(Taken from the Code of Federal Regulations, Title 45, Part 46, Subpart A)
Research means 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 which is considered research for other
purposes. For example, some demonstration and service programs may include research
Human participant means a living individual about whom an investigator (whether professional or student)
conducting research obtains data through intervention or interaction with the individual
or identifiable private information.
IRB approval means the determination of the IRB that the research has been reviewed and may be
conducted at an institution within the constraints set forth by the IRB and by other
institutional and federal requirements.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological examinations
Vulnerable populations are groups of individuals who require additional measures to ensure that rights,
privacy, welfare, and civil liberties are protected. These groups include children,
prisoners, pregnant women, and people with mental, physical, and/or intellectual disability.
People with intellectual disability are not officially considered a vulnerable population
in the current code of federal regulations as there is no subpart devoted to this
group. They are included here as their inclusion appears to be consistent with the
spirit of the regulations. Refer to the current code of federal regulations for additional
information concerning vulnerable populations.