It is paramount that investigators understand their responsibilities and the regulations that cover their research work.  These are:

Health Canada , Therapeutic Products Directorate, Good Clinical Practices and ICH Guidelines

Investigators are responsible for conducting clinical research in accordance with the rules and regulations as defined by Health Canada, Therapeutic Products Directorate which can be found by clicking here.

For further information about ICH Guidelines, please click here.

Guidelines that govern these areas in the United States can be found at

• Title 21, Part 50 (Informed Consent)

• Title 21, Part 56 (Institutional Review Boards)

• Title 21, Part 312 (Investigational New Drug Application)

• Title 21, Part 812 (Investigational Device Exemption)

The Helsinki Declaration

A fundamental guiding principle of worldwide clinical research, the Helsinki Declaration guides the conduct of both investigators and ethics boards.

• Please click here.

Federal and Provincial Privacy Legislation

Investigators must adhere to both the Federal, Personal Information Protection and Electronic Documents Act (PIPEDA) and local provincial privacy legislation.

Obtaining Informed Consent

The investigator or a designee must, with each subject, provide an explanation of the study and ensure the subject clearly understands the study including the full risks and benefits, if any. The informed consent form must be signed in front of the investigator or the designee.