Recommendations for core elements for participant consent documents used in human genomics research in Canada
| Core consent elements* | Example of consent clause language* |
|---|---|
| Research data | |
| Participants should be given a full description of the type of data collected for research, including whole genome or exome sequencing of the sample and the ongoing collection of clinical data from participants’ medical records or charts, administrative databases, etc. | You are being invited to participate and asked to give consent for the whole genome or exome sequencing of the DNA from your sample and for access to your genetic data by the pan-Canadian Human Genome Library, to be used for research purposes. You are also being asked to provide clinical data that includes some personal information, such as your age, ethnicity and family’s health history. If you agree, we will also request health information about you from your family health care provider or health care provider of choice and from other institutions or registries that may have your health information; for example, [where applicable, include any relevant governmental or administrative health data repository]. We may get coded research data from other studies that you were involved in, including future studies. |
| International sharing | |
| It should be made clear to the participant that there will be international sharing of genetic and clinical data. | The Canadian Human Genome Library will share your genetic and clinical data with researchers that it has approved. Researchers around the world — who may include researchers from academia, charitable organizations, hospitals and for-profit companies, such as drug companies — may request access to your coded data, overseen by a strict access governance process that includes patient and community participation. |
| Future research use | |
| 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. | Your coded stored genetic and clinical data will be accessible through the Canadian Human Genome Library for future research on what makes you sick and keeps you healthy. |
| Commercial use | |
| It should be made clear in the consent that genetic and clinical data will be used for commercial purposes. | It is possible that future research using your data will eventually lead to the development of new diagnostic tests, new drugs or other commercial products. If this happens, you will not receive any share of profits or compensation. |
| Controlled access | |
| Participants should be told that the sharing of genetic and clinical data will be conducted through a controlled-access mechanism. | Your coded data will be accessible only to researchers approved by the Canadian Human Genome Library, after review by its access committee. The access committee will verify, among other criteria, that the proposed research use conforms with the objectives of the Canadian Human Genome Library, and that the research team applying for access has obtained the proper research ethics approval (if applicable). Approved researchers will sign agreements. These agreements will control how the data will be used. The access committee will also determine not only who will have access to the data, but also when, in what format and for what specific use. |
| Location of storage | |
| Participants should be told that genetic and clinical data in the library will be stored on centralized servers in Canada. | Data in the Canadian Human Genome Library are under the responsibility of a Canadian, federally funded national group and are made accessible through a platform for genome sequencing and analysis. Data accessible through the Canadian Human Genome Library are stored on servers located in Canada, including cloud-based servers. |
| Duration of storage | |
| Consent forms should explain that genetic and clinical data will be stored indefinitely. | The data stored in the Canadian Human Genome Library will be kept until they are no longer useful for research or as required by law. |
| Data withdrawal | |
| Participants should be told that it will not be possible to withdraw data that have already been distributed and used. | If you decide to withdraw from the Canadian Human Genome Library, your data will no longer be shared, and no new data will be collected. If you decide to withdraw, your data stored in the library will no longer be accessible by the library as of the time of your notification. However, it may be impossible to withdraw your data once they have been processed and shared with other researchers. In these cases of total withdrawal being impossible, your identity will continue to be protected. |
| Reidentification | |
| Consent forms should explain that there is a low risk that the participant could be reidentified in the future. | There is always a small risk that your data may be used to reidentify you. Genetic information is unique to every person, just like a fingerprint. This means it is possible that you can be identified by your genetic code. However, this is not easy to do. As technology advances, there may be new ways of linking data back to you that we cannot foresee today, despite the strict security measures. The potential reidentification or unintentional release of your genetic and clinical research data could lead to loss of privacy for you or your biological relatives. |
| Recontact (includes mature minors) | |
| Consent forms should include an option for recontact of participants. Although not mandatory, it is recommended that, where applicable, mature minors be included in the consent process and given the option for recontact as well. | I understand that the data I provide will be used for many different research studies in the future. Rarely, recontact may be necessary in some cases (e.g., if additional information is required). |
| Assent | |
| There should be an option for obtaining assent of children, where applicable. | If you decide you want to be in this library, please print or write your name. If you decide that you don’t want to be in it, then all you have to do is tell me [insert name]. Note: The assent of a minor, capable of understanding the nature of the research, could be indicated with a signature (which could be electronic) or printed name, or by obtaining verbal assent. |
↵* The examples and explanations are tailored for the Canadian Human Genome Library. The wording may vary depending on the requirements of other research projects.