In the course of a study involving human participants, researchers may make a finding that has potential health or reproductive importance to an individual participant (health-related findings or “HRFs”). Whether and how HRFs should be fed back to the research participant is currently subject to intense debate. Given the absence of guidance and lack of evidence and consensus on how HRFs should be handled, this framework has been developed to help researchers identify and consider the relevant issues when designing and implementing a policy on the feedback of HRFs. It will also provide useful guidance for members of Research Ethics Committees and Research Governance Committees.
The report can be downloaded here and page 2 contains the framework.
The development of this framework has been informed by a wider project, including: a review of the international literature focused on the legal and ethical issues; a review of existing policies and practice in the UK and US; an analysis of the costs and timescales associated with feedback in genetics and imaging studies; research on public attitudes towards the feedback of HRFs, which found that generally there is a strong preference for feedback particularly where a condition is serious and treatable; and a workshop focusing on the legal issues associated with HRFs.
Findings from the patient survey can be found at the link below.