Institutional Review Board (IRB)

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 irb@bridgeport.edu.

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 irb@bridgeport.edu.

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.

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

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

1. Social Behavioral Research OR Biomedical Research
2. Social Behavioral Responsible Conduct of Research OR Biomedical Responsible Conduct of Research
3. 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.

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 irb@bridgeport.edu.

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

• Office for Human Research Protections (OHRP)
  • OHRP Human Subject Regulations Decision Charts
  • 45CFR46 (2018 Requirements)
  • OHRP International Standards and National Policies
  • OHRP IRB Guidebook
• U.S. Food and Drug Administration (Guidance for IRBs, etc.)
  • 21 CFR Parts 50 and 56
  • FDA Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
  • Frequently Asked Questions on Botanical Drug Product Development (Addresses Dietary Supplements and INDs)
  • Development and Approval Process (Drugs)
  • Medical Devices
  • Mobile Medical Applications
  • Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors
• Department of Health and Human Services – HIPAA
• National Institutes of Health (NIH) Office of Research Integrity (ORI) Research Involving Human Subjects
  • NIH Certificates of Confidentiality Kiosk
  • NIMH Human Subject Research Issues
  • NIH Scientific Data Sharing
• ClinicalTrials.gov
• Department of Energy – Human Subjects Protection Program
• NASA Human Research Program
• National Science Foundation (NSF)
• U.S. Department of Education Protection of Human Subjects in Research
• U.S. Department of Energy Human Subject Protection Program
• U.S. Department of Veterans Affairs Program for Research Integrity Development and Education (PRIDE)
• Walter Reed Army Institute of Research Human Subject Protection Branch (HSPB)
• Department of the Navy – Human Research Protection Program
• National Institute of Justice – Human Subjects and Privacy Protection
• Department of Education
  • Protection of Human Subjects
  • US Department of Education (FERPA)
  • Protection of Pupil Rights Amendment (PPRA)

Training for research with human participants

• Collaborative IRB Training Initiative (CITI)

IRB professional organizations/forums/accreditation

• Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
• IRB Discussion and News Forum

IRB/bioethics

• The Hastings Center
• DHHS – Office of Research Integrity

International research ethics guidelines

• Council for International Organizations of Medical Sciences (CIOMS) – International Ethical Guidelines for Health-related Research Involving Humans (PDF)
• Nuffield Council on Bioethics (UK)
• World Health Organization (WHO) Ethics Publications
• Listing of International Bioethics Organizations
• General Data Protection Regulation (GDPR)

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 irb@bridgeport.edu.