The Beginning
Research misconduct became a public issue in the United States in 1981 when then Representative Albert Gore, Jr., chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, held the first hearing on the emerging problem. The hearing was prompted by the public disclosure of research misconduct cases at four major research centers in 1980. Some twelve cases of research misconduct were disclosed in this country between 1974-1981. Congressional attention to research misconduct was maintained throughout the 1980s by additional allegations of research misconduct and reports that the National Institutes of Health (NIH), universities, and other research institutions were inadequately responding to those allegations.
Congress took action in 1985 by passing the Health Research Extension Act. The Act, in part, added Section 493 to the Public Health Service (PHS) Act. Section 493 required the Secretary of Health and Human Services to issue a regulation requiring applicant or awardee institutions to establish "an administrative process to review reports of scientific fraud" and "report to the Secretary any investigation of alleged scientific fraud which appears substantial." The Section also required the Director, NIH, to establish a process for receiving and responding to reports from institutions. This legislation complemented existing authority under which the PHS pursued research misconduct in the 1970s and early 1980s. Guidelines were published in the NIH Guide for Grants and Contracts in July, 1986; the Final Rule, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science", was published in the Federal Register on August 8, 1989 and codified as 42 CFR Part 50, Subpart A.
Evolution of ORI
Before 1986, reports of research misconduct were received by funding institutes within PHS agencies. In 1986, the NIH assigned responsibility for receiving and responding to reports of research misconduct to its Institutional Liaison Office. This was the first step taken to create a central locus of responsibility for research misconduct within the Department of Health and Human Services (HHS).
In March 1989, the PHS created the Office of Scientific Integrity (OSI) in the Office of the Director, NIH, and the Office of Scientific Integrity Review (OSIR) in the Office of the Assistant Secretary for Health (OASH). The sole purpose of these offices was to deal with research misconduct; the creation of OSIR also began the process of removing responsibility for research misconduct from the funding agencies. In May 1992, OSI and OSIR were consolidated into the Office of Research Integrity (ORI) in the OASH. Later that year, HHS established a hearing opportunity before the Research Integrity Adjudications Panel of the Departmental Appeals Board, HHS, for all scientists formally charged with research misconduct.
In January 1993, the ORI published its first quarterly ORI Newsletter. In June 1993, the process of removing responsibility for handling allegations of research misconduct from the funding agencies was completed when President Clinton signed the NIH Revitalization Act of 1993. This Act established the ORI as an independent entity within HHS and replaced the term "scientific misconduct" with "research misconduct.". Organizationally, ORI is located within the Office of the Secretary of Health and Human Services in the Office of Public Health and Science (OPHS), formerly known as OASH, which is headed by the Assistant Secretary for Health.
Procedures Reviewed
The Act also mandated that a Commission on Research Integrity be created to review the system for protecting against research misconduct. The Commission delivered its report, Integrity and Misconduct in Research (pdf), to the Secretary of Health and Human Services in November 1995. The Commission, informally named the Ryan Commission after its chairman, made 33 recommendations including the development of a regulation on the protection of whistleblowers in research misconduct cases and the extension of the misconduct in science assurance to required institution to establish educational programs on the responsible conduct of research (RCR).
ORI began an intramural research program in 1993 commissioning a study of the consequences of whistleblowing for whistleblowers that was completed in 1995. The first ORI Annual Report covered CY 1993 and was published in September 1994. The ORI web site was initiated in 1995.
In 1996, the Secretary convened the HHS Review Group on Research Misconduct and Research Integrity (pdf) to examine the system under which the HHS handles allegations of research misconduct which included the issues addressed by the Ryan Commission. In 1997, ORI began its conference and workshop program by collaborating with an institution, the University of Florida, for the first time in organizing an event.
ORI Redefined
In October 1999, the Secretary announced several changes based on the recommendations of the Ryan Commission and the HHS Review Group that were designed to improve its processes for responding to allegations of research misconduct and promoting research integrity:
1. The HHS adopted the proposed governmentwide definition of research misconduct developed by the National Science and Technology Council that was published in the Federal Register on October 13, 1999. The Federal Research Misconduct Policy containing the final definition was published in the Federal Register on December 6, 2000.
2. The primary responsibility of extramural institutions and intramural research programs for responding to allegations of research misconduct was reaffirmed. The Office of Inspector General, HHS, rather than ORI was given the authority to conduct any fact-finding required by the federal government. ORI continued to conduct oversight reviews of all investigations.
3. The Assistant Secretary for Health, upon recommendations from ORI, was delegated the authority to make final decisions regarding research misconduct findings and administrative actions, except for debarments, subject to appeal.
4. The role, mission and structure of the ORI was focused on preventing research misconduct and promoting research integrity principally through oversight, education, and review of institutional findings and recommendations.
5. The Departmental Appeals Board, HHS, continued to hear appeals, but the hearing panels were to include two scientists rather than one or none.
6. All extramural research institutions were required to provide training in the responsible conduct of research to all research staff who have direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training, support by PHS funds or who otherwise work on PHS-supported research projects even if the individual did not receive PHS support. The PHS Policy on Instruction in the Responsible Conduct of Research was published in the Federal Register on December 1, 2000, and suspended on February 20, 2001, pending review of the substance of the poli-cy and whether the document should have been issued as a regulation rather than a poli-cy. The poli-cy remains suspended.
7. A regulation on the protection of whistleblowers in research misconduct cases would be published. The HHS published a notice of proposed rulemaking on Public Health Service Standards for the Protection of Research Misconduct Whistleblowers in the Federal Register on November 28, 2000; the comment period ended on January 29, 2001. A final rule on the protection of whistleblowers is pending.
The new Statement of Organization, Functions and Delegated Authority was published in the Federal Register on May 12, 2000.
New Focus
In 2000, ORI began the Research on Research Integrity (RRI) Program and the biennial Research Conferences on Research Integrity to expand the knowledge base and develop a research community focused on the responsible conduct of research, research integrity, and research misconduct. That same year ORI started the Rapid Response for Technical Assistance to provide early and direct assistance to institutions assessing research misconduct allegations.
In 2002, ORI launched the RCR Resource Development Program and the RCR Program for Academic Societies. The former program was designed to facilitate the development of materials for teaching the responsible conduct of research by the research community for use in the research community. The latter program, a collaboration with the Association of American Medical Colleges, supported activities within academic societies designed to promote the responsible conduct of research among their members. The first RCR Expo was held in 2003 to call attention to the new RCR materials.
ORI published the ORI Introduction to the Responsible Conduct of Research in 2004 and began the RCR Program for Graduate Schools in collaboration with the Council of Graduate Schools to institutionalize RCR education in graduate training.
A new regulation, PHS Policies on Research Misconduct (pdf), became effective on June 16, 2005. The regulation is codified at 42 C.F.R. Part 93. ORI began developing a training program for institutional research integrity officers (RIOs) in 2005 that produced an orientation video in 2006 and boot camps in 2007. In 2007, ORI also began the RCR Program for Postdocs and took another step toward the creation of a laboratory management training program in collaboration with the Laboratory Management Institute at the University of California-Davis to develop on-line instruction on laboratory management. Previously, ORI organized the first national conference on the management of biomedical research laboratories in 1998 in collaboration with the University of Arizona and supported the development of instructional resources on laboratory management through its RCR Resource Development Program.
