How can researchers deal with incidental findings? Guidance document gives practical tools

Incidental findings are a major ethical concern in biomedical research. Consistent policies and practices for the detection, management and communication of incidental findings across biobanks are lacking in the Netherlands. Current international ethical guidance suggests that researchers should anticipate the occurrence of incidental findings and set up pathways for the handling of incidental findings, but they do not specify what these pathways should look like. BBMRI-NL is in the position to help advance and harmonize guidelines across research centers in the Netherlands. In one of the voucher projects of BBMRI-NL, a practical-ethical guidance document was developed for the handling of incidental findings in biobanks and biomedical research.

What offers the guidance document?

This guidance document aims to support researchers, biobank managers and research ethics review committees in decision-making and policy development regarding the detection, management and communication of incidental findings in biobanks and biomedical research. The guide involves a framework with seven steps for which decisions must be made regarding the handling of incidental findings: anticipation of findings, information towards donors or research participants, collection of data, data analysis, confirmation of detected findings, communication of incidental findings, and referral and follow-up. Each step consists of actively phrased action points (e.g. “Step 2.1: Inform participants about the possibility that incidental findings can be found”).

The guide does not prescribe for each step what should be done. Biobanks or studies can be very different in design and can raise different sets of expectations in donors or research participants, leading to a variation in their requirements for the responsible management of incidental findings. The guide does describe minimal requirements and outlines a range of options for each step in the seven-step framework. The steps apply to different types of research, among others genetics, imaging and pathology. Moreover, it provides researchers with practical examples of how other research groups have set up their pathways (best practices).

Development of the guidance document

The guidance document was developed by Nikkie Aarts and Eline Bunnik, researchers at the department of Medical Ethics and Philosophy of Medicine at Erasmus University Medical Center, in cooperation with the BBMRI-NL ELSI team. The document builds on two previously published papers by Meike Vernooij and Eline Bunnik. One paper presented a seven-step framework for the handling of incidental findings in imaging research, which was expanded and translated to the wider context of biobank research. The other paper stressed the fact that incidental findings are not the result of chance, but of technical and institutional decisions made by researchers. In addition, when developing the guidance, they built on literature research and interviews with key stakeholders in BBMRI-NL and its associated biobanks or studies.

The document can be found here.

June 18, 2018