Below are answers to some frequently asked questions about the NUNM IRB’s policies and procedures. If you have a question about the IRB, but do not see it listed below, please contact the NUNM IRB Liaison, Lita Buttolph.
Q: If my research project is a case study or case series, do I need to submit in full to the IRB?
A: Not all research studies must be reviewed by the IRB. Please see the IRB Review Exemptions page for guidelines to determine if your study may be automatically exempt from review by the IRB or if it may be petitionable for exemption of a full IRB review after an initial review by the IRB is conducted.
Q: Do I send my documents directly to the IRB?
A: No. All communications with the IRB, including study submissions, should happen via the IRB Liaison, Lita Buttolph.
Q: For a prospective case study or case series, should the physicians involved submit a Disclosure of Significant Financial Interest (DSFI) form but not complete Responsible Conduct of Research (RCR) and Health Insurance Portability and Accountability Act (HIPAA) training?
A: For a prospective case study or case series, if the physicians are not co-investigators, they do not need to provide a signed DSFI form nor are they required to complete RCR and HIPAA training.
Q: Which forms do I need to submit to the IRB for my study?
A: Please see the IRB Documents page for a full list of documents that are required for a study submission to the IRB.
Q: Who can be a Principal Investigator (PI) on my study?
A: To be a PI, an individual must be a current NUNM faculty member (covered by NUNM’s insurance) and affiliated with the Helfgott Research Institute.
Q: I’m an NUNM student working on a research study, can I be the PI?
A: NUNM students are not eligible to be principal investigators, regardless of their qualifications. Students must have an NUNM faculty member serve as PI on their study.
Q: Who can be a Clinical Investigator (CI) on my study?
A: If the study is occurring on the NUNM campus, the CI on the study must be a current NUNM faculty member affiliated with the Helfgott Research Institute.
If the study is occurring off the NUNM campus, the CI must be a clinician associated with the off-campus site.
Q: I’m an alumnus of NUNM, can I send my study to the NUNM IRB for review?
A: Only if the PI meets the requirements above.
Q: My study doesn’t meet the PI requirement. How can I have it reviewed?
A: Western IRB provides independent IRB services. Their website is: www.wirb.com
Q: I’m not a student, does my study still need to go through Scientific Review before being sent to the IRB?
A: As a matter of procedure, all IRB submissions will be reviewed by the Helfgott Scientific Review Committee prior to its being sent to the IRB. Your protocol and all necessary forms and addenda should be considered final and complete upon their submission to Helfgott. During review, SRC members will work with you to make any appropriate revisions and edits. If the submission passes SRC review, applications are then sent, at the beginning of the following month, to the IRB for review. Please see the Scientific Review and IRB Submissions page for deadlines and contact the NUNM IRB Liaison, Lita Buttolph, if you have any questions.
Q: What’s the first step in conducting a study?
A: All Student Projects: Contact Doug Hanes, Student Research Specialist, for pre-submission of all student projects, initial submissions, and PRAFs.
All Non-Student Projects: Contact NUNM IRB Liaison, Lita Buttolph, for submission of all non-student projects, initial submissions, and PRAFs.
Q: Does my thesis project need to be reviewed by the IRB?
A: For students submitting educationally-oriented studies, please submit the IRB Exemption and Expedited Review Petition Form as well as the Initial Review Questionnaire (IRQ). Complete only the portions of the IRQ that are relevant. Both documents may be found on the IRB Documents page.
Q: Are there submission deadlines I need to know about?
A: Yes. Please see the Scientific Review and IRB Submissions page for specific deadlines.
Q: My study was approved by the IRB, do I need to send anything else to the IRB?
A: Yes. All studies approved by the IRB must submit annual Continuing Review documents (see IRB Documents for this form) to the IRB via the NUNM IRB Liaison, Lita Buttolph. Additionally, any proposed changes to a protocol must be approved by the IRB; a Protocol Revision Amendment Form (PRAF) must be submitted for this action (see IRB Documents for this form). Any adverse events must also be reported (see IRB Documents for adverse events forms and logs). Once a study is completed and no further data analysis, publications, presentations, etc. will occur, the investigators must submit a Final Review document to the IRB via the NUNM IRB Liaison, Lita Buttolph, (see IRB Documents for this form).
In addition to the processes listed above, all investigators on each study must submit their annual DSFI (Disclosure of Significant Financial Interest – see IRB Documents for this form) to the IRB Liaison as well as certificates of completion for their RCR and HIPAA trainings.
Q: What is the Belmont Report?
A: Please see this page for information about the Belmont Report.
Q: Is there a Code of Federal Regulations for Human Subjects Research?
A: Please see this page for more information about U.S. federal regulations about human subjects research.