Hypothesis-generating projects with extensive datasets often have the potential for the emergence of secondary significant health-related information during the project.
Significant secondary health findings are information that emerges in a project without being covered by the project's purpose, about the participant unexpectedly suffering from or with certainty or high probability is predisposed to get a life-threatening or clearly serious illness, which can be treated, prevented, or alleviated.
It is worth noting in this context that feedback can be greatly beneficial for participants, just as the lack of feedback can risk damaging trust in researchers if it later turns out there was something to report back. Conversely, feedback can also create unnecessary worry or pose a burden on the healthcare system, which has to follow up on the information that has been reported back. It must therefore be ensured that any feedback is handled in accordance with the rules in the feedback regulation[1] and established ethical principles. If it is assessed that there is a predominant possibility for the emergence of significant secondary health findings in the hypothesis-generating project, the researcher must describe the composition of an expert committee, which is to be established upon the emergence of such findings.
The starting point of the feedback regulation is that only serious secondary health findings are reported back, where
- the disease or disease predisposition can be significantly prevented, treated, or alleviated,
- the disease or disease predisposition has significant importance for the participant or research participant,
- the clinical validity of the finding, and
- the method for detecting the finding is secure.
Therefore, the expert committee must consist of a licensed health professional within the disease area being researched, and must additionally consist of members who possess the necessary expertise to assess the aforementioned 4 conditions.