For the protection of human subjects.
Kenyon College believes ethics and ethical principles extend to all spheres of human activity. The IRB review process and informed consent are the beginning and not the end of ethical responsibility to human research subjects.
Kenyon College is especially concerned with and committed to safeguarding the welfare, rights, and privacy of all persons who participate as subjects in research projects conducted under its auspices, and to ensuring that the subjects of such research are aware of their rights and the protections available to them. Moreover, the College is required to assure the federal government that such safeguards are being provided and enforced for federally funded research involving human subjects. By reviewing proposals for research, the IRB helps to protect both the College and the researcher against potential legal implications of neglecting to address important ethical issues of participants. However, the IRB performs ethical analysis of proposed research and does not just make determinations of legal compliance.
The Kenyon College IRB is guided by the ethical principles set forth in the Belmont Report: Respect for Persons, Beneficence, and Justice. We strive to create a culture of respect for, and awareness of, the rights and welfare of human research participants while facilitating compliance by our researchers with federal regulations.
Fulfilling our obligations under these regulations is important for several reasons other than just being in compliance with the regulations:
The role of the Kenyon College Institutional Review Board (IRB) is to foster ethical treatment of human research participants and to oversee all research (broadly defined) involving human subjects conducted under the auspices of Kenyon College by its faculty, students, and staff. All research projects involving human subjects -- regardless of the source of funding -- require the review and approval from the Kenyon College IRB prior to gathering any data or information from the subjects.
The Kenyon College IRB also reviews research conducted by outside investigators involving Kenyon College students, personnel, records, or facilities. Researchers not affiliated with Kenyon College, who wish to come onto the Kenyon College campus, or use Kenyon records to identify potential subjects, must have a Kenyon sponsor, either a Kenyon College Faculty Member or Administrator, and provide the IRB with a previously approved application from an IRB at an institution with an FWA and submit a completed Kenyon application to the Kenyon College IRB. The outside researchers must have approval from the Kenyon College IRB before they are allowed any access to Kenyon College records or contact with Kenyon College students or personnel.
The ultimate responsibility for treatment of human research subjects rests with the researcher. Researchers' informed participation in this process helps to ensure a positive, ethical, and responsible climate for scholarly research at Kenyon College. Ethics should never be sacrificed to expediency.
All Kenyon College researchers involved in human subjects research must complete the requisite training. Outside researchers must have proof of human subjects protection education.
Review of all research proposals involving human subjects research must take place prior to the commencement of such research.
Research involving human subjects carried on at, by or under the auspices of Kenyon College must comply with the College's IRB procedures. The IRB reviews research proposals that contemplate a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge" (45 CFR 46.102d.) Generalizable knowledge means research findings that apply to individuals and circumstances beyond those being studied. Results of a study are considered generalizable if they have relevant characteristics of and implications for more individuals than those in the sample studied. "Generalizable" also frequently implies that research findings will be published, presented, or shared publicly in some other manner at any point after the completion of the study.
The chairs of individual departments and programs and heads of administrative divisions will be responsible for reviewing and acknowledging by way of signature all research proposals involving human subjects originating with faculty members, staff, or students in their departments or divisions prior to submission of such proposals to the IRB. The chairs and heads will make a recommendation to the IRB as to the level of review: exempt, expedited, or full. see Review Categories
The IRB administrator and/or chair will consider each application and decide if the proposal needs no further review (exempt) or requires an expedited or full review. The initial review of any research protocol starts with the determination of: