Research Compliance

Human Subjects Research

UB’s Institutional Review Boards (IRB) are responsible for the review and approval of all proposed research involving human subjects at University of Bridgeport. Such proposed research activities must be approved by the designated IRB prior to the collection of any data or conducting any experiments. UB subscribes to CITI Program’s courses in Human Subjects Research for required training.

University of Bridgeport’s Federalwide Assurance (FWA) number is FWA00016119.

Proposed research may be exempt, expedited (single IRB member review), or require the review of the fully convened IRB. This is determined by the IRB administrator in consultation with IRB Co-chairs. The fully convened IRB meets four times a semester on set dates to review faculty and student research proposals determined to require full board review. UB’s Human Research Protection Program Plan is in compliance with the U.S. Department of Health and Human Services’ Code of Federal Regulations 45 CFR 46.

IRB instructions and forms can be found here.

If you are a doctoral student utilizing Survey Monkey to conduct research, frequently asked questions can be found here.

If you are a master’s student utilizing Survey Monkey for a thesis, frequently asked questions can be found here.

If you are not sure about the status of your proposed research, email irb@cranioklepty.com.

Biosafety

The University is committed to maintaining safe conditions in the use of biological specimens and agents for learning, teaching, and the research environment. The Biological Safety Officer works with academic units, researchers, and facilities personnel to ensure that staff and students are protected from exposure to infectious agents, to prevent environmental contamination, and for compliance with federal, state, and local regulations. UB subscribes to CITI Program’s courses in Biosafety and Biosecurity for required training.

For research, UB’s Institutional Biosafety Committee is responsible for assessing and approving the biosafety containment level for proposed research involving recombinant DNA, synthetic nucleic acid molecules and other potentially hazardous biologics.

Conflicts of Interest

Federal regulations require institutions to have policies and procedures in place to ensure that investigators disclose Significant Financial Interests that may present an actual or potential conflict of interest in relation to externally sponsored research. Such disclosures must be made prior to the submission of a proposal for funding and, in the case of an actual conflict of interest, the institution must develop a specific mechanism by which the conflict of interest will be satisfactory managed, reduced, or eliminated prior to award or acceptance of an award.

UB’s Conflict of Interest Policy and forms can be found here.

Intellectual Property

The prompt and open dissemination of the results of research and creative work among scholars and, eventually, to the public at large is essential to the University’s mission of education and research. A clear statement of ownership of intellectual property and the allocation of rights and privileges regarding such property within the University community is intended to enable each participating student and employee to thrive in the University’s academic environment. The commercial development and distribution of the results of research and creative work to benefit the inventor or creator and the economy is part of the University’s mission of public service. The University of Bridgeport’s Intellectual Property Policy is intended to facilitate the development of intellectual property arising at the University and to provide an incentive to University inventors or creators to participate in such development while acknowledging the University’s primary goal of the discovery and dissemination of knowledge.

UB’s Intellectual Property Policy and forms can be found here.

Biological and Biomedical Research

The University recognizes the biological and biomedical research offers great opportunities for a better understanding of biological mechanisms and pathways that lead to targeted and more effective therapies for diseases and harmful conditions. Therefore, working at an appropriate biosafety containment level and with the appropriate safety precautions is essential for mitigating those risks.

UB’s Institutional Biosafety Committee (IBC) is responsible for the review and approval of all proposed research involving involves the use of recombinant DNA, infectious agents, and other potentially hazardous biologicals and chemicals that pose safety risks. Such proposed research must be approved by the IBC prior to the start of research. UB’s IBC is registered with NIH’s Office of Science Policy.

The IBC adheres to NIH’s Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and all pertinent requirements for research. Therefore, the Institutional Biosafety Committee’s primary responsibility is to work with its researchers to ensure that research involving the criteria described above is carried out accordingly.

Researchers who propose to conduct biological and biomedical research are required to submit an application to the IBC for review and approval prior to initiating the proposed research.

IBC instructions and forms can be found here.

If you have further questions or want to submit your completed application, email ibc@cranioklepty.com.

Research Integrity

The responsible conduct of research, known by its acronym RCR, is widely defined as “the practice of scientific investigation with integrity.” The Office of Research Integrity (part of the U.S. Department of Health and Human Services) identifies nine core instructional areas for RCR:

• Research Misconduct
• Protection of Human Subjects
• The Welfare of Laboratory Animals
• Conflicts of Interest
• Data Management Practices
• Mentor and Trainee Responsibilities
• Collaborative Research
• Authorship and Publication
• Peer Review

The University promotes the education and practice of the responsible conduct of research. Discipline-focused RCR instruction (biomedical, social and behavioral, physical science, humanities, engineering, or administrators) is available to the UB community through its subscription to CITI Programs. In addition, for NSF grants, all faculty, undergraduate students, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research are required to complete UB-designated training prior to conducting the research. For NIH grants that require RCR training, specified personnel are required to complete CITI Programs training and face-to-face, in-person training in fulfillment of NIH RCR education requirements.

UB policies related to Research Integrity, i.e., Responsible Conduct of Research Policy, Policy, Procedures on Research Misconduct, Human Subject Protection Program Plan, and Financial Conflict of Interest Policy can be found here.