Visit the following pages for detailed information on the steps in the IRB application process.
- Scientific Review and IRB Submissions – Detailed information on how to submit your project for scientific review and to the IRB.
- Scientific Review and IRB Documents – Required and supplemental documents for scientific review and IRB submissions.
- Responding to the IRB – Information on the process following submission of your application, resubmission, tips and tricks for crafting a resubmission response.
- IRB Review Exemptions – Types of projects that are automatically exempt or may be exempt upon IRB review.
- IRB Expedited Reviews – Requirements and categories of projects to be eligible for expedited review.
- Adverse Events – Definitions and requirements for reporting adverse events.
- Frequently Asked Questions – Answers to commonly asked questions about the IRB process.
Why is IRB Approval Required?
The Helfgott Research Institute at 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.
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 NUNM IRB Liaison, Lita Buttolph.
For the complete NUNM Policy and Procedure on Managing Financial Conflicts of Interest in Research, including key definitions and responsibilities of the university, please see the policy 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.