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Please note: a complete protocol, with ALL necessary addendum forms, must be submitted with these forms. After your study receives IRB Approval, please submit an electronic copy of your lay summary to Lita Buttolph in order to highlight your research on the Helfgott website.

Before you begin your study, check to see if an IRB review is required.

Required documents for scientific review:

• SR One–Page Proposal – 05.18.18
• SR Checklist – 05.18.18 (for full submission review)

Required documents for all IRB submissions:

• Consent Form Template – 05.25.17
• Initial Review Questionnaire – 04.27.17
• Study Protocol (see links to  template and example protocol under “Protocol Resources” below)
• Completed Checklist for IRB Review – 05.18.18

Each investigator must complete a:

Disclosure of Significant Financial Interests (DSFI) Form – 08.23.21

and undergo RCR and HIPAA training. Email completed forms to: NUNM IRB Liaison, Lita Buttolph.

Select documents from the list below may be required depending on the study design:

• IRB Exemption/Expedited Review – 05.18.18 (if applicable)
• Secondary Data Analysis Projects – 07.21.16
• Biological Specimens Collection and Storage Form – 07.19.16
• Dietary Supplement, Herbal Remedy, or Other Complementary or Alternative Remedy Form  – 07.19.16
• Focus Groups, Interviews, Questionnaires, Surveys, or Non–Interventional Observations Form  – 07.19.16
• Investigational Devices  – 07.19.16
• Investigational Drugs  – 07.19.16
• Decisionally Impaired Adults Form – 07.19.16
• Consent Form Template – 05.25.17
• Non–NUNM Data Collection Form  – 07.19.16
• Waiver of Authorization Form – 06.22.18
• IRB Agreement & Authorization Form  – 05.02.17
• IRB Authorization Agreement – 05.02.17

Protocol Resources

Refer to the SPIRIT 2013 Checklist here.

• Protocol Template – 02.02.17
• Example Protocol – 01.20.16

Background Resources

• How to Write Specific Aims – 07.21.16

Case Reports

• Case Series Instructions – 07.21.16
• Consent Form for Case Reports – 11.06.19

Medical Responsibility Assurances Forms

• PI Assurances Form – 12.06.16
• CI Assurances Form – 07.19.16

Telephone Script (if applicable)

• Telephone Screening Template – 07.21.16

Advertisement (if applicable)

• Advertisement Criteria – 07.21.16
• Example Advertisement – 06.05.15

Resources for Approved Studies

• Adverse Events Log – 07.19.16
• Unanticipated Problem Reporting Form – 07.19.16
• Adverse Events Spontaneous Reporting Form – 07.19.16
• Protocol Deviation Violation Form – 07.19.16
• Protocol Revision and Amendment Form (PRAF) – 07.19.16
• Protocol Revision Amendment Form–no signature – 07.19.16
• Continuing Review Form – 07.19.16
• Final Review Form (FRF) – 04.10.17
• Reactivation Request – 07.19.16
• Basic Blood Draw Informed Consent & Authorization Form – 07.21.16
• Lay Language Protocol Summary – 07.21.16
• W–9 Letter Form – 07.21.16