Protection of Human Subjects

Scope.

This provision defines the scope of FDA regulations regarding the protection of human subjects in clinical investigations.

General requirements for informed consent.

Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject...

Exception from informed consent requirements for minimal risk clinical investigations.

The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of inf...

Exception from general requirements.

This provision outlines the specific criteria and documentation requirements for waiving informed consent in clinical investigations involving life-threatening situations, investigational drugs in military operations, or emergency use of investigational in vitro diagnostic devices.

Exception from informed consent requirements for emergency research.

This provision outlines the specific criteria and IRB oversight requirements for conducting clinical investigations in emergency, life-threatening situations where informed consent cannot be obtained.

Elements of informed consent.

This provision defines the mandatory and optional information that must be disclosed to research subjects to ensure informed consent is valid.

Documentation of informed consent.

This provision establishes the requirements for documenting informed consent through written forms, including the use of short forms and witness requirements.

Definitions.

This provision defines key terms used in FDA regulations regarding the protection of human subjects in clinical investigations.

IRB duties.

This provision mandates that IRBs review and approve clinical investigations involving children only if they meet specific regulatory criteria for safety and ethical conduct.

Clinical investigations not involving greater than minimal risk.

Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:

Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the in...

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.

Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit fo...

Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

If an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of § 50.51, § 50.52, or § 50.53, the clinical investigati...

Requirements for permission by parents or guardians and for assent by children.

This provision mandates that IRBs establish procedures for obtaining child assent and parental permission for clinical investigations involving children.

Wards.

This provision outlines specific requirements for including children who are wards of the state in clinical investigations, including the mandatory appointment of an independent advocate.