OFFICE OF RESEARCH INTEGRITY

The United States Office of Research Integrity (ORI) has broad responsibilities for monitoring investigations of misconduct and promoting integrity in research supported by the Public Health Service (PHS). It is administratively located in the Office of Public Health and Science (OPHS) within the Office of the Secretary of Health and Human Services (OS, HHS) and reports to the Secretary of HHS through the Assistant Secretary for Health (ASH). The scope of its responsibilities extends to about four thousand research institutions worldwide. Although separate from the major PHS research funding agencies, such as the National Institutes of Health (NIH), the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA), ORI works with these agencies as well as other government agencies to promote responsible conduct in federally supported research.

Origin and Development

The origins of ORI extend back to the early 1980s when Congress began formal investigations into a number of widely reported cases of misconduct in research. The federal agencies that supported the research and the research community initially assured Congress that misconduct in research was rare and appropriately handled through professional self-regulation. However, after more cases emerged, some involving high profile researchers, Congress intervened and passed the Health Research Extension Act of 1985 requiring PHS to establish a formal definition of and provisions for investigating misconduct in PHS-funded research.

In response to the Congressional call for action, PHS published an Interim Policy on Research Misconduct in 1986, followed in March 1989 by the announcement that two offices would be established to investigate and adjudicate research misconduct cases: the Office of Scientific Integrity (OSI) in the Office of the Director of NIH and the Office of Scientific Integrity Review (OSIR) in the Office of ASH (OASH). Five months later in August 1989, in a so-called Final Rule for research misconduct, PHS outlined the responsibilities of the new offices as well as those of research institutions accepting PHS funds for research. The two offices were combined in May 1992 to form the ORI, located in OASH.

During its early years, ORI focused the majority of its efforts on research misconduct, including the investigation of individual cases, the development of an assurance program for institutional misconduct policies, and the organization of programs designed to help research institutions develop expertise for handling their own misconduct cases. In the early twenty-first century, spurred in part by a reorganization plan published in May 2000, more attention has been given to understanding the factors that influence research integrity and ways to foster responsible conduct in research. These efforts are promoted through both funding and professional support for conferences, educational programs, and research projects.

Relations to Science, Technology, and Ethics

The ORI role in the discussion of the relationships between science, technology, and ethics is concerned with actual researcher practices and whether these practices conform to the standards and/or ideals for responsible conduct in research. Accordingly its efforts generally do not encompass the consideration of broader ethical questions, such as the appropriateness of particular research topics or the ethical dilemmas posed by human- or animal-subject research. ORI is also concerned principally with biomedical and behavioral research. Its work, however, relies on methods and advice from the social sciences, natural sciences, humanities, and relevant professions.

ORI has played a prominent, if at times controversial, role in stimulating the national debate about the importance of integrity in research and the adoption of policies to promote responsible conduct in research. During the 1990s, ORI and its counterpart agency in the National Science Foundation (NSF), the NSF Office of the Inspector General, assumed the lead in defining research misconduct and establishing procedures for its investigation. The three inappropriate behaviors that were identified by PHS and NSF as antithetical to responsible conduct in research—fabrication, falsification, and plagiarism (FFP)—quickly became community standards and were adopted by many research institutions as the basis of their misconduct policies. The common federal definition of research misconduct, formulated in December 2000, begins with FFP. During the prolonged discussion of the definition of research misconduct in the 1990s other options were suggested, but none received wide acceptance by the research community.

ORI has also played an important role in encouraging the research community to think of integrity in research as more than simply avoiding misconduct. Others have contributed to this effort. In 1992 a National Academy of Sciences (NAS) Report, Responsible Science, argued that along with misconduct researchers must be concerned with other questionable research practices, such as the failure to maintain adequate records, improper or undeserved authorship, or the inappropriate use of statistics. Through its conference programs and research on research integrity grants, ORI continues to encourage serious discussion of and research on the many factors that foster and detract from integrity in research.

Finally ORI is deeply involved in efforts to foster education on the responsible conduct of research (RCR). National recognition of the importance of RCR can be traced to the 1989 Institute of Medicine Report, The Responsible Conduct of Research in the Health Sciences. Within a year, NIH made RCR education a requirement for all Training Grant (T-32) applications and in 2000 ORI proposed, but later suspended, a requirement that would have made RCR education mandatory for key personnel on all PHS-funded research. Whether or not ORI ever issues a final RCR policy/requirement, it is committed to and is providing resources for developing and assessing ways to improve integrity in research through education.

The pressures and public concerns that led to the formation of ORI are unlikely to disappear in the near future. While the number of cases remains small in comparison to the size of the research community, research misconduct remains a problem that continues to undermine public confidence. Moreover, as the financial, political, and social stakes of research outcomes grow in importance, the significance of questionable research practices takes on new meaning. Improper or undisclosed conflicts of interests have been discovered in the deaths of subjects enrolled in clinical trials and the biased reporting of research results. Research data are sometime improperly hoarded, taken, or used. Authorship standards vary widely and are frequently abused. As long as the human side of research remains an important factor in shaping both practice and outcomes, ORI, its companion agencies elsewhere in government, and institutional research offices should continue to play an important role in protecting the public's investment in research.

NICHOLAS H. STENECK

SEE ALSO Misconduct in Science;Research Integrity.

BIBLIOGRAPHY

Bivens, Lyle W. (1994). "ORI and Misconduct Investigations." Science 263: 593.

Commission on Research Integrity, U.S. Department of Health and Human Services. (1995). Integrity and Misconduct in Research: Report of the Commission on Research Integrity. Washington, DC: Author. This Report began the internal review process that led to the reorganization plan published in May 2000.

Hallum, Jules V., and Suzanne W. Hadley. (1990). "OSI: Why, What, and How." ASM News 56(12): 647–651.

Institute of Medicine, and Committee on the Responsible Conduct of Research. (1989). The Responsible Conduct of Research in the Health Sciences. Washington, DC: National Academy of Sciences. The first major report to urge research institutions to institute training in the responsible conduct of research.

National Academies of Science. (1992). Responsible Science: Ensuring the Integrity of the Research Process. Report of the Committee on Science Engineering and Public Policy, Panel on Scientific Responsibility and the Conduct of Research. Washington, DC: National Academy Press. A careful study of the issues raised by misconduct in research that influenced later discussions even though its proposed definition of research misconduct was not adopted.

Pascal, Chris B. (1999). "The History and Future of the Office of Research Integrity: Scientific Misconduct and Beyond." Science and Engineering Ethics 5(2): 183–198.

Pascal, Chris B. (2000). "Scientific Misconduct and Research Integrity for the Bench Scientist." Proceedings of the Society for Experimental Biology in Medicine. 224(4): 220–230.

Price, Alan R. (1994a). "The 1993 ORI/AAAS Conference on Plagiarism and Theft of Ideas." Journal of Information Ethics 3(2): 54–63.

Price, Alan R. (1994b). "Definitions and Boundaries of Research Misconduct—Perspectives from a Federal-Government Viewpoint." Journal of Higher Education 65: 286–297.

Steneck, Nicholas H. (1994). "Research Universities and Scientific Misconduct—History, Policies, and the Future." Journal of Higher Education 65: 310–330.

Steneck, Nicholas H. (1999). "Confronting Misconduct in Science in the 1980s and 1990s: What Has and Has Not Been Accomplished?" Science and Engineering Ethics 5(2): 1–16.

Steneck, Nicholas H., and Mary D. Scheetz. (2002). Investigating Research Integrity: Proceedings of the First ORI Research Conference on Research Integrity. Washington, DC: Office of Research Integrity.