NRC policy for research involving human participants

Table of contents

1.0 Overview

Through this policy, the NRC affirms that excellence in ethics and respect for human dignity are essential to excellence in research.

The NRC thus requires that all research in which it participates shall be in compliance with NRC's policies and procedures for adhering to accepted ethical standards as described below.

The NRC shall not, therefore, carry out any research involving human participants without the approval of the NRC Research Ethics Board (NRC-REB) or as otherwise prescribed in Standard operating procedures (SOP) approved by the NRC's Senior Ethics Officer pursuant to the terms of this policy.

2.0 Definitions

The following definitions of "research", "human participants" and "NRC participation" describe the breadth of activities covered by this policy.

2.1 Research

For the purposes of this policy, "research" includes fundamental research which is defined as "an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation." "Research" under this policy also includes applied research carried out for practical applications with the intention not only to gain new knowledge, but to confirm existing knowledge, to generate hypotheses, to evaluate concepts, and to develop new products, processes, or technologies.

2.2 Human Participants

For the purposes of this policy, the following is defined as research that requires ethics review and approval by the NRC-REB before the research commences: Research involves human participants, as specified above:

  • when the actions or opinions or responses of human beings are studied in natural or staged environments;
  • or when human biological materials (e.g., organs, tissues, cells, body fluids or excreta) obtained from living humans, cadavers, embryos or fetal tissues are studied;
  • or when personal identifiable or private documents, data or other materials including images of the body and personal health data, that have not been placed in the public domain with the consent of the person directly affected, are studied;
  • or when research involving a secondary use of human biological materials or data from human participants as described above, when individual or combined information is identifiable.

2.3 NRC Participation

NRC participates in research when:

  • NRC employees undertake or collaborate in the research;
  • NRC allows the use of its equipment, laboratories, products, or facilities in the research; or
  • NRC provides financial support to the research, such as through the NRC Industrial Research Assistance Program (NRC-IRAP).

3.0 NRC Research Ethics Board

The NRC-REB is a body appointed by the NRC's Secretary General and established pursuant to this policy to:

  • review and determine whether to give ethics approval to proposed or ongoing research involving human participants brought to it by the NRC through the Senior Ethics Officer;
  • provide leadership and a resource for education and guidance to NRC's employees and others who use NRC facilities or funds in the application of ethical principles to the conduct of research involving human participants;
  • help the NRC to ensure compliance with appropriate human research ethics policies and procedures;
  • and help the NRC to ensure high ethical standards in all aspects of its research, programs and services through advice on issues brought to it by the Senior Ethics Officer.

The NRC-REB reports to the NRC's President and Senior Executive Committee through the Secretary General on the advice of the Senior Ethics Officer. The NRC's Senior Ethics Officer has responsibility for recommending appropriate amendments to this policy, for providing appropriate support to the NRC-REB, and for ensuring that the policy is communicated within the NRC. All NRC employees have a responsibility to adhere to this policy as appropriate in their work.

The NRC-REB provides independent advice and service to NRC.

Though decisions on research program priorities and funding approvals rest with NRC, a decision by the NRC-REB to deny ethics approval cannot be reversed by NRC management.

4.0 Adherence to Accepted Standards

To provide primary guidance to principles and practices in this area, NRC has adopted the TCPS 2—2nd edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and as subsequently amended by the Interagency Panel on Research Ethics.

For research that deals with the assessment of pharmaceuticals, biologicals, medical devices and other regulated products, NRC requires adherence to the statement of Good Clinical Practices by the International Conference on Harmonization as adopted by Health Canada and as subsequently amended.