FOR IMMEDIATE RELEASE
Jan 13, 2006
Contact: HHS Press Office
PROMOTING INTEGRITY IN RESEARCH
Overview: The Department of Health and Human Services operates a collaborative system to promote integrity in biomedical and behavioral research supported or conducted by agencies of the U.S. Public Health Service (PHS). The system for preventing, detecting, and investigating research misconduct and promoting research integrity involves cooperative efforts among individual scientists, research institutions, and PHS agencies, especially the National Institutes of
Health. The HHS Office of Research Integrity (ORI) oversees this system. Some 4,000 institutions receive research funds from PHS agencies. Institutions that receive PHS support for research or research training are required to establish policies to respond to allegations of research misconduct, including protections for both the accused (also referred to as the respondent) and the complainant. When misconduct is found, HHS may propose that certain administrative and corrective actions be imposed. If a finding of research misconduct is made, the respondent may request a hearing before the HHS Departmental Appeals Board (DAB).
In 2005, HHS adopted new regulations on research misconduct on May 17,2005 to implement the Federal-wide definition of research misconduct and make other updates to the original HHS regulation published in 1989. The new regulation was published at Federal Register, Vol. 70, p. 28370, May 17, 2005. It will be codified at 42 CFR Part 93. The new definition of research misconduct means "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." This regulation became effective on July 16, 2005 and will apply to any new allegations made after that date. All allegations made before July 16, 2005, will be subject to the old definition of scientific misconduct included in 42 CFR Part 50, Subpart A. A new Subpart E of 42 CFR Part 93 will govern any appeals to the HHS Departmental Appeals Board, where the respondent requests an opportunity to contest the charges of research misconduct after July 16, 2005. Both the new regulation and the old regulation are posted on the ORI website at http://ori.dhhs.gov More information about HHS efforts to promote research integrity is available on the Web at ori.dhhs.gov.
Public concerns about integrity in research gained national attention in the U.S. following the public disclosure of misconduct cases at four major research centers in 1980. Congressional and public attention to the issue continued throughout the 1980s. In 1985, Congress enacted the Health Research Extension Act, which required institutions seeking PHS research funds 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." To carry out the law, the PHS in March 1989 created the Office of Scientific Integrity (OSI) in the Office of the Director at NIH, and an Office of Scientific Integrity Review (OSIR) in the HHS Office of the Assistant Secretary for Health. In June 1992, these offices were merged to create the Office of Research Integrity (ORI), and HHS established a mechanism to provide scientists formally charged with misconduct with an opportunity for a hearing.
In 2000, HHS modified ORI's role to focus more on education and outreach. In addition to its oversight responsibilities, ORI now emphasizes education and training in the responsible conduct of research in order to promote research integrity and prevent misconduct, and research and evaluation programs. Consistent with this mission, ORI has developed resources with the research community to provide education programs in the responsible conduct of research and, in collaboration with NIH, developed a new research program to study integrity issues.
RESEARCH INTEGRITY - A SHARED RESPONSIBILITY
Promoting research integrity requires a collaborative effort involving scientists, institutions and the PHS. The PHS is responsible for ensuring the integrity of the research it supports, protecting public health, and monitoring compliance with the misconduct regulations. Under the ORI regulation, primary responsibility for responding to allegations of research misconduct rests with institutions, which generally have the administrative and scientific expertise to assess allegations.
On occasion, an institution may not be in a position to properly conduct its own investigation. In such instances, institutions can enlist the services of other organizations or individuals that specialize in conducting such investigations. In 2000, ORI established a Rapid Response for Technical Assistance program to provide direct help to institutions conducting inquiries and investigations. ORI generally is responsible for overseeing the collaborative system for promoting research integrity in PHS-supported research programs. ORI also provides technical assistance and policy guidance to enable institutions to conduct their own investigations effectively. ORI staff includes scientists, attorneys, educators and other personnel with expertise and experience in oversight and investigations, education, technical assistance, research and evaluation, and compliance issues. ORI staff responds to more than 200 allegations of research misconduct each year. Since 1992, ORI has addressed about 3,000 allegations of misconduct, about 20 percent of which require a formal inquiry.
RESPONDING TO MISCONDUCT ALLEGATIONS
HHS regulations require each PHS applicant or awardee institution to have an administrative policy for responding to allegations of research misconduct. Generally, when an allegation of research misconduct is received by an institution, a preliminary assessment is conducted to determine whether the allegation falls within the PHS definition of misconduct, whether PHS funding or an application for funding is involved, and whether the allegation is specific enough to allow for investigation. If these criteria are met, the institution initiates an inquiry to determine whether there is sufficient substance to the allegation to warrant a full investigation. If an institution decides that an investigation is needed, the institution seeks to determine whether misconduct occurred, who committed it, and the extent and seriousness of the misconduct. If misconduct is found, many institutions permit the respondent to appeal the finding within the institution.
In some cases, it may be necessary for HHS to conduct the investigation, such as when an allegation raises special public health or safety issues or an unavoidable conflict of interest exists for the research institution. When an HHS investigation is required, ORI will refer the allegation to the HHS Office of Inspector General (OIG). The OIG may supplement its investigation team with scientific experts as necessary. If the OIG determines that a criminal statute was violated, the matter is referred to the U.S. Department of Justice. The U.S. Department of Justice may also initiate its own civil or criminal investigation. The institution must submit a report of the investigation and its resulting findings to the ORI. The ORI reviews the report to determine whether the investigation was thorough, competent, objective, and fair. As part of its oversight responsibilities, ORI will perform a careful review of the record of the institution's investigation, including documents and witness testimony, to determine whether the available evidence supports the institution's findings.
If an investigation results in a finding of misconduct, ORI will review the finding and the supporting evidence as well as any actions recommended by the institution. If ORI concludes that a finding of misconduct is warranted, it will issue PHS findings of research misconduct and seek to resolve the case through appropriate administrative actions. Potential administrative actions may include: correction of the scientific literature; special plan of supervision to ensure integrity of future scientific research; required certification of the accuracy of scientific data; required certification of the accuracy of sources and contributions for scientific ideas and writings; and prohibition against service on PHS advisory committees or as a consultant. Under the OR regulation, the HHS Debarring Official may also issue a notice of proposed debarment, which would prohibit the accused scientist from receiving Federal funds. These actions are for specified periods depending on the nature and gravity of the misconduct.
If the ORI and Assistant Secretary for Health make a finding of misconduct, the accused scientist may request, within 30 days of receipt of the notification of findings, a hearing before the HHS Departmental Appeals Board (DAB) under the new Subpart E of the revised 2005 research misconduct regulations. Throughout this process, counsel may represent the accused scientist, and the ORI (with legal support from the HHS Office of the General Counsel) will represent the Department.
PROTECTING ALL PARTICIPANTS
The HHS research misconduct regulation provides protection for respondents and complainants in research misconduct cases. Institutions are required to protect the confidentiality of the individuals involved, including the respondent. Respondents are informed about the allegation. During an inquiry, a respondent is usually interviewed, confronts and presents evidence, and suggests witnesses. The draft inquiry report is presented to the respondent for comment. If an investigation follows, the respondent is interviewed, sometimes more than once, confronts and presents additional evidence, and suggests additional witnesses. The investigation report is also presented to the respondent for comment. In addition to protecting the confidentiality of the complainants, institutions are required to undertake diligent efforts to protect the position and reputation of those individuals who make allegations of research misconduct in good faith. The institution is also required to take reasonable steps, as appropriate, to restore the reputations of respondents when allegations are not confirmed.
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last Revised: February 17, 2006