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Past Interpretations of the TCPS

Subject REB Review of Previously Reviewed Administrative Research and Secondary Data Use
Keywords 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
TCPS Articles 1.1, 1.2, 2.1, 3.3, 3.4
Date January 2005

PDF REB Review of Previously Reviewed Administrative Research and Secondary Data Use .pdf

1. Thank you for your correspondence in which you ask the following questions:

  1. If a researcher changes institutions, does data he previously collected at a former institution need to be reviewed by the Research Ethics Board (REB) at the new institution? Your question implied that the data may have been originally collected for other purposes than research.
  2. Do university administrative surveys need REB approval?
  3. What are the repercussions if funds are released prior to ethics approval?
  4. What is the process in place for auditing ethics review?

2. The first two questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE). PRE provides interpretative advice on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)1. As elaborated below, the TCPS indicates that research conducted at a new institution, involving data collected at a former institution, may be legitimately reviewed again by an REB at the new institution. The original purpose of the data collection and its intended use may also raise ethical issues concerning the secondary use of data. The TCPS also indicates that administrative surveys that implicate research involving humans are generally subject to REB review, unless particular exceptions apply.

3. The latter two questions fall outside PRE’s mandate. Typically, they would be responded to by the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC), or the Social Sciences and Humanities Research Council (SSHRC). As a courtesy, the Secretariat on Research Ethics has inquired on your behalf and provides a summarized response in the Appendix below.

Institutional Ethics Review and Secondary Use of Data

4. Ethics Review: You ask whether a researcher’s project from his former institution needs to undergo REB review at his new institution. Under article 1.2 of the TCPS, “The institution in which research involving human subjects is carried out shall mandate the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of, the institution..” If the described project actively implicates “research involving humans” at the new or second institution—e.g., the analysis of data collected from participants for purposes of generalizable knowledge via preparation of a research thesis—then it may be subject to review. Under this understanding, a university that requires a researcher to submit the research to its REB is not acting contrary to the standards of the TCPS. To facilitate and help determine the appropriate level of review, the researcher might provide the new REB with information and contacts for communicating with the first institution. The new REB might apply a proportionate approach to review, and request basic documentation to facilitate this review, such as a copy of the informed consent documentation, a copy of the signed ethics approval certificate from the first institution, or a copy of the original research proposal.

5. REB review by the second institution seems warranted in this case, since it is unclear from your question whether the project, which may implicate “research involving humans,” underwent REB review at the first institution. Under the scenario you describe, it is also not clear if the data in the survey initially done for university student services were collected for administrative purposes or for a “research” project. You indicate that students participating in the survey were informed of their rights but not of the potential use of the information for a thesis research paper. Beyond basic ethics review needs, the scenario raises consent and privacy/confidentiality issues for a researcher’s use of data for secondary purposes.

6. Secondary Data Use: Under articles 3.3 and 3.4 of the TCPS, ethics review for the secondary use of data is generally required for research involving “identifying information.” The project needs REB review if the data are not anonymized or if they allow identification of the survey participants in published reports; by informational elements or linkage between dates, demography, and size of population; etc. If the data are anonymized and contain no identifying information, then ethical review is generally not required. But since no ethics review appears to have been done at the former institution, a minimum of expedited review at the new institution would help to confirm the anonymous or identifying nature of the data. TCPS articles 3.3 and 3.4 further indicate that researchers need to satisfy several conditions if they are to access and use identifying data for secondary research purposes. Out of respect for participants and their privacy interests, for instance, participants’ consent or non-objection to use is normally essential to the secondary use of identifying information, unless relevant exceptions apply.2

7. In considering the consent and privacy issues, the TCPS advises REBs and researchers to adopt a proportionate approach: the higher the risk of stigma or harms that may arise from disclosure of sensitive identifying information, the greater are the required procedural protections. A duly composed REB may thus examine, case by case, important issues arising out of secondary use: e.g., the context in which data were collected; the expectations of the individuals or institutions at the time of the collection of the data with regard to its use, retention and disclosure; its sensitivity and risk of stigmatization, anonymity or nominative nature; data ownership, storage and security; and the standards of relevant provincial or federal laws (e.g., privacy or education acts).

Administrative Surveys and REB Review

8. You also ask whether university administrative surveys need REB approval. On the one hand, research involving human participants generally requires ethics review under article 1.1 of the TCPS. Thus, surveys that qualify as research involving humans generally require REB review—expedited or otherwise—whether conducted by a researcher or an administrator. On the other hand, TCPS article 1.1(d) exempts from ethics review organizational “… studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to the terms and conditions of employment or training.” Between these principles lies a grey zone: “performance reviews or studies that contain an element of research in addition to assessment may need ethics review.” As we have suggested in a previous interpretation,3 regarding the line between “research” and quality assurance, the primary intent and basic function of the project may clarify the need for, and scope of, any REB review. Relevant questions about the study/project will provide further clarification:

  1. Is the study’s goal to contribute to generalizable knowledge? Or is its goal to correct or enhance a service, program or project?
  2. Do the essential elements of the project correspond to those of quality assurance or performance review? Does the project contain elements of research?
  3. Does the project implicate basic consent or privacy/sensitive information issues that may require ethics review by an REB or other university body?
  4. Will the results of the study be published?

9. The commentary to article 1.1(d) indicates that when in doubt on a particular project, REBs should be consulted. We would also point out that since we are currently involved in deliberations on a similar inquiry about REB review of surveys,4 we shall soon be in a position to share our response to that similar question.

10. Otherwise, as indicated, your questions regarding certificates of ethics approval and auditing/accountability processes lie beyond the mandate of PRE. The Secretariat on Research Ethics has made general inquiries on these matters. Summary responses are found in the appendix below.

We hope you find this information helpful to your TCPS research ethics needs.

Sincerely,

Secretariat on Research Ethics,
on behalf of the Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


Appendix

11. Please find below the summary responses provided by the Secretariat on Research Ethics, as a courtesy to you, based on information received following general inquiries with the Agencies. PRE has had no involvement in these matters, because they involve issues beyond its mandate.


Release of Funds Prior to Ethics Approval

12. You ask about the repercussion of a university not awaiting a certificate of ethics approval before granting funds. A general response is found in the Memorandum of Understanding on Roles and Responsibilities in the Management of Federal Grants and Awards of June 2002 (MOU), which is the formal written agreement between the Agencies and the institutions that receive funds from CIHR, NSERC and SSHRC.5 Under Schedule 1 of the MOU, institutions are responsible to establish and maintain effective policies, systems, procedures and controls to ensure—prior to the release of funds—adherence to all conditions and requirements with respect to research involving humans (among other policies), and to respond to the Agencies’ reasonable requests for information related to a grant or award during the course of an on-site financial monitoring visit or investigation. Under Schedule 2 of the MOU, the Agencies may request institutions to report periodically on the status of their ethics review process. (See also Schedule 8 of the MOU, Resolution of Issues of Non-Compliance).


Audits and Accountability of Ethics Process

13. You also ask about an auditing/accountability process for human research ethics, the frequency of any such audits, and who might undertake them. Again, a general response is found in the MOU and in particular Schedule 1 (Financial Management) and Schedule 2 (Ethics Review of Research Involving Humans). Schedule 2 outlines the Agencies’ expectations regarding the release of funds for research involving human subjects prior to the research starting. Schedule 1 outlines the responsibilities of institutions with respect to administration and release of funds in accordance with Agencies’ conditions and requirements for research involving human subjects.


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. See TCPS article 3.4 (REB may condition access to secondary use of data on informed consent, etc.). In exceptional circumstances, TCPS article 2.1 authorizes the REB to waive the usual requirement of consent if five conditions are satisfied that objectively indicate the impracticability of doing so. Article 3.4(b) also allows alternatives to consent, in exceptional circumstances.
  3. See Interagency Advisory Panel on Research Ethics. Definition of Quality Assurance Studies, Performance Review and Research (April 2003).
  4. Interagency Advisory Panel on Research Ethics. Survey Research by University Administrators: Requirement of REB Review (January 2005).
  5. www.nserc.gc.ca/institution/mou_e.htm