Understand the policies, legislation and regulations relating to your research.
Updated February 17, 2023
Fraser Health research policies
- Research policy
Covers research activities that can be conducted at Fraser Health and process for handling allegations of research-related misconduct.
- Clinical Research Overhead Rates Policy
Acknowledges that indirect costs are attributable to all industry and academic sponsored research projects including clinical research, and provides a mechanism for Fraser Health to optimize its recovery of some or all these indirect costs through clearly established overhead rates to support sustainability.
- Collection, use and disclosure of personal information for research related purposes
As a public body and a steward of personal information, we are accountable for the protection of the privacy and confidentiality of all personal information under its custody and control in accordance with existing legislation, public expectations and internationally accepted fair information practices.
- Ethical conduct of research and other studies involving human participants
This policy is intended to create a research environment within Fraser Health in which the protection of human subjects is considered a priority.
- Intellectual property
Describes the rights and responsibilities, regarding ownership, use and control of intellectual property of Fraser Health and of employees and privileged physicians who develop or participate in the development of intellectual property, research data and research tools, and all proprietary information.
- Research integrity
Describes our commitment to fostering an environment that promotes integrity in research and scholarship.
- Provision of research related services to non-Fraser Health researchers
Departments may be asked by external researchers to provide services related to specific research projects.
Research Data Management Institutional strategy
- Fraser Health Research Data Management Institutional strategy
Fraser Health’s Research Data Management Institutional strategy recognizes the importance of data as a research output and outlines how Fraser Health will provide our researchers with an environment that enables and supports research data management, in fulfillment of the Canadian Tri-Agencies (NSERC, SSHRC and CIHR) Tri-Agency Research Data Management (RDM) Policy requirements.
Other Fraser Health policies
Canadian privacy legislation
- Freedom of Information and Protection of Privacy Act
See Part 3 - Protection of Privacy: Division 2: Use and Disclosure of Personal Information by Public Bodies - Articles 32 and 35.
- A Guide to B.C.’s Personal Information Protection Act for Businesses and Organizations
The complimentary legislation for the private sector is the Personal Information Protection Act.
- Personal Information Protection and Electronic Documents Act
The Personal Information Protection and Electronic Documents Act (PIPEDA or the PIPED Act) is a Canadian law relating to data privacy.
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
We comply with the Canadian Tri-Council Policy on the Ethical Conduct for Research Involving Human Subjects. This policy, which sets the Canadian standard for research involving human subjects, is adhered to by academic and health care delivery organizations across Canada.
Regulated clinical trials
Researchers conducting clinical trials that are regulated by Health Canada must also adhere to the following guidelines:
- International Conference on Harmonization: E6 - Good Clinical Practice
- Health Canada: Food and Drug Regulations: Part C – Drugs: Division 5 – Drugs for Clinical Trials Involving Human Subjects
- Health Canada: Guidance Document: Part C, Division 5 (GUI-0100)
- Health Canada: Notice: Period reduced for keeping clinical trial records for drugs and natural health products
- Health Canada: Food And Drug Act: Medical Device Regulations Part 3 - Medical Devices For Investigational Testing Involving Human Subjects
- Health Canada: Food And Drug Act: Natural Health Products Regulations Part 4 - Clinical Trials Involving Human Subjects
U.S. funded/regulated research
Researchers who conduct research funded either by the United States Department of Health and Human Services or other U.S. government agencies or regulated by the United States Food and Drug Administration must comply with the following regulatory requirements for any of the funded research.
- U.S. Department of Health and Human Services - 45 CFR Part 46
- U.S. Food and Drug Administration - Code of Federal Regulations Title 21 Food and Drugs
- Subchapter A: Part 11 Electronic Records; Electronic Signatures
- Subchapter A: Part 50 Protection of Human Subjects
- Subchapter D: Part 312 Investigational New Drug Application
- Subchapter H: Part 812 Investigational Device Exemptions
- World Medical Association: Declaration of Helsinki
The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.