Ethics Policy for Research Involving Human Participants

Recommended by the Academic Council on March 25, 2024
Adopted by the Senate on August 13, 2024

1 - Foreword

Human research can contribute to enriching our knowledge, but it also carries ethical risks. It is essential to take appropriate measures to ensure that it is conducted responsibly, thus preserving public trust and the integrity of those involved in this research. By adopting this policy, Royal Military College Saint-Jean (hereinafter RMC Saint-Jean) ensures that human research activities conducted within or outside its premises adhere to recognized ethical standardsFootnote 1. This policy also aims to meet the expectations and requirements of granting agenciesFootnote 2 and complements the RMC Saint-Jean Research Integrity Policy. Consequently, these two policies reinforce the academic status of RMC Saint-Jean.

2 - Objectives

2.1. Define the key terms related to research ethics involving human participantsFootnote 3;

2.2. Specify the ethical principles guiding human research at RMC Saint-Jean;

2.3. Establish the composition and operational rules of the RMC Saint-Jean Research Ethics Board (hereinafter Board);

2.4. Outline the process for evaluating research projects involving human participants at RMC Saint-Jean;

2.5. Define the respective responsibilities of various stakeholdersFootnote 4 and the governance framework for research ethics involving human participants at RMC Saint-Jean.

3 - Scope

This policy applies to any individual, from all disciplines, employed by RMC Saint-Jean with an indeterminate or fixed-term status who conducts research activities involving human participants either outside or within RMC Saint-Jean premises. It also applies to any external individual, regardless of academic or professional status, who carries out research involving human participants at RMC Saint-Jean.Footnote 5

4 - Ethical Principles

RMC Saint-Jean acknowledges that respect for human dignity is a fundamental value in research, expressed through the following three principles, as formulated by the three Councils in their Policy Statement (TCPS 2, pages 6-9):

4.1. Respect for Persons

This principle acknowledges the intrinsic value of all human beings as well as their right to respect and consideration. It includes the dual moral duty of respecting individuals' autonomy by seeking their free, informed, and ongoing consent, and of protecting vulnerable persons whose autonomy is developing, hindered, or diminished.

4.2. Concern for Well-being

This principle means that researchers and the Board will strive to protect the well-being of participants*, including their privacy and personal information, and, in some cases, to promote it in light of foreseeable risks* associated with the research. This will be done by providing participants with sufficient information so they can properly assess the risks and potential benefits of their participation in the research.

4.3. Justice

This principle relates to the duty to treat individuals fairly and equitably. To be fair, one must show equal respect and concern for each person. To be equitable, the benefits and burdens of research must be distributed so that no segment of the population bears an excessive share of the burdens or is deprived of the benefits derived from research knowledge.

5 - Research Ethics Board

5.1. Mandates and Authority

The Board is mandated to assess the ethical acceptability of any research project involving human participants conducted under its authority or auspices. It is also responsible for monitoring ongoing research, referring to this policy and all relevant documents, including the TCPS 2 (2022).

To this end, the leadership of the Academic Wing or, as needed, the Rector of RMC Saint-Jean delegates and grants the Board the authority to approve, reject, or halt any proposal or continuation of research involving human participants. Likewise, the Board is authorized to recommend modifications when applicable, whether the research is conducted at RMC Saint-Jean or elsewhere by one of its members.

While RMC Saint-Jean respects the authority delegated to the Board and complies with its decisions, as an academic institution, it remains responsible for research conducted under its authority and auspices. In this context, the Research Dean’s Office may refuse to allow research to be conducted under its authority, even if the Board has approved its ethical aspects. However, the Dean of Research cannot approve or authorize the implementation of a research project if the Board has not deemed it ethically acceptable.

5.2. Composition

5.3. Members

5.4. Meetings

The Board meets at least once per session and whenever the Chair deems it necessary. To allow researchers to prepare their work or questions, the Board must schedule and publish a calendar of project review meetings.

5.5. Decision-Making on Ethical Acceptability

Decisions regarding the ethical acceptability of projects are based on the minimum standards mentioned in TCPS 2 and are founded on project reviews or progress reports.

5.6. Minutes

The minutes must demonstrate that decisions are made in a reasonable and fair manner. They must clearly justify and document the Board’s decisions. In case of disagreements, through the Research Advisor and in agreement with the Board, they will be accessible to authorized institutional representatives, researchers, and funding agencies. They will facilitate tracking the evaluation of research projects and help with reevaluations or appeals.

6 - Procedure for Evaluating Research Projects Involving Human Participants

6.1. Submission of Projects

After review by the Research Dean’s Office, researchers wishing to undertake a research project involving human participants must submit their file to the Board Secretary for ethical acceptability evaluation. The file includes all documents related to the research project, including the free and informed consent form.

Upon receipt, the Board Chair and Vice-Chair determine, based on their assessment of the level of risk to participants, whether the project should undergo full Board evaluation* or delegated evaluation* (e.g., when a naval or officer cadet participates in graduate-level research that may lead to publication or dissemination of results).

Requests for adjustments, modifications, or additional information may be submitted to the researcher during the process.

6.2. Proportional Approach to Ethical Evaluation

The Board adopts an ethical evaluation approach that is proportional to the level of risk associated with the research based on predefined criteria: the lower the level of risk to participants, the lower the level of review (delegated evaluation); conversely, the higher the level of risk to participants, the more thorough the review (full Board evaluation).

Regardless of the evaluation level adopted, the proportional approach used to assess the ethical acceptability of research is based on the concept of minimal risk and involves consideration of foreseeable risks, potential benefits, and ethical implications of the research in question.

6.3. Research Monitoring

The researcher must propose a monitoring process to the Board when submitting their request for ethical acceptability. They must submit a brief annual report to the Board and promptly notify it upon completion of their activities. The Board may require progress reports if research projects present more than minimal risk or if risk levels increase during the research.

The Board reviews the annual report during its monthly meeting following the document’s receipt. It verifies that the researcher has adhered to the commitments made when submitting their project, which led to the issuance of their ethical acceptability certificate. If the Board finds that a researcher has failed to comply with the ethical guidelines set by the certificate for research involving human participants, the certificate will be revoked, and the incident will be reported to the Research Advisor, who will inform the Dean of Research and the leadership of the Academic Wing.

6.4. Relationship Between Ethical Evaluation of Research and Scientific Review

As part of the ethical evaluation of research, the Board must examine ethical implications but may also assess the quality and relevance of the methodology and the research project as a whole if it considers a potential impact on the well-being of participants.

The Board will first base its evaluation on ethical acceptability and, if applicable, on relevant scientific standards in the specific discipline.

6.5. Evaluation of Free and Informed Consent

A research project cannot begin unless the intended participants or authorized third parties have been able to provide free and informed consent in the official language of their choice.

Participant consent must:

1. be voluntary, given without manipulation, coercion, or undue inducement. For example, an officer cadet or military personnel at RMC Saint-Jean cannot be designated by military authority to participate in research. Additionally, participants must be able to withdraw their consent at any time without prejudice, including any impact on their career or work environment;
2. be based on all necessary information to ensure informed consent.

The researcher must ensure that participants have adequate opportunities to discuss and reflect on their participation throughout the consent process.

6.6. Respect for Justice and Equity in Research Participation

The principle of justice ensures that no individual, group, or community should bear an unfair share of the direct inconveniences of participating in a research project or be unjustly deprived of its potential benefits.

While considering the scope and objectives of their research project, researchers must strive for an inclusive selection of participants. They must not exclude individuals from participating based on characteristics such as culture, language, religion, race, disability, sexual orientation and gender, ethnicity, language proficiency, or age-unless there is a valid reason for exclusion.

Individuals or groups who may be in a vulnerable situation within the research context should neither be unduly included in the project nor automatically excluded due to their vulnerability.

6.7. Respect for Privacy and Data Confidentiality*

The collection, use, and disclosure of personal information require special attention. Private information obtained in a professional or research setting must be kept confidential. In this context, researchers generally commit in writing to respecting the confidentiality of collected data and the anonymity of subjects; the free and informed consent form is typically used for this purpose.

Despite this obligation to maintain confidentiality and anonymity, researchers are required to report certain information to the appropriate authorities if they become aware of cases such as child abuse, infectious diseases, or intentions of homicide.

6.8. Research Involving First Nations, Inuit, or Métis Peoples of CanadaFootnote 7

Each First Nations, Inuit, and Métis community has a unique history, culture, and traditions. These cultures embrace values that are central to constructive relationships for both themselves and researchers. TCPS 2 (2022) cites, for example, the principle of “reciprocity,” which establishes an obligation to give something in exchange for a gift received.

Historically, research in Canada involving Indigenous peoples has primarily been conducted by researchers who were not part of these communities. As a result, the methods and approaches used often failed to adequately consider the worldviews of Indigenous populations. Research conducted under such conditions frequently did not benefit these communities, leading to a degree of skepticism toward research—especially when carried out under the leadership of non-Indigenous individuals. Consequently, it has become increasingly important to adapt research approaches and methodologies when designing projects involving First Nations, Inuit, and Métis communities.

6.9. Collection of Human Biological MaterialFootnote 8

The use of human biological material raises several ethical concerns. TCPS 2 (2022) primarily highlights the following aspects: access to and acceptable use of this material, respect for privacy when using information obtained through this material, and the value that certain individuals and groups place on the human body. Therefore, it is essential to evaluate this type of research with sensitivity to the values, beliefs, and attitudes of the individuals from whom the material originates.

7 - Research Involving Multiple Authorities

Research involving human participants that requires the involvement of multiple institutions or the intervention of several committees includes the following situations:

1. a single research project conducted by a team of researchers affiliated with different institutions;
2. multiple research projects conducted independently by researchers affiliated with different institutions, but with data integration at a certain stage to form a single research project;
3. a single research project conducted by researchers affiliated with one institution, but involving data collection or participant recruitment across different institutions;
4. a single research project conducted by researchers affiliated with more than one institution (e.g., RMC Saint-Jean and a college or university);
5. a single research project conducted within one institution but requiring limited collaboration from individuals affiliated with other institutions or organizations (e.g., statisticians, laboratory technicians, social workers, or teachers);
6. a single research project conducted by one or more Canadian researchers in a province, territory, or country other than the one where their Canadian research institution is located.

In these cases, the research ethics committees of each participating institution conduct their own ethical evaluation of the research project and render their independent decisions, either simultaneously or sequentially. Each involved party (institution, Board, or researcher) must be aware of its responsibilities. To coordinate the overall evaluation process effectively, various research ethics committees may communicate with each other.

Any research conducted outside RMC Saint-Jean, including internationally, must first undergo evaluation by the RMC Saint-Jean Board and the appropriate committee at the research site, where such a committee exists and holds legal authority and procedural guidelines.

8 - Reevaluation of the Board’s Decision

If a request for ethical acceptability is denied or approved with modifications that, in the researcher’s view, compromise the integrity or feasibility of the proposed research, the researcher has the right to challenge the decision and the Board’s reasoning by requesting a reevaluation of the file. In accordance with the principles of justice toward the researcher, the Board has a duty to reevaluate the project.

If, after reevaluation, the Board upholds its decision, the researcher may request that the Appeal Board review the case.

9 - Right and Appeal Procedure

The research ethics committee of another institution, with which RMC Saint-Jean has an agreement, acts as the Appeal Board.

Thus, after the project reevaluation process, a researcher who disagrees with the final decision of the RMC Saint-Jean Board may appeal by submitting a written request either to the Dean of Research (or equivalent) of their institution, who then forwards it to the Dean of Research at RMC Saint-Jean if the researcher is external, or directly to the Dean of Research at RMC Saint-Jean if they are employed by the institution. In both cases, the Research Advisor is informed that an appeal request (hereafter, the request) has been filed. The request includes the ethical approval form, correspondence with the RMC Saint-Jean Board, reasons for the disagreement, and any other relevant documents for project review.

The Dean of Research at RMC Saint-Jean forwards the request to the Director of Studies or the Dean responsible for the research ethics committee at the institution designated as the Appeal Board. Upon receipt, the Appeal Board Secretary formally acknowledges the request, informs the researcher and the Dean of Research at RMC Saint-Jean of the review date, and notifies the Research Advisor of this date. Only documents included in the request may be assessed by the Appeal Board.

If necessary, the Appeal Board may seek expert opinions relevant to the research area of the request, but it must inform RMC Saint-Jean. Any costs related to expert consultations are borne by RMC Saint-Jean. The request is examined following the standard procedure used by the research ethics committee acting as the Appeal Board.

Within fifteen (15) business days after the meeting, the Chair of the Appeal Board issues a written decision to the researcher, the Chair of the Board, and the Dean of Research at RMC Saint-Jean. The Research Advisor is informed of the final decision but does not have access to the complete file. The request and all related documents are confidentially returned to the Board Secretary and stored according to the regulations outlined in article 5.5.1 of this policy. The decision is final and applies to both the researcher and RMC Saint-Jean.

All responsibility related to the Appeal Board’s decision, including legal aspects, rests with RMC Saint-Jean.

No appeal can be submitted to funding agencies.

10 - Sharing of Responsibilities

The Academic Council may, when necessary, evaluate the implementation of the policy and proceed with its revision.

Any additions or modifications to the policy are approved by the Senate following a recommendation from the Academic Council. When needed, the Academic Council establishes a committee responsible for the revision. This committee conducts consultations with the relevant departments and services. Its recommendations are submitted to the Academic Council.

10.1. Academic Wing Leadership

The Director of Studies or, if applicable, the Rector is responsible for:

1. adopting and amending this policy with the majority agreement of the Academic Council members;
2. appointing Board members;
3. delegating to the Board the authority to approve, request modifications of, suspend, or reject any research project involving human participants conducted at RMC Saint-Jean or by one of its members, and, if applicable, granting ethical acceptability;
4. delegating to the Research Dean’s Office the responsibility of ensuring the proper functioning of the Board while maintaining its integrity;
5. receiving the Board’s annual activity report.

10.2. Research Dean’s Office

Regarding research oversight, the Research Dean’s Office is represented by the Dean of Research and the Research Advisor.

10.3. Research Ethics Board

The Board is responsible for:

1. Evaluating the ethical acceptability of research projects submitted to it and overseeing ongoing research in accordance with this policy, TCPS 2 (2022) and the Policy on Responsible Conduct of Research;
2. ensure that the ethical acceptability evaluation for all research activities conducted at RMC Saint-Jean, including those conducted by naval and officer cadets be conducted consistently with this policy, TCPS 2 (2022) and the Policy on Responsible Conduct of Research;
3. making decisions on the ethical acceptability of research efficiently and in a timely manner;
4. developing reference documents for submission requests (submission form) and facilitating ethical evaluation (consent form template);
5. planning and providing the Research Advisor with a schedule of project review meeting dates;
6. responding to reasonable requests from researchers regarding the evaluation of their projects;
7. clearly justifying and documenting its decisions;
8. communicating its final decision in writing, accompanied by the ethical acceptability certificate, to the researcher;
9. informing the Research Advisor about granted ethical acceptability certificates and ongoing research projects at RMC Saint-Jean.

10.4. Board Members

Board members are responsible for:

1. attending regular Board meetings, except in exceptional cases;
2. evaluating requests in accordance with the ethical principles outlined in article 4, with a particular focus on the well-being of participants, especially officer cadets;
3. striving to reach a consensus in decision-making;
4. disclosing any actual, potential, or perceived conflicts of interest, as defined in the Policy on Research Integrity.
5. ensuring the confidentiality of Board discussions.

10.5. Delegated Departmental Evaluators

Delegated departmental evaluators are responsible for:

1. assessing the ethical acceptability of research activities conducted by students, in accordance with this policy;
2. disclosing any actual, potential, or perceived conflicts of interest to the Board, as defined in the Policy on Research Integrity;
3. informing the Board of decisions made on its behalf.

10.6. Researcher

The researcher is responsible for:

1. complying with the ethical rules outlined in this policy;
2. submitting the research project to the Board for ethical acceptability approval (ensuring that all necessary documents for an informed decision by Board members are included – submission form, consent form, document retention procedures, participant invitations, questionnaires – );
3. obtaining ethical approval with a final Board decision marked as “approved” before beginning the research. Any data collection started without this ethical approval will be automatically halted and deemed unauthorized; the researcher must delete all collected data, and no certificate will be issued until a new request is submitted;
4. responding satisfactorily to the Board’s requests for modifications or clarifications;
5. submitting proposed modifications to the Board and obtaining approval before proceeding with the research and data collection;
6. including the reference number assigned to the project by the Board and the final approval date on all information sheets and consent forms;
7. informing the Board Chair of any serious events, harm, or adverse effects as soon as they are observed;
8. contacting the Research Advisor responsible for research oversight to obtain authorization for access to the RMC Saint-Jean site.
9. For research involving multiple authorities:
   • providing the Board with a list of other ethics committees evaluating the research activities and the ethical acceptability certificates obtained;
   • identifying methodological elements that cannot be changed without invalidating the research as a whole;
10. for research monitoring, informing the Board of any changes related to the research:
    • submitting a new request for ethical acceptability in the case of major changes to a research project;
11. for appeals, requesting the Dean of Research to submit the project for evaluation by the Appeal Board if the researcher wishes to challenge the Board’s decision.

11 - Adoption, Implementation, and Dissemination of the Policy

The Research Ethics Policy for Human Participants was adopted by the Academic Council on March 25, 2024. It was implemented on August 13, 2024.

This policy is disseminated across all departments and services at RMC Saint-Jean, as well as on the RMC Saint-Jean website.

12 - Evaluation of Implementation and Policy Revision

The Academic Wing leadership may evaluate the implementation of the policy and make revisions as needed.

Any additions or modifications must be approved by the Academic Director following consultation with the Academic Council. If necessary, the Academic Council may establish a Board responsible for reviewing the policy. This Board must conduct consultations with relevant departments and services. Its recommendations are then submitted to the Academic Council.

13 - GlossaryFootnote 10

Proportional Approach to Ethical Research Evaluation: assessment of foreseeable risk level to determine the appropriate level of research evaluation (delegated review for minimal-risk research or full committee review for research involving more than minimal risk). Consideration of predictable risks, potential benefits, and ethical implications during initial and ongoing evaluations.

Autonomy: a person’s ability to understand information and act accordingly based on their own will; the ability to exercise judgment in making decisions about their actions, such as deciding whether to participate in research.

Well-being: a quality experienced by an individual in all aspects of life. Well-being is influenced by factors such as physical, mental, and spiritual health, as well as material, economic, and social conditions.

Confidentiality: the ethical and, in some cases, legal responsibility of individuals or organizations to protect entrusted information that identifies participants from unauthorized access, use, disclosure, modification, loss, or theft.

Consent: a person’s indication of agreement to participate in a research project. Consent must be free (voluntary), informed, and continuous.

Delegated Evaluation by the Board: the level of review designated for minimal-risk research projects. Evaluation is conducted by designated Board members, except in cases of ethical review for student research conducted as part of a course, which may be delegated to the department, faculty, or an equivalent entity.

Full Board Evaluation: the required level of review for research projects involving more than minimal risk. Evaluation is conducted by all Board members in a plenary session and is generally expected for any research involving human participants.

Participant: an individual whose data or responses to interventions, stimuli, or questions posed by the researcher impact the research question. Also referred to as “human participant,” “subject” ou “research subject.”

Minimal-Risk Research: research in which the probability and magnitude of potential harm resulting from participation are no greater than those inherent in aspects of the participant’s daily life associated with the research project.

Risk: the possibility of harm occurring. The foreseeable risk level for research participants or third parties is assessed based on the severity or extent of the harm and the likelihood of its occurrence.

Vulnerability: a limited ability to adequately protect one's own interests within a given research project. It may arise from restricted capacity or limited access to social goods such as rights, developmental opportunities, and power. Individuals and groups may experience different vulnerabilities at different times, depending on circumstances.

Date modified:

2025-08-15