(a) Research misconduct involving Public Health Service (PHS) support is contrary to the interests of the PHS and the Federal Government, to the health and safety of the public, to the integrity of research, and to the conservation of public funds.

(b) The U.S. Department of Health and Human Services (HHS) and institutions that apply for or receive PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training share responsibility for the integrity of the research process. HHS has ultimate oversight authority for PHS-supported research, and for taking other actions as appropriate or necessary, including the right to assess allegations and to perform inquiries or investigations at any time. Institutions and institutional members have an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS-supported work, and primary responsibility for responding to and reporting allegations of research misconduct, as provided in this part.

The purpose of this part is to—

(a) Establish the responsibilities of HHS, the Office of Research Integrity (ORI), and institutions in addressing allegations of research misconduct;

(b) Define what constitutes research misconduct in PHS-supported research;

(c) Establish the requirements for a finding of research misconduct;

(d) Define the general types of administrative actions HHS may take in response to research misconduct;

(e) Require institutions to:

(1) Develop and implement policies and procedures for reporting and addressing allegations of research misconduct covered by this part;

(2) Provide HHS with the assurances necessary to permit institutions to participate in PHS-supported research;

(f) Protect the health and safety of the public, promote the integrity of PHS-supported research and the research process, and conserve public funds.

(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) 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) PHS-supported biomedical or behavioral extramural or intramural research;

(3) PHS-supported biomedical or behavioral extramural or intramural research training programs;

(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) Research records produced during PHS-supported research, research training, or activities related to that research or research training; and

(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.

A finding of research misconduct made under this part requires that:

(a) There be a significant departure from accepted practices of the relevant research community; and

(b) The misconduct be committed intentionally, knowingly, or recklessly; and

(c) The allegation be proven by a preponderance of the evidence.

(a) Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.

(b) Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:

(1) Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the use of, republication of, or citation to the portion(s) of the research record (e.g., processed data, journal articles, funding proposals, data repositories) alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent.

(i) When the respondent uses, republishes, or cites to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized, in submitted or published manuscripts, submitted PHS grant applications, progress reports submitted to PHS funding components, posters, presentations, or other research records within six years of when the allegations were received by HHS or an institution, this exception applies.

(ii) For research misconduct that appears subject to the subsequent use exception, institutions must document their determination that the subsequent use exception does not apply. Such documentation must be retained in accordance with § 93.318.

(2) Exception for the health or safety of the public. If ORI or the institution, following consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public, this exception applies.

(a) Standard of proof. An institutional or HHS finding of research misconduct must be proved by a preponderance of the evidence.

(b) Burden of proof. (1) The institution or HHS has the burden of proof for making a finding of research misconduct. A respondent's destruction of research records documenting the questioned research is evidence of research misconduct where the institution or HHS establishes by a preponderance of the evidence that the respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations. A respondent's failure to provide research records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request.

(2) The respondent has the burden of going forward with and proving, by a preponderance of the evidence, all affirmative defenses raised. In determining whether HHS or the institution has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

(3) The respondent has the burden of going forward with and proving, by a preponderance of the evidence, any mitigating factors relevant to a decision to impose administrative actions after a research misconduct proceeding.

(a) Disclosure of the identity of respondents, complainants, and witnesses while conducting the research misconduct proceedings is limited, to the extent possible, to those who need to know, as determined by the institution, consistent with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions. This limitation on disclosure of the identity of respondents, complainants, and witnesses no longer applies once an institution has made a final determination of research misconduct findings. The institution, however, must disclose the identity of respondents, complainants, or other relevant persons to ORI pursuant to an ORI review of research misconduct proceedings under this part.

(b) Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who need to know to carry out a research misconduct proceeding.

(c) This section does not prohibit institutions from managing published data or acknowledging that data may be unreliable.

(a) When more than one agency of the Federal Government has jurisdiction over a research misconduct allegation, HHS will cooperate with the other agencies in designating a lead agency to coordinate the response of the agencies to the allegation. Where HHS is not the lead agency, it may, in consultation with the lead agency, take appropriate action.

(b) In research misconduct proceedings involving more than one agency, HHS may refer to the other agency's (or agencies') evidence or reports if HHS determines that the evidence or reports will assist in resolving HHS issues. In appropriate cases, HHS may seek to resolve allegations jointly with the other agency or agencies.