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e-CFR data is current as of January 15, 2021

Title 40Chapter ISubchapter APart 26Subpart D → §26.402


Title 40: Protection of Environment
PART 26—PROTECTION OF HUMAN SUBJECTS
Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA


§26.402   Definitions.

The definitions in §26.102 shall be applicable to this subpart as well. In addition, the following terms are defined:

(a) For purposes of this subpart, Administrator means the Administrator of the Environmental Protection Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been delegated by the Administrator.

(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(d) Parent means a child's biological or adoptive parent.

(e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent on behalf of a child to general medical care.

(f) Observational research means any research with human subjects that does not meet the definition of research involving intentional exposure of a human subject in §26.202(a).

[71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019]

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