DAOD 5061-0, Research Involving Human Subjects

Table of Contents

1. Introduction
2. Definitions
3. Policy Direction
4. Authority
5. References

1. Introduction

Date of Issue: 1998-08-20

Application: This is an order that applies to members of the Canadian Ared Forces (CAF) and a directive that applies to employees of the Department of National Defence (DND).

Approval Authority: This DAOD is issued under the authority of the Assistant Deputy Minister (Human Resources - Military) (ADM(HR - Mil)).

Enquiries: Director of Health Operations (DHO)

2. Definitions

human research ethics committee (comité d'éthique en matière d'étude sur des sujets humains)

A human research ethics committee is a committee established to review the protocol of a research project involving human subjects prior to the start of the project.

human subject (sujet humain)

Human subjects are living persons who voluntarily participate in a study through interaction with a researcher or by granting permission to use their records.

informed consent (consentement éclairé)

Informed consent is voluntary agreement to become a human subject in a research project, with full understanding of the project's rationale, procedures, risks, benefits, expected outcomes, measures to ensure human subjects' confidentiality, expected follow-up studies, data retention, anticipated time commitment and the intended disclosure. The human subject's consent must be sought for secondary uses of the data concerning the human subject.

protocol (protocole)

A protocol is the detailed plan by which research is conducted.

research project (projet de recherche)

A research project is any study designed to contribute to general knowledge

risk (risque)

Risk is the possibility of physical, psychological, financial or social harm.

3. Policy Direction

Context

3.1 Research involving human subjects includes:

1. the evaluation of vehicles or equipment to determine their effect on human subjects;
2. the study of behaviour;
3. the testing of processes, drugs, vaccines, biological, investigational medical devices or devices involving human subjects, or biological tissue products originating from human subjects;
4. the development of new standard operating procedures or specialized procedures involving potential risk in excess of that usually inherent in the individual's daily life, occupation or field of service; and/or
5. the solicitation, acquisition or use of confidential information or opinions.

3.2 Research involving human subjects does not include:

1. the evaluation of vehicles or equipment without consideration of their effect on human subjects;
2. the study of training or field operations in which new features introduced will not increase risk, or stress, to personnel beyond the level already present in their daily life, occupation or field of service; and
3. the collection or use of existing data or medical specimens where these sources are available to the public or where the information is recorded in such a way that the human subjects cannot be identified.

Policy Statement

3.3 The DND and the CAF shall sponsor, support or conduct research projects involving human subjects only where:

1. the research provides scientifically valid advancements in knowledge that justify the risks involved;
2. the research substantially benefits the DND or the CAF in the pursuit of operational tasks and missions or departmental priorities; and
3. participation is voluntary and is based on the full, informed consent of the human subjects.

Requirements

3.4 Every research project sponsored, supported or conducted by the DND and the CAF is dependant upon the approval of a human research ethics committee. The committee shall review and, if appropriate, approve:

1. the protocol of all research projects involving human subjects, and
2. the use of DND employees or CAF members as human subjects;

3.5 The review must take place before the start of the research project.

3.6 All DND research contracts must reflect the direction outlined in the DAOD 5061 series.

3.7 Directors General responsible for the conduct of research and the Medical Services Research Board shall establish human research ethics committees to review research projects undertaken in their areas of responsibility. These committees shall conduct themselves in accordance with the Tri-Council Code of Conduct for Research Involving Humans, this policy and the instructions derived from it.

4. Authority

Authority Table

4.1 The following table identifies the authorities responsible for implementing this policy.

5. References

Acts, Regulations, Central Agency Policies and Policy DAOD

• Not applicable in this DAOD.

Other Reference

• DAOD 5061-1, Research Involving Human Subjects - Approval Procedures