A new consensus statement from a National Institutes of Health (NIH) funded US working group has agreed that biobanks ‘shoulder significant responsibility’ for the feedback of incidental findings (IFs) of potential medical importance.
Last year’s PHG Foundation report on the advent of clinical genome sequencing noted that the issue of these unexpected discoveries required urgent attention, recommending that in the short-term steps should be taken to minimise IFs in medical practice (see previous news).
However, large-scale genomic research, which exists very much on the interface between research and medicine, is another area of major concern, and opinions are divided on how IFs should be handled – ignored, as per normal research practice, or fed back to research participants for whom the information may be medically relevant? To inform participants of results is necessarily more logistically complex (and costly), as well as raising different issues of ethics and consent, but there is growing interest in this approach (see previous news).
The new biobank recommendations conclude that findings should be returned to participants, where this is possible, under specific circumstances: where they are analytically valid, identify ‘an established and substantial risk of a serious health condition’ and are clinically actionable - ie. where there is some sort of medical intervention available to reduce the risk or identify and treat the condition.
The article forms part of a special issue of the journal Genetics in Medicine examining the feedback of findings from genetic research.