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Past Interpretations of the TCPS

The Interagency Advisory Panel on Research Ethics (PRE) is pleased to share a growing collection of its official responses to written requests for interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (1998).

By responding to written questions on the TCPS, PRE seeks to support the needs of participants, researchers and Research Ethics Boards (REBs) in the effective use and understanding of the TCPS. Answering these questions also helps PRE to identify issues, gaps and ambiguities in the TCPS that may warrant clarification or amendment. Posting these interpretations on the Web is one way for PRE to respond to the evolving needs of the TCPS-user community. It is also in keeping with PRE’s mandate to develop a publicly accessible bank of interpretations.

PRE considers institutional REBs—with their expertise, delegated authority, and awareness of their particular institutional requirements—as the primary point of contact in their community. PRE is not an appeal body for TCPS-related decisions made by institutional REBs, and it does not provide legal advice or opinions.1

Given the breadth of modern research needs and topics, interpretations of provisions or apparent ambiguities of the TCPS vary in their level of complexity. Some written requests for interpretations are answered by the Secretariat on Research Ethics (SRE). SRE refers new or complex TCPS questions to PRE. For issues that require broader or in-depth consultation, PRE obtains input from external sources. As with the TCPS, responses to interpretation questions also evolve and may be further refined based on input from the community.

The following table lists PRE’s interpretations of the first edition of the TCPS, 1998 (with 2000, 2002, 2005 amendments). To make them publicly available, they were translated and anonymized.

PRE Interpretations of the 1st edition of the TCPS (1998)
Subject Key Words TCPS Articles
Academic Freedom and the Role of the REB
(July 2003)
academic freedom, role of REB, ethics review, accountability, independence 1.2
Applicability of the TCPS to Agency-funded Organizations as well as those not Funded by the Agencies
(July 2004)
application of the TCPS, reach of the TCPS N/A
Consent Procedures for Research in Schools, and Complaints About Research Projects
(June 2004)
schools, consent, accountability, responsibility, role of REB, role of PRE, role of the Agencies, role of institutions, public school REBs, complaints 1.14, 2.1
Data Withdrawal in Emergency Health Research Situations
(December 2007)
Emergency interventions, informed consent, exceptions to consent requirement, rights over subject data 2.1, 2.2, 2.4, 2.8, ethics framework
Definition of Quality Assurance Studies, Performance Review and Research
(April 2003)
quality assurance, performance review, assessment, evaluation, research 1.1
Ethical Considerations Related to Life Models in the Fine Arts
(December 2002)
models, fine arts, research, naturalistic observation, privacy, confidentiality 1.1, 2.3, Section 3
Institutional Permission to Conduct Research
(November 2004)
academic freedom, permission/organizational consent, authorization, exceptions to consent, critical research, organizations, corporations, governments 1.5, 1.14, 2.1, 2.2
Inter-University Ethics Approval, Naturalistic Observation and Privacy
(September 2003)
waiver, consent, documentation, public, naturalistic observation, impracticable, anonymized, REB review, videotaping, data, privacy, confidentiality, risk, anonymity, identifiable 1.1, 1.2, 1.6, 2.1(c), 2.3, 2.4, 3.1, 3.2
Member Knowledgeable in Law and REB Membership
(December 2007)
Member knowledgeable in law, in-house vs. external legal counsel, potential conflict of interest, REB membership, role of REB members 1.1, 1.3, 1.12
Minimal Risk with Children and Inclusion of Vulnerable Persons in Research
(December 2007)
Minimal risk, children, vulnerable persons, competence, harms and benefits, inclusion in research 2.5, 5.3, Section 1, part C1
Occasional Videoconference Meetings for REBs
(December 2006)
face-to-face meeting of REBs, videoconferencing, operational issues of REB meetings, REB decision-making, communications technologies, quorum 1.7, 1.9
Proposed Establishment of Extra-Jurisdictional REB Subcommittee
(March 2005)
Institutional agreements, REB jurisdiction, REB authority, REB liability, ethics review, regional cooperation, REB subcommittee 1.2, 1.3, 1.4, 1.11, 1.14
Quorum for Research Ethics Boards
(February 2003)
REB review, quorum, membership, representation, consultation 1.3, 1.7
Reasonably Designed Inclusion and Exclusion Criteria and Applicable Human Rights Legislation
(January 2003)
inclusion, exclusion, competence, representation, participation, research, consent, law, discriminatory, benefits, burdens, human rights, justice 1.3, 2.5, 5.1, 5.3
Record Retention: Departmental Reviews of Student Projects
(February 2004)
departmental versus other levels of review, archiving, record retention in the TCPS, record retention in other norms and jurisdictions, parameters and considerations, undergraduate research 1.3, 1.8
REB Jurisdiction and Research Involving Humans Requiring Ethics Review
(October 2005)
REB jurisdiction, requirement for REB review, researchers’ multiple affiliations, student activities and research, co-op programs, reach of the TCPS 1.1, 1.2, 1.4, 1.14
REB Legal Disclaimers and Inter-University Research Ethics Responsibilities
(May 2003)
disclaimer, liability, REB responsibilities, legal, ethics approval/review 1.3, 1.13, 1.14, 2.4
REB Membership and Decision Making: TCPS
Articles 1.3 and 1.7

(July 2003)
REB membership, REB composition, REB review 1.3, 1.7
REB Membership—Individuals Knowledgeable in Ethics
(December 2004)
REB membership, ethics knowledge 1.3
REB Review of Previously Reviewed Administrative Research and Secondary Data Use
(January 2005)
Institutional ethics review, secondary use of data, identifying information, administrative surveys, requirement for ethics review of previously reviewed research, release of funds and ethics approval, audits and accountability of ethics process 1.1, 1.2, 2.1, 3.3, 3.4
REB Role in Reviewing the Safety of Researchers
(December 2007)
Roles and responsibilities of REBs, risks to human participants, safety of researchers, research in other jurisdictions, institutional liability 1.1, 1.14, page 1.3
Requirement for REB Review of a Technical Service
(December 2007)
Ethics review, technical service, research, level of involvement in research, non-eligible institutions, other ethical issues, data processing 1.1, 1.2, 1.6, Section 1.G
Research or Art? Video Documentation of Reactions to Performing Arts
(November 2003)
art, research, naturalistic observation, consent, privacy, confidentiality, videotaping, data storage, practicably, secondary use, identifiable 1.1, 2.1, 2.3, 3.2
Researchers and the Duty to Warn: Limits on the ‘Continuum of Confidentiality?’
(April 2007)
Privacy, confidentiality, ethics and law, limits of confidentiality, free and informed consent, Tarasoff duty. Ethics Framework, 1.3, 2.4, Section 3
Retention of Research Data
(April 2005)
Data, data retention, length of data retention, considerations thereto, local institutional policy, exceptions thereto, field and purpose of research, archiving 3.2, Section 2, Section 3
Status of REB Decisions in the Absence of an REB Quorum
(May 2006)
REB membership, quorum in an REB, REB decision making, knowledgeable in law or ethics, ad hoc members of REBs 1.3, 1.6, 1.7
Survey Research by University Administrators: Requirement of REB Review
(January 2005)
Surveys/questionnaires, quality assurance studies, quality assessment, performance review, proportionate review, administrative survey, exemptions, research conducted by administrators vs. researchers, role of REB, requirement for REB review 1.1, 3.2
Third-Party Interviews or Secondary Use of Data
(October 2005)
Third-party interviews, secondary use of data, research requiring ethics review, exceptions thereto, privacy and confidentiality, free and informed consent 1.1, 1.6, 2.1, 2.4, 3.1, 3.3, 3.4, 3.5
US Ethics Committee Review of Clinical Trials in Canada
(September 2003)
jurisdiction, ethics review, clinical trials, international harmonization, ICH-GCP, OHRP 1.14
Use of Student Subject/Participant Pools in Research
(July 2006)
Recruitment, captive populations, coercion, dual-role of researcher/teacher, informed consent, research requiring review, students, subject pools, undue inducements, voluntariness, penalties Ethics Framework, 1.1, 1.6, 1.13, 2.2, 2.4.

1 Interpretations provided are based on the TCPS. In their application by REBs, they may be modified to take into consideration the research under review as well as the laws in effect in the province or territory.