This document, created by the three Canadian granting councils and adopted by the Thunder Bay Regional Health Sciences Centre, provides guidelines for handling the various ethical issues that arise in human subject research. It is a “living document” and continues to evolve as issues emerge and develop. A 45-minute tutorial on the TCPS is available online through the Inter-Agency Panel on Research Ethics (PRE). Investigators are strongly encouraged to read the Statement and to take the online tutorial before preparing their protocol submissions.
Health Canada has adopted the International Conference on Harmonization Tri-Partite Guideline: Good Clinical Practice: Consolidated Guideline (GCP) as its own policy. GCP is designed as an ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects and that generate data that are intended to be submitted to regulatory authorities for the purposes of licensing new interventions in health care. GCP should be fully understood by researchers who are carrying out research that they intend to submit to regulatory authorities.
This document, produced by the Canadian Institutes of Health Research (CIHR) covers best practice guidelines to protecting participant privacy and confidentiality in health research.
Personal Health Information Act (PHIPA)
The Personal Health Information Protection Act, 2004 (PHIPA) sets out rules to protect a patient’s personal health record across the health system. “Health information custodians” (healthcare providers and organizations in the healthcare sector) must follow these rules when collecting, using or sharing a patient’s personal health information.