International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) - E6 (R2)

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As its full name indicates, ICH-GCP E6 (R2) is an internationally accepted set of guidelines. These guidelines were  created to protect the safety of clinical research participants while also ensuring high quality data. It is important for all research personnel to be familiar with these guidelines and to implement them in all aspects of their clinical research work. 

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You can learn more about the history and importance of ICH-GCP in clinical research here.

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The Food and Drugs Act, Part C, Division 5: Drugs for Clinical Trials Involving Human Subjects

 

This section of Canada's Food and Drug Regulations outlines the requirements set out by Health Canada for Canadian researchers that are involved in clinical trials with human subjects. Since Health Canada is the national regulatory body that oversees clinical trial research across the country, it is their expectation that researchers are working under these regulations.

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Health Canada also provides a Guidance Document (GUI-0100) to assist researchers with the interpretation of the Part C, Division 5 regulations, as well as to apply the guidelines of ICH-GCP E6 (R2).

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Other useful resources provided by Health Canada include:

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- A pre-inspection package to help you prepare for a regulatory inspection by Health Canada

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- FAQ page for Clinical Trials

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- Guide 0043 - Classification of observations made in the conduct of inspections of clinical trials

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Canada's federal government has put in place ​The Personal Information Protection and Electronic Documents Act (PIPEDA) which lays out the privacy laws for private-sector organizations. 

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In addition, each province and territory has its own set of privacy legislation. In particular, the provinces of Alberta, British Columbia and Quebec have been deemed to have privacy laws substantially similar enough to PIPEDA that they are exempt from PIPEDA. 

 

For the purposes of research in Canada, it is important to be familiar with the privacy laws pertaining to Health Records, both federally (PIPEDA) and locally. Below are the relevant privacy laws for each province and territory:

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•  Alberta: Health Information Act

•  British Columbia: eHealth (Personal Health Information Access and Protection of Privacy) Act

•  Manitoba: Personal Health Information Act

•  New Brunswick: Personal Health Information Privacy and Access Act

•  Newfoundland and Labrador: Personal Health Information Act

•  Northwest Territories: Health Information Act

•  Nova Scotia: Personal Health Information Act

•  Nunavut: ​​no acts specific to Health Records

•  Ontario: Personal Health Information Act, 2004

•  Prince Edward Island: Health Information Act

•  Quebec: Régie de l’assurance maladie du Québec

•  Saskatchewan: Health Information Protection Act

•  Yukon: Health Information Privacy and Management Act

• TCPS-2: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018) is a Canadian guideline for the ethical conduct of research involving human subjects. It is the official ethics policy used by Canadian federal research agencies such as: the CIHR, SSHRC, and NSERC.

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• The following documents are ethical guidelines for the protection of humans in clinical research. These documents began to emerge following the atrocities carried out in the name of research during World War II:

 

​The Nuremburg Code: Directives for Human Experimentation (1949)

 

​The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects  (1964 first version adopted, 2013 current version)

 

The Belmont Report: ​Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979) 

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• The Code of Federal Regulations (CFR), Title 45, Part 46: Protection of Human Subjects is used by researchers in the USA to ensure the protection of human subjects. Although Canadian researchers are not required to comply with these regulations, they are an excellent resource.