Who is conducting the study?
The principal investigator is the researcher in charge of the study and is responsible for the scientific and ethical conduct of the study. This person agrees to conduct the study in compliance with the regulations outlined below and is responsible for making sure that all members of the research team are qualified and properly trained to fulfill their roles in the study.
All research studies conducted within or on behalf of Sunnybrook Health Sciences Centre must be in compliance with the Tri-Council Policy Statement and the Ontario Personal Health Information Act.
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)
A policy on the ethical conduct for research involving human participants.
- Ontario Personal Health Information Protection Act (PHIPA) 2004
A law for keeping the personal health information of patients private, confidential and secure by imposing rules relating to its collection, use and disclosure.
All clinical trials regulated by Health Canada must also comply with Good Clinical Practice Guidelines and the Food and Drug or Device Regulations of Health Canada.
- International Conference on Harmonization (ICH) Guidance E6: Good Clinical Practice (GCP): Consolidated Guideline
A set of guidelines that outline the ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve research participants. Compliance with this standard provides public assurance that the rights, safety and well-being of research participants are protected.
- Part C Division 5 of the Food and Drug Regulations of Health Canada
A law that outlines the requirements of an application for authorization to sell or import a drug for the purposes of a clinical trial, as well as the obligations for conduct of a trial.
- Part 3 of the Medical Devices Regulations of Health Canada
A law that outlines the requirements of an application for authorization to sell or import a medical device for the purposes of investigational testing involving research participants.
Next: Who is sponsoring or paying for the study?
Previous: What is informed consent?
