Informed consent from patients and research participants is required in order to share omics and related health data for research. GHGA has developed a toolkit for clinicians, researchers and institutions wanting to submit omics data to GHGA. The different modules can be integrated into existing consent documents and 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 Modular Consent Toolkit contains four consent modules:

  • The Data Sharing Module describes a way of sharing data securely for scientific research that is not limited to GHGA.
  • The De-Identification Module provides information on the process of removing direct identifiers and the security status of de-identified data. .  
  • The Controlled Access Module provides information on the controlled access process, used by the GHGA Data Infrastructure and comparable infrastructures to make Datasets available to researchers and research institutions.
  • The Consent Options Module allows the Data Subject to record their consent decision concerning downstream data sharing.

 

The modules are available in both english and german, they are discribed in detail in this whitepaper. In addition to the consent modules, the whitepaper includes a check list to assess whether consent forms which have been updated with the Modular Consent Toolkit are sound.

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.

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. 

 

 

Full citation of the publication:

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. https://doi.org/10.5281/zenodo.6828131