The following commonly used terms are defined in accordance with 45 CFR 46.102, as amended from time to time.
Human subject - A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.
Legally authorized representative - An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Minimal risk - 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.
Research - 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 that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Consent - Legally effective and informed consent obtained from each subject or the subject's legally authorized representative. In the case of research involving a minor, consent shall be obtained from the parents or a legal guardian as well.
Human subjects research - Research involving human subjects the purpose of which is to develop or contribute to generalizable knowledge.
Quorum - A quorum is defined as two-thirds of the full committee excluding the non-voting member.
Definition of Exempt from IRB Review:
- Normal Educational Practices and settings. Study of normal educational practices that will be conducted in commonly accepted settings.
- Anonymous Education Tests, Surveys, Interviews, or Observations. Involves the use of education tests, survey procedures, interview procedures, or observations of public behavior. May not include identifiers.
- Identifiable Subjects in Special Circumstances. If section b subjects are elected or appointed public officials or candidates for public office or federal statutes require without exception that the confidentiality be maintained.
- Collection or Study of Existing Data.
- Public Benefit or Service Programs. Must be conducted by or subject to the approval of department or agency head, designed to study, evaluate, or examine public benefit or service programs, procedures, changes in or alternative under the programs, etc.
- Taste and Food Evaluation and Acceptance Studies. Limited to taste and food quality evaluation studies that do not involve risks of indigestion or vitamin deficiencies. Studies involving consumption of alcohol, vitamins, or supplements are not eligible for exempt status. (Bankhart & Amdur, 2006).
Definition of Expedited Review:
- Research activities that present no more than minimal risk and are listed in a National Institutes of Health guidance document as an “adjunct” to the DHHS and FDA regulations
- “minor changes in previously approved research during the period (of one year or less) for which approval is granted.”