From the Guidelines
The correct answer is C. Office of Research Integrity. The Office of Research Integrity (ORI) is the primary federal agency responsible for overseeing investigations of alleged research misconduct in biomedical and behavioral research supported by the U.S. Department of Health and Human Services (HHS) 1. ORI specifically handles cases involving fabrication, falsification, or plagiarism in research funded by agencies like the National Institutes of Health. While the FDA and CDER have regulatory oversight roles in their respective domains, they do not have the primary responsibility for investigating research misconduct allegations. The NIH funds research but refers misconduct investigations to ORI. Understanding this distinction is important for researchers and clinical trial staff seeking GCP certification, as it clarifies the reporting structure and accountability mechanisms for maintaining research integrity in federally funded studies. Key points to consider include:
- The role of ORI in investigating research misconduct
- The distinction between regulatory oversight and research misconduct investigation
- The importance of understanding the reporting structure and accountability mechanisms for research integrity. Note that the study from 2009 1 does not provide relevant information for this question, as it focuses on combating extensively drug-resistant tuberculosis and does not address research misconduct investigations.
From the Research
Agencies Overseeing Investigations of Alleged Research Misconduct
- The Office of Research Integrity (ORI) is responsible for protecting the integrity of research supported by grants awarded for the Public Health Service extramural research program 2.
- ORI monitors investigations into alleged or suspected scientific misconduct by institutions that receive Public Health Service funds 2, 3.
- ORI oversees institutional efforts to investigate and report misconduct, and recommends administrative actions when misconduct is identified 3.
- The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts 3.
- While other agencies such as the Food and Drug Administration and the National Institutes of Health may be involved in research oversight, the Office of Research Integrity is specifically responsible for overseeing investigations of alleged research misconduct 2, 3, 4, 5.
- Therefore, the correct answer is C. Office of Research Integrity.
Relevant Agencies
- Office of Research Integrity (ORI): responsible for protecting the integrity of research supported by Public Health Service grants 2, 3, 4, 5.
- Public Health Service (PHS): provides funds for extramural research grants and has a definition of scientific misconduct 2, 3.
- National Institutes of Health (NIH): may be involved in research oversight, but is not specifically responsible for overseeing investigations of alleged research misconduct 2, 3.
- Food and Drug Administration (FDA): may be involved in research oversight, but is not specifically responsible for overseeing investigations of alleged research misconduct 2, 3.
- Center for Drug Evaluation and Research: may be involved in research oversight, but is not specifically responsible for overseeing investigations of alleged research misconduct 2, 3.