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HHS/OASH RIN: 0937-AA12 Publication ID: Fall 2023 
Title: Public Health Service Policies on Research Misconduct 

The Office of Research Integrity (ORI) proposes to update CFR 42 part 93, Public Health Service (PHS) Policies on Research Misconduct (2005). The regulation covers any entity receiving research funding from any PHS agency. It requires recipient entities to provide assurance to ORI that they have established policies and procedures for handling research misconduct, to report annually on the actions they take under the assurance, and to cooperate with ORI in assessing, investigating, and taking appropriate action on supported findings of research misconduct. Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion. Further, a finding of research misconduct requires that (a) There be a significant departure from accepted practices of the relevant research community; (b) the misconduct be committed intentionally, knowingly, or recklessly; and (c) the allegation be proven by a preponderance of the evidence. ORI may apply administrative actions to researchers found to have committed research misconduct, ranging from supervision of their research, retraction or correction of published articles, prohibition from receiving PHS funding for a prescribed time, or suspension or debarment for periods ranging from 1 year to lifetime. ORI aims to clarify responsibilities, expectations, and processes; redirect respondent appeals of ORI findings or sanctions; and strengthen ORI compliance actions through updating the regulation.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 93   
Legal Authority: 42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 289b   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/06/2023  88 FR 69583   
NPRM Comment Period End  12/05/2023 
Additional Information: RFI soliciting input on areas of current regulation to change, posted 9/1/2022, comment period closes 10/31/2022
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, Tribal 
Small Entities Affected: Businesses, Organizations  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL:   Public Comment URL:  
RIN Data Printed in the FR: No 
Agency Contact:
Wanda Jones
Acting Director, Office of Research Integrity
Department of Health and Human Services
Office of Assistant Secretary for Health
1101 Wootton Parkway, Suite 240,
Rockville, MD 20852
Phone:240 453-8800