Core elements of participant consent documents for Canadian human genomics research and the National Human Genome Library: guidance for policy

Abstract

Use of a standardized set of consent elements can support the development of the federated Canadian Human Genome Library, in which advanced machine learning methods can be applied to determine which genetic factors contribute to health and disease for those living in Canada.

Public attitudes towards genomic data sharing: results from a provincial online survey in Canada

“…In Canada, a pan-Canadian Human Genome Library (CHGL) is to be launched in 2023, a federated data network for the sharing of locally held genomic and clinical information, but also the point of contact for Canada’s participation in international large-scale genomics projects [ 47 ]. In preparation, a core set of informed consent elements have been developed that include not only a description of the data collected and relatively standard consent elements, but also sections on international data sharing, commercial use and future research use [ 47 ]. Our findings suggest that participant preferences can be better considered and respected by the inclusion of these latter elements in particular.…”

“…Our findings suggest that participant preferences can be better considered and respected by the inclusion of these latter elements in particular. This guidance and sample consent language [ 47 ] should be useful for researchers to enable responsible genomic data sharing, while allowing participants to make informed data sharing decisions.…”

Sharing genomic data for health research: institutional trust and trustworthiness, and informed consent

“…Largescale federated data networks like the proposed Canadian Human Genome Library (CHGL) represent a potential way of providing secure access to these data to researchers beyond select institutions. 1 However, the promise of human genomics research has been encumbered by ethical concerns about data sharing. One particular concern is whether it is possible to obtain informed consent to the population-level research that genomic databases like the CHGL are intended to facilitate.…”

“…3 Nevertheless, even when participants do give their valid consent to share their genomic data, it will inevitably be on the basis of a degree of uncertainty, as indicated by the authors of the related guidance for policy in their stipulation that participant consent forms should include an explanation that "future health research will be conducted with participants' data on a range of health outcomes that are unknown at this time". 1 Longstaff and colleagues are surely correct to emphasize the importance of consent. However, ensuring that participants provide clear consent to research is at best complementary to other kinds of protections and controls for how individual data are used.…”