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, Emily Stack.
For the complete NUNM Policy and Procedure on Managing Financial Conflicts of Interest in Research, including key definitions and responsibilities of the university, 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.
Responding to the IRB
After Initial Submission to the IRB
An initial IRB submission is due by 5 p.m. on the first Tuesday of the month. Every third Tuesday of the month, the IRB convenes to collectively review the submitted documents. After the IRB meeting, the IRB Chair, Primary Reviewer, and IRB Administrative Assistant put together a Committee Summary that thoroughly describes the study’s points that need further addressing.
The study will be assigned one of the following categories:
- Approved – No additional changes are required in order for this study to start. This includes recruitment.
- Contingent Approval – Minor changes are required before study can start (i.e. recruitment may NOT start). Study materials can be resubmitted to the IRB Liaison at the investigating team’s earliest convenience.
- Deferred – Too many edits are required for contingent approval; another full IRB review is required. The investigating team must submit their study documents to the IRB Liaison at the normal IRB deadline, first Tuesday of the month.
- Rejected – Major modifications are needed in order for the study to be considered for approval.
One of these four terms will be indicated at the bottom of your IRB Committee Summary. It is important to carefully review this document. In the summary, the IRB will describe in detail their decision for choosing the status they chose as well as any modifications you can make in order to improve the study and/or its status.
Resubmissions must include a response to each of the IRB’s concerns on the Committee Summary. Include the response directly below the described concern and in a different color font, preferably blue. Use track changes to show revisions in all relevant documents, as well as, provide a clean copy of the document with changes made. (Please add ‘_clean’ at the end of the document title.)
Please also include the original IRB Checklist and check the “resubmission” box, indicating that the study is a resubmission.
Tips & Tricks
The IRB is your partner and acts as the first legal step to having a study with your name on it. The IRB’s job is to make sure each study is conducted ethically and that participants are protected from harm. When corresponding with the IRB, or any professional organization, diplomacy and clear communication should always be the first priority.
Other factors to consider when composing your response:
- Provide a logical and/or scientific explanation for choices – especially if you are not taking the IRB’s advice. Be very thorough in your response.
- Use professional language– reflect your education and training in your choice of words.
- Respond to EVERY aspect of the Committee Summary – don’t leave anything out; the IRB will notice and ask you to resubmit.
- Attend the IRB review of your study (highly recommended).
Another way to ensure clear communication is to relay any minor questions to the IRB Liaison before you submit. If there are any larger questions or pressing matters, the IRB Liaison can always relay your question(s) to the IRB for you.