GHGA Modular Consent Toolkit now available
Informed consent from patients and research participants is required in order to share omics and related health data for research. GHGA has now published a whitepaper, containing guidance on how to update consent documents for clinicians, researchers and institutions wanting to submit data to GHGA. These updates inform patients and research participants about the possibility of sharing their omics data with genome archives such as GHGA and enable data to be shared via the GHGA Data Infrastructure and comparable secure research data infrastructures.
The GHGA consent modules are based on a review of current best practice examples, including consent document templates produced by the Medical Informatics Initiative (MII), and the ongoing works on consent clauses and consent recommendations within the Global Alliance for Genomics and Health (GA4GH) and the Beyond One Million Genomes (B1MG) project.
The Modular Consent Toolkit contains four consent modules:
- The Data Sharing Module
- The De-Identification Module
- The Controlled Access Module
- The Consent Options Module
Developed as a service for Data Submitters who intend to share data for secondary research use, the toolkit might also be of use for data collected for routine clinical care, another valuable source for biomedical research.
Bruns, Andreas, Benet-Pages, Anna, Eufinger, Jan, Graessner, Holm, Kohlbacher, Oliver, Molnár-Gábor, Fruzsina, Parker, Simon, Schickhardt, Christoph, Stegle, Oliver, & Winkler, Eva. (2022). Consent Modules for Data Sharing via the German Human Genome-Phenome Archive (GHGA) (1.0). Zenodo. doi.org/10.5281/zenodo.6828131