IRB & Research Compliance

Notice: In response to state and federal guidelines to contain the spread of COVID-19, Kean University is conducting remote education during the Spring 2020 semester. Following the University guidelines, the IRB office will not be accepting in-person applications.  During this period, all IRB applications must be submitted via email at irb@kean.edu. All questions should be sent to irb@kean.edu. Thank you for your cooperation in this matter.

Important Changes: IRB Guidance on Human Subjects Research  (March 20, 2020)

CURRENT STUDIES

All studies that involve in-person, face-to-face interactions with participants including faculty, staff, students and community participants must be paused.

Research studies that limit participant interactions to online or remote communication, remote data collection or secondary data analysis may continue.

Investigators are encouraged to modify their procedures to replace in-person study visits with remote options for questionnaires, survey, screening and consenting, if possible. NOTE: The IRB must approve amendments to the study protocol before changes can be implemented.

The IRB is continuing to work remotely and is holding meetings virtually. We will expedite all change requests. If your anticipated spring or summer graduation is dependent on completion of your study, please include “TIME SENSITIVE” in the subject line when you send your change amendment to irb@kean.edu.

There is no need to submit an amendment to pause a study.

FUTURE STUDIES

The IRB will continue to review and approve submissions according to the calendar posted on the IRB website. However, priority will be given to the processing of amendments to existing studies that are time sensitive.

The IRB may approve applications for future studies that involve in-person or face-to-face interactions but explicitly note that enrollment cannot start until the pause in research activities is lifted.

The IRB strongly encourages investigators to consider whether proposed new human research studies must be submitted at this time, especially if the studies involve in-person procedures.

If you have questions or concerns, please feel free to email irb@kean.edu 

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Kean University supports research as an integral element of its mission to advance and disseminate knowledge. The University's practices and policies in support of research firmly uphold the highest standards of ethics and integrity and comply with all federal and state regulations and guidelines. To help fulfill this mission, Kean University has established an Institutional Review Board, an appointed group of researchers from across disciplines, who review all human subjects research applications according to federal and state regulations and university policies. All faculty, students, and employees who conduct research involving human subjects must comply with University Policy and Procedures for the Protection of Human Subjects in Research.

Institutional Review Board

The Institutional Review Board (IRB) is charged with the review of proposed research protocols to ensure that the rights of human subjects are protected and that risk of harm to subjects is minimized. The framework for the protection of human subjects is set in Federal regulation.

IRB members review all assigned research protocols to ensure that:

• Risks to subjects are minimized
• Risks to subjects are reasonable in relation to anticipated benefits
• Selection of subjects is equitable
• Informed consent is properly obtained from all prospective subjects and documented
• Subject’s privacy and confidentiality are protected
• Appropriate additional safeguards are incorporated for any vulnerable subjects

IRB Application Deadlines - AY2019-2020

                                                                                                   Important Notice 

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies issued changes to the regulations governing human subject research. These changes will go into effect on January 21, 2019. The regulatory requirements apply differently depending on whether the study was initiated before January 21, 2019, or on or after January 21, 2019. For more information, click here.  

Click here for the summary of the revised common rule