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Electronic Code of Federal Regulations

e-CFR Data is current as of August 28, 2014

Title 42Chapter ISubchapter HPart 93 → Subpart D


Title 42: Public Health
PART 93—PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT


Subpart D—Responsibilities of the U.S. Department of Health and Human Services


Contents

General Information

§93.400   General statement of ORI authority.
§93.401   Interaction with other offices and interim actions.

Research Misconduct Issues

§93.402   ORI allegation assessments.
§93.403   ORI review of research misconduct proceedings.
§93.404   Findings of research misconduct and proposed administrative actions.
§93.405   Notifying the respondent of findings of research misconduct and HHS administrative actions.
§93.406   Final HHS actions.
§93.407   HHS administrative actions.
§93.408   Mitigating and aggravating factors in HHS administrative actions.
§93.409   Settlement of research misconduct proceedings.
§93.410   Final HHS action with no settlement or finding of research misconduct.
§93.411   Final HHS action with settlement or finding of research misconduct.

Institutional Compliance Issues

§93.412   Making decisions on institutional noncompliance.
§93.413   HHS compliance actions.

Disclosure of Information

§93.414   Notice.

General Information

§93.400   General statement of ORI authority.

(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 if jurisdiction exists under this part in any matter;

(3) Forwarding allegations of research misconduct to the appropriate institution or HHS component for inquiry or investigation;

(4) Recommending that HHS should perform an inquiry or investigation or issue findings and taking all appropriate actions in response to the inquiry, investigation, or findings;

(5) Notifying or requesting assistance and information from PHS funding components or other affected Federal and state offices and agencies or institutions;

(6) Reviewing an institution's findings and process;

(7) Making a finding of research misconduct; and

(8) Proposing administrative actions to HHS.

(b) Requests for information. ORI may request clarification or additional information, documentation, research records, or evidence from an institution or its members or other persons or sources to carry out ORI's review.

(c) HHS administrative actions. (1) In response to a research misconduct proceeding, ORI may propose administrative actions against any person to the HHS and, upon HHS approval and final action in accordance with this part, implement the actions.

(2) ORI may propose to the HHS debarring official that a person be suspended or debarred from receiving Federal funds and may propose to other appropriate PHS components the implementation of HHS administrative actions within the components' authorities.

(d) ORI assistance to institutions. At any time, ORI may provide information, technical assistance, and procedural advice to institutional officials as needed regarding an institution's participation in research misconduct proceedings.

(e) Review of institutional assurances. ORI may review institutional assurances and policies and procedures for compliance with this part.

(f) Institutional compliance. ORI may make findings and impose HHS administrative 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.

§93.401   Interaction with other offices and interim actions.

(a) ORI may notify and consult with other offices at any time if it has reason to believe that a research misconduct proceeding may involve that office. 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 Inspector General (OIG), or other appropriate investigative body. 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.

(b) ORI may notify affected PHS offices and funding components at any time to permit them to make appropriate interim responses to protect the health and safety of the public, to promote the integrity of the PHS supported research and research process, and to conserve public funds.

(c) 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.

Research Misconduct Issues

§93.402   ORI allegation assessments.

(a) When ORI receives an allegation of research misconduct directly or becomes aware of an allegation or apparent instance of research misconduct, it may conduct an initial assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.

(b) If ORI conducts an assessment, it considers whether the allegation of research misconduct appears to fall within the definition of research misconduct, appears to involve PHS supported biomedical or behavior research, research training or activities related to that research or research training, as provided in §93.102, and whether it is sufficiently specific so that potential evidence may be identified and sufficiently substantive to warrant an inquiry. ORI may review all readily accessible, relevant information related to the allegation.

(c) If ORI decides that an inquiry is warranted, it forwards the matter to the appropriate institution or HHS component.

(d) If ORI decides that an inquiry is not warranted it will close the case and forward the allegation in accordance with paragraph (e) of this section.

(e) ORI may forward allegations that do not fall within the jurisdiction of this part to the appropriate HHS component, Federal or State agency, institution, or other appropriate entity.

§93.403   ORI review of research misconduct proceedings.

ORI may conduct reviews of research misconduct proceedings. In conducting its review, ORI may—

(a) Determine whether there is HHS jurisdiction under this part;

(b) Consider any reports, institutional findings, research records, and evidence;

(c) Determine if 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;

(d) Obtain additional information or materials from the institution, the respondent, complainants, or other persons or sources;

(e) Conduct additional analyses and develop evidence;

(f) Decide whether research misconduct occurred, and if so who committed it;

(g) Make appropriate research misconduct findings and propose HHS administrative actions; and

(h) Take any other actions necessary to complete HHS' review.

§93.404   Findings of research misconduct and proposed administrative actions.

After completing its review, ORI either closes the case without a finding of research misconduct or—

(a) Makes findings of research misconduct and proposes and obtains HHS approval of administrative actions based on the record of the research misconduct proceedings and any other information obtained by ORI during its review; or

(b) Recommends that HHS seek to settle the case.

§93.405   Notifying the respondent of findings of research misconduct and HHS administrative actions.

(a) When the ORI makes a finding of research misconduct or seeks to impose or enforce HHS administrative actions, other than debarment or suspension, it notifies the respondent in a charge letter. In cases involving a debarment or suspension action, the HHS debarring official issues a notice of proposed debarment or suspension to the respondent as part of the charge letter. The charge letter includes the ORI findings of research misconduct and the basis for them and any HHS administrative actions. The letter also advises the respondent of the opportunity to contest the findings and administrative actions under Subpart E of this part.

(b) The ORI sends the charge letter by certified mail or a private delivery service to the last known address of the respondent or the last known principal place of business of the respondent's attorney.

§93.406   Final HHS actions.

Unless the respondent contests the charge letter within the 30-day period prescribed in §93.501, the ORI finding of research misconduct is the final HHS action on the research misconduct issues and the HHS administrative actions become final and will be implemented, except that the debarring official's decision is the final HHS action on any debarment or suspension actions.

§93.407   HHS administrative actions.

(a) In response to a research misconduct proceeding, HHS may impose HHS administrative actions that include but are not limited to:

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

(2) Letters of reprimand.

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

(4) Suspension 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 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 the PHS.

(9) No participation in any advisory capacity to the PHS.

(10) Adverse personnel action if the respondent is a Federal employee, in compliance with relevant Federal personnel policies and laws.

(11) Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts 9.4 and 309.4, or both.

(b) In connection with findings of research misconduct, HHS also may seek to recover PHS funds spent in support of the activities that involved research misconduct.

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

§93.408   Mitigating and aggravating factors in HHS administrative actions.

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. HHS considers aggravating and mitigating factors in determining appropriate HHS administrative actions and their terms. HHS may consider other factors as appropriate in each case. The existence or nonexistence of any factor is not determinative:

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

(g) Present responsibility. Is the respondent presently responsible to conduct PHS supported research?

(h) Other factors. Other factors appropriate to the circumstances of a particular case.

§93.409   Settlement of research misconduct proceedings.

(a) HHS may settle a research misconduct proceeding at any time it concludes 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 the ORI made a finding of research misconduct.

§93.410   Final HHS action with no settlement or finding of research misconduct.

When the final HHS action does not result in a settlement or finding of research misconduct, ORI may:

(a) Provide written notice to the respondent, the relevant institution, the complainant, and HHS officials.

(b) Take any other actions authorized by law.

§93.411   Final HHS action with settlement or finding of research misconduct.

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

(a) Provide final notification of any research misconduct findings and HHS administrative actions to the respondent, the relevant institution, the complainant, and HHS officials. The debarring official may provide a separate notice of final HHS action on any debarment or suspension actions.

(b) Identify publications which require correction or retraction and prepare and send a notice to the relevant journal.

(c) Publish notice of the research misconduct findings.

(d) Notify the respondent's current employer.

(e) Take any other actions authorized by law.

Institutional Compliance Issues

§93.412   Making decisions on institutional noncompliance.

(a) Institutions must foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with PHS supported research.

(b) ORI may decide that an institution is not compliant with this part if the institution shows a disregard for, or inability or unwillingness to implement and follow the requirements of this part and its assurance. In making this decision, ORI may consider, but is not limited to the following factors—

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

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

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

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

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

§93.413   HHS compliance actions.

(a) An institution's failure to comply with its assurance and the requirements of this part may result in enforcement action against the institution.

(b) ORI may address institutional deficiencies through technical assistance if the deficiencies do not substantially affect compliance with this part.

(c) If an institution fails to comply with its assurance and the requirements of this part, HHS may take some or all of the following compliance actions:

(1) Issue a letter of reprimand.

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

(3) Place the institution on special review status.

(4) Place information on the institutional noncompliance on the ORI Web site.

(5) Require the institution to take corrective actions.

(6) Require the institution to adopt and implement an institutional integrity agreement.

(7) Recommend that HHS debar or suspend the entity.

(8) Any other action appropriate to the circumstances.

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

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

Disclosure of Information

§93.414   Notice.

(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.

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



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