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Tri-Council Policy Statement (TCPS) : Ethical Conduct for Research Involving Humans. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Public Works and Government Services Canada, 1998. (with amendments in 2000, 2002 and 2005)

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Link: http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm

The Canadian Institutes of Health Research (CIHR), formerly known as the Medical Research Council, is the premier agency for health research in Canada. All applicants applying for CIHR grants and awards are bound by ethical guidelines developed by the three Canadian Research Agencies CIHR, the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC). The Inter-Agency Advisory Panel on Research Ethics is a body of external experts who advise on the evolution, interpretation and use of the TCPS. Across Canada, most of the 80+ university or college-affiliated research institutions have adopted the TCPS.

Much of this document deals with roles and responsibilities of Research Ethics Boards (REB, called IRBs in the USA). However, there are also clearly written sections on Free and Informed Consent, Privacy and Confidentiality, Conflict of Interest, Inclusivity in Research, Research Involving Women, Clinical Trials, Human Genetics Research, and Use of Human Tissue for Research. The two appendices are particularly useful: one is a succinct listing of the types of research requiring ethics review; the other is a summary of the 52 recommendations arising from the TCPS.

Section 3, Privacy and Confidentiality, advocates a balanced approach, while articulating the general rule to protect privacy and confidentiality through notification and consent of the individual whose personal health information (PHI) is involved. If PHI is involved, REB approval must be sought, even for secondary uses of data. The onus of responsibility is on the REB to decide whether PHI is essential to the research; whether the researcher will take all appropriate measures to protect the privacy of individuals and to safeguard the confidentiality of PHI; and that individuals to whom the data refer have not objected to secondary use of their PHI. The REB must decide whether informed consent is required or not; if this is waived, then the REB may require the researcher to design an appropriate strategy for informing the subjects, or to undertake consultations with representatives of those who contributed data.

More recently, clearer guidelines have emerged concerning data linkages and protection of privacy and confidentiality (see Sept 2002 update).

A web-based tutorial on the TCPS is available at: www.pre.ethics.gc.ca/english/tutorial/index.cfm