§ 46.401 To what do these regulations apply?
§ 46.402 Definitions
§ 46.403 IRB duties
§ 46.404 Research not involving greater than minimal risk
§ 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
§ 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition
§ 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
§ 46.408 Requirements for permission by parents or guardians and for assent by children
§ 46.409 Wards

Terms Used In CFR > Title 45 > Subtitle A > Subchapter A > Part 46 > Subpart D - Additional Protections for Children Involved as Subjects in Research

  • Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.