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| Institutional Compliance Issues | 93.412 – 93.413 | |||||||
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42 U.S.C. 216 and 289b
89 FR 76295, Sept. 17, 2024, unless otherwise noted.
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Subscribe to: 42 CFR Part 93 Subpart D - Institutional Compliance Issues
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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.