Assessing Public Attitudes to Health Related Findings in Research

During scientific research involving human participants, researchers may find something that has direct significance for a participant's health such as an undiagnosed disease or an increased risk of illness. These health-related findings may be relevant to the scientific research question (a "pertinent finding") or completely unrelated (an "incidental finding"). Health-related science findings can be of varying severity and may occur during different types of research involving human participants, including imaging and genetic studies.

Observing that there is limited understanding of public attitudes towards whether and how these health-related findings should be communicated, the Wellcome Trust and Medical Research Council commissioned research to address this evidence gap. "Assessing Public Attitudes to Health Related Findings in Research" reports the findings of this research, which was undertaken in the United Kingdom (UK) in 2011 and 2012. The qualitative phase included 8 extended focus groups with the general public and 20 in-depth interviews with research participants and people affected by medical conditions. The quantitative phase consisted of a survey of 1,105 members of the public.

Amongst the communication-related findings:

• "[T]here was a strong belief that participants should be clearly informed about what would and would not be fed back at the start of the process as part of the consent process. This would then give them the personal choice as to whether they would want take part in the research and also allow them to consider, where the choice was available, if they would want feedback."
• "For most participants the preferred method of delivery of this information was through a combination of written material and discussion with a researcher or medical professional. It was felt by the majority of participants that simply providing written material was not sufficient. This written material, including the consent form, could potentially contain a large amount of potentially complex information and it was thought that some people may have difficulties reading and understanding written material. Further, participants agreed that many people do not read written information presented to them in other contexts."
• "If a health-related finding is discovered, there was an overwhelming preference for face-to-face feedback among survey respondents. Such feedback was particularly valued when it was about conditions that were life-threatening. Feedback via letter was the second most acceptable form of feedback across all types of condition, followed by telephone, with email being seen as the least acceptable form of feedback."

Recommendations presented in the report for researchers:

• "Participants showed overwhelming support for the return of health related findings to research participants, particularly where a condition is serious and treatable. Researchers should therefore consider the feedback of findings when designing and setting up a study to ensure that potential research participants have the information they need to decide whether to take part in a study."
• "Respondents viewed the consent process as a critical point for potential participants to receive information on health related findings before agreeing to take part in research. It is therefore essential that information on feedback is presented clearly and in an accessible form that members of the public are able to understand."
• "Respondents valued the role of health professionals or those they had an existing relationship with in the feedback process and it was seen as important that those receiving feedback have sufficient information and access to follow up. Researchers should take these factors into account in designing the feedback process and ensure that those receiving feedback have sufficient information and access to follow up advice."
• "...It is important that the results of this study are considered within the context of the low level of understanding of the process of medical research, particularly where they are to be used to inform policy development. This finding also has important implications for how researchers communicate with research participants, particularly to avoid a gap developing between participants' expectations and their experience of taking part in research. Further research in a number of areas would enhance the evidence base for policy decisions on the feedback of findings to individuals. This should encompass a wider range of stakeholders, including those who have had findings returned to them and health professionals."