All sources category
Exempt Expedited Research
Exempt research, expedited review, and low-risk research provisions.
Cascade
Source collection
All sources
Category group
Research Human Subjects
Category
Exempt Expedited Research
Grouped by instrument
Expand an instrument to inspect matching provisions
Instruments
2
Shown
4
Citation
21 CFR § 56.104
Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from the requirements of this part for IRB review:
Group
Research Human Subjects
Category
Exempt Expedited Research
Domain
Other
Topics
Irb exemptions, Clinical investigation exemptions
Citation
21 CFR § 56.110
Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
Group
Research Human Subjects
Category
Exempt Expedited Research
Domain
Other
Topics
Expedited irb review, Minimal risk research