Institutional Review Board

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

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

• Seven 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?

How to Submit a New Protocol for Review

1. Complete the online CITI training module
2. Obtain permissions and signatures as necessary
3. NEW Software Platform CAYUSE: For new initial submissions, go to nyit.app.cayuse.com and start your new application. View instructions for completing protocol submission. Please note, for modifications, renewals, or terminations on legacy protocols, please submit the appropriate form to egazzola@nyit.edu. For assistance completing submissions, please contact Eileen Gazzola at egazzola@nyit.edu. For instructional videos on completing submissions, visit support.cayuse.com.

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

• 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
• Clinical Trial Checklist (PDF) – to determine if your protocol is a Clinical Trial
• NIH Clinical Trial Decision Tree (PDF)
• Case Study and Case Reports Information (PDF)
• 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.

• 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 New York Tech

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
• 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?

• The Conflict of Interest/Financial Interest Disclosure Form (via Cayuse Software with your OKTA single sign on) is required for all protocols. Each investigator on the project must complete before the final IRB approval.
• Guidelines for SARRC Review
• 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 New York Tech. Contact OSPAR for a copy of the template. See Grant Preparation page for instructions.)
• MRI Research
  • Overview of fMRI Use for IRB
  • MRI Consent Template
  • fMRI Participant Safety Screening and Consent Form

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
• Department Chair Approval Form: 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:

• Sample REDCap Survey Header with disclaimer (Word)
• Sample Qualtrics Survey Header with disclaimer (Word)
• Long form (Word) – Appropriate for most biomedical and health related studies
• Short form (Word) – Appropriate for most minimal risk studies
• Sample Assent Form Template 7 to 10 (Word)
• Sample Assent Form Template 11 to 14 (Word)
• Sample Assent Form Template 15 to 17 (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

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