Notice Number: NOT-OD-19-020

Key Dates
Release Date: October 17, 2018

Issued by
National Institutes of Health (NIH)

Purpose

The NIH strives to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. To this end, the NIH works with recipient institutions and the HHS Office of Research Integrity (ORI) to maintain the integrity of NIH-funded research. This notice reminds recipient institutions of their responsibilities in handling suspected or confirmed research misconduct in NIH-funded research. This notice also clarifies the requirement for recipient and subrecipient institutions, foreign or domestic, to hold assurances with ORI and outlines procedures for recipient institutions to communicate matters related to research misconduct proceedings to the NIH and ORI.

Recipient and subrecipient institution compliance and assurance
Subpart A of 42 CFR 93 defines research misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. To be eligible for PHS funding, domestic and foreign institutions must maintain an assurance on file with ORI. The assurance is the institution's certification that it has developed and will comply with its written policies and procedures for responding to allegations of research misconduct in PHS-supported research that meets the requirements of 42 CFR 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.

Recipient institution responsibilities, including those to ORI and NIH, in handling allegations of research misconduct and conducting research misconduct proceedings
The recipient institution has primary responsibility for ensuring that it conducts its NIH-funded project in accordance with the approved application and budget and with the terms and conditions of the award. When the recipient institution receives research misconduct allegations or initiates proceedings, the institution must carry out its responsibilities with extra care to provide confidentiality to the extent required by 42 CFR 93.108 to all respondents, complainants, and research subjects identifiable from the research records and evidence. If the recipient institution initiates a research misconduct investigation, it must take any necessary steps, in addition to its normal and ongoing responsibilities under the award, to protect the scientific integrity of the project; to protect human participants, live vertebrate animals and the environment; to ensure the proper expenditure of funds and, if appropriate, continuation of the project during the investigation; and to provide reports to ORI. ORI staff members are available to provide technical assistance to any institution that is responding to an allegation of research misconduct involving PHS funds through its Rapid Response for Technical Assistance (RRTA) program. NIH IC staff members are available to provide guidance and to work with recipient institutions to protect funded projects from the adverse effects of research misconduct.

Communication to ORI and NIH
The recipient institution’s engagement with ORI as provided in 42 CFR 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 misconduct 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 Center Grants Management Officer. 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 regulations, 42 CFR 93.108. The final institutional investigation report must be submitted to ORI, as outlined in Subpart C of 42 CFR 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.

Inquiries

Please direct all inquiries to:

NIH Extramural Research Integrity Officer
Office of Extramural Research (OER)
Email: [email protected]