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
Procedures for Responding to Allegations of Research Misconduct
It is the policy of the Kean University Institutional Review Board (IRB) that any external researcher must demonstrate that they have obtained IRB approval at their host institution or the institution of origin for the research project in question prior to obtaining approval from the Kean IRB. In order to obtain Kean IRB approval, external researchers must get a Kean full-time faculty member to sponsor their project. Sponsorship in this instance will consist of the Kean faculty member serving as either the faculty sponsor (if the external researcher is an undergraduate or graduate student at another academic institution) or as the co-PI (if the external researcher is a fellow-faculty member or a post-doc).
For this policy, external researchers refer to those researchers who come from institutions other than Kean University. All external researchers will have to submit an application to the Kean Institutional Review Board.
External researchers must also complete the CITI training program and submit proof of completion; the CITI course sends an electronic acknowledgment of completion) with their application.
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). External researchers must submit one copy of the full packet of materials submitted to the IRB at their home institution, including the letter of IRB approval for the project, to the Kean IRB Office.
For research activities that qualify as exempt from IRB review, the evidence must be provided from the home institution that exempt status has been granted.
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.
It is the policy of the Kean University Institutional Review Board (IRB) that payments to participants, in the form of cash, gift cards, or merchandise, are not allowed. Participants may be entered into a lottery with other participants for the opportunity to win a single gift card, but directly rewarding participants for taking part in a research study will not be approved.
There are several reasons for this. The most pertinent is the issue of coercion. Giving money or a gift card of any value may create a situation where research participants feel influenced to participate when they really do not want to. Research participants should never feel the slightest bit of obligation to take part in a research study.
Revisions to Common Rule
January 19, 2017: The U.S. Department of Health and Human Services and 15 other federal agencies today issued a final rule to update regulations that safeguard individuals who participate in research.
Most provisions in the new rule will go into effect in 2019. As necessary during the next few months, we will update the information on the IRB & Research Compliance website and also update forms and procedures.
Important elements in the final rule issued today 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.