(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.

(a) When ORI receives an allegation, it may conduct an assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.

(b) If ORI conducts an assessment and determines an inquiry is warranted, it forwards the matter to the appropriate institution or HHS component.

(c) If ORI conducts an assessment and determines an inquiry is not warranted, it will close the case and forward the allegation in accordance with paragraph (d) in this section.

(d) ORI may refer allegations that do not fall within the jurisdiction of this part to the appropriate HHS component, Federal or state agency, institution, organization, journal, or other appropriate entity.

(a) In conducting its review of research misconduct proceedings, ORI will:

(1) Determine whether this part applies;

(2) Consider the institutional record and determine whether the institutional record is sufficient, provide instructions to the institution(s) if ORI determines that revisions are needed or additional allegations of research misconduct should be addressed, and require institutions to provide the respondent with an opportunity to respond to information or allegations added to the institutional record;

(3) Determine whether the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity, and competence to support the conclusions; and

(4) After reviewing in accordance with paragraphs (a)(1) through (3) of this section, determine whether to close the case without further action or proceed with the case.

(b) If ORI determines to proceed with the case, ORI will:

(1) Obtain additional information or materials from the institution, the respondent, complainants, or other sources, as needed;

(2) Conduct additional analyses, as needed;

(3) Provide the respondent the opportunity to access the institutional record, any additional information provided to ORI while the case is pending before ORI, and any analysis or additional information generated or obtained by ORI;

(4) Provide the respondent the opportunity to submit information to ORI;

(5) Allow the respondent and the respondent's attorney, if represented, to meet virtually or in person with ORI to discuss the information that the respondent has provided to ORI;

(6) Have ORI's virtual or in-person meeting(s) with the respondent transcribed and provide a copy of the transcript to the respondent for review and suggested correction;

(7) Close the administrative record following paragraphs (b)(3) through (6) of this section;

(8) Provide the respondent the opportunity to access the complete administrative record; and

(9) Take any other actions necessary to complete ORI's review of the research misconduct proceedings.

(a) After completing its review of the administrative record, ORI may:

(1) Close the case without a separate ORI finding of research misconduct;

(2) Make findings of research misconduct and propose and take HHS administrative actions based on the administrative record; or

(3) Seek to settle the case.

(b) The lack of an ORI finding of research misconduct does not overturn an institution's determination that the conduct constituted professional or research misconduct warranting remediation under the institution's policy.

(a) When ORI makes a finding of research misconduct or proposes HHS administrative actions, it notifies the respondent in a charge letter. The charge letter:

(1) Includes ORI's findings of research misconduct, including the basis for such findings in the administrative record, and any proposed HHS administrative actions;

(2) Advises the respondent how to access the administrative record; and

(3) Informs the respondent of the opportunity to contest the findings and proposed HHS administrative actions under subpart E of this part.

(b) ORI sends the charge letter by certified mail, private delivery service, or electronic mail or other electronic means to the last known address of the respondent or the last known principal place of business of the respondent's attorney, if represented.

Unless the respondent contests the findings and/or the proposed HHS administrative actions contained in the charge letter within the 30-day period prescribed in § 93.501(a), the ORI findings and HHS administrative actions are final.

(a) Based on the administrative record, HHS may impose administrative actions that include but are not limited to:

(1) Clarification, correction, or retraction of the research record.

(2) Letter(s) of reprimand.

(3) Imposition of special certification or research integrity assurance requirements to ensure compliance with applicable regulations or terms of HHS grants, contracts, or cooperative agreements.

(4) Suspension of award activities under, or termination of, a PHS grant, contract, or cooperative agreement.

(5) Restriction on specific activities or expenditures under an active PHS grant, contract, or cooperative agreement.

(6) Special review of all the respondent's requests for PHS funding.

(7) Imposition of supervision requirements on a PHS grant, contract, or cooperative agreement.

(8) Certification of attribution or authenticity in all requests for support and reports to PHS.

(9) Prohibition of the respondent in participating in any advisory capacity with the PHS.

(10) Recommending that the relevant agency take adverse personnel action(s), if the respondent is a Federal employee, in compliance with relevant Federal personnel policies and laws.

(b) In connection with research misconduct findings, HHS also may seek to recover PHS funds spent supporting activities involving research misconduct.

(c) Any authorized HHS component may impose, administer, or enforce administrative actions separately or in coordination with other HHS components, including, but not limited to ORI, OIG, and the PHS funding component.

(d) HHS administrative actions under this part do not include suspension or debarment. Regardless of whether HHS administrative actions are imposed under this part, HHS may pursue suspension and debarment under the HHS suspension and debarment regulations.

The purpose of HHS administrative actions is remedial. The appropriate administrative action is commensurate with the seriousness of the misconduct and the need to protect the health and safety of the public, promote the integrity of the PHS-supported research and research process, and conserve public funds. ORI considers the following aggravating and mitigating factors in determining appropriate HHS administrative actions and their terms. The existence or nonexistence of any factor is not determinative.

(a) Knowing, intentional, or reckless. Were the respondent's actions knowing or intentional or were the actions reckless?

(b) Pattern. Was the research misconduct an isolated event or part of a continuing or prior pattern of dishonest conduct?

(c) Impact. Did the misconduct have significant impact on the proposed or reported research record, research subjects, other researchers, institutions, or the public health or welfare?

(d) Acceptance of responsibility. Has the respondent accepted responsibility for the misconduct by:

(1) Admitting the conduct;

(2) Cooperating with the research misconduct proceedings;

(3) Demonstrating remorse and awareness of the significance and seriousness of the research misconduct; and

(4) Taking steps to correct or prevent the recurrence of the research misconduct?

(e) Failure to accept responsibility. Does the respondent blame others rather than accepting responsibility for the actions?

(f) Retaliation. Did the respondent retaliate against complainants, witnesses, committee members, or other individuals?

(g) Continued risk to PHS funding. Does the respondent demonstrate responsible stewardship of research resources?

(h) Other factors. Are other factors relevant to the circumstances of a particular case?

(a) HHS may settle a research misconduct proceeding at any time it determines that settlement is in the best interests of the Federal Government and the public health or welfare.

(b) Settlement agreements are publicly available, regardless of whether ORI made a finding of research misconduct.

(c) A settlement agreement precludes the respondent from contesting any ORI findings of research misconduct, HHS administrative actions, or ORI's jurisdiction in handling the research misconduct proceeding.

When the final HHS action does not result in a settlement or finding of research misconduct, ORI may provide written notice to the respondent, the relevant institution, the complainant, and HHS officials.

When a final HHS action results in a settlement or research misconduct finding(s), ORI may:

(a) Provide final notification of any research misconduct findings and HHS administrative actions to the respondent, the relevant institution, and appropriate HHS officials.

(b) Provide final notification of any research misconduct findings and HHS administrative actions to the complainant(s).

(c) Send a notice to the relevant journal, publisher, data repository, or other similar entity identifying publications or research records that require correction or retraction.

(d) Publish notice of the research misconduct findings.

(e) Notify the respondent's current employer if the employer is an institution subject to this part.

ORI may determine an institution is not compliant with this part if the institution does not implement and follow the requirements of this part and its own research integrity assurance. In making this decision, ORI may consider, but is not limited to the following factors:

(a) Failure to establish and comply with policies and procedures under this part;

(b) Failure to respond appropriately when allegations of research misconduct arise;

(c) Failure to report to ORI all investigations and findings of research misconduct under this part;

(d) Failure to cooperate with ORI's review of research misconduct proceedings; or

(e) Other actions or omissions that have a material, adverse effect on reporting and responding to allegations of research misconduct.

(a) If ORI determines an institution is not compliant with this part, it may take a compliance action against the institution.

(b) If ORI determines an institution is not compliant with this part, ORI may take any or all of the following compliance actions:

(1) Require the institution to accept and/or implement technical assistance provided by ORI.

(2) Issue a letter of reprimand.

(3) Require the institution to take corrective actions.

(4) Place the institution on special review status. For a designated period, ORI will closely monitor the institution's activities for compliance with this part. Monitoring may consist of, but is not limited to, compliance reviews and/or audits.

(5) Direct that research misconduct proceedings be handled by HHS.

(6) Any other action appropriate to the circumstances.

(c) If an institution fails to comply with the requirements of this part, ORI may refer the institution to the SDO for consideration under the HHS suspension and debarment regulations.

(d) If the institution's actions constitute a substantial or recurrent failure to comply with this part, ORI may revoke the institution's research integrity assurance under § 93.301 or § 93.303.

(e) ORI may make public any findings of institutional noncompliance and ORI compliance actions.

(a) ORI may disclose information to other persons for the purpose of providing or obtaining information about research misconduct as permitted under the Privacy Act, 5 U.S.C. 552a and ORI's system of records notice for research misconduct proceedings.

(b) ORI may disclose or publish a notice regarding settlements, ORI findings of research misconduct, and HHS administrative actions, and release or withhold information as permitted by the Privacy Act and the Freedom of Information Act, 5 U.S.C. 552.