Topic

International Legal & Ethical Requirements

Who is this for?

University of Toronto (U of T) professors/faculty members, postdoctoral fellows, research team members, and students who are conducting the following types of research.

  • Human research and/or research that involves personal information obtained from outside of Canada 
  • Human research funded by United States federal agencies or sponsors that adhere to US Office of Human Research Protections regulations

What do I need before I can begin?

Determine where the research will be conducted and/or where the personal information for research purposes will be obtained.

International Research

If research will be conducted in or funded by another country, it is important to understand the legal and ethical requirements of that country.

According to Article 8.3 (b) of the Tri-Council Policy Statement 2 (TCPS 2), “Research conducted under the auspices of a Canadian research institution and conducted outside of its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior research ethics review by both: i. the Research Ethics Board (REB) at the Canadian institution under the auspices of which the research is being conducted; and ii. the REB or other responsible review body or bodies, if any, at the research site.”

It is therefore necessary for researchers conducting studies in countries with ethics review procedures to submit to an REB-equivalent in that country. If research is to be conducted in a country without such resources, or in regions where government knowledge of the project would jeopardize the research and/or where human rights violations are commonplace, documentation from a non-government agency or expert on the cultural appropriateness of the research is helpful, when available.

A good resource is the International Compilation of Human Research Standards.

US-Funded Research

Under the United States Department of Health and Human Services (DHHS) Human Subjects Protection Regulations §45 C.F.R.46.103 (The Common Rule), every institution engaged in human participant research supported or conducted by a US government agency or sponsor that follows DHHS requirements, i.e. NIH-sponsored research, must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP).

The University of Toronto (U of T) holds a Federal-Wide Assurance (FWA), which will cover all DHHS-supported research projects that have undergone ethics review at the University.

U of T’s Assurance is coded: FWA00005463 – U Toronto.

For any questions regarding the use of the FWA or NIH funding, please reach out to the Research Funding Manager, US & International within the Division of the Vice-President, Research & Innovation (VPRI).

Under the FWA, all investigators submitting for DHHS-supported agency grants or contracts require education on the protection of human participants in research. Assurance that an appropriate course has been taken is needed for all renewals and new applications once a decision on funding has been reached by the agency (in other words, no course – no funds). This includes the Principal Investigator(s) (PI) and research team members. The following two online courses are recognized by the U of T as fulfilling this responsibility.

The TCPS tutorial is recommended as it educates researchers on Canadian guidelines, which are more applicable to University policies. Both courses are recommended for all researchers, students and REB members to take, as they provide a good foundation for ethical conduct in human participant research.

VPRI Role

  • Provide guidance on the legal and ethical requirements and where to find resources

VPRI Contact

Staff

Rachel Zand

Director, Human Research Ethics
Research Oversight & Compliance Office (ROCO)
(416) 946-3389

Staff

Jason Darby

Research Funding Manager, US & International
Research Services Office (RSO)
(416) 946-5568

Staff

Krista Montgomery

Research Funding Manager, US & International Funding
Research Services Office (RSO)
(416) 978-2155

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