20. Understanding Regulations Governing Research: Policies & Guidelines

Tri-Council Policy Statement (TCPS)

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans is a research ethics policy statement established by three of Canada's federal research agencies (Canadian Institute of Health Research [CIHR], Natural Sciences and Engineering Research Council of Canada [NSERC] and Social Sciences and Humanities Research Council [SSHRC]) and was published in 1998. A revision of the policy statement (TCPS2) was published in December of 2010 and revised again in December of 2014.

The policy statement applies to all institutions eligible to receive or administer funding from one or more of the Agencies and to members of those institutions - faculty, staff and students. Requirement to adhere to this research ethics policy statement is a condition of funding. All universities in Manitoba are currently aligned with the policy statement and obligate researchers who receive Agencies' funding to comply with the obligations outlined therein.

Although Researchers who are under other types of funding are not mandated to comply with TCPS2, as good research practice, it is strongly recommended that all research comply with TCPS2. Researchers are strongly encouraged to familiarize themselves with this research ethics policy statement which can be found at Panel on Research Ethics - TCPS2 - December 2014

Training on the TCPS2 Course on Research Ethics (CORE) as required by the University of Manitoba Research Ethics Board can be accessed at TCPS2 CORE

International Council for Harmonization - Good Clinical Practice (ICH-GCP)

ICH-GCP provides technical requirements for human pharmaceutical research and is widely adopted by regulatory authorities throughout the world, including Health Canada and the US Food and Drug Administration. The ICH website offers a wealth of information on quality guidelines (such as good manufacturing guidelines), safety guidelines, efficacy guidelines (such as Good Clinical Practice Guidelines) and multidisciplinary guidelines. To learn more on ICH Guidelines visit the International Council for Harmonization (ICH)