IRB Policies

Kean University’s practices and policies in support of research firmly uphold the highest standards of ethics and integrity and comply with all federal regulations and guidelines. 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.

Kean University Policy Governing Research with Human Subjects

Recruitment of participants by External Researchers

External researchers who are unaffiliated with Kean University but wish to recruit participants on Kean University campus must request permission from the IRB before recruiting students, or employees at Kean (via any method of recruitment).

Kean IRB only considers the protection of human subjects and does not give permission for the researcher to conduct the research at Kean University. Therefore, the researcher must obtain permission from the appropriate university official relative to the research to be conducted after the Kean IRB review. 

Revisions to Common Rule

January 19, 2017: The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research.

Important elements in the final rule issued include:

• The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
• Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies.
• For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement.
• The establishment of new exempt categories of research based on the level of risk they pose to [adult] participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
• Removal of the requirement to conduct a continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
• A requirement that consent forms for certain federally funded clinical trials be posted on a public website.