Institutional Review Board

Contact Eileen Gazzola, IRB Administrator at egazzola@nyit.edu or 516.686.7488, for more information.

Institutional Review Board COVID-19 Documents

Frequently Asked Questions of the Institutional Review Board for the Protection of Human Subjects:

Six steps for submitting a protocol for review
How do I Complete the Required IRB Training?
What type of review should I request?
What forms are required to submit my protocol?
How do I describe my project to the IRB?
How do I write a consent or assent form?
When should I submit my protocol for review?
Where should I send my application and protocols?
Whom do I contact with questions?

Six steps to submitting a protocol for review

Complete the online training module
Determine which type of review is appropriate for your project
Complete the Request for Exemption or the Application for Expedited or Full Review and attach materials as necessary
Describe your project to the IRB according to the questions on the Request for Exemption or Application for Expedited or Full Review form
Obtain permissions and signatures as necessary
Submit the complete package and copies as indicated on the forms to the appropriate IRB

Federal Policies and Guidance

The Belmont Report
Protection of Human Subjects (45 CFR 46)
Office for Human Research Protections/DHHS
HHS Human Subjects Protection Update – Revised Common Rule
National Science Foundation Guidelines (PDF)
- National Science Foundation Frequently Asked Questions about Social and Behavioral Science Research
National Institutes of Health Guidelines
The US Department of Education Guidelines
Human Subjects Regulations Decision Charts: 2018 Requirements

NYIT IRBs

IRB Human Research Protections Manual and Guidance for Submitting Protocols

The most common reason for delay in IRB review is lack of information about the study procedures, recruitment, or instruments. Please read the instructions carefully and answer all questions on the forms. Direct questions to the Office of Sponsored Programs and Research at x7488.

Describing your Research to the IRB: a guide for presenting your research to the IRB (PDF)
IRB Reviewer's Full Review Checklist (PDF) – for use by IRB members for a Full Review protocol
IRB Reviewer's Exempt Checklist (PDF) – for use by IRB members for an Exempt protocol
IRB Reviewer's Expedited Checklist (PDF) – for use by IRB members for an Expedited protocol
Clinical Trial Checklist (PDF) – to determine if your protocol is a Clinical Trial
NIH Clinical Trial Decision Tree (PDF)
Human Subjects Decision Trees
New York Tech Procedures and Guidelines Manual, Volume 1 (PDF)
New York Tech Procedures and Guidelines Manual, Volume 2 (PDF)

Completing the Required IRB Training

All key personnel, including students, are required to register with the Collaborative Institutional Training Initiative (CITI) and complete a CITI online training program before beginning their research. To register, follow the New Learner Account Registration instructions appended below. To complete the training, go to citiprogram.org. Once the training is completed, you will be prompted to print out a certificate of completion. Submit a copy of the certificate with your request for IRB approval. Keep a copy for your records.

What type of review should I request?

There are three types of protocols: exempt, expedited, and full review. If your project does not fall in one of the exempt or expedited categories, then it will be reviewed by the IRB at a monthly meeting. Please note: Protocols that qualify for exempt or expedited status are reviewed on a rolling basis and can be submitted at any time.

Categories of Research that Qualify for Exemption (Submit the Request for Exemption form, below)
Categories of Research that Qualify for Expedited Review (Submit the Application for Expedited or Full Review form, below)

What forms are required to submit my protocol to the IRB?

Request for Exemption (PDF) and in Word (Required for requesting exempt status) *Please note that your department chair's signature is now required on the Request for Exemptions form.*
Application for Expedited or Full Review (PDF) and in Word (Required for protocols that require expedited or full review)
The Conflict of Interest/Financial Interest Disclosure Form (fillable PDF will be initiated by OSPAR through Adobe Sign) associated with the revised Conflict of Interest in Research/Sponsored Programs Policy is required for all protocols. Each investigator on the project must complete, sign, and return a disclosure form prior to submission.
Academic Health Care Center SARRC Flow Chart, Standard Operating Procedures Form, and Delegation of Responsibilities Log (Word). (Complete and attach the Standard Operating Procedures Form and Delegation of Responsibilities Log to all IRB applications involving the NYITCOM Academic Health Care Center (AHCC). AHCC protocols must be approved by the NYITCOM Scientific Advisory Research and Review Committee (SARRC) before they are submitted to the IRB. Review by the SARRC takes approximately 10 days. SARRC approval must be attached to the protocol at the time of IRB submission.)
Medical Education Research: Request Form for NYITCOM Institutional Research Data/NYITCOM Student Records (PDF). (Complete and attach to all IRB applications involving NYITCOM institutional data, student records, and/or medical education research. Any such protocol must be reviewed and approved by the NYITCOM Education Research Data Committee (ERDC), and ERDC notification of approval must be attached, before it is submitted to the IRB. Review by the ERDC takes approximately 10 business days.)
Collaboration Agreement Template (Required for any intended collaboration between NYITCOM and other schools and colleges of NYIT. Contact OSPAR for a copy of the template. See Grant Preparation page for instructions.)

Other Forms*

Protocol Renewal Fill-in Form: PDF | Word
Protocol Modification Fill-in Form: PDF | Word
Fill-in Report of Adverse Effects: PDF | Word
Protocol Termination Fill-in Form: PDF | Word
Procedures for Minors (High School Student Interns) Assisting with Research Activities: PDF
Attachment A – Additional Investigators and Key Personnel: PDF | Word
Attachment C – Student Participation in Research: PDF | Word

* If using the PDF versions, please download the forms and open in Adobe Reader or Acrobat in order to sign electronically.

Use the consent form templates provided below. One of these templates, as appropriate to your study, must be used. The consent form should be on department letterhead.

Consent form templates:

Long form (Word) – Appropriate for most biomedical and health related studies
Short form (Word) – Appropriate for most minimal risk studies
Assent form template (Word)
Parental Consent form template (Word)
Guidance on assent for minor subjects
Tips on Informed Consent from OHRP

When should I submit my protocol?

Protocols that qualify for exempt or expedited status are reviewed on a rolling basis and can be submitted at any time. Protocols that require full committee review should be submitted according the meeting and deadline schedule.

Where should I send my protocol?

Office of Sponsored Programs and Research
Institutional Review Board (IRB)
516.686.7488
grants@nyit.edu