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| General Information | 93.400 – 93.401 | |||||||
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42 U.S.C. 216 and 289b
89 FR 76295, Sept. 17, 2024, unless otherwise noted.
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(a) ORI review. ORI may respond directly to any allegation of research misconduct at any time before, during, or after an institution's response to the matter. The ORI response may include but is not limited to:
(1) Conducting allegation assessments;
(2) Determining independently whether jurisdiction exists under this part;
(3) Forwarding allegations of research misconduct to the appropriate institution or HHS component for inquiry or investigation;
(4) Requesting clarification or additional information, documentation, research records, or other evidence as necessary from an institution or its members or other persons or sources to carry out ORI's review;
(5) Notifying or requesting assistance and information from PHS funding components, other affected Federal and state offices and agencies, or institutions;
(6) Reviewing the institutional record and directing the institution to address deficiencies or additional allegations in the institutional record;
(7) Making a finding of research misconduct; and
(8) Taking actions as necessary to protect the health and safety of the public, to promote the integrity of PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, or to conserve public funds.
(b) ORI assistance to institutions. ORI may:
(1) Provide information, technical assistance, and procedural advice to institutional officials as needed regarding an institution's research misconduct proceedings and the sufficiency of the institutional record; and
(2) Issue guidance and provide information to support institutional implementation of and/or compliance with the requirements of this part.
(c) Review of institutional research integrity assurances. ORI will review institutional research integrity assurances and policies and procedures for compliance with this part.
(d) Institutional compliance. ORI may make findings and impose ORI compliance actions related to an institution's compliance with this part and with its policies and procedures, including an institution's participation in research misconduct proceedings.
(a) ORI may notify and consult with other entities, including government funding agencies, institutions, journals, publishers, and editors, at any time if those entities have a need to know about or have information relevant to a research misconduct proceeding.
(b) If ORI believes that a criminal or civil fraud violation may have occurred, it shall promptly refer the matter to the Department of Justice (DOJ), the HHS Office of Inspector General (OIG), or other appropriate investigative body.
(c) ORI may provide expertise and assistance to the DOJ, OIG, PHS offices, other Federal offices, and state or local offices involved in investigating or otherwise pursuing research misconduct allegations or related matters.
(d) ORI may notify affected PHS offices and funding components at any time to enable them to take appropriate interim actions.
(e) The information provided will not be disclosed as part of the peer review and advisory committee review processes but may be used by the Secretary in making decisions about the award or continuation of funding.
(f) ORI may refer a research misconduct matter to the SDO at any time for consideration under the HHS suspension and debarment regulations. ORI may provide technical assistance and share other information that the SDO needs to know to consider the referred matter.