, health professionals, patient groups, ethicists and representatives from the Department of Health and regulatory agencies.
The afternoon began with two talks introducing issues relating to the discovery of health-related findings in research. Dr Bill Newman provided a consultant geneticist's perspective, describing differences in the management of health-related findings in the clinic and in research studies. Professor Graeme Laurie introduced the ethical and legal issues that arise upon the discovery of health-related findings in participants during research. The discussions that followed identified several key themes, and aimed to make suggestions of how to move forward.
Workshop attendees agreed that a one-size-fits-all policy on feedback cannot be applied to all studies. The context of any individual study will affect when, how, and what is appropriate to feed back to participants. For example, the type of finding – a genetic test, an imaging scan or a blood test – and whether the study was conducted in the clinic could affect whether feedback occurs. No consensus was reached at the meeting about when the benefits of feedback might outweigh the harms, but several important factors were identified, including the severity of the condition and the certainty that the finding is accurate and meaningful.
The extent to which researchers have a duty to feedback health-related findings was not clear. However, it was agreed that a researcher's duty differed depending on whether they were a clinician or not. Related to this, workshop participants felt that it was vital to involve appropriate clinical expertise when feeding back findings and that a clear chain of responsibility for this process should be established during study design.
Another important factor determining whether, and how, such findings should be fed back is participant expectations. Expectations are not only influenced by study context, but also by personal preferences. Systematic empirical evidence on public opinions relating to the feedback of health-related findings in research is required to provide an evidence base to support the development of best practice. The Wellcome Trust has commissioned Opinion Leader to conduct a piece of research on public attitudes, which will report early in 2012.
Consent was agreed to be a vital consideration in whether to feed back health-related findings, because it is the point at which researchers can manage the expectations of participants, and understand their wishes regarding such findings. Workshop attendees supported an individual's 'right not to know' particular information, and thought this should be incorporated in the research consent process. However, it was acknowledged that a clinician might need to override a participant's 'right not to know' because of their clinical duty of care, or when findings have implications for family members or the wider public.
In conclusion, it was agreed that whether, and how, health-related findings are fed back should be considered during the design of all research studies involving human participants. There was broad agreement that principles to guide researchers through these issues were desirable, although they cannot be overly prescriptive. The Wellcome Trust and the Medical Research Council are working together to develop principles on health-related findings to support the research community.