What is it? Why is it important?
Incidental findings are observations, results, or other findings that may occur during the analysis of Biological Material (BM), but which are unrelated to the primary goal of the analysis. For example, the discovery of a genetic marker unrelated to the disease under investigation.
Donors of BM / HrPD have the right to information and the right to abstain from information (e.g. study results, incidental findings). These rights are documented in PIS/ICF, and the SP-INV/Site-INV is required to know and respect the wishes of a donor.
Incidental findings can be communicated to donors if they are:
- Analytically valid (e.g. the performed analysis is valid with respect to a clinical diagnosis)
- Clinically significant (e.g. has health-related relevancy)
- Actionable (e.g. are expected to have an impact based on lifestyle changes and/or medical interventions)
What do I need to do?
Be aware that with the analysis of BM, the probability of recording incidental findings exist.
Based on the planned analysis:
- Assess the potential probability of incidental findings
- Inform donors about the probability of incidental findings, and document whether they wish to be informed
- Set up a process on how to handle the occurrence of incidental findings (e.g. documentation, how to inform donors while respecting their wishes for information)
- What process should be in place to validate potential incidental findings (e.g. by clinical diagnostics)
Incidental findings and EC:
- EC can decide to sidestep a donor`s right, if an incidental finding is deemed crucial for the current and ongoing safety and health of a donor
- Some ECs require that donors, who do not wish to be informed about potential incidental findings, be excluded from research participation
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
- Biobank Regulation
Swissethics – see in particular
- Topics/Position papers/Incidental findings
Jui-Chu Lin et al. Managing « incidental findings » in biobank research
HRA see in particular article
- Art 8 Right to receive information