NRC Policy for Research Involving Human Subjects

		In this section...
		1.0 NRC Policy for Research Involving Human Subjects
		2.0 Overall Context
		3.0 Definitions: Research Involving Human Subjects
		4.0 Research Ethics Board (REBS)
		5.0 Adherence To Canadian Standards

1.0 NRC Policy for Research Involving Human Subjects

No research involving human subjects with which NRC is involved shall be carried out without the approval of one of NRC's Research Ethics Boards.

For research projects seeking NRC Industrial Research Assistance Program (NRC-IRAP) funding, NRC will accept the ethics review by an REB that is mandated by the organization where the research is carried out, and/or that complies with the regulatory requirements of Health Canada for ethics review of activities under the Food and Drugs Act, or with the TCPS under the Tri-Council MOU Mechanism.

2.0 Overall Context

NRC affirms that excellence in research cannot be achieved without excellence in ethics

NRC requires that all research with which it is involved shall be in compliance with NRC's policies and procedures for meeting standards of ethics.

3.0 Definitions: Research Involving Human Subjects

The following descriptions of "research", "human subjects" and "NRC participation" are intended to indicate the breadth of research involving human subjects covered by this policy.

Research
Research includes, for example, fundamental and applied research, development of new products and technologies, or evaluation of processes and technologies, that are carried out with the intention to, for example, gain new knowledge, confirm existing knowledge, generate hypotheses, develop new products or technologies, or evaluate concepts, technologies or products.

Human subjects
Research involves human subjects when, for example, 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 e.g., living humans, cadavers, embryos or fetal tissues, are studied, or when personal or private documents or other materials that have not been placed in the public domain with the consent of the person directly affected, are studied.

NRC involvement
NRC is involved in research involving human subjects when:

• NRC's employees undertake or collaborate in such research
• NRC allows the use of NRC equipment, laboratories or facilities
• NRC provides financial support, such as through IRAP, for such research
• NRC provides products that it has developed for research

4.0 Research Ethics Board (REBS)

NRC's Research Ethics Boards are established to:

• Ensure high standards of ethics in all aspects of research involving human subjects;
  
  
• Review and determine whether to give ethics approval to, to reject, to require modifications to, or to terminate any proposed or ongoing research involving human subjects;
  
  
• Provide a resource for education, guidance and leadership, to NRC's employees and to others who use NRC facilities or funds, in the application of ethical principles to the conduct of research involving human subjects;
  
  
• Help NRC to ensure compliance with appropriate human research ethics governance policies and procedures.

NRC has two Research Ethics Boards:

• NRC's Winnipeg REB (W-REB) oversees research involving human subjects in the Institute for Biodiagnostics;
  
  
• NRC's Ottawa REB (O-REB) oversees all other NRC research involving human subjects , including that supported by IRAP.

Accountability
NRC's Research Ethics Boards report to the Senior Executive Committee through the Secretary General of NRC.

Independence
NRC's Research Ethics Boards provide independent advice and service to NRC. A decision by a Research Ethics Board to deny ethics approval cannot be reversed by NRC's management.

5.0 Adherence To Canadian Standards

To provide primary guidance to principles and practices in this area, NRC has adopted the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998), 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 originally adopted in 1997 by Health Canada and subsequently amended.