With the growing importance of high-throughput analytical techniques in biomedical research, the likelihood for discovering unexpected health risks or signs for disease in human biological samples – incidental findings – is increasing. In the clinical setting, medical professionals are responsible for reporting these to patients if the need arises. "For biobank samples collected on the basis of broad consent and used in biomedical research, there is no equivalent for this procedure," write Dr. Jörg Geiger and his co-authors in their paper "GBA/GBN-position on the feedback of incidental findings in biobank-based research: consensus-based workflow for hospital-based biobanks", recently published in the European Journal of Human Genetics. The publication presents a procedure developed by representatives of the interdisciplinary Bank of Biomaterials and Data Würzburg (ibdw) and coordinated with German Biobank Node (GBN) and German Biobank Alliance (GBA), which closes the regulatory gap and can serve as a template for other clinical biobanks. This is because if biospecimens and associated data are obtained by or on behalf of a biobank, the biobank is also responsible for dealing with possible incidental findings.
Identification by a Trusted Third Party (TTP)
The procedure developed consists of seven steps, each of which is documented. In the first step, the origin of the samples in question is checked. An expert then assesses whether the genetic or non-genetic finding is clinically relevant. A Trusted Third Party (TTP) establishes the identity of the donor – neither the researchers nor the biobank are informed. The TTP also checks whether the donor has indicated that he/she wishes to be informed about incidental findings or not ("right not to know"). In the fourth step, a clinician consults the patient's file and takes into account this information when deciding whether to inform the donor. Finally, the attending physician communicates the findings, the clinical relevance and potential consequences.
Further information and links:
- Geiger, J., Fuchs, J., Starke, M. et al. GBA/GBN-position on the feedback of incidental findings in biobank-based research: consensus-based workflow for hospital-based biobanks. Eur J Hum Genet (2023). https://doi.org/10.1038/s41431-023-01299-8
- Recordings of the GBN workshop "My genes are mine! Use of genomic data of probands and patients" (3 May 2018)
- Interview with Prof. Dr. Jochen Taupitz
