Additional considerations* for human genome research consent documents
| Topic | Description† |
|---|---|
| Any limitations on consent for open data sharing and extent of those limitations | The guideline text is based largely on the accepted concepts of open data sharing, guided by the FAIR principles. (5) For the Canadian Human Genome Library, sensitive data will be accessed through a controlled-access system. However, the working group is aware that some potential research participants, for various reasons, may not be willing to consent to open data sharing, even for nonsensitive data sharing. Mechanisms to allow data sharing with agreed-upon governance for Indigenous people, or others with similar concerns, may result in more inclusive opportunities. For example, the Global Indigenous Data Alliance, (17) supporting international Indigenous Sovereignty, has enhanced the FAIR principles with the CARE principles (Collective Benefit, Authority to Control, Responsibility and Ethics) and OCAP (ownership, control, access and possession). (18) |
| Processes for the management and return of material incidental findings | Researchers have the obligation to return findings if they are material (analytically valid, clinically significant and actionable) and if participants have opted in to receiving them. (19) Exceptions include when return is impractical or impossible. |
| Clarifying purpose and distinguishing between individual, societal and other benefits of research participation | Research is intended to produce societal benefits and to not benefit participants directly, although this may change over time. The results could become available, but this may be years in the future, if at all. |
| The collection, use and disclosure of personal identifiers | Researchers may be required to list any personal identifiers that will be necessary to collect for data linking purposes, such as a personal health number, and any unique identifiers that will need to be produced by the CHGL to follow participants over time. |
| The need to access biospecimens | The CHGL will not host a biobank. However, individual research projects may need to access or transfer biospecimens in order to validate results from these studies or use analytic tools or innovations that may not be available to all CHGL-accredited researchers. These biospecimens may have been collected as part of clinical care or participation in a research study. If access is necessary, researchers may be asked to clarify how they will follow the storage, sharing and destruction requirements that govern biospecimens kept at a local site. Biospecimens should typically be coded before leaving any local site. They will be shared with CHGL-approved researchers and their collaborators, which may include commercial collaborators. |
| The need to access administrative data | Health Data Research Network Canada has prepared a resource (20) for researchers on informed consent wording for linking to administrative data across Canada. This wording can be included in consent forms to ensure that administrative data can be shared with these studies. |