Research Ethics Policy

 

Status Draft — Pending review by the Academic Advisory Committee and approval by the President
Approving Body President, Canadian College of Traditional Chinese Medicine
Date Adopted Pending
Effective Date Pending
Date of Last Review N/A
Supersedes N/A

Purpose
This policy establishes ethical standards, procedures, and oversight mechanisms for research involving human subjects, management of research data, and handling of research funds in the Honours Bachelor of Traditional Chinese Medicine (HBTCM) program at the Canadian College of Traditional Chinese Medicine (CCTCM). It ensures all research activities adhere to Canadian ethical standards, including the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), while protecting the rights, welfare, and dignity of research participants.

Scope
This policy applies to all research activities conducted by CCTCM faculty, staff, and students, including HBTCM thesis research, faculty scholarship, clinical outcome studies, and any research involving human subjects. It governs research ethics review processes, informed consent procedures, data management, and research fund administration.

 

Guiding Principles
CCTCM’s research ethics framework is guided by the core principles of TCPS 2:

–Respect for Persons: Research recognizes the intrinsic value of human beings and respects their autonomy, dignity, and capacity for self-determination. This principle requires:

  • Informed consent from research participants
  • Special protections for individuals with diminished autonomy
  • Respect for privacy and confidentiality
  • Freedom to withdraw from research without penalty

–Concern for Welfare: Research aims to protect participants’ physical, psychological, social, and economic welfare. Researchers must:

  • Minimize risks to participants
  • Maximize benefits where possible
  • Ensure risks are proportionate to anticipated benefits
  • Monitor participant welfare throughout research

-Justice:Research treats people fairly and equitably. This principle requires:

  • Fair distribution of research benefits and burdens
  • Appropriate inclusion of diverse populations
  • Special attention to vulnerable or marginalized groups
  • Avoidance of exploitation

Research Ethics Board (REB) Partnership

-External REB Arrangement: CCTCM maintains a formal partnership with an external Research Ethics Board for the review of all research proposals involving human subjects. This arrangement ensures that research conducted by CCTCM faculty and students receives expert ethical review by qualified REB members while CCTCM retains ultimate institutional responsibility for ethical research conduct.
The external REB partnership provides:

  • Review of research proposals for ethical compliance by qualified REB members with expertise in ethics, research methodology, relevant law, and community representation
  • Assessment of risks and benefits to participants
  • Evaluation of informed consent procedures
  • Monitoring of ongoing research for ethical compliance
  • Investigation of allegations of research misconduct
  • Guidance on complex ethical issues in research

-Research Ethics Coordinator: CCTCM designates the Academic Dean (or designate) as the Research Ethics Coordinator, responsible for:

  • Serving as primary liaison with the external REB
  • Ensuring faculty and students understand REB submission requirements
  • Reviewing research proposals for completeness before REB submission
  • Maintaining records of research ethics approvals and ongoing research
  • Monitoring compliance with REB-approved protocols
  • Coordinating responses to REB requests for additional information or modifications
  • Addressing research ethics concerns at the institutional level

Research Requiring REB Review

REB review is required for all research involving:

  • Living human participants
  • Human biological materials (blood, tissue, cells)
  • Personal information about identifiable individuals
  • Clinical interventions or treatments
  • Surveys, interviews, or questionnaires collecting personal information

Research exempt from REB review includes:

  • Quality assurance and program evaluation using anonymous data
  • Research using publicly available data with no identifiable information
  • Literature reviews and theoretical research
  • Research on deceased individuals where no identifiable information is used

Researchers uncertain about whether REB review is required must consult with the Research Ethics Coordinator before commencing research.

Research Proposal Submission Process

-Internal Review: Before submission to the external REB, researchers submit proposals to the Research Ethics Coordinator for internal review. The Coordinator:

  • Verifies that all required documentation is complete
  • Ensures informed consent forms and recruitment materials are appropriate
  • Confirms researchers have completed required TCPS 2 training (see §13)
  • Provides guidance on REB submission requirements
  • Identifies ethical concerns requiring attention before REB submission

-REB Submission: The Research Ethics Coordinator submits complete proposals to the external REB, including:

  • Research protocol describing objectives, methodology, participant recruitment, data collection procedures, and analysis plans
  • Informed consent forms and recruitment materials
  • Assessment of risks and benefits
  • Data management and confidentiality procedures
  • Qualifications of research team members
  • Conflict of interest disclosures
  • Evidence of TCPS 2 training completion

-REB Review and Decision: The external REB reviews proposals according to its established procedures and timelines and provides written decisions indicating:

  • Approval to proceed
  • Approval with modifications required
  • Deferral pending additional information
  • Rejection with rationale

The Research Ethics Coordinator communicates REB decisions to researchers and assists with required modifications or additional information. Research may not commence until REB approval is granted.

Informed Consent Requirements

-Elements of Informed Consent: Informed consent must include:

  • Purpose of the research
  • Research procedures and participant involvement
  • Potential risks and benefits
  • Confidentiality and data security measures
  • Right to withdraw without penalty
  • Contact information for the research team and REB
  • Compensation or reimbursement, if applicable

-Consent Process: Informed consent requires:

  • Adequate time for participants to consider participation
  • Opportunity to ask questions and receive answers
  • Language appropriate to participants’ comprehension level
  • Written documentation of consent (signature or electronic confirmation)
  • Ongoing consent for long-term research

-Special Considerations: For vulnerable populations (minors, individuals with cognitive impairments), researchers must:

  • Obtain consent from legally authorized representatives
  • Seek assent from participants when appropriate
  • Provide additional safeguards to protect welfare

Data Management and Confidentiality

-Data Collection and Storage: Researchers must:

  • Collect only data necessary for research objectives
  • De-identify data when possible
  • Store data securely (encrypted digital files, locked physical storage)
  • Limit access to authorized research team members
  • Retain data for a minimum of seven (7) years post-publication or project completion, or longer where required by the partner REB or applicable legislation, including the Personal Health Information Protection Act, 2004 (PHIPA)

-Confidentiality Protections: Researchers protect participant confidentiality by:

  • Using codes rather than names in data files
  • Storing identifying information separately from research data
  • Reporting aggregate findings only (no individual identification)
  • Obtaining participant permission before publishing identifiable information
  • Destroying identifying information after the data retention period

-Data Sharing: Researchers may share de-identified data with other researchers only when:

  • Original consent included permission for data sharing
  • A data sharing agreement ensures confidentiality protections
  • The REB approves data sharing arrangements

Research Involving CCTCM Students or Patients

-Student Research Participants:

  • Participation must be voluntary with no penalty for non-participation
  • Research cannot affect academic evaluation or standing
  • Faculty conducting research with their own students must use third-party consent procedures
  • Alternative assignments must be available for non-participants

-Clinic Patient Research Participants: Research involving CCTCM clinic patients must comply with the Personal Health Information Protection Act, 2004 (PHIPA). Additional safeguards include:

  • Participation cannot affect quality of care received
  • Practitioners must clearly distinguish research from clinical care
  • Patients must be informed they can decline participation without affecting treatment
  • Research data must be kept separate from clinical records

Thesis Research Requirements

-Student Responsibilities: All HBTCM students completing thesis research must:

  • Complete TCPS 2 training as required under §13 of this policy
  • Submit research proposals to the Research Ethics Coordinator for internal review
  • Obtain REB approval before commencing data collection
  • Work under the supervision of a faculty advisor with research expertise
  • Adhere to the approved research protocol
  • Report any adverse events or protocol deviations to the Research Ethics Coordinator and REB immediately
  • Submit final thesis for review before public defence

-Faculty Advisor Responsibilities: Faculty advisors are responsible for:

  • Ensuring students understand and comply with research ethics requirements
  • Reviewing student proposals for ethical soundness before REB submission
  • Monitoring student adherence to approved protocols
  • Reporting concerns about research ethics compliance to the Research Ethics Coordinator

Ongoing Research Monitoring and Reporting

-Annual Continuing Review: For research extending beyond one year, researchers submit annual continuing review reports to the REB through the Research Ethics Coordinator, including:

  • Number of participants enrolled
  • Any adverse events or unanticipated problems
  • Protocol modifications
  • Current status of research (active enrolment, data analysis, completed)

-Protocol Modifications: Any modifications to approved research protocols require REB approval before implementation. Researchers submit modification requests through the Research Ethics Coordinator describing proposed changes and rationale.

-Adverse Events and Unanticipated Problems: Researchers must report adverse events or unanticipated problems to the Research Ethics Coordinator immediately (within 24–48 hours), who in turn communicates with the REB. The REB determines whether research should be modified, suspended, or terminated to protect participant welfare.

-Research Completion: Upon research completion, researchers submit final reports to the REB through the Research Ethics Coordinator indicating the completion date, total participants enrolled, and disposition of research data.

Research Misconduct

-Definition of Misconduct: Research misconduct includes:

  • Fabrication or falsification of data
  • Plagiarism (see also the CCTCM Academic Integrity Policy)
  • Failure to obtain required REB approval
  • Violation of informed consent procedures
  • Breach of confidentiality
  • Failure to disclose conflicts of interest
  • Conducting research differently from the REB-approved protocol without approval

-Investigation and Consequences: Allegations of research misconduct are reported to the Research Ethics Coordinator and investigated jointly by CCTCM and the external REB. Confirmed misconduct may result in:

  • Immediate suspension of research activities
  • Requirement to notify participants and other affected parties
  • Disciplinary action (students and faculty) per CCTCM policies
  • Reporting to professional regulatory bodies (e.g., CTCMPAO)
  • Publication retraction

CCTCM maintains ultimate responsibility for addressing research misconduct by its faculty and students, even when using an external REB.

TCPS 2 Training Requirements

-Mandatory Training: All individuals conducting research involving human participants must complete the TCPS 2 online training course (Course on Research Ethics — CORE) before submitting research proposals for REB review. This includes:

  • Faculty principal investigators
  • Student researchers (including thesis students)
  • Research assistants involved in participant recruitment or data collection

Certificates of TCPS 2 training completion must be submitted with research proposals. Training must be renewed every three (3) years for researchers conducting ongoing research.

Research Involving Indigenous Peoples

-Compliance and Engagement: Research involving Indigenous peoples, communities, or Indigenous knowledge systems must comply with Chapter 9 of TCPS 2. Researchers proposing such research must:

  • Engage the relevant Indigenous community or communities early in the research design process
  • Seek community consent in addition to individual participant consent, where appropriate
  • Negotiate research agreements addressing data ownership, use, and dissemination
  • Ensure research provides meaningful benefits to the community
  • Respect community protocols for the protection of traditional knowledge

The Research Ethics Coordinator will provide guidance on Chapter 9 requirements and facilitate connections with community partners as needed.

Management of Research Funds

-Fund Administration: When CCTCM receives research funding from external sources:

  • Funds are administered through CCTCM’s financial office
  • Separate accounts are maintained for each funded project
  • Expenditures must align with approved budgets and funding agreements
  • Regular financial reports are provided to funding agencies as required

-Researcher Responsibilities: Principal investigators are responsible for:

  • Using funds only for approved research purposes
  • Maintaining detailed expense records
  • Ensuring compliance with funding agency requirements
  • Reporting financial irregularities to CCTCM administration immediately

-Financial Oversight: The Financial Office Manager monitors research fund expenditures and reports irregularities to the President/Director. Misuse of research funds constitutes serious misconduct subject to disciplinary action and potential legal consequences.

Institutional Responsibility

-Scope of Responsibility: While CCTCM uses an external REB for research ethics review, the College maintains ultimate institutional responsibility for:

  • Ensuring all research conducted under its auspices receives appropriate ethical review
  • Monitoring compliance with REB-approved protocols
  • Providing appropriate resources and support for ethical research conduct
  • Maintaining research ethics records and documentation
  • Addressing research misconduct by faculty and students
  • Ensuring researchers understand and comply with ethical standards
  • Protecting the rights and welfare of research participants in CCTCM-affiliated research

Policy Review

This policy shall be reviewed every three (3) years by the Research Ethics Coordinator and President/Director to ensure continued alignment with TCPS 2, partner REB requirements, and evolving ethical standards.

Related Documents and References

  • CCTCM Academic Integrity Policy
  • CCTCM Copyright Policy
  • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2022)
  • TCPS 2 Course on Research Ethics (CORE)
  • Personal Health Information Protection Act, 2004 (PHIPA)
  • Copyright Act (R.S.C., 1985, c. C-42)