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:
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.
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.
RCR Requirement for Students
RES 518 Research and Ethics and RES 505 Bioethics fulfill the RCR (5 year renewal) training requirement. Additional trainings are held as needed. Contact Morgan Schafer at email@example.com for more information about scheduling additional trainings.
RCR Requirement for Faculty and Staff
As of February 2015, training in Responsible Conduct of Research is required every 5 years (in accordance with NIH standards set in place) for faculty, staff, and other affiliated researchers. For new and renewing researchers, an annual classroom RCR training is conducted. Contact Kendal Kubitz at firstname.lastname@example.org for more 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 email@example.com 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 Kendal Kubitz at firstname.lastname@example.org for information about scheduled trainings.
Financial Conflicts of Interest
In addition, NCNM policy requires that 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. We require anyone involved in current research at NCNM and Helfgott to annually disclose any significant financial interest with a Disclosure of Significant Financial Interest form (found on the IRB Documents page). Questions concerning financial conflict of interest disclosures may be directed to Kendal Kubitz, email@example.com. 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.
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.