NOTE: This procedure is consistent with the Tri-Council Policy Statement TCPS2 Chapter 12: Human Biological Materials, including materials related to Human Reproduction.
Research proposing the initial collection and use of human tissue requires ethics review by the Research Ethics Board (REB) and consent of the tissue donor.
The collection and use of human tissue for research purposes should be undertaken with the free and informed consent of the donor.
In the case of donors who lack capacity, consent may be given by advance directive or by an authorized third party.
In the case of deceased donors, consent may be given by advance directive or by an authorized third party.
1. Consent for Future Use
To facilitate the appropriate subsequent use of human tissue, consent forms must provide potential participants with a range of choices relating to the future use of their tissue.
Options might include, for example:
a. Refusing any future use of their tissue in research;
b. Permitting only anonymous use of their tissue in research;
c. Permitting identified, identifiable or coded use of tissue for one particular study only;
d. Permitting identified, identifiable or coded use of their tissue for any study relating to the condition for which the sample was originally collected;
e. Permitting future contact by researchers to seek consent for other studies;
f. Permitting coded use of their biological materials for any kind of future study.
Researchers that maintain collections or repositories of tissue:
a. Will ensure that appropriate facilities are used, policies and procedures to ensure that tissue is stored safely and in accordance with applicable standards; and
b. Will establish appropriate physical, administrative and technical safeguards to ensure that the privacy of tissue donors is protected.
2. Free and Informed Consent
For the purpose of obtaining free and informed consent, the full range of information set out in the Procedures for Free and Informed Consent will be provided by the REB. In addition, researchers who seek to collect human tissue for research are required to provide potential donors or authorized third parties, and the REB with the following information:
a. The type and amount of tissue to be taken;
b. The manner in which tissue will be taken, and the safety and invasiveness of the procedures for acquisition;
c. Potential uses of the tissue, including any commercial uses;
d. Measures to protect the privacy of individual donors, ensure confidentiality of the data, and minimize harm to donors;
e. The length of time the tissue will be kept, how it will be preserved, and any limits on its use; and
f. Where applicable, the researchers’ plan for disclosure of clinically relevant information derived from the tissue.
3. Secondary Use of Data
Researchers are required to seek REB approval for the secondary use of tissue. Researchers must satisfy the REB that:
a. Use of the tissue is essential to the research;
b. They will take appropriate measures to protect the privacy of and minimize harms to the individuals from whom tissue was collected, and to ensure confidentiality; and
c. Individuals from whom the tissue was collected did not object to secondary use at the initial stage of collection or otherwise make known their objection.
Last updated June 22, 2015
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