Canadian Policies and Guidelines:
Policy Statement: Ethical Conduct for Research Involving
Humans (TCPS 2: December 2010)
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.
Good Clinical Practice (GCP): Consolidated Guideline
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.
Best Practices for Protecting Privacy in Health Research
This document, produced by the Canadian Institutes of
Health Research (CIHR) covers best practice guidelines
to protecting participant privacy and confidentiality
in health research.
Ontario Privacy Legislation:
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.