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Past Interpretations of the TCPS

Subject Requirement for REB Review of a Technical Service
Keywords Ethics review, technical service, research, level of involvement in research, non-eligible institutions, other ethical issues, data processing
TCPS Articles 1.1, 1.2, 1.6, Section 1.G
Date December 2007

PDF Requirement_for_REB_Review_of_a_Technical_Service_december_2007.pdf

1. This is in response to your inquiry on the requirement for research ethics board (REB) review related to, as you describe it, “technical service” that a researcher affiliated to an institution eligible1 to administer Agency’s funding provides to other researchers as part of the latter’s research involving humans. In this first scenario, the researcher performs his technical service within the jurisdiction of his institution and is compensated for his/her service by a transfer of grant funds from the principal researchers’ grant funds. This researcher’s role is limited to offering “technical expertise” and is not involved in preparing grants application(s), project descriptions, nor publications/articles related to the research project. You question the requirement for REB review at the “technical” researcher’s institution in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), given the exclusively “technical” nature of the services provided by the researcher to the overall project, and with the understanding that the other researchers/recipients of the service would have submitted the project for review by the appropriate research ethics board (REB) within their institution(s).

2. You also raise two other scenarios that suggest a more active involvement of the researcher offering the technical service in the research, and inquire whether the interpretation would be different in those other cases.

3. Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice2.

First Scenario: Is it Research Involving Humans?

4. According to the TCPS (page 1.1), research “involves a systematic investigation to establish facts, principles or generalizable knowledge.” Your description suggests that the researcher providing the technical service conducts biochemical analyses of biological nature (plasma, saliva, urine) originating from patients and collected by the other researchers who request this service. While the samples are processed by the researcher offering the technical service3, s/he has no involvement before or after this process. Based on the information you provided, it is our understanding that the nature of the contribution by this researcher is technical service limited in nature to this activity. A technical service that is not qualified as “research involving humans” would not require REB review in accordance with the TCPS. In the commentary to Article 1.1 of the TCPS, research “involves a systematic investigation to establish facts, principles or generalizable knowledge.” PRE has provided other interpretations4 relevant to the definition of research which suggest that the intent and purpose of an activity are determining factors in qualifying an activity as research involving humans.

Second Scenario: Researcher More Involved in the Research Project

5. In the second scenario, it is suggested that the researcher offering the technical service may have a more active role and, therefore, s/he would become or be seen to be actively involved in the research. As the researcher’s contribution would not simply be limited to a technical service, the researcher may be considered a collaborator or co-investigator (sometimes referred to as co-applicant) in the research. In this case, that the researcher would be required to undergo REB review within his/her institution as an active contributor to multi-centred research5, and in accordance with TCPS Article 1.2: “The institution in which research involving human subjects is carried out shall mandate the REB to approve, reject,… any proposed or ongoing research involving humans that is conducted within, or by members of, the institution…..” (Emphasis added). REB review would be conducted in accordance to TCPS Article 1.6, the proportionate approach to research ethics review.

6. CIHR, NSERC and SSHRC have their own set of definitions of a collaborator versus co-applicant or co-investigator. You may wish to refer to those definitions on the Agencies’ websites6, taking into account the nature and source of funding of research under consideration.

Third Scenario: Technical Services Offered to Others in Non-eligible Institutions

7. In the third scenario, you suggest that the request for technical service may originate from others external to the university sector e.g. institutions non-eligible for Agency funds, and which, therefore, may not be required to follow the TCPS. This suggests the potential that the overall research project may not have undergone REB review. In this case, it would be prudent to either conduct an REB review within the researcher’s institution where the technical service is provided, or the researcher may agree to provide his/her technical service conditional upon the requirement for ethics review by an REB duly constituted in accordance with the TCPS.

Data Processed by the Researcher Providing Technical Service

8. It is our understanding that the endogenous substances that the researcher offering technical service processes originate from patients and are biological in nature (plasma, saliva, urine). The researcher conducts biochemical analyses and returns the remaining clinical samples to the researchers who originally collected them. In this case, the researcher offering the technical service does not play an active “research” role. However, in all three scenarios, and by virtue of receiving those samples and storing them during the processing period within his/her institution, some ethical issues need to be considered. For example, the biological samples raise issues related to privacy, confidentiality, whether they are anonymous when the researcher receives them, whether they were collected based on informed consent, where and how will the researcher offering the technical service store the samples, and who has access to them. In addition to the ethical issues this raises, other provincial policies and privacy laws may also be applicable.

9. In any case, the researcher needs to abide by professional, legal and other provincial requirements.

Thank you for your inquiry. We hope you find this information useful.

Sincerely,


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


  1. “Agency” refers to one of the three Canadian federal granting Agencies: the Canadian Institutes for Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC), and Social Sciences and Humanities Research Council of Canada (SSHRC).
  2. 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 the 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.
  3. According to the Merriam-Webster Online dictionary http://www.m-w.com/, a “technical consultant” is defined as having special and usually practical knowledge especially of a mechanical or scientific subject; while a “service” is defined as the work performed by one that serves, helps, use, benefit, or one that contributes to the welfare of others.
  4. See for example, http://pre.ethics.gc.ca/eng/archives/tcps-eptc/interpretations/interpretation006/; and http://pre.ethics.gc.ca/eng/archives/tcps-eptc/interpretations/interpretation010/";
  5. Refer to Section 1.G of TCPS; page 1.11 on “Review of Multicentred Research”.
  6. A “collaborator”, “co-applicant” and “co-investigator” are defined on the CIHR website at http://www.cihr-irsc.gc.ca/e/22630.html#1-B1, SSHRC’s website at http://www.sshrc.ca/web/apply/background/definitions_e.asp#11, and NSERC’s website at
    http://www.nserc.gc.ca/professors_e.asp?nav=profnav&lbi=11a1.