Federal Regulations
The United States Department of Education, as well as other federal agencies, has established regulations1 which require all covered research projects be reviewed and approved by an IRB before the research takes place. These regulations, known as the Federal Policy for the Protection of Human Subjects or “Common Rule” are based on internationally recognized and established ethical principles.(2)
Under these regulations, institutions are charged with ensuring the rights of human subjects in research conducted under the institution’s auspices. IRBs are authorized to approve, request modification in, or disapprove research activities [34 CFR 97.109(a)] and to conduct continuing reviews of the research activities at intervals appropriate to the degree of risk, but not less than once a year [34 CFR 97.109(e)].
Federal regulations define research and human subjects as follows:
Research: The regulations define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” It includes activities which meet this definition, whether or not conducted under a program considered “research” for other purposes. [34 CFR 97.102(d)] If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research.
Human Subject: The regulations define human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information.” [34 CFR 97.102(f)(1) and (2)]
The general regulations cited above are recognized by American College of Education even in cases where doctoral research is not funded by a grant or contract from the United States Department of Education.
1Information About the Protection of Human Subjects in Research Supported by the Department of Education.
2Code of Federal Regulations Title 34 Department of Education PART 97 - Protection of Human Subjects by the Department of Education.
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