Institutional Review Board (IRB) / Independent Ethics Committee (IEC)

All clinical investigations involving human participants, data, or specimens must be reviewed and approved by a duly constituted Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before study initiation. The IRB/IEC is responsible for safeguarding the rights, safety, and well-being of all study participants. This includes: Reviewing the study protocol, informed consent documents, and recruitment materials to ensure ethical conduct and compliance with applicable regulations.

• Assessing the balance of potential risks and anticipated benefits to participants.
• Ensuring that adequate informed consent procedures are in place and properly documented.
• Monitoring ongoing studies through periodic reviews, as required by local regulations or institutional policies.
  The composition, functions, and operations of the IRB/IEC shall be in accordance with:
• ICH-GCP E6 (R2) – International Council for Harmonisation Good Clinical Practice
• ISO 14155 – Clinical investigation of medical devices for human subjects – Good clinical practice
• Applicable national, regional, and local regulatory requirements (e.g., 21 CFR Part 56 in the United States, EU MDR 2017/745 in Europe).

No study-related activities may commence until written approval from the IRB/IEC has been obtained and documented. Any protocol amendments or significant changes to study documents must also receive IRB/IEC review and approval before implementation, unless required to eliminate immediate hazards to participants."