FDA 21 CFR Parts 50 and 56 Informed Consent and IRB
Human subject protection, informed consent and institutional review board requirements for clinical investigations.
Sectors
Articles (35)
§ 50.1 Scope.§ 50.3 Definitions.§ 50.20 General requirements for informed consent.§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations.§ 50.23 Exception from general requirements.§ 50.24 Exception from informed consent requirements for emergency research.§ 50.25 Elements of informed consent.§ 50.27 Documentation of informed consent.§ 50.50 IRB duties.§ 50.51 Clinical investigations not involving greater than minimal risk.§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.§ 50.55 Requirements for permission by parents or guardians and for assent by children.§ 50.56 Wards.§ 56.101 Scope.§ 56.102 Definitions.§ 56.103 Circumstances in which IRB review is required.§ 56.104 Exemptions from IRB requirement.§ 56.105 Waiver of IRB requirement.§ 56.106 Registration.§ 56.107 IRB membership.§ 56.108 IRB functions and operations.§ 56.109 IRB review of research.§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.§ 56.111 Criteria for IRB approval of research.§ 56.112 Review by institution.§ 56.113 Suspension or termination of IRB approval of research.§ 56.114 Cooperative research.§ 56.115 IRB records.§ 56.120 Lesser administrative actions.§ 56.121 Disqualification of an IRB or an institution.§ 56.122 Public disclosure of information regarding revocation.§ 56.123 Reinstatement of an IRB or an institution.§ 56.124 Actions alternative or additional to disqualification.