42 C.F.R. § 93.102 – Applicability.

(a) Every extramural or intramural institution that applies for or receives PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training must comply with this part.
(b) This part applies to allegations of research misconduct involving:
1. (1) Applications or proposals for PHS support for biomedical or behavioral extramural or intramural research, biomedical or behavioral research training, or activities related to that research or research training;
2. (2) PHS-supported biomedical or behavioral extramural or intramural research;
3. (3) PHS-supported biomedical or behavioral extramural or intramural research training programs;
4. (4) PHS-supported extramural or intramural activities that are related to biomedical or behavioral research or research training, such as, but not limited to, the operation of tissue and data banks or the dissemination of research information;
5. (5) Research records produced during PHS-supported research, research training, or activities related to that research or research training; and
6. (6) Research proposed, performed, reviewed, or reported, as well as any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in an awarded grant, contract, cooperative agreement, subaward, or other form of PHS support.
(c) This part does not supersede or establish an alternative to any applicable statutes, regulations, policies, or procedures for handling fiscal improprieties, the ethical treatment of human or animal subjects, criminal matters, personnel actions against Federal employees, or addressing whistleblowers and/or retaliation.
(d) This part does not supersede or establish an alternative to the HHS suspension and debarment regulations set forth at 2 CFR part 180, as implemented by HHS at 2 CFR part 376; and 48 CFR part 9, subpart 9.4, as supplemented by HHS at 48 CFR part 309, subpart 309.4. The Suspension and Debarment Official SDO and ORI may coordinate actions to the extent consistent with the SDO's and ORI's respective authorities. Such coordination includes jointly issuing notices or seeking settlements of actions and proceedings.
(e) This part does not prohibit or otherwise limit how institutions handle allegations of misconduct that do not fall within this part's definition of research misconduct or that do not involve PHS support.