Code of Federal Regulations (alpha)

CFR /  Title 40  /  Part 26  /  Sec. 26.402 Definitions.

The definitions in Sec. 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 Sec. 26.202(a).

(g) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.