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Human Subjects Research/Institutional Review Board (IRB)

The IRB is composed of members of the University and local communities. The individual members contribute the professional competency necessary to review specific research activities representing a broad range of disciplines through experience and expertise in their fields. In addition, the IRB seeks diversity in race, gender, and cultural backgrounds to promote sensitivity to community attitudes and respect for the rights and welfare of human subjects. If you are interested in serving on the IRB, contact the IRB Administrator at .

The fully convened IRB meets every third Thursday of the month (except in April) on the UB campus or via Zoom and is made up of the following members:

Kevin Kelliher, PhD, IRB Co-Chair, Chiropractic
David Oberleitner, PhD, IRB Co-Chair, Psychology
John Chick, EdD, Education
Fredrick Dombrowski, PhD, Counseling
Meghan Gonick, ND, Acupuncture
Gregory Gray, Dc. Chiropractic
Abu Gafar Hossion, PhD, Chemistry
Laura Morello, EdD
David Peterson, PhD, Criminal Justice
Pamela Tunnell, DC, Chiropractic
Marcia Lorentzen, EdD, Community Member
Fred Pierre-Louis, Alternate Community Member

IRB meeting dates and deadlines

Studies that involve minimal risk are eligible for expedited or exempt review and can be submitted at any time. For questions regarding the risk-level of a study, contact .

Submissions requiring full board review must be submitted by the submission deadline (which is two weeks before the full board meeting date). Submissions, including completion of your department’s internal review process, must be submitted by 4:30pm on submission deadline. When a submission is incomplete or additional information is needed it extends the review cycle and the amount of time to get final approval.

When a submission is received it will be assessed for completeness and to identify any missing information and will be placed on the agenda when determined by the IRB.

IRB meeting dates and deadlines can be found on the UB portal.

IRB Reliance Agreement

IRB Reliance is when one IRB agrees to serve as IRB of Record for another institution. The IRB Administrator will provide information to assist researchers with collaborative and multi-site research issues, including helping identify the best single IRB review option for their studies and facilitating reliance agreements. To obtain assistance with reliance, please contact us at .

For studies involving non-UB research sites associated with their own IRB and/or personnel who are not affiliated with UB, please contact us at .

Mentor IRB, forms, and templates

Effective July 1, 2024, UB’s IRB will accept research studies on the Mentor IRB platform. Please click the button below to begin. NOTE: If the log-in page asks for the institution ID, please type “ub” in the text box.

Mentor IRB

Human Subject Research Determination

The following can be accessed through the Mentor IRB link above

Investigator Manual
Submission Components
Consent Templates

Important! When preparing an announcement (e.g. Purple Knights Weekly or external sites), please be reminded that tag lines and headings should provide information about the study and should not emphasize that subjects are paid for participation - if applicable to your study. The IRB study number is required on any announcement.

If you are not sure about the status of your proposed research, contact the IRB administrator for an initial discussion.

For full board reviews where a study involves more than minimal risk, a complete IRB applications must be submitted at least (2) weeks before the set IRB Meeting Schedule (see calendar on right) for consideration.

NOTE: If documents are not submitted accordingly, the IRB will review it at the next month's scheduled meeting.

Further during breaks (e.g., winter/spring/summer), researchers must anticipate a longer processing time for IRB review and approval of applications since the IRB is not scheduled to meet at these times.

Policies and procedures

All research involving any human participants or subjects requires Institutional Review Board (IRB) approval for the safety of subjects, researchers, and the University of Bridgeport (UB), as per the document Human Research Protection Plan.

Required training (CITI)

CITI Human Subjects Research Training

Human Subjects Research training is required by the IRB at the time of application. UB now subscribes to the on-line training provided by the Collaborative Institutional Training Initiative (CITI) human subjects online training program. Create a new registration and select "University of Bridgeport" as your organization. The training is valid for a three-year period, after which a refresher CITI course or additional training must be completed.

Depending on the type of research you will be conducting, the following modules will be required:

Exempt research

Social Behavioral Research or Biomedical Research

Expedited/full board

Social Behavioral Research OR Biomedical Research
Social Behavioral Responsible Conduct of Research OR Biomedical Responsible Conduct of Research
Conflict of Interest

NOTE: Your IRB application will NOT be considered complete without valid training certificate uploaded to Mentor IRB on record.

Human Subjects Research Training Renewal

After your three-year valid training has lapsed, you must take a refresher CITI course.

Research compliance monitoring

Human subjects research at UB is monitored by the IRB. The goal of the Monitoring Program is to assess compliance of human subjects research with federal, state, and local law, and UB policies, to identify areas for improvement, and to provide recommendations based on best practices, current policies and the guidelines for the conduct of research as stated in the Belmont Report. Through our education efforts, we provide the most current information to investigators and students through education, training, and monitoring to help ensure all human subjects research is conducted in accordance with the IRB approved protocol. All studies, including those approved under the Exempt Category, are subject to audit. Categories of audits include routine, informed consent, for-cause and investigator-initiated. Except in cases where the safety of participants is a concern, or where the IRB specifically requests an unannounced audit, audits will be scheduled within two weeks of receiving notice. Immediately following the audit, the IRB Administrator will provide a brief summary of findings to the principal investigator and student researcher if applicable. The results of compliance reviews will be reported to the HRPP Institutional Official, IRB Co-Chairs (when the IRB of record), the investigator, and other UB leadership, as appropriate. A detailed report of the audit findings, any required follow up, and recommendations will be sent to the researchers. Additional details about the HRPP monitoring program and audit procedures are outlined in HRPP Manual.

If you have questions regarding the auditing process, or would like to schedule a time to meet with the IRB Administrator for an individual or group education session, please contact .

Resources

Research Data Security
Human Subject Useful Links and Websites

UB

Office of Institutional Effectiveness
Family Educational Rights and Privacy Act (FERPA)
Health Insurance Portability and Accountability Act (HIPAA)
In response to growing concerns about keeping health information private, the United States Congress adopted the Health Insurance Portability and Accountability Act (HIPAA) of 1996. This privacy rule creates national standards to protect individuals’ personal health information.
- NOTE: If you have any questions or concerns about UB Clinics Notice of Privacy Practices and/or use of UB Clinic data for research purposes, please contact the UB Clinics Privacy Officer at 203-576-2355.

Federal Government

Training for research with human participants

Collaborative IRB Training Initiative (CITI)

IRB professional organizations/forums/accreditation

IRB/bioethics

International research ethics guidelines

Virtual office hours

Reach out to the IRB Administrator for questions about submitting to the IRB, human subjects regulations, post approval support, or general guidance on IRB processes.

Please email .

Contact the Institutional Review Board (IRB)

Email