Research misconduct, responsibilities of institutions, office of research integrity (ORI)

4.1.27 Research Misconduct

Title 42 CFR 93, PHS Policies on Research Misconduct (the "PHS regulation"), Subpart C, "Responsibilities of Institutions" specifies recipient responsibilities to have written policies and procedures for addressing allegations of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion., to file an Assurance of Compliance with the HHS Office of Research Integrity (ORI), and take all reasonable and practical steps to foster research integrity. Research misconduct"Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion." is defined by Subpart A of 42 CFR Part 93 as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Subpart D, "Responsibilities of the U.S. Department of Health and Human Services," specifies that ORI has responsibility for addressing research integrity and misconduct, monitors institutional investigations of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. and facilitates the responsible conduct of research through education, preventive, and regulatory activities (http://www.ori.dhhs.gov).

To be eligible for PHS funding, domestic and foreign institutions must have approved assurances and required renewals on file with ORI. The responsible institutional official must assure on behalf of the institution that the institution (1) has written policies and procedures in compliance with 42 CFR Part 93 for inquiring into and investigating allegations of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. in PHS-supported research and (2) complies with its own policies and procedures and the requirements of 42 CFR Part 93. In addition, recipient institutions must foster a research environment that promotes the responsible conduct of research. Domestic and foreign subrecipient institutions must also maintain an assurance by submitting form PHS-6315 to ORI. An institution establishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant application form or when the institution files a separate assurance form. Once established, institutions maintain their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and March 1 each year), submitting their policy for responding to allegations of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. for review when requested by ORI, revising their policy when requested by ORI to bring the policy into compliance with the PHS regulation, and complying with the PHS regulation.

As stated throughout the NIHGPS, the recipient has primary responsibility for ensuring that it is conducting its NIH-funded project in accordance with the approved application and budget and the terms and conditions of the award. The recipient must carry out its responsibilities with extra care where research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. has been found or where a research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. investigation has been initiated, as specified in 42 CFR Part 93, Subpart C. The recipient must report promptly to ORI any decision to initiate an investigation of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion..

The regulations specify the timing of an institutional investigation, related reporting to ORI, notice to the respondent, custody of records, documentation, opportunity for respondent to comment on the report, and the components on a final institutional investigative report.

If a misconduct investigation is initiated, the recipient must take any necessary steps, in addition to its normal and ongoing responsibilities under the grant, to protect the scientific integrity of the project, protect human subjects and live vertebrate animals, provide reports to ORI, and ensure the proper expenditure of funds and continuation of the project during the investigation, if appropriate. ORI staff members are available to provide technical assistance to any institution that is responding to an allegation of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. involving PHS funds. NIH ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. staff members are available to provide guidance and to work with recipient institutions to protect funded projects from the adverse effects of research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion..

The recipient institution's engagement with ORI as provided in 42 CFR Part 93 does not substitute for its engagement with NIH to ensure ongoing compliance with the terms and conditions of award. When the recipient institution finds, learns of, or suspects research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. that impacts or might impact the conduct or performance of an NIH-supported project(s), whether at the recipient organization or at a third-party subrecipient organization, the recipient must work with NIH to assess the effect on the ability to continue the project, as originally approved by NIH. If the recipient institution determines that a change of scope or a change of PD/PI or other senior/key personnel is required, the institution must promptly obtain approval from the NIH funding Institute or CenterThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. Grants Management OfficerAn NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. When a recipient institution finds, learns, or suspects that falsified, fabricated, or plagiarized information has affected the integrity of NIH-supported research, including but not limited to, applications for funding and progress reports, or published research or research products supported by NIH funds, NIH has a need to know this information, and the institution must immediately provide information on the affected research to the NIH Office of Extramural Research – Research Integrity (OER-RI), in a manner consistent with the ORI confidentiality provision at, 42 CFR § 93.108. The final institutional investigation report must be submitted to ORI, as outlined in Subpart C of 42 CFR Part 93.

The NIH retains the authority to provide oversight regarding the management of grants and cooperative agreements. Accordingly, the NIH may take action(s) to protect the health and safety of the public, including research participants, to promote the integrity of the PHS supported research and research process, and to conserve public funds. When a recipient fails to comply with the terms and conditions of award, the NIH may take one or more enforcement actions including disallowance of costs, withholding of further support, or suspension or termination of the grant. These actions are described in Administrative Requirements-Enforcement Actions.

Where research misconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. has affected data validity or reliability, ORI or NIH may request that the recipient and its employee/collaborator authors submit a correction or retraction of the data to a journal, publish the corrected data, or both. If the recipient does not comply, NIH may invoke its rights, under 45 CFR §75.322, to access the data (including copyrightable material developed under the award), and may then have the data reviewed, and notify the journal.