22 March 2021
Patients and participants who donate their genomic and related health data for research might not realize how and when such data may be shared (or not) with their own family members. In an effort to streamline the consent development process and make it easier for individuals to understand the issues surrounding familial consent, the GA4GH Regulatory and Ethics Work Stream (REWS) recently developed Familial Consent Clauses. Approved by the GA4GH Standards Steering Committee earlier this year, Familial Consent Clauses provide researchers with a typology of relevant sample clauses found in research studies and regulations around the world to guide the drafting of consent forms. The sample consent language can be adapted across a variety of research and healthcare settings to describe how a patient or participant’s genomic and related health data may be shared with family members.
“For a variety of reasons, patients and research participants may or may not want to share their test results with family members. Familial Consent Clauses help navigate different scenarios in a way that respects familial contexts, individual preferences, and privacy,” said Professor Bartha Maria Knoppers, Director of the Centre of Genomics and Policy at McGill University. Dr. Knoppers co-leads development of the Familial Consent Clauses alongside Megan Doerr of Sage Bionetworks and Susan Wallace of the University of Leicester.
These clauses are based on an international analysis of positions and approaches to familial consents, published last year in The American Journal of Bioethics.1 The study illustrates the diversity of international positions, ranging from deference to an individual’s refusal to warn at-risk family members, to physician discretion, to a legal obligation to communicate with family members. Genetics is necessarily “familial,” and this typology of emerging approaches aims to serve as a resource for countries, institutions, researchers, and healthcare professionals.
The Familial Consent Clauses feeds into an ongoing project from the REWS Consent Task Force, which aims to provide a direct “one-stop” resource and catalogue of template clauses for Driver Projects, national initiatives, clinicians, and researchers that can be adapted across different normative environments and genomic studies. Familial Consent Clauses join the larger GA4GH Consent Toolkit, two of which have already been approved: Consent Clauses for Genomic Research and Consent Clauses for Rare Disease Research. Three more guidance documents are on the way, including: Pediatric Consent Clauses to Genetic Research, Consent Clauses for Large Scale Initiatives, and Clinical Consent Clauses for Genetic Testing.
To contribute and get involved with the REWS Consent Task Force, reach out to firstname.lastname@example.org.
1. Knoppers, Bartha Maria, and Kristina Kekesi-Lafrance. “The Genetic Family as Patient?.” The American Journal of Bioethics 20.6 (2020): 77-80. https://doi.org/10.1080/15265161.2020.1754505