Brevard College encourages the conduct of research and collaboration with other educational institutions, agencies, and organizations. In this regard, the College, while respecting the right of faculty to full academic freedom in research, is firmly committed to adhering to basic ethical principles and federal policy regarding the conduct of research involving human subjects. It is the policy of Brevard College to ensure that the rights and welfare of human subject research participants are adequately protected in research conducted under its auspices. Further, federal laws require these protections. The basis for the College’s policy is the Code of Federal Regulations (45CFR46) and federal leadership for the protection of human subjects is vested in the National Institutes of Health’s Office for Protection from Research Risks (OPRR) and the Food and Drug Administration (FDA). OPRR has the general responsibility for protection of humans in research, and the FDA regulates the use of experimental drugs and medical devices.
Brevard College supports the basic ethical principles underlying the acceptable conduct of research involving human subjects, as set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research and the American Psychological Association (APA) General Principles. Five basic principles (respect for persons, beneficence, fidelity, integrity, and justice) are particularly relevant to the protection of human subjects in biomedical and behavioral research, and are the accepted requirements for the ethical conduct of such research.
- Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
- Beneficence entails an obligation to protect persons from harm by maximizing anticipated results and minimizing possible risks of harm.
- Fidelity and responsibility supports the development of trust and adherence to professional standards of conduct.
- Integrity involves accuracy, honesty, and truthfulness, striving to keep promises and avoid unwise or unclear commitments.
- Justice requires that the benefits and burdens of research be distributed fairly.
Moreover, the principle of respect for persons underlies the need to obtain informed consent; the principle of beneficence underlies the need to minimize risks; the principle of fidelity requires adherence to ethical standards necessary for the responsible conduct of research; the principle of integrity requires honest communication needed for trust; and the principle of justice requires that subjects be fairly treated.
Brevard College has set standards for the conduct of research which mandate well-conceived and well-conducted research. To assist in maintaining those standards, an Institutional Review Board (IRB) must be established. This Policy and Procedure Manual for Research Involving Human Subjects provides detailed information to support institutional policies for guaranteeing compliance with federal regulations governing the protection of human subjects and to guide investigators in procedures relevant to the development of research protocols that include human subjects. Throughout this manual, humans whose physiologic or behavioral characteristics are the object of study are referred to as “subjects”; however, the College in no way intends to demean the humanity and individualism of such persons. Recognizing that regulations and policies and procedures are no guarantee of ethical conduct, it is the responsibility of individual researchers to make ethical considerations central in the conduct of research and to have a clear understanding of their duties to human subjects.
This Policy and Procedure Manual for Research Involving Human Subjects was developed under the direction of the Human Subject Review Board Task Force established by the Dean of the College in the fall of 2002. All faculty members, staff, students and affiliated researchers (on or off campus) are responsible for familiarizing themselves and complying with these policies, once they are approved.