Institutional Review Board
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
- Education, Social Science and Behavioral Research (ESB)
- Biomedical and Health Sciences Research (BHS)
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
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.
- NYIT Policy on Required Education in the Protection of Human Research Participants
- Frequently Asked Questions for Training in Human Subject Protection
- Collaborative Institutional Training Initiative (CITI Program) New Learner Account Registration for NYIT
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 (Word). (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 (PDF) and in Word (Required for any intended collaboration between NYITCOM and other schools and colleges of NYIT. See Grant Preparation web page for instructions.)
- 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
* If using the PDF versions, please download the forms and open in Adobe Reader or Acrobat in order to sign electronically.
How do I write a consent or assent form?
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)
- 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?
Contact Eileen Gazzola, IRB Adminstrator at email@example.com or 516.686.7488, for more information.