29 September 2020
The Steering Committee of the Global Alliance for Genomics and Health (GA4GH) has approved three new products that support the genomic and health data collection process. The Ethics Review Recognition (ERR) Policy is a document detailing key elements of the ethics review process to improve how Research Ethics Committees review research projects involving genomic and related health data. The other two new deliverables—Machine Readable Consent Guidance (MRCG) and Consent Clauses for Genomic Research (CCGR)—both aim to facilitate interoperable data sharing that upholds data donor consent. Together, these three deliverables facilitate genomic and health research that protects the interests of both participants and researchers.
Ethics Review Recognition Policy
The ERR Policy, produced by the GA4GH Regulatory and Ethics Work Stream (REWS), was developed to standardize the process of reviewing research projects in which genomic or health data is to be shared across institutional or national boundaries. Currently, Research Ethics Committees—sometimes known as Ethics Review Boards—review proposed studies that involve human research participants to ensure the ways in which data is collected and used are ethical, legal, and respectful of each participant’s wellbeing. As many new studies work to utilize existing data, additional ethics reviews are necessary. “This exacerbates the burden placed on Research Ethics Committees to thoroughly and consistently review proposals, increases the time a proposed research study spends waiting for approval, and uses up financial resources that could otherwise be allocated to advances in research and medicine,” said Edward Dove, Co-Chair of the REWS.
The ERR Policy addresses the problems currently faced by Research Ethics Committees and researchers by establishing a standard framework for ethics reviews.
“When this standard process is recognized and accepted by Research Ethics Committees around the world,” explained Dove, “proposed studies will only need to undergo an ethics review once and the review will be accepted by ethics committees in different institutions and countries.”
Consent Clauses for Genomic Research
The CCGR is a document outlining sample consent language for aspects of genomic research—particularly around data sharing and data linkage—that researchers can use in creating consent forms. The CCGR is part of an ongoing effort from the REWS Consent Task Force which aims to provide sample consent language for a variety of research and healthcare settings in which a patient or participant’s genomic and health data may later be shared or used in future studies. Using the CCGR to draft consent documents, researchers can ensure that their participants understand how their data may be used and shared throughout its lifetime and provide their consent accordingly.
“In addition to increasing interoperability, the CCGR also helps researchers and review committees by eliminating ambiguity around the language that is appropriate to use in consent documents and streamlining the development of such documents,” said Susan Wallace, who led the development and maintains updates of the CCGR.
Machine Readable Consent Guidance
The MRCG was produced by the GA4GH Data Use and Researcher Identities (DURI) Work Stream in collaboration with REWS and outlines a process for mapping consent language to the standard data use terms outlined in the GA4GH Data Use Ontology (DUO). DUO terms describe the scope of permitted research purposes for which a dataset can be used in a machine readable manner. Currently, Data Access Committees (DACs) manually evaluate each data access request to determine if a researcher’s intended use aligns with the permissions the participant granted when consenting to donate their data in the primary research project. Using MRCG, the participant consent form can be created in a way that aligns unambiguously to DUO codes and thus can be electronically attached to that participant’s data in perpetuity. Together, the MRCG and CCGR lessen the workload of DACs and ensure consistency in approving data access requests by requiring human-readable consent forms to use standard language around data sharing and data linkage as a prerequisite for translating consent forms into a machine-readable format.
“The interoperability between MRCG and other GA4GH deliverables that streamline the process of granting access to datasets is critical,” said Tiffany Boughtwood, who helped develop the MRCG and DUO. “As these standards are adopted, we’re going to see data being used much more frequently and rapidly, which means more advancements in science and medicine.”
The ERR Policy, CCGR, and MRCG each support the ethical and responsible sharing of genomic and health data across boundaries by simplifying and standardizing the ethics review and consent processes. Institutional Review Boards or Ethics Review Committees wishing to adopt and implement these standards can contact the REWS Coordinators (ERR and CCGR) or DURI Work Stream Technical Manager, Melissa Konopko (MRCG).