6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Please refer to section 2.7.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

Yes.

Please refer to chapters 3 and 12 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS 2022”).

https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html.

Chapter 3 of the TCPS 2022 sets out the ethical requirements for consent in research involving humans.

• Section A of Chapter 3 addresses the General Principles of Consent.
• Section B describes Departures from General Principles of Consent.
• Section C discusses Decision-Making Capacity.
• Section D outlines the requirement that Consent Shall Be Documented.
• Section E addresses Broad Consent for the Storage of Data and Human Biological Materials for Future Unspecified Research.

https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter3-chapitre3.html

Chapter 12 of the TCPS 2022 sets out the ethical considerations for the use of human biological materials including materials related to human reproduction for research.

• Sections A to D of Chapter 12 provide guidance on research involving human biological materials. For the purposes of the TCPS 2022, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids.
• Section E addresses research involving the subset of biological materials that are related to human reproduction.
• Section F addresses research involving the subset of human biological materials known as "human pluripotent stem cells."

https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter12-chapitre12.html

6.3 Does the local authority require any specific documents for customs clearance?

Yes.

The Canadian Trade Controls Bureau is responsible for issuing permits and certificates for various products listed in the Export Control List, including biological material. The Export and Brokering Control handbook contains information on how to obtain necessary permits for the export of controlled items. An advisory opinion may be sought to confirm the group an item may be identified under. Electronic copies should be uploaded via the Export Controls Division online EXCOL system, in support of a permit application. An example of how to list supporting documents in EXCOL is provided.

Other considerations to be taken into account are export prohibitions and sanctions. The service standard for the processing of an export permit is between 10 and 40 business days, depending on the third parties required to be consulted.

https://www.international.gc.ca/controls-controles/about-a_propos/expor/before-avant.aspx?lang=eng