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Conducting Research with Human Subjects
Eckerd College endorses faculty and student research that advances knowledge and supports learning. In order to ensure that research with human subjects is conducted by faculty and/or students in a manner that respects the rights, maintains the well-being and guarantees the privacy of those who participate in it, as well as the ethical principles embraced by Eckerd College, the College has developed pertinent policies and procedures that will be governed by an Institutional Review Board (IRB).
History of the Institutional Review Board (IRB) Process
In the early 1970s, the federal government commissioned a group of scientists and ethicists operating within the Department of Health and Human Services to identify the ethical principles that should govern research and serve as the foundation of a new law that delineated the guidelines and limits of scientific research with human subjects. Out of this process was born the concept of the "Institutional Review Board", a supervisory group to be created at laboratories, hospitals, academic institutions where research is conducted, to protect the human subjects as well as the integrity of the researchers.
Background: The Principles and the Law
In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created by the National Research Act under the U.S. Department of Health, Education and Welfare (renamed the US Department of Health and Human Services in 1979), became the responsible group for identifying the basic ethical principles for the conduct of biomedical and behavioral research involving human subjects. The Commission also was charged with the development of guidelines to implement the principles it identified. In 1979 the Belmont Report was issued – so-called because the Commission met in the Smithsonian Institution's Belmont Center. (Click here for related history) The official law, Title 45 (Public Welfare) Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects or 45 CFR 46, revised in 2009, is available here.
The law is based on the following three overarching principles:
- Respect for individuals and their capabilities: …"individuals should be treated as autonomous agents, and that persons with diminished autonomy (i.e., capability for self-determination based on age, illness, external demands) are entitled to protection."
- Beneficence: "Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms."
- Justice: This principle considers two features, that the selection of research subjects is not based on expedience but …"for reasons directly related to the problem being studied;" and that the benefits derived from publicly funded research be made available to all, not only those who can easily afford them.