Office of Research Integrity

Office of Research Integrity
Name	Office of Research Integrity
Formed	1992
Jurisdiction	United States Department of Health and Human Services
Headquarters	Rockville, Maryland
Parent agency	United States Department of Health and Human Services

Contents

Office of Research Integrity is the U.S. federal office charged with oversight of research integrity in biomedical and behavioral sciences. It operates within the United States Department of Health and Human Services and interacts with agencies such as the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Science Foundation, and the Department of Veterans Affairs. The office develops policies and adjudicates allegations involving research misconduct by recipients of Public Health Service support, coordinating with institutions such as the Johns Hopkins University, the Harvard University, the University of California, San Francisco, the Massachusetts Institute of Technology, and the University of Pennsylvania.

History

The office emerged from reforms following high-profile scandals in the late 20th century, prompting Congressional action through statutes like the Public Health Service Act and oversight by committees including the United States Senate Committee on Labor and Human Resources and the United States House Committee on Energy and Commerce. Early influences included inquiries such as the investigations into the work of individuals at institutions like the Rockefeller University and the Mayo Clinic, and reports by bodies including the Institute of Medicine and the National Academy of Sciences. Leadership transitions involved figures who had worked with agencies like the National Institutes of Health, the Office of Inspector General (United States Department of Health and Human Services), and the Office of Research Integrity predecessor entities that were shaped by reforms after cases connected to the Cold Spring Harbor Laboratory and the Salk Institute for Biological Studies.

The office enforces regulations derived from statutes such as the Public Health Service Act and policies implemented by the National Institutes of Health and the Agency for Healthcare Research and Quality. Its functions include reviewing allegations of falsification, fabrication, and plagiarism from institutions like the University of Texas Southwestern Medical Center, the Stanford University, and the Yale University, issuing findings that can affect grants administered by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the National Institute of Mental Health. The office also issues debarments and administrative actions that may interact with systems overseen by the Office of Inspector General (United States Department of Health and Human Services), the Federal Bureau of Investigation, and the Department of Justice.

Investigations follow procedures aligned with regulations promulgated by the Public Health Service and the National Institutes of Health, engaging institutional research integrity officers from universities such as the University of California, San Diego, the Duke University, and the Emory University to conduct inquiries and investigations. When findings warrant action, the office issues administrative remedies including exclusion lists and settlement agreements that affect grant eligibility at the National Institutes of Health, National Science Foundation, and other agencies like the Department of Defense. Enforcement actions have involved coordination with federal entities such as the Office of the Inspector General (United States Department of Health and Human Services), the FBI, and the United States Attorney's Office.

The office issues guidance documents and policy statements that influence practices at research institutions including the Rockefeller University, the Scripps Research Institute, and the Fred Hutchinson Cancer Research Center, and informs standards adopted by journals such as the New England Journal of Medicine, the Journal of the American Medical Association, and Nature (journal). It has contributed to authorship guidelines used by societies like the American Association for the Advancement of Science, the American Society for Cell Biology, and the Society for Neuroscience, and interacted with regulatory frameworks such as those developed by the Office for Human Research Protections and the International Committee of Medical Journal Editors.

High-profile investigations have involved researchers affiliated with institutions like the Harvard University, the University of Pittsburgh, and the University of Minnesota, producing sanctions that affected grant awards from the National Institutes of Health and prompted institutional reforms at places including the Massachusetts General Hospital, the Brigham and Women's Hospital, and the Cleveland Clinic. Cases reviewed by the office have influenced legislation debated in the United States Congress and inquiries conducted by committees such as the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Oversight and Reform, and have had ripple effects on publishing policies at titles like Science (journal), The Lancet, and Cell (journal). The office's actions continue to shape expectations at research organizations including the Wellcome Trust, the Howard Hughes Medical Institute, and major universities worldwide.