Scope

1. Does TCPS 2 apply to any organization or individual who plans to carry out research involving humans? (August, 2011)

As indicated in the introduction to the Policy, TCPS 2 applies to all research conducted under the auspices of any institution that is eligible to receive and administer research funds from any of the three federal Agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada). Eligible institutions are those that have entered into the Memorandum of Understanding on Roles and Responsibilities in the Management of Federal Grants and Awards with the Agencies. An eligible institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students, regardless of where the research is conducted. This means that TCPS 2 applies to Agency and non-Agency-funded research, as well as non-funded research, that takes place under the auspices of the eligible institution and its affiliates. Typically, eligible institutions include Canadian universities, colleges and affiliated hospitals.

Other organizations have chosen to adopt the TCPS to guide the ethical conduct of research involving humans that falls within their institutional jurisdictions. For example, some private REBs and other federal government entities such as Health Canada, the National Research Council, and the Department of National Defence have done so. In academic and other settings where TCPS 2 applies, it is often one of several norms that complement applicable legal, institutional and professional standards.

2. Does program evaluation require REB review? (August, 2011)

REB review would be required only if program evaluation falls within the definition of research or serves as a component of a research project. Although program evaluation may share some methods and techniques with those employed in research (such as data collection and data analysis), the intent and objectives of the data collection, as well as the further use of the collected data, may be determining factors for establishing whether it is research and whether it should be reviewed by an REB. The determination of whether an evaluation study is research and therefore requires REB review should be made on a case-by-case basis, and should be guided by the definition of research in TCPS 2 (see Application to Article 2.1). TCPS 2 exempts from REB review program evaluation activities normally administered in the ordinary course of operation of an organization (see Article 2.5). If the collected data for such activities is later proposed for research purposes, it is considered secondary use of information not originally intended for research, and may require REB review at that time. Where in doubt about the applicability of TCPS 2 or the requirement for REB review of a particular research project, the researcher should consult the REB.

3.  When conducting research in Canada, should researchers from abroad be required to obtain REB approval in Canada? (December, 2011) NEW

TCPS 2 does not require research conducted by researchers from abroad to undergo REB review in Canada unless at least one of the following is true:

• the research is conducted under the auspices of a Canadian institution eligible to receive and administer research funds from one of the three federal research Agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada) (see TCPS 2 Interpretations, Scope # 1). 
• the source of funding comes from a Canadian institution or is administered through a Canadian institution.
• at least one of the research collaborators is affiliated with a Canadian institution.

However, even in the absence of these conditions, access to research sites and research participants should be determined on a case-by-case basis. Some institutions have voluntarily adopted TCPS 2 or require ethics review by a private research ethics board.  It is the researchers’ responsibility to determine whether access to the research site or its members is subject to research ethics approval from any such body.  Even if not subject to TCPS 2, researchers conducting research in Canada would be subject to the applicable laws, regulations and policies in effect, including, but not limited to those concerning the protection of privacy of participants, confidentiality, and the capacity of participants to consent.

4. How do researchers and REBs judge that a space described in a research proposal is a public place qualifying for exemption from REB review as specified in Article 2.3? (December, 2011) NEW

The assessment of whether a space is a public place must be made on a case-by-case basis.  The first consideration is whether the space in question is open to the public and intended to serve the public (e.g. museums, parks, libraries, shopping malls).  The second key consideration is whether the proposed research fulfills the three conditions of the exemption in Article 2.3: a lack of researcher involvement/interaction with the individuals or groups concerned, a lack of any reasonable expectation of privacy, and the impossibility of identifying specific individuals in the dissemination of research results.  If all conditions are met, the proposed research involving the observation of people in a public place would be exempt from REB review. If there is any doubt as to whether a particular  condition has been satisfied, for example whether the people being observed have a reasonable expectation of privacy, then the proposal should be submitted to the REB for consideration. 

5.  Should surveys conducted by administrators rather than researchers under the auspices of an eligible institution be submitted for REB review? (December, 2011) NEW

It is the intended purpose of the survey that determines the requirement for REB review, not the role of the person administering it. TCPS 2 does not provide for any exemption from REB review based on who conducts the research.  If it is determined that the intended purpose of administering the survey is research, then it would require REB review (Article 2.1). If the survey is normally administered as an operational requirement for quality assurance, quality improvement, or for program evaluation purposes, then it would not require REB review (Article 2.5), because the survey would not be considered “research” as defined in this policy. Also refer to TCPS 2 Interpretations, Scope # 2.