The Helfgott Research Institute at the National University 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, NUNM 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 NUNM 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.
Responsible Conduct of Research (RCR) Training
Protecting Human Research Participants
Formerly Responsible Conduct of Research (RCR) training.
RES 505 Bioethics and RES 521 Integrative Research Fundamentals II fulfill the training requirement (five year renewal). Additional trainings are held as needed. Contact Kim Tippens 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, 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 Kim Tippens 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, firstname.lastname@example.org for information about scheduled trainings.
Financial Conflicts of Interest
In addition, NUNM 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 NUNM and Helfgott to annually disclose any significant financial interest with a Disclosure of Significant Financial Interest form. Questions concerning financial conflict of interest disclosures may be directed to Kendal Kubitz, email@example.com.
For the complete NUNM Policy and Procedure on Managing Financial Conflicts of Interest in Research, including key definitions and responsibilities of the College, please take a look at this document 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, NUNM laboratories do not house animal research facilities or conduct animal experiments.