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Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans


Updates to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998)

Update of May 2000

The changes are indicated below in bold and italics:

  • Article 1.11: Appeals

    (a) In cases when researchers and REBs cannot reach agreement through discussion and reconsideration, an institution should permit review of a REB decision by an appeal board, provided that the board's membership and procedures meet the requirements of this Policy. No ad hoc appeal boards are permitted.

    (b) Small institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two institutions decide to use each other's REB as an appeal board, a formal letter of agreement is required.

    (c) The Councils will not entertain any appeals of REB decisions.

  • Section 1,B.1, Authority of the REB, Article 1.2. (page 1.3):

    the following text was added regarding multi-centred research:

    Each institution is accountable for the research carried out in its own jurisdiction or under its auspices. An institution can authorize its REB(s) to accept the review of other REBs constituted under the Tri-Council Policy Statement if it so wishes. This might involve specific agreements between institutions for sharing the work.

  • The following errors were corrected in the French translation:

    Article 1.3 (a): Membership of the REB

    English: "at least two members have broad expertise in the methods or in the areas of research."

    French: "deux personnes au moins auront une connaissance étendue des méthodes ou des disciplines de recherche."

    Article 1.7: Meetings and Attendance

    English: "When there is less than full attendance, decisions requiring full review should be adopted only if."

    French: " En cas d'absence d'un ou de plusieurs membres, les décisions exigeant que des projets fassent l'objet d'une procédure d'évaluation complète devraient être adoptées seulement si.." (page 1.4)

    Article 2.1(c): Requirement for Free and Informed Consent

    Correction to the French Translation

    English: "The REB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent."

    French: "Les CÉR peuvent soit approuver une procédure de consentement qui ne comprend pas ou qui modifie un ou tous les éléments du processus de consentement..."

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