What is ORI’s mission?
The mission of the Office of Research Integrity (ORI) is to protect the health and safety of the public, promote the integrity of U.S. Public Health Service 1 (PHS)-supported research and conserve public funds by ensuring the integrity of all PHS-supported work (with the exception of the regulatory research integrity activities of the Food and Drug Administration).
In support of its mission, ORI:
- oversees and directs PHS research integrity activities on behalf of the HHS Secretary, including the oversight of research misconduct proceedings, education and training in the responsible conduct of research, activities designed to promote research integrity and prevent misconduct, and research and evaluation programs;
- reviews institutional policies and procedures to ensure compliance with ORI’s regulation (42 CFR Part 93);
- takes compliance actions against institutions; and
- makes findings of research misconduct and proposes administrative actions in connection with biomedical or behavioral research, research training, or related activities conducted or supported by PHS.
It is important to note that ORI is not authorized to investigate fraud relating to HHS grants. Information about reporting fraud can be found below.
What is research misconduct and how does ORI oversee it?
The Public Health Service Policies on Research Misconduct regulation (42 CFR Part 93) defines research misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication means making up data or results and recording or reporting them. Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism means the appropriation of another person's ideas, processes, results, or words, without giving appropriate credit. Research misconduct does not include honest error or differences in opinion.
HHS and institutions that apply for or receive PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training share responsibility for the integrity of the research process. Allegations of research misconduct often are received by the institution where the alleged misconduct occurred. Allegations of research misconduct are also received by ORI, which forwards them to institutions, as appropriate.
In either scenario, allegations of research misconduct are initially handled by institutions in accordance with their policies and procedures. Institutions may take actions against individuals they find to have committed research misconduct. ORI has no direct involvement in institutional decision-making.
When an institution completes an investigation under ORI’s regulation, it transmits its files to ORI for oversight review. Following its oversight review, ORI may separately find that an individual committed research misconduct and propose and take HHS administrative actions. Institutions may have standards of conduct different from the standards for research misconduct under ORI’s regulation. ORI findings of research misconduct or HHS settlements of research misconduct proceedings, or the absence thereof, do not affect institutional findings or actions taken based on an institution's standards of conduct.
Does ORI investigate fraud?
No. ORI’s regulatory authority is limited to the oversight of research misconduct as defined above involving PHS-funded biomedical or behavioral research, research training, or related activities. ORI does not have authority to investigate fraud.
What if I suspect financial or other types of fraud?
Please visit the HHS Office of the Inspector General’s website at https://oig.hhs.gov/fraud/grant/ to learn about types of possible grant fraud and how to report it to HHS. NIH’s Division of Program Integrity also handles some relevant activities as explained on NIH’s website at https://www.nih.gov/institutes-nih/nih-office-director/office-management-assessment-oma/division-program-integrity, and individuals can report potential fraud to NIH at nihhotline@mail.nih.gov. To report other types of fraud against HHS, please visit: https://oig.hhs.gov/fraud/.
In addition, general resources about reporting fraud are available at the Department of Justice’s website at https://www.justice.gov/civil/report-fraud and https://www.justice.gov/criminal/criminal-fraud/report-fraud, as well as the Oversight.gov website at https://www.oversight.gov/where-report-fraud-waste-abuse-or-retaliation.
PHS consists of the following components within HHS: the Office of the Assistant Secretary for Health, the Office of Global Affairs, the Administration for Strategic Preparedness and Response, the Advanced Research Projects Agency for Health, the Agency for Healthcare Research and Quality, the Agency for Toxic Substances and Disease Registry, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, and any other components of HHS designated or established as components of PHS.
