Institutional Review Board for the Protection of Human Subjects

Frequently Asked Questions

• 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

1. Complete the online training module
2. Determine which type of review is appropriate for your project
3. Complete the Request for Exemption or the Application for Expedited or Full Review and attach materials as necessary
4. Describe your project to the IRB according to the questions on the Request for Exemption or Application for Expedited or Full Review form
5. Obtain permissions and signatures as necessary
6. 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
• Advanced Notice of Proposed Rulemaking (ANPRM), 7/26/2011

• 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

NYIT IRBs

• 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 or hkabashi@nyit.edu.

• Investigator Responsibilities and Instructions for Applying for IRB Approval (PDF)
• Describing your Research to the IRB: a - guide for presenting your research to the IRB (PDF)
• IRB Reviewer's Checklist (PDF) - for use by IRB member when reviewing protocols

Completing the Required IRB Training

All key personnel, including students, are required to complete an online training program before beginning their research. To complete the training, go to http://phrp.nihtraining.com. 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 for Request for Exemptions*
• Application for Expedited or Full Review (PDF) and in Word (Required for protocols that require expedited or full review)
• Financial Interest Disclosure Form (PDF) and in Word (Required for all protocols. Each investigator on the project must complete, sign, and return a disclosure form prior to submission.)
• Academic Health Centers Clinical Research Project Checklist (PDF) and in Word (Must be completed, signed, and attached to all protocols involving the NYCOM Academic Health Care Center.)

Other forms

• Protocol Renewal Form (PDF) and Interactive PDF and in Word
• Protocol Modification Form (PDF) and Interactive PDF and in Word
• Report of Adverse Effects (PDF) and in Word
• Protocol Termination Form (PDF) and Interactive PDF and in Word

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 (Word)

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?

Linda M. Reuter, CIP
IRB Consultant
Office of Sponsored Programs and Research
Tower House, Room B10
516.686.7488
lreuter@nyit.edu