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Past Interpretations of the TCPS

Subject Third-Party Interviews or Secondary Use of Data
Keywords third-party interviews, secondary use of data, research requiring ethics review, exceptions thereto, privacy and confidentiality, free and informed consent
TCPS Articles 1.1, 1.6, 2.1, 2.4, 3.1, 3.3, 3.4, 3.5
Date October 2005

PDF Third_Party_Interviews_or_Secondary_Use_of_Data_October2005.pdf

1. This is in response to your question in which you inquire whether a researcher’s use of data collected by sports trainers constitutes “third-party interviews” and therefore does not require ethical review under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Your question has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

2. Your question raises issues related to research requiring ethics review and its exceptions, secondary use of data, privacy and confidentiality, and free and informed consent. As elaborated below, the data to which you refer is unlikely to qualify as “third-party interviews,” records or archival material publicly available—material that is exempt from Research Ethics Board (REB) review. Rather, you have described the use in research of data collected for a purpose other than the research itself; this constitutes secondary use of data. Secondary use of data with identifying information requires REB review.

Research Requiring Ethics Review and its Exceptions

3. Article 1.1 outlines the general TCPS principle of prospective research ethics review, subject to applicable exceptions. Article 1.1(a) indicates that “All research that involves living human subjects requires review and approval by an REB… before the research is started….” [emphasis added]. Article 1.1(c) outlines the exception for third-party interviews: “Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review.…” Article 1.1(c) thus excludes from REB review “research that is based exclusively on publicly available information. This includes documents, records, specimens or materials from public archives, published works and the like, to which the public is granted access.”2 Information derived from publicly available third-party interviews does not require REB review, because such research involves no interaction with research participants, and the data is publicly accessible through public records or archives. (Please also see commentary to Article 1.1 on page 1.2, as well as Article 3.1 on page 3.2, concerning publicly available information.)

Secondary Use of Data

4. The situation to which you refer likely comprises secondary use of data under the TCPS. The TCPS defines secondary use as “the use in research of data contained in records collected for a purpose other than the research itself. Common examples are patient…records…originally produced for therapeutic…purposes, but now proposed for use in research.”3 Similarly, information collected by athletic trainers from athletes, and which is now proposed for use in research, falls within the TCPS definition of secondary use of data. Should your data involve personal identifying information, it would be subject to REB approval under TCPS Articles 3.3 to 3.5. It is not clear from your query if this is the case, or if the data are anonymized. Even if anonymized, they would still be subject to REB review4, following the proportionate approach to ethics assessment (Article 1.6).

Privacy, Confidentiality, Free and Informed Consent

5. You indicate that the research will not be based on direct contact with the athletes, but rather on data collected by sports trainers regarding the athletes’ injuries. Were the athletes made aware that the data obtained from the sports trainers would be used in research? This question and its answer raise issues of confidentiality and consent. Under Section 3 of the TCPS, information that is disclosed in a professional or research relationship should be held confidential and not be shared with others, unless the participant consents or unless other limited exceptions apply.

6. As noted, if identifying information is involved, REB approval should be sought for secondary uses of data under TCPS Article 3.3. Part of the justification is that “the REB must carefully appraise the possibility of identification, in particular with regard to the extent of the harm or stigma that might be attached to identification.”5 Might some athletes wish for identifying injuries to remain private? Article 3.4 further indicates that the secondary use of identifying information may be dependant on the free and informed consent of those who contributed the data, or on an appropriate strategy for informing participants, or on consultation with representatives of those who contributed data. If it is determined that contact will be made, then Article 3.5 indicates that it must be authorized first by the REB. As the commentary to this article indicates:

It is evident that individuals or groups might be sensitive if they discover that research was conducted on their data without their knowledge; others may not want any further contact. This potential harm underlines the importance for researchers to make all efforts to allow subjects the right to consent that their data and private information be part of a study.6

7. In some cases, it might be objectively impracticable to seek the free and informed consent from individuals who provided the information. The TCPS outlines a limited exception to the general requirement that consent, notice or authorization be obtained in Article 2.1(c)7. The onus is on the researcher to show that all of these conditions are met for an REB to consider waiving or altering normal consent procedures.8 (General conditions for free and informed consent are outlined in TCPS Article 2.4). One of the REB responsibilities is to balance “the need for research against infringements of privacy and minimizing any necessary invasions of privacy.”9

We hope that this information proves helpful to your TCPS research ethics deliberations.

Sincerely,

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


  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. TCPS, page 3.2.
  3. TCPS, page 3.4.
  4. See commentary on TCPS, page 3.2.
  5. TCPS, page 3.5.
  6. TCPS, page 3.6.
  7. Article 2.1(c), requires the REB “to find and document” that “i. The research involves no more than minimal risk to the subjects; ii. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects; iii. The research could not practicably be carried out without the waiver or alteration; iv. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and v. The waived or altered consent does not involve a therapeutic intervention.”
    To ensure that such alterations or waivers do not “adversely affect” participants’ privacy rights, for instance, such considerations would need to be evaluated in the context of applicable privacy laws. See TCPS Context of an Ethics Framework, F: (Ethics and Law) and TCPS section 3 (Privacy and Confidentiality).
  8. Please see TCPS Subsection G: “Putting Principles into Practice in the Context of an Ethics Framework,” page i.9.
  9. TCPS, page 3.2.