Institutional Review BoardThe 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, all research activity, regardless of funding and including student projects, which include the collection of tissues, blood, genetic material, and private information, as well as clinical studies, surveys, and chart reviews all require IRB approval. The mission of the IRB is to evaluate each study to ensure protection of human study participants. While certain types of research studies may be eligible for exemption from review, only the IRB has the authority to approve research or grant exemptions.
FormsInvestigators may download all the forms necessary for a complete IRB submission on the IRB Documents Page (in the left menu). Please note that a complete protocol, with ALL necessary addendum forms, must be submitted with these forms. Student Researchers who are designing a study should be in close contact with Student Research Specialist, Morgan Schafer (mschafer@ncnm.edu) well before any IRB submission date.
Scientific Review and IRB SubmissionsAll IRB submissions, including Protocol Revision and Amendment Forms (PRAF), must be submitted through the administrative offices of the Helfgott Research Institute. The IRB does not accept forms directly from investigators or researchers. Complete IRB submissions must be sent, in electronic form, to the Associate Director of Research, Kevin Marsman (kmarsman@ncnm.edu) by the submission due dates listed below (the first Monday of the month, excluding holidays). If at all possible, please do not submit paper forms. If an electronic signature or scanner is not available, you may drop off just the signature page(s) to the desk of Kevin Marsman in the NCNM, Administrative Building Suite #250, 049 SW Porter St. Portland, OR 97201. As a matter of procedure, all IRB submissions will be reviewed by the Helfgott Scientific Advisory Committee (SAC) prior to its being sent to the IRB. Your protocol and all necessary forms and addendums should be considered final and complete upon their submission to Helfgott. During review, SAC members will work with you to make any appropriate revisions and edits. If the submission passes SAC review, applications are then sent, at the beginning of the following month, to the IRB for review. Please note that this means that from the time you submit your application for scientific review to the earliest possible approval date by the IRB is about a month and half. An IRB deferment or "approval with modifications" will necessarily add to that turn around time. Scientific Review Committee (SAC) submission due dates for 2012 (first Monday of the month):
Full IRB Meetings are generally convened on the third Tuesday of the month.
Protocol Revision/Amendment Forms (PRAFs)PRAFs (modifications to approved studies) must be sent electronically to Kevin Marsman (kmarsman@ncnm.edu). The IRB does not accept PRAFs directly from investigators. Typically, a PRAF does not need to go through the full SAC review process. Assuming that it is accurate and complete, Helfgott will gather all PRAFs and forward them on to the IRB every two weeks for immediate consideration. However, if the modification is complex or may substantially affect human subjects, the PRAF may not be expeditable by the IRB chair and will need to go to the next scheduled IRB meeting. Please Note: In order for a PRAF to undergo a full IRB review in a given month, it must be submitted to the IRB by the first Tuesday of that month. If you have a concern that your modification may require full review please be in contact with Kevin Marsman (kmarsman@ncnm.edu) to assure that your PRAF gets to the IRB in time for the next scheduled IRB meeting or you may need to wait for the following month's full review. The following, every other Thursday, are the PRAF due dates:
Contact Information:Student Research Specialist Associate Director of Research IRB Coordinator IRB Chair |