The Institutional Review Board (IRB) is a federally mandated committee whose purpose is to ensure that the rights, well-being and safety of human subjects in research are protected and that human subject research at Kenyon College is compliant with applicable federal regulations and guidelines. Consequently, the IRB reviews all studies involving human participants prior to the initiation of work, approves research that meets established criteria for the protection of human subjects, and is the backstop to ensure that human participants are properly informed about, and protected during, the study. In accordance with federal regulations, human subjects research conducted by employees, students, or other agents of Kenyon College must receive IRB approval or determination of exemption prior to the initiation of such activities. Furthermore, research must remain under IRB oversight until all activities involving human subjects are complete. Please see the section below, "What is Human Subject Research and When is IRB Approval Needed," to further discern whether your project requires IRB approval before it can move forward.
Safeguarding the Welfare, Rights and Privacy of Human Participants in Research
Kenyon College believes ethics and ethical principles extend to all spheres of human activity and is guided by the ethical principles set forth in the "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research," which has respect, beneficence, and justice as its foundations. As an institution we strive to create a culture of respect for, and awareness of, the rights and welfare of human participants throughout the research process and the IRB facilitates compliance with federal regulations related to those ethics and ethical principles. More specifically, Kenyon College is 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 all participants are aware of their rights and the protections available to them. That is, to make sure human participants are not placed at undue risk and that they are able to give un-coerced informed consent for their participation in research. Additionally, 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 and approving proposals for human subject research, the IRB helps ensure that the federal government safeguards that protect human participants are being provided and enforced. The IRB review should also remind the principal investigators (PIs) of their role in ensuring compliance with all applicable regulations, because they are ultimately responsible for protecting the rights, well-being and safety of their human participants on a day-to-day basis.
What is Human Subject Research and When is IRB Approval Needed
Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). Research is defined by HHS as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The funding source or format for dissemination does not matter. The regulations set forth under the HHS “Common Rule” (Title 45 CFR 46 subpart A), outline the baseline standard of ethics for government funded research and this is the baseline upon which all Kenyon human subjects research is based. To help determine if your study will need IRB review, examine the sections of the HHS Common Rule (reproduced below) where terms associated with research and human subjects are defined. After reading these definitions, it may be helpful to examine the decision flow charts provided by the Office for Human Research Protections (particularly Chart 01) to determine whether IRB approval is required for specific work. If you have questions about whether your project should be reviewed by the IRB, contact Kenyon’s IRB at IRB@kenyon.edu. If you have questions about oral history projects, reviewing the section on Oral History may help.
HHS Definition of Research from the Common Rule
Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Activities that contribute to generalizable knowledge are those that:
- seek underlying principles that have predictive value and can be applied to other circumstances;
- identify general explanations or themes that a person can extrapolate past the participants in the study.
- publication is not a requirement to classify work as research or to indicate production of generalizable knowledge.
Some common activities are not deemed to be research:
Scholarly and journalistic activities (including the collection and use of information) that focus directly on the specific individuals about whom the information is collected. This can include, oral history, journalism, biography, literary criticism, legal research, and historical scholarship.
HHS Definition of Human Subject and Related Terms from the Common Rule
Human subject: a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention: includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction: includes communication or interpersonal contact between investigator and subject.
Private information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Identifiable private information: is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Identifiable biospecimen: is a biospecimen for which the identity of the subject is or may readily be ascertained.