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Institutional Review Board & Research Integrity

The Helfgott Research Institute at the National College of Natural Medicine requires that all faculty, employees, and students comply with certain policies and procedures as published by the Department of Health and Human Services (DHHS), in Title 45 Code of Federal Regulations Part 46 (45 CFR 46), regarding the rights and welfare of human research subjects. Additionally, NCNM is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research, known as The Belmont Report.

According to the Code of Federal Regulations, “Human Subjects” are defined as:

"Living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." [45 CFR 46.102(f)(1-2)]

Thus, the mission of the NCNM IRB is to ensure the protection of human subjects in research. The IRB evaluates all clinical studies, student projects or surveys that involve the collection of tissue, blood, genetic material, or any other identifiable private health information. While certain types of research studies may be eligible for exemption from review, only the IRB has the authority to grant such exemptions.

Research Integrity

The National College of Natural Medicine shall require the highest standards of quality, ethics and integrity in the conduct of scientific research by its faculty, residents, students and other affiliated investigators. The advancement of knowledge through research relies upon the trust of the scientific community and the public-at-large in the integrity of the scientific process. For these reasons, NCNM considers unethical behavior a breach of that confidence and shall promptly deal with all instances of possible research misconduct.

Responsible Conduct of Research (RCR) Training

RCR Requirement for Students

RES 518 Research and Ethics and RES 505 Bioethics fulfill the annual RCR training requirement. Additional trainings are held as needed. Contact Morgan Schafer at mschafer@ncnm.edu for more information about scheduling additional trainings.

RCR Requirement for Faculty and Staff

Training in Responsible Conduct of Research is required every year for faculty, staff, and other affiliated researchers. To facilitate timely fulfillment of this requirement, an annual classroom RCR training is conducted. Contact Krista Bargsten at kbargsten@ncnm.edu for information.

Health Insurance Portability and Accountability Act (HIPAA) Training

HIPAA Requirement for Students

Training in HIPAA regulations is required every five years for students. Contact Morgan Schafer at mschafer@ncnm.edu for more information.

HIPAA Requirement for Faculty and Staff

Training in HIPAA regulations is required every five years for faculty, staff, and other affiliated researchers. Contact Krista Bargsten at kbargsten@ncnm.edu for information about scheduled trainings.

Financial Conflicts of Interest

In addition, NCNM policy requires there be public accessibility to information concerning significant financial interests that have been disclosed to the college and determined to be financial conflicts of interest in research. Questions concerning financial conflict of interest disclosures may be directed to Krista Bargsten, kbargsten@ncnm.edu. For the complete NCNM Policy and Procedure on Managing Financial Conflicts of Interest in Research, including key definitions and responsibilities of the College, please follow the link below.

Managing Financial Conflicts of Interest in Research

This policy is written to be in compliance with and extensively quotes from the Department of Health and Human Service's issuance of the August 25, 2011 Final Rule on Financial Conflict of Interest Rules and Regulations.

 

In keeping with the principles of natural medicine, NCNM laboratories do not house animal research facilities or conduct animal experiments.