The ClinGen Broad Data Sharing Consent Resource is seeking partners. To preview these materials, please visit www.clinicalgenome.org/share.
Background: Genomic data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine. The need for broad access to data, however, must be balanced with the need to respect patient autonomy and privacy, and consent should be obtained before sharing individual-level data. While obtaining consent for data sharing in the research setting is now routinely practiced, obtaining consent for data sharing in the clinical setting has been hindered by a lack of time and resources at both ends of the clinical encounter (clinician and clinical laboratory). To address this need, we are developing broad data sharing consent resources for use by clinicians and clinical laboratories. As part of the development process, ClinGen is also engaging with key stakeholders through interviews and focus groups to assess their opinions on resource content and the feasibility of implementation in the clinical setting.
Concept: The ClinGen Broad Data Sharing Resource includes a one-page consent form and series of brief online supplemental videos. The consent form is intentionally a single page in length to allow for quick initial review in the clinical setting, and contains language consistent with the intent of the NIH Genomic Data Sharing Policy and the NHGRI Informed Consent Resource. Patients who wish to learn more about the data sharing process will be encouraged to visit a website to view the supplemental videos, which provide more detailed information on key topics, such as the risks and benefits of data sharing. We are also exploring the offering the option of online consenting for those individuals needing more time to consider their decision.
For more information, please contact us and/or review the materials below.