Research
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 activities.
Human Subject
Human subject 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
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
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 or tests.
- Vulnerable populations include children, prisoners, pregnant women, or people with 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. Be sure to refer to the current code of federal regulations for information concerning vulnerable populations.