Institutional Review Board

What is the IRB?

Manhattan University’s Institutional Review Board (IRB) considers projects proposed by faculty, students, and administrators involving the use of human subjects as participants in research. The IRB Committee must approve any research proposal before the research can be conducted. Completed applications should be submitted well in advance of when you plan to begin data collection.

In addition, all external research that wishes to recruit participants from Manhattan University’s faculty, staff, students, or administrators is also subject to review and approval. Outside researchers should contact the IRB at irb@manhattan.edu for details, and 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’ (DHHS) Common Rule to evaluate what constitutes research and what constitutes 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, quantitative or qualitative, and data analysis to answer a question, including but not limited to surveys, interviews, focus groups, data analyses, constitutes systemic investigation.
  - What is generalizable knowledge?
    - Generalizable knowledge is knowledge resulting from research conclusions that will be applied to populations that are outside the specific study population. In other words, generalizable knowledge is often generalized or applied beyond study populations. Generalizable knowledge is also that knowledge which contributes to theoretical literature or field of study, in which the primary beneficiaries are researchers, scholars, and practitioners. Finally, generalizable knowledge includes research results that are intended to be replicated.
- The Common Rule also specifies some scholarly activity that it does not count as research per the definition above. These activities are thus excluded from IRB review, but researchers are encouraged to check with the IRB if they are unsure. Excluded scholarly activities include:
  - Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, historical scholarship)
  - Public health surveillance activities
  - Research for criminal justice or criminal investigative purposes
  - Authorized operational/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)

Please do not attempt to decide if your project is research or not, or involves human subjects or not. Please contact the IRB at irb@manhattan.edu to help make this determination.

What is the IRB Review Process?

The responsibility of researchers (student, staff, faculty, and administrator)
- All researchers submitting an IRB application must first complete the CITI ethics training Social and Behavioral Research modules (see CITI link below). Ethics certification is valid for 3 years from the date of completion and must be renewed every 3 years.
- All researchers submitting an IRB application must review the document (below) “How to Determine Type of Review” as well as the other informational documents. These documents will help the researcher to determine the appropriate application to submit.
- All researchers must complete the appropriate application form and email it with all appropriate and required supplementary documents to irb@manhattan.edu.
- All researchers are expected to make the corrections, additions, and changes requested by the IRB and resubmitted their application as indicated.
- All researchers are expected to alert the IRB of any adverse events during or following data collection.
- All researchers are expected to update the IRB of any changes to the approved protocol.
The responsibility of the IRB Committee
- The IRB Chairperson (Vice Chair, if the Chairperson has a conflict of interest) will review all exempt and expedited applications. These applications will be reviewed in the order received with a response issued to the researchers within 2 weeks of submission. Expedited applications may be reviewed by additional IRB committee members. The IRB may request additional information, changes, and corrections.
- The full IRB committee will convene with an outside reviewer to review all full review applications. These applications will be reviewed in the order received within 1-2 months of submission. The IRB may request additional information, changes, and corrections.
- The IRB will issue an official approval letter once all additions, corrections, and changes have been made. No research can be conducted without the official approval letter.

What happens if I conduct research without IRB approval OR if I conduct research that differs from that which is described in my approved protocol?

All researchers and collaborators who conduct human subjects research without prior IRB approval will be subject to official sanctions. Sanctions 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, presentations based on the project

The sections below provide documents and documentation that will help you through the IRB process. Please reach out to the IRB at irb@manhattan.edu at any time with questions or concerns.

Sections:

Informational Documents
Application Forms - Please note that the application forms are in Google Document format. Please use Google Documents to complete the form. Download a completed copy as a PDF for submission.
Consent, Assent, and Permission Templates - Please note that the templates are in Google Document format. Please use Google Documents to amend the templates. Download an amended copy as a PDF for submission.
Additional Forms and Templates - Please note that the templates and forms are in Google Document format. Please use Google Documents to amend the templates and forms. Download an amended copy as a PDF for submission.
CITI Training Information
1. CITI Training instructions
2. Link to CITI training
IRB Committee Membership
1. Chairperson - Dr. Kimberly Fairchild
2. Vice Chair - Qian Wang
3. Secretary - Georgios Koimisis
4. Members (2021-2022)
  1. Kimberly Fairchild
  2. Bernadette Lopez-Fitzsimmons
  3. Tekeyah Sears
  4. Georgios Koimisis
  5. Peyman Honarmandi
  6. Ian Levy
  7. Min Jung Kim
  8. Jing Liu
  9. Richard Gustavson
  10. Qian Wang
  11. Samira Hassa