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

October 2005

Editorial and technical corrections for institutional names, contact information, standard TCPS citation form, typographical errors, etc.

Numerical Listing according to order of articles in the TCPS

The changes are indicated below in bold and italics:

• Section 1, article 1.1 (c), (page 1.2, line 10)
  
  The following correction has been made in accordance with article 1.1. (c) Where the research involves interaction with the individual in public life or an artist as a research subject by way of a request for an interview or for access to private papers, the ethics review should focus only on whether these requests will be made in accordance with appropriate ethical and professional standards.

Update September 2002

• 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.

Update May 2000

• 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…"

Update May 2000

Article 1.7: Meetings & Attendance (page 1.8)

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)

Update May 2000

• 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.

Update May 2000

• 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..."

Update May 2000

• Section 2: article 2.1. (c), iii:
  
  The following correction has been made:
  
  The research could not practicably be carried out without the waiver or alteration

Update September 2002

• Section 3, Privacy and Confidentiality; Article 3.6. Data Linkage.
  
  The following text has been added at the end of the explanatory text:
  
  Only a restricted number of individuals should perform the function of merging databases; researchers should either destroy the merged file immediately after use, or use enhanced security measures to store it. Whether the data are to be used statistically or otherwise, confidentiality of the information must be maintained by all members of the research team. When a merged database identifies a person or a group who might be at significant risk of harm, it may be appropriate to contact those at risk or the appropriate authorities. The REB and the record holder should also be notified.

Update September 2002