Part 50 - Protection of Human Subjects  


Subpart A - General Provisions
§ 50.1 - Scope.
§ 50.3 - Definitions.
Subpart B - Informed Consent of Human Subjects
§ 50.20 - General requirements for informed consent.
§ 50.21 - Effective date.
§ 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.
Subpart C - XXX
§ 50.40 - Applicability.
§ 50.42 - Purpose.
§ 50.44 - Restrictions on clinical investigations involving prisoners.
§ 50.46 - Composition of institutional review boards where prisoners are involved.
§ 50.48 - Additional duties of the institutional review boards where prisoners are involved.
Subpart D - Additional Safeguards for Children in Clinical Investigations
§ 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.