Documents & Announcements
ClinGen Expert Panel Conflict of Interest Policy
Expert Panels within ClinGen are expected to represent the diversity of expertise in the field and should be composed of a sufficient number of eligible expert reviewers to address academic and financial conflicts of interest that may arise. Members will be asked to declare COI and pre-existing activities or new initiatives that coincide with their involvement in ClinGen upon joining a Variant or Gene Curation Expert Panel, and will be reminded periodically to update their information. This information will be publically available on the ClinGen website.
Types of COI
Academic: An individual may be perceived to have an “academic” conflict of interest when they have participated in scientific discoveries or the general body of knowledge regarding a particular gene or variant.
Financial: An individual may be perceived to have a “financial” conflict of interest if they have a financial relationship (employment or consulting) with a commercial entity that provides genetic testing services and where there could be a vested interest in a particular gene or variant classification.
Management of COI
Individuals with academic or financial COI may serve on Gene and Variant Curation Expert Panels and are welcome to voice their opinions about the evidence, but should not be assigned as the primary reviewer or sole arbiter of gene-disease clinical validity or variant pathogenicity in cases where they have a perceived COI.
- This provision is more important when there is limited data available and it was primarily provided by that individual or the individual’s lab group.
- If there is general consensus there is no need to remove oneself; however, if there is a difference of opinion, there should be a recusal.
Expert Panel members are expected to be open with their group about other pre-existing activities or new initiatives that coincide with their involvement in ClinGen. The member(s) and the CDWG chairs should come to an agreement on how to manage the overlap.
- Disclose independent gene or variant curation efforts that may potentially overlap with the scope of their ClinGen work. For example, a lab preparing to publish their specific assertions about variant pathogenicity, internal gene curation efforts, or development of disease or gene-specific specifications of the ACMG/AMP guidelines.