Follow these instructions if you are submitting a new study for full board or expedited review.
Step 1: Determine whether your study meets the criteria for expedited review ([45 CFR 46.110 and 21 CFR 56.110). If it does not, it will go to the Full Board for Review.
|As appropriate, submit the following appendices/forms:
- Appendix – Children: Submit this form when you plan to enroll children (ages 0-17) in your study.
- Appendix – Pregnant Women, Fetuses and Neonates: Submit this form when you plan to enroll pregnant women, fetuses, or non-viable or uncertain viability neonates in your study.
- Appendix – Prisoners: Submit this form when you plan to enroll prisoners in your study.
- Appendix- Cognitively Impaired: Submit this form when you plan to enroll cognitively impaired persons in your study.
- Appendix – Devices: Submit this form when your study involves the use of a device.
- Appendix – Drugs/Biologics: Submit this form when your study involves the use of a drug or biologic
- Appendix – Department of Defense Supplement: Submit this form if you will be using funding from the Department of Defense to conduct this study.
- Controlled Substance Form
- Application for Waiver of Informed Consent and/or HIPAA authorization: Submit this form to request any type of waiver for consent or HIPAA authorization
- For lists of who to obtain signatures from, please click here.
- If research is being conducted at multiple Northwell Health sites, facility approval must be obtained for all of the sites
- If study personnel are from multiple departments, approval must be obtained from all departments represented
Step 3: The following items must be completed by all study personnel.
Step 4: Assemble your submission packet. A submission packet will include all of the above completed and signed items as well as the following:
- Research Protocol in MS Word format or (if sponsored study) searchable PDF format
- This should be a detailed plan describing the objectives, design, methodology, statistical considerations, etc. of the study. Click here for a template with guidance on required elements
- Any of the following as applicable to the study:
- Consent Form in MS Word format
- Any other written information to be provided to subjects, such as:
- Survey and/or other research instruments
- Any advertising or recruitment materials
- Instructions, education, letters, etc.
- Investigator’s Brochure
- Data Collection Forms
- Copy of FDA Form 1572
- Copy of the complete grant application (if the research has been submitted as a grant proposal for potential funding)