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

Table of Contents

1. Introduction
2. Definitions
3. Human Subject Restrictions
4. Protection for Human Subjects
5. Research
6. Protocal Summary Format
7. Consent
8. Sample Consent Form
9. References

1. Introduction

Date of Issue: 1998-08-20

Application: This is an order that applies to members of the Canadian Armed 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 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.

principal investigator (expert principal)

A principal investigator is the individual responsible for the experimental design or development of the protocol for a research project.

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. Human Subject Restrictions

Physical or Mental Conditions

3.1 Human subjects must not have physical or mental conditions that may make participation more hazardous than it would be for a typical healthy person, unless such a condition is required for the research project. A human research ethics committee must specifically approve the use of human subjects with a pre-existing condition.

Representation

3.2 Researchers must try to include all groups to whom the research outcome might be applied, whether by gender, race, ethnic background or other distinction.

Restricted Human Subjects

3.3 Members of the CAF undergoing Basic Officer Training and Recruit Training must not be used as human subjects in research unless the Director General of Health Services or the Director General of Military Personnel has been briefed regarding the research protocol and has authorized this use.

Forbidden Human Subjects

3.4 Prisoners, prisoners of war, detainees or institutionalized, mentally disabled persons must not be used as human subjects.

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4. Protection for Human Subjects

Duty/Work Status

4.1 When personnel have agreed to participate as human subjects in a DND and/or CAF sponsored, supported or conducted research project:

1. DND employees are considered to be at work; and
2. CAF members are considered to be on duty.

4.2 The signature of their commanding officer or supervisor on a consent form indicates they have been reassigned from regular duties to participate in the project.

Waiver of Legal Rights

4.3 Human subjects shall not be required to waive, either orally or in writing, any of their legal rights. For example, they shall not be required to release a person, organization or agency from liability.

Remuneration

4.4 Human subjects who are CAF members may be entitled to remuneration, under QR&O 205.48, where exposure to abnormal stress and discomfort is anticipated.

4.5 Such remuneration is designed to facilitate collaboration by indemnifying human subjects for their stress and discomfort. It is not intended to distort or influence the subject's freedom of choice.

4.6 Other advantages, inducements or benefits are improper and shall not be offered.

Compensation for Disability or Death

4.7 In the event of disability or death of personnel participating as human subjects in a DND and/or CAF sponsored, supported or conducted research project:

1. adjudication for civilian employees is by the Provincial Workers' Compensation Board; and
2. adjudication for military members is by the Veterans Review and Appeal Board.

4.8 Despite the fact that a member or employee has been reassigned from regular duties to participate in the research project, the disability or death may not be viewed by adjudicators as attributable to work or military duties and, as a result, the disability or death may not be compensated/pensionable.

Supervision

4.9 A suitable, qualified, military or civilian physician or dentist, other than the principal investigator, shall be responsible for the medical or dental welfare of all human subjects.

Confidentiality

4.10 The following applies to the confidentiality of research on human subjects:

1. Only members of the research team are permitted to handle identifying data.
2. Only those researchers who need to link data to particular human subjects shall be allowed to do so.
3. Publication of research findings cannot identify human subjects without their written consent.
4. There shall be no greater intrusion into the privacy of the subject than is absolutely necessary to achieve the required results. The provisions of the Privacy Act shall apply to all research projects.
5. When contracting out research, data must be handled in a manner consistent with the provisions of the Privacy Act.
6. Identifiers shall be destroyed after the link with the subject is no longer required. If there is a valid reason to keep this information for an extended period of time, access to the information shall be strictly controlled and no derivative uses shall be permitted without the subject's consent.

Right to Access and Correct Information

4.11 Human subjects have the right to access personal information about themselves as well as correct erroneous information about themselves.

4.12 The Privacy Act requires that personal information be described in a bank of information and that this information be provided to the Treasury Board for publication in Info Source.

5. Research

Results

5.1 The research project should yield results that are not provable by other methods or by research involving less risk.

5.2 The human research ethics committee will not approve the research project if they believe similar research has been done before and no significant new knowledge or clarification is likely to be gained.

Precautions

5.3 The research team will ensure all reasonable precautions are taken. It will not initiate any research if there is any possibility that injury, disability or death may occur.

5.4 The research team must acquire sufficient knowledge from animal or laboratory experiments and from the literature or other sources to give assurance of reasonable safety prior to the use of human subjects.

5.5 The principal investigator and each member of the research team shall terminate a human subject's participation at any stage if it is possible that continuation may result in injury, disability or death.

Researcher Qualifications

5.6 Only persons possessing the requisite scientific or medical qualifications shall conduct the research.

Protocol Summary

5.7 The principal investigator shall include a protocol summary, in plain language, as part of the full protocol submitted to the Committee. This shall be provided to the subject and must include all information listed in the section entitled Protocol Summary Format.

Sample Consent Form

5.8 The principal investigator shall include a sample consent form, in plain language, as part of the full protocol submitted to the Committee. This form is required for the recruitment of all human subjects to the research project and must include all information listed in the section entitled Sample Consent Form.

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6. Protocol Summary Format

Required Information

6.1 A protocol summary must provide a subject with the following information:

7. Consent

Voluntary Consent

7.1 All individuals must give their informed consent to be used as human subjects in a research project, and will retain the right to choose to participate, or withdraw, without any form of constraint or coercion.

7.2 Researchers are not entitled to assume the human subject is consenting; only an affirmative statement, verbally or in writing, constitutes consent.

Consent by Subordinates

7.3 A request for human subjects shall not be made by a superior to a subordinate unless the concept of voluntary consent is explained to the prospective subject by a third party in a full and responsive discussion, prior to the signing of a consent form.

7.4 No influence shall be used to encourage consent.

Consent by Patients

7.5 Researchers who wish to recruit patients as human subjects must give them an opportunity to discuss the potential risks and benefits of their participation in the research, in private with their primary care physician.

Physicians' Obligations

7.6 When a patient is considering participating as a subject in a research project, the patient's primary care physician, based on his or her best clinical judgement of the patient's therapeutic needs, must:

1. discuss with the patient:
   1. his or her prognosis without participation in the research;
   2. his or her prognosis should he or she choose to participate in the research;
   3. alternative therapy or procedures available; and
   4. experimental aspects of the proposed research; and
2. provide the patient with:
   1. an estimate of the likely success or failure of all the research procedures that may be offered;
   2. an estimate of the risks and possible adverse effects of all the research procedures that may be offered;
   3. a clear distinction between procedures in the protocol and those that would be part of normal patient care; and
   4. a clear statement that the patient's medical needs will be addressed to the extent therapeutically possible, regardless of whether the patient chooses to participate in the proposed research.

7.7 In the case of experimental therapy trials, an alternate recognized method of treatment will be made available.

Withdrawal or Refusal of Consent

7.8 Human subjects may withdraw their consent and discontinue participation at the earliest moment, which in the opinion of the principal investigator, is safe. The human subjects shall not be prejudiced in any way by their termination of participation.

7.9 CAF members are not subject to administrative action or to punishment under the Code of Service Discipline for choosing not to take part in, or continue to take part in, experiments as human subjects.

Career Implications

7.10 Personnel shall not suffer any adverse career consequences or receive any career enhancements solely as a result of their decision to participate or not in a research project.

8. Sample Consent Form

I, _____ having reached the age of majority for the province in which I am residing, agree to participate in the research project entitled _____ under the direction of _____(principal investigator) conducted at______ (name of institution). I acknowledge that my participation in this research project is completely voluntary.

I have read and understood the description of the project provided in the attached protocol summary, including its purpose, methods of research and the risks associated with my participation.

I understand that the findings of the study may be published, but my anonymity in material arising from this study will be maintained. In no way will my name be identified or attached to the study.

I have been assured that any personal information concerning me that is revealed in connection with this study will be kept in strict confidence except as data unidentified as to source, unless I specifically consent to the release of the information.

I understand that my participation in this study is entirely voluntary and that I may decide to stop participating at any time without any consequences to my career.

I understand that if my participation in the study results in a medical condition rendering me unfit for service, I may be released from the Canadian Forces

If I choose not to participate in this study, or if I choose to withdraw from the study, I understand that I will receive the current conventional treatment for my medical condition (delete if not applicable).

Details of the study have been explained to me by _____ and my questions about the study have been answered.

I may obtain additional information about the project and have any questions about the study answered by contacting _____.

I am aware that I am considered to be at work/on duty while participating in this research project. The signature of my commanding officer or immediate supervisor on this form indicates that I have been reassigned from regular duties to participate in the project.

Since the Veterans Review and Appeal Board or Provincial Workers' Compensation Board adjudicate cases of disability or death on an individual basis, I understand that there is no guarantee that any disability or death sustained as a participant in this study will be viewed as having arisen out of or having been directly connected with work/military duty. Consequently, such disability or death may not be pensionable or compensated.

Name of Participant Name of Witness Name of Superior
Signature of Participant Signature of Witness Signature of Superior Date Date Date

9. References

Acts, Regulations, Central Agency Policies and Policy DAOD

• QR & O 205.48, Stress Allowance for Test Participants
• DAOD 5061-0, Research Involving Human Subjects

Other Reference

• Privacy Act R.S.C. 1985 c. P-21