Protocol Submission: Exempt Research
How to Submit a Protocol to the IRB: Exempt Research
Step 1: Determine whether your study meets the criteria for this category (see Policy 1.1, Exempt Research ).
Step 2: Click on the underlined links below to download and complete the IRB submission forms for full board review.
Note: If you are conducting a retrospective chart review study, use the forms specific to that category (see Chart Review Studies).
IRB Submission Forms for Exempt Research
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| IRB Form 1 | Proposal Flow Sheet |
| IRB Form 1a | Study Personnel - Documentation of Required Education |
| IRB Form 4 | Complete the Protocol Summary on the Top of the first page of Form 4 only |
| IRB Form 3 | Conflict of Interest Questionnaire (one for the PI and a separate form for each investigator listed on Form 1a) |
| IRB Form 4a | Application for Determination of Exempt Status |
| IRB Form 4c | HIPAA Compliance |
Step 3: Assemble your submission packet. A submission packet must include all completed IRB submission forms (in numerical order) plus the following:
- Research Protocol (the detailed plan describing the objectives, design, methodology, statistical considerations, etc. of the study – click here for guidance on required elements.)
- Data Collection Forms (if appropriate)
- Any other written information to be provided to subjects
- Survey and/or other research instruments
Step 4: You may submit your completed packet – with all required signatures – to the Office of the IRB by the following methods:
A. Email your submission to the Office of the Institutional Review Board at irb@nshs.edu as attached documents in an editable format such as Word or Excel.
B. All submission forms that require signatures should be signed by the appropriate person and sent to the IRB by one of the following methods:
- Email signed forms to irb@nshs.edu as attached PDF documents, OR,
- Fax signed forms to the Office of the Institutional Review Board at 516-562-3105, OR, you may choose to
- Mail signed submission forms to the Office of the Institutional Review Board, 350 Community Drive, Manhasset, NY 11030 via interoffice OR,
- Hand-deliver signed submission forms to the Office of the Institutional Review Board. See: Directions to the Office of the IRB.
Please contact the Office of the Institutional Review Board if you have any questions or need assistance:
● Phone: 516-562-3101 ● Email: irb@nshs.edu ● Fax: 516-562-3105
Case managers for specific departments can be found by clicking here.