Federal category
IRB Governance
IRB governance, IRB review, committee operation, and institutional research oversight.
Cascade
Source collection
Federal
Category group
Research Human Subjects
Category
IRB Governance
Grouped by instrument
Expand an instrument to inspect matching provisions
Instruments
2
Shown
6
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 § 56.108
IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB shall:
Group
Research Human Subjects
Category
IRB Governance
Domain
Other
Topics
Irb operations, Irb functions
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
Citation
21 CFR § 56.115
IRB records.
Group
Research Human Subjects
Category
IRB Governance
Domain
Governance Quality
Topics
Irb record keeping, Research documentation