Policy position on health-related findings in research
In the course of a study involving human participants, researchers may make a finding that has potential health or reproductive importance for a research participant (“Health Related Findings” or “HRFs”). Potential HRFs include both findings that relate to the aims of the study (pertinent findings) and findings that are unrelated to the aims of the study (incidental or unsolicited findings). They do not include aggregated research findings that are not meaningful at an individual level.
We consider that it is appropriate for researchers to feed back HRFs where the potential benefits of feedback to an individual clearly outweigh the potential harms and it is feasible to do so. However, at this time, we do not consider it appropriate to advocate a single approach to the feedback of HRFs because further empirical evidence is needed on the harms and benefits associated with feedback and, since research contexts vary widely, the balance of public and individual harms and benefit must be assessed on a study-by-study basis.
This policy position sets out our expectations of researchers and the role of the Trust in relation to HRFs. This policy should be read in conjunction with the associated framework [PDF 422KB], which has been developed to help researchers identify and consider the relevant issues when designing and implementing a policy on the feedback of HRFs.
We expect all of our funded researchers to carefully consider the issues around HRFs when establishing a study involving human participants or re-consenting participants for follow-on research to an existing study.
In particular, researchers must:
- have a policy that indicates whether or not HRFs will be fed back to individuals that can be clearly articulated, and be able to demonstrate the reasoning behind their policy to research participants, funders and the Research Ethics Committee;
- include clear information on the study policy on the feedback of HRFs in the consent process; and
- in cases where the policy is to provide individual feedback on HRFs, develop a practical feedback pathway that is adequately resourced.
Feedback pathways must be adequately resourced and therefore there may be costs associated with the feedback of HRFs. There are two types of potential cost associated with the return of HRFs.
First, research-associated costs in determining if a finding is reportable, which the researcher must ensure are covered. These may include the validation of the HRF and the return of these to the research participant or their primary healthcare provider.
Second, the healthcare-associated costs of acting on the HRF should the participant choose to do so, which are not the researcher’s responsibility.
The allocation of research-associated costs and healthcare-associated costs is likely to depend on the nature and setting of the research. The costs of healthcare following the feedback of an HRF are always healthcare-associated costs, but the allocation of other costs is likely to depend on the nature and setting of the research. For example, for a study conducted in a clinical setting in which the participant is also a patient, the validation and subsequent follow up may be considered as a healthcare-associated cost because it is part of their care. However, in a non-clinical setting, researchers may need to make arrangements to involve those with appropriate clinical expertise in the validation, which may be considered as research-associated costs.
All those seeking Wellcome funding should consider their approach to HRFs at the research proposal stage. We reserve the right to see the study policy on HRFs during the application process or lifetime of the grant. Where researchers expect to provide feedback for a particular study, the research-associated costs should be budgeted in the grant application. In line with existing practice, we will:
- cover reasonable research-associated costs related to the feedback of HRFs, but will not cover any healthcare-associated costs.
We cannot provide any further advice on HRF policy in specific cases and nor do we accept any responsibility for any matter arising out of any HRF policy.
Whether and how HRFs should be reported back to the research participant is currently subject to ongoing debate and the landscape will continue to evolve as the evidence base develops. In light of this, we:
- will monitor the external landscape and keep both our policy position and framework under review; and
- would welcome competitive applications to our grant schemes for research that would address gaps in the evidence base.