1.0 Introduction
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission published The Belmont Report articulating the ethical principles that guide the conduct of research with human subjects and continues to serve as the foundation of Title 45 Code of Federal Regulations Part 46 (hereafter 45 CFR 46).
In the design, conduct, approval and review of research, Kenyon College officials, the IRB members, and investigators adhere to the basic principles set forth in The Belmont Report : respect for persons, beneficence, and justice.
In consideration of RESPECT for persons, Kenyon College investigators must seek and obtain voluntary informed consent from potential research participants. Informed consent means that participants are given explicit assurances of the voluntary nature of their involvement in terms that are easy to understand, and that they are not under duress or pressured to serve as participants. The consent process also includes information about the research project that will assist participants in deciding whether to participate in the study or not. In addition, respect means honoring the privacy of individuals and maintaining confidentiality.
The principle of BENEFICENCE requires that researchers maximize the potential benefits to participants, or to society, while minimizing the potential risks of harm. The extent of protection depends on the risks and benefits of the proposed research. All participants should be treated in an ethical manner. Benefits to participants, or benefits in the form of generalized knowledge gained from the research, should always outweigh the risks. If there are any risks resulting from participation in the research, then there must be benefits, either to the participants or society.
JUSTICE means that subjects must be selected fairly and that both the risks and benefits of research are distributed evenly. In the language of The Belmont Report : "Who ought to receive the benefits of research and bear its burdens?" Investigators should take precautions not to select participants simply because of convenient availability, manipulability, their compromised positions, or because of social, racial, sexual, economic, or cultural biases institutionalized in society.
Kenyon College believes ethics and ethical principles extend to all spheres of human activity.
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." Many U.S. government departments and private funding agencies have their own human subjects research policies. PIs should check to see if a funding agency has policies and procedures that go beyond Kenyon College IRB policies.
All research involving people as research participants carried out by Kenyon College faculty, staff, and students must be carried out in accordance with Kenyon College IRB policies. The Kenyon College IRB also reviews research conducted by outside investigators using Kenyon College students, personnel, or facilities.