IRB Frequently Asked Questions

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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.

Submission Process

Q: What’s the first step in conducting a study?

A: Scientific review and approval is required prior to IRB submission, either by the Research Program Chair or the Director of Research.

Student Research: Contact Dr. Heather Zwickey for approval prior to submission of all student IRB submissions and modifications.

Non-Student Research: Contact Director of Research Dr. Ryan Bradley with inquiries regarding contract research. Contact NUNM IRB Liaison for IRB questions and submission of all non-student IRB submissions and modifications.

Q: Which forms do I need to submit to the IRB?

A:  Please see the IRB Documents page for a full list of documents that are required for a study submission to the IRB.

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.

Q: Are there submission deadlines I need to know about?

A: Yes. Please see the Scientific Review and IRB Submissions page for specific deadlines.

External Research & Investigator Qualifications

Q: Does the NUNM IRB review external research?

A: Yes. Please note that the IRB determines which type of review is required. The schedule of fees is available on the Contract Research page under “IRB Review”.

Q: What is considered external research?

A: Any research that is not submitted by an NUNM principal investigator (PI).

Q: Who is considered an NUNM PI?

A: To be an NUNM 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: Yes. However, the review fee will apply if the PI does not meet the requirements above.

Case Studies & Case Series

Q: If my research project is a case study or case series, do I need to submit in full to the IRB?

A: 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 you may petition for exemption of a full IRB review. In either case, an initial review by the IRB is required.

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.

Other Common Questions

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: 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. 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, (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.