Topic

Regulations & Policies for Research Involving Human Participants

Who is this for?

  • Departmental chairs and faculty deans reviewing and approving ethics protocol submissions
  • Professors/faculty members, postdoctoral fellows, research team members, and students who are conducting human research for submission to the Research Ethics Board (REB)
  • Course instructors and undergraduate students conducting course-based human research
  • Researchers with Toronto Academic Health Science Network (TAHSN) hospital REB approvals that involve the University of Toronto (U of T)
  • Research Ethics Board (REB) members

Overview

Research involving human participants is subject to a range of regulations and policies. The research methodology, types of data to be collected and how, the participant population and the location/jurisdiction all affect what regulations and policies researchers must adhere.

Clinical Trials

A ‘clinical trial’ is a research study where human participants are prospectively assigned to one or more interventions to evaluate the effects of these interventions on health-related outcomes.

All studies meeting the definition of clinical trial must be registered through an internationally recognized Clinical Trial Registration database. For example, ClinicalTrials.gov or the ISRCTN Registry.

In addition to the Tri-Council Policy Statement (TCPS 2), clinical trial researchers should follow the International Council for Harmonisation: Good Clinical Practice (E6) guidelines.

Health Canada-Regulated Clinical Trials

Clinical trials that involve testing of new drugs, devices or natural health products, or those previously approved in new populations may require registration with Health Canada.

Health Canada-regulated clinical trials must be sponsored by a third party to be conducted at U of T. The sponsor is required to ensure compliance with Health Canada regulations throughout all aspects of the clinical trial, including submitting a clinical trial application (CTA), providing sufficient and ongoing monitoring of the project, and assuming responsibility for any adverse or unanticipated events.

U of T cannot act as the sponsor for Health Canada-regulated clinical trials.

Health Canada requirements for drug, device and natural health product clinical trials can be found below.

Cannabis

To obtain, possess and use cannabis for research purposes the researcher(s) must apply for, obtain and maintain a licence. For further details, see the Cannabis Licensing Application Guide.

If the research falls under the definition of clinical trial, Health Canada regulations for drugs will apply and a third-party sponsor is required.Please see the Clinical Trials section on this page for further information.

Personal Health Information

Collection and/or use of personal health information must be compliant with Ontario’s Personal Health Information Protection Act (PHIPA). This includes research involving collection of personal health information (PHI) directly from participants as well as secondary use of PHI collected for other (e.g. clinical) purposes.

Personal Information

Research involving collection and/or use of personal information originally collected for a non-research purpose by a public institution in Ontario (e.g. university, hospital or government) must be compliant with Ontario’s Freedom of Information and Protection of Privacy Act, in particular Part III – Protection of Individual Privacy.

The standard for maintaining privacy described in the Act should be applied for all personal information collected or used in research. Also see Data Security Standards for Personally Identifiable and Other Confidential Data in Research.

Research with First Nations, Metis or Inuit Populations

Chapter 9 of TCPS 2 provides ethical guidance for research that involves Indigenous participants and/or communities. First National research should also comply with OCAP®, which involves four principles: ownership, control, access and possession.

International Research

Research that is funded by a United States (US) government agency, or in collaboration with a US institution must comply with and be reviewed in consideration of US regulations, such as the US Health and Human Services Policy for the Protection of Human Research Subjects, in addition to Canadian regulations. Research that may involve research participants from the European Union may require compliance with the General Data Protection Regulation (GDPR).

School Boards

All research to be conducted in schools must have administrative consent/permission prior to recruitment. Some school boards, including the Toronto District School Board, require protocol review by their Research Committee before gaining administrative permission. Please contact the school board to be involved with your research for further information.

Faculty, Staff & Students of U of T

Researchers who wish to conduct research with students, staff and faculty at the University of Toronto or gain access to data about them must follow the Guidelines and Procedures Regarding Access to University of Toronto Faculty, Students and Staff for Research Purposes.

Forms & Downloads

VPRI Role

  • Provide policy and procedural advice and guidance to researchers in the planning and execution of their research to ensure compliance with all of the relevant regulations and policies
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