Chapter 6 — Ethics, Integrity & Commercial Support

Chapter 6 — Ethics, Integrity & Commercial Support

6.1 Policy Statement

ARmed for Medical Training and Consultancy – LLC – OP.C is committed to delivering CME/CPD education that is free from commercial bias and undue influence, in strict alignment with the DOH CME/CPD Quality Assurance Manual.

All financial and in-kind support must be managed transparently, through written agreements that guarantee independence in planning, faculty selection, and educational content. Learners must be informed of the source and nature of support, and all relevant financial relationships must be disclosed and mitigated.

6.2 Rationale

  • DOH Quality Assurance Manual: prohibits logos, trade names, and promotional messages in accredited education; requires separation of commercial support from educational design and delivery.
  • Activity Development Guide: highlights the risk of bias if planners or faculty have financial relationships with ineligible companies; mandates COI disclosure and mitigation.
  • Upholding integrity and independence build trust, ensures credibility with learners, and safeguards the organization against loss of accreditation.

6.3 Principles of Ethical CME/CPD

  1. Independence: All decisions regarding educational content, learning objectives, faculty, and assessment are made by ARmed committees only.
  2. Transparency: All financial relationships are disclosed to learners and regulators.
  3. Separation of Promotion from Education: Commercial promotion is strictly separated from accredited CME/CPD.
  4. Accountability: All commercial support is documented, reported, and retained for 6 years.

6.4 Conflict of Interest (COI) Governance

6.4.1 Disclosure

  • All planners, faculty, and reviewers must disclose relevant financial relationships from the past 24 months.
  • Disclosure forms are reviewed by the Oversight Committee before activity approval.

6.4.2 Mitigation

  • Abstaining from participating in decision-making.
  • Peer-review of educational materials.
  • Replacing conflicted faculty when necessary.
  • Documenting mitigation in the activity file.

6.4.3 Learner Notification

  • Standard disclosure statement presented at the start of the activity:
    “All relevant financial relationships have been mitigated. This activity is free from commercial bias.”

6.5 Commercial Support Management

6.5.1 Educational Grants

  • Must be unrestricted, payable to ARmed (the provider), never directly to faculty.
  • Governed by a Letter of Agreement (LOA) signed by ARmed and the supporter before the activity.

 

6.5.2 Prohibited Practices

  • No sponsor involvement in topic selection, faculty choice, or content approval.
  • No use of trade names, logos, or product images in slides, handouts, or certificates.
  • No distribution of promotional material in educational sessions.

6.5.3 Acknowledgment of Support

  • Sponsors may be acknowledged in logistics materials only (e.g., brochure back page, schedule, signage outside educational rooms).
  • Acknowledgment must be limited to:
    • Name of company.
    • Statement of financial support.
  • Example: “This activity is supported by an unrestricted educational grant from [Company Name].”

6.6 Monitoring for Bias

  • Learners must be asked on the evaluation form whether they perceive any bias in the activity.
  • Oversight Committee reviews evaluation data for bias indicators.
  • Reports of bias trigger immediate review and corrective actions (e.g., faculty retraining, revision of materials, notification to DOH if severe).

6.7 Escalation & Corrective Actions

  • Minor issues (e.g., unintentional use of trade names in slides) → corrected by faculty with documentation.
  • Moderate issues (e.g., incomplete COI disclosure) → escalated to Scientific Director; faculty participation suspended until resolved.
  • Serious issues (e.g., sponsor influencing content) → escalated to Oversight Committee and reported to DOH within 10 working days .

6.8 Documentation and Retention

  • All COI disclosures, mitigation notes, LOAs, acknowledgments, and related correspondence retained for 6 years.
  • Stored in the Activity File for each event, accessible for DOH audits.

6.9 Continuous Quality Improvement

  • Trends in bias reports and COI issues are reviewed annually.
  • CAPA log updated with preventive strategies (e.g., new COI training, stricter review checklists).
  • Benchmarking against international standards (ACCME Standards for Integrity and Independence).

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