Research Subject to Regulation
28 CFR § 46.102: Definitions [28 CFR PART 46—PROTECTION OF HUMAN SUBJECTS]
(e) Research subject to regulation,
and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).