Institutional Review Board (IRB)

The Institutional Review Board (IRB) of Colorado Chinese Medicine University (CCMU) is responsible for the ethical review and ongoing oversight of research involving human participants conducted under the authority of the University. The IRB operates independently to protect the rights, safety, and welfare of research participants.

IRB Authority & Independence

The CCMU IRB is formally authorized by the Board of Directors to conduct independent ethical review of human subjects research. While the IRB is administratively supported by the Research Department, all ethical review determinations are made independently by the IRB. Institutional leadership and administrative units do not influence IRB deliberations or decisions.

IRB Scope of Review

The IRB reviews research activities involving human participants, including but not limited to observational studies, clinical and educational research, case-based studies, and retrospective data analysis. CCMU’s research focus emphasizes the evaluation and documentation of the effectiveness and application of Traditional Chinese Medicine through ethically conducted human subjects research.

IRB Review Process

The IRB oversees the ethical review process throughout the lifecycle of a research project, including:

• Initial review of research protocols

• Review of amendments and modifications

• Continuing review and study progress oversight

• Review of unanticipated problems and noncompliance

• Decisions to approve, require modifications, suspend, or terminate research

All reviews are conducted in accordance with institutional policies, ethical principles, and applicable regulatory requirements.

Researcher Responsibilities

Researchers and research personnel are responsible for conducting research in compliance with approved protocols, ethical standards, and applicable regulations. Researchers must obtain IRB approval prior to initiating research and maintain ongoing communication with the IRB throughout the study.

IRB Office & Contact

The IRB Office serves as the administrative point of contact for IRB-related submissions, communications, and participant inquiries. The IRB Office operates independently from research teams and provides a channel for research participants to raise questions, concerns, or complaints related to research participation.

IRB Office Contact:
Email: irb@ccmu.edu

Regulatory Status

Colorado Chinese Medicine University (CCMU) is registered with the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), as an organization operating an Institutional Review Board (IRB).
CCMU has been assigned Institutional Organization (IORG) Number: IORG0011703.

This registration confirms that CCMU is recognized by OHRP as an institution operating an IRB in accordance with applicable federal requirements.

IRB registration with OHRP does not by itself constitute a Federal wide Assurance (FWA).

Policies & Procedures

IRB policies, standard operating procedures, submission guidance, and related documents are available to researchers upon request or through the Research Department portal.

Chairman

Members

The CCMU Institutional Review Board is composed of individuals with diverse professional backgrounds to ensure comprehensive and balanced ethical review of human subjects research. IRB members are appointed by the University and collectively possess expertise relevant to the scientific, clinical, ethical, and community aspects of research.

The IRB membership includes, but is not limited to, the following roles and perspectives:

• Chairperson with experience in research ethics and human subjects protection

• Members with clinical and academic expertise relevant to Traditional Chinese Medicine

• Members with scientific or methodological research backgrounds

• A non-scientific member to represent ethical and community perspectives

• At least one member independent of the University to provide an external viewpoint

IRB members are required to complete appropriate training in research ethics and human subjects protection and must disclose and manage any potential conflicts of interest in accordance with institutional policies.

Specific member identities are maintained by the IRB Office and made available to regulatory authorities or authorized parties upon request.