Any activity that meets the federal definitions of RESEARCH and HUMAN SUBJECTS requires IRB review.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Levels of IRB Review
Human subjects research is review by Bradley’s IRB (CUHSR) under the following categories.
Exempt Review - Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review.
Expedited Review- Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by a member of the IRB committee.
Full Board Review - Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) will receive review at a fully convened IRB committee meeting.
CUHSR will review some projects that may be “Not Human Subjects Research” but may require approval with regard to ethical treatment of human subjects. Some quality assurance projects will fall into this category.