Institutional Review Board (IRB)

Manhattan University’s Institutional Review Board (IRB) reviews research involving human subjects to help ensure that projects are conducted ethically and in compliance with federal regulations. IRB approval is required before human subjects research may begin.

Faculty, students, staff, administrators, and external researchers who wish to recruit participants from the Manhattan University community should contact the IRB early in the planning process.

Contact the IRB Before You Begin

Before You Begin

If your project involves surveys, interviews, focus groups, observations, data analysis, or interaction with people as part of research, it may require IRB review. Please do not attempt to make this determination on your own. Contact the IRB at irb@manhattan.edu for guidance before beginning data collection.

External researchers who wish to recruit Manhattan University faculty, staff, students, or administrators must also receive review and approval. Outside researchers should be prepared to share IRB approval documentation from their home institution.

What Needs IRB Review?

The IRB follows the Department of Health and Human Services’ Common Rule to evaluate whether a project is considered research involving human subjects.

What constitutes research?

Research is defined by the Common Rule as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)

What constitutes systematic investigation?

Any activity that involves data collection and data analysis to answer a question may constitute systematic investigation. This includes, but is not limited to, surveys, interviews, focus groups, and quantitative or qualitative data analyses.

What is generalizable knowledge?

Generalizable knowledge refers to research conclusions that may be applied beyond the specific study population. This includes knowledge that contributes to theoretical literature or a field of study, benefits researchers, scholars, or practitioners, or is intended to be replicated.

What activities may be excluded from IRB review?

The Common Rule identifies some scholarly activities that are not considered research under this definition. Researchers are still encouraged to check with the IRB if they are unsure.

• Scholarly and journalistic activities, such as oral history, journalism, biography, literary criticism, legal research, and historical scholarship
• Public health surveillance activities
• Research for criminal justice or criminal investigative purposes
• Authorized operational or governmental activities

What are human subjects?

Human subjects are defined as “a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” (45 CFR 46)

IRB Review Process

Researcher Responsibilities

• Complete the CITI ethics training Social and Behavioral Research modules before submitting an IRB application. Ethics certification is valid for 3 years from the date of completion.
• Review “How to Determine Type of Review” and the other informational documents before selecting an application form.
• Complete the appropriate application form and email it with all required supplementary documents to irb@manhattan.edu.
• Make any corrections, additions, or changes requested by the IRB and resubmit materials as directed.
• Alert the IRB of any adverse events during or following data collection.
• Notify the IRB of any changes to an approved protocol.

IRB Committee Responsibilities

• The IRB Chairperson, or Vice Chair if the Chairperson has a conflict of interest, will review exempt and expedited applications. These applications are reviewed in the order received, with a response typically issued within 2 weeks of submission.
• Expedited applications may be reviewed by additional IRB committee members. The IRB may request additional information, changes, or corrections.
• The full IRB committee will convene with an outside reviewer to review full review applications. These applications are reviewed in the order received, usually within 1-2 months of submission.
• The IRB will issue an official approval letter once all additions, corrections, and changes have been made. No research may be conducted without the official approval letter.

Research Without IRB Approval

Researchers and collaborators who conduct human subjects research without prior IRB approval, or who conduct research that differs from an approved protocol, may be subject to official sanctions.

Sanctions may include, but are not limited to:

• Immediate suspension and termination of the research project
• Immediate destruction of all data collected and analyses conducted
• Notification of subjects of non-compliance
• Retraining on ethical principles and guidelines
• Academic integrity sanctions for student researchers
• Retraction of any papers, posters, or presentations based on the project

IRB Documents, Forms, and Templates

The sections below provide documents and resources to help you prepare for the IRB process. Contact the IRB at irb@manhattan.edu with questions or concerns.

Submit IRB Materials

Informational Documents

• Pandemic Related IRB Adjustments to Research Protocols Involving Human Subjects
• How to Determine Type of Review
• Student Course Related Research Checklist
• Guidelines for Research with Children
• IRB Course Related Student Project Policy

Application Forms

Application forms are provided in Google Document format. Please use Google Documents to complete the form, then download a completed copy as a PDF for submission.

• Form A - Exempt
• Form B - Expedited and Full
• Form C - Protocol Amendment

Consent, Assent, and Permission Templates

Templates are provided in Google Document format. Please use Google Documents to amend the template, then download an amended copy as a PDF for submission.

• Consent
• Child Written Assent
• Child Verbal Assent
• Parental Permission

Additional Forms and Templates

Additional templates and forms are provided in Google Document format. Please use Google Documents to amend the template or form, then download an amended copy as a PDF for submission.

• Debriefing Template
• Adverse Event Reporting Form
• Institutional Authorization Agreement
• FERPA IRB Form

CITI Training Information

• CITI Training Instructions
• CITI Program Training

IRB Committee Membership, 2025-2026

Chairperson: Dr. Georgios Koimisis

Members:

• Heidi Laudien (KSAS)
• Gerardo Carfagno (KSAS)
• Peyman Honarmandi (SOE)
• Antoine Nicolas (KSAS)
• Georgios Koimisis (OMSB)
• Evelyn Scaramella (KSAS)
• Bernadette Lopez-Fitzsimmons (Lib, KSAS)