Genomic Consent: New Guidelines to Help Researchers and Patients

How can Canada optimize the impact of human genome sequencing to advance our understanding of disease? new guidance of CMAJ (Journal of the Canadian Medical Association) presents an important factor for obtaining patient consent for researchers and policy makers in this growing field.

“Human genomics — the study of whole genes in individuals or populations — is increasingly being integrated into research and rapidly being incorporated into clinical care, including health records,” said guideline author and director of the Institute. Dr. Christopher McMaster writes: Genetics, Canadian Institutes of Health Research (CIHR). “If most of the genomic data obtained in Canada could be accessed and analyzed collectively, the level of understanding of the role of genomics in determining the health and disease predisposition of Canadians would be greatly improved.”

In 2023, the Canada-wide Human Genome Library (CHGL) will launch as a central resource for sharing locally held genomes and related health and medical information. Using advanced artificial intelligence and machine learning techniques, we can identify genetic factors that contribute to the health and disease of Canadians.

“Consent is an essential and necessary tool to enable personalized medicine for Canadians,” says Dr. McMaster.

To ensure the success of the library, a standardized set of core consent elements for Canadian human genomics research to support appropriate Research Ethics Board (REB) approval and subsequent sharing of genomic and health data. is required for The guidelines address topics such as research data, international sharing, commercial and future research use, storage, controlled access, participant re-identification and re-contact, and consent for minor participants. increase.

“The core elements of genomic consent help increase transparency for research participants,” says Dr. McMaster. “This guidance will enable researchers to collect human genome data in a consistent manner that accounts for how participant data is used now and in the future.”

It also streamlines REB submission and approval, which is an important part of the research process.

“This guidance will make it easier for clinicians and researchers to determine the essential core elements to include in REB submissions,” said co-author of the guidelines and Associate Scientific at the CIHR Institute of Genetics. Director Etienne Richer, Ph.D. “In the case of REB, it will become clearer which minimal elements to look for when reviewing submissions containing genomic elements. We hope that the whole process will be smoother.”

and Related commentary, Dr Mackenzie Graham, Welcome for Ethics and Humanities Centre, University of Oxford, Oxford, UK writes: How people’s data is used is out of their direct control. Participants should be able to make an informed decision as to whether or not a trustworthy agency is trustworthy before trusting it with their health data. ”

“Key Elements of the Canadian Human Genomics Research and National Human Genome Library Participant Consent Document: Policy Guidance” will be released on November 15, 2022.

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