Federal category
Research Informed Consent
Research consent, broad consent, consent documentation, and consent waiver provisions.
Cascade
Source collection
Federal
Category group
Research Human Subjects
Category
Research Informed Consent
Grouped by instrument
Expand an instrument to inspect matching provisions
Instruments
5
Shown
23
Citation
21 CFR § 56.109
IRB review of research.
Institutional Review Boards are required to review, approve, or disapprove research activities and ensure informed consent processes are followed.
Group
Research Human Subjects
Category
IRB Governance
Domain
Governance Quality
Topics
Irb review process, Informed consent documentation
Citation
21 CFR § 56.111
Criteria for IRB approval of research.
IRBs must determine that specific criteria regarding risk minimization, equitable subject selection, and informed consent are met before approving research.
Group
Research Human Subjects
Category
IRB Governance
Domain
Governance Quality
Topics
Irb approval criteria, Risk benefit analysis