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In October 1999, HHS announced plans to improve the integrity of research and reduce research misconduct. Key changes included recommendations that HHS adopt a new definition of research misconduct and separate the inquiry and investigation process from the adjudication process, whereby cases requiring federal fact finding would be carried out by the HHS Office of Inspector General. In addition, the ORI will recommend findings and sanctions to the Assistant Secretary for Health, who will make the final decisions regarding scientific misconduct, subject to appeal.

BACKGROUND

Before 1981, allegations of scientific misconduct were handled in an informal manner by institutions and federal agencies. Scientific misconduct gained prominence as a public issue in the U.S. in 1981, prompted by the public disclosure of scientific misconduct cases at four major research centers in 1980. Congressional and public attention to scientific misconduct continued throughout the 1980s as additional allegations of scientific misconduct arose. These events gave rise to a concern that the existing system failed to protect the interests of the scientific community, the American taxpayer, or the institutions involved.

Congress took action in 1985 through the Health Research Extension Act. The Act required institutions seeking federal research grants 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." Guidelines were published in the NIH Guide for Grants and Contracts in July 1986; and a final regulation was published in the Federal Register on August 8, 1989.

To carry out the law, the Public Health Service 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 consolidated into the Office of Research Integrity, and HHS established a hearing opportunity for all scientists formally charged with misconduct.

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 research it supports and monitoring compliance with the federal regulations. Allegations of misconduct generally involve scientists, and scientific expertise may be needed to resolve questions that arise at different stages of review. At the same time, institutions have the administrative and scientific personnel resources to assess allegations. Thus, primary responsibility for responding to allegations of scientific misconduct rests with institutions, while the ORI generally performs a review and oversight function and provides technical assistance, workshops and policy guidance to institutions to enable them to conduct their own investigations. On occasion, an institution may not be in a position to properly conduct their own investigation. In such instances, institutions can enlist the services of organizations that specialize in conducting such investigations instead of conducting their own investigation.

HHS regulations require each PHS applicant or awardee institution to have an administrative policy for responding to allegations of scientific misconduct. ORI assures these administrative policies comply with the requirements of the HHS regulations. In general, the procedure is as follows:

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 scientific misconduct, whether PHS funding is involved, and whether the allegation is specific enough to allow 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 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 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 on a case by case basis.

The institution must submit a report of the investigation and the resulting finding to the ORI. The ORI reviews the report to determine whether the investigation was fair, objective and competent. 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 institution's findings are supported by the record.

If an investigation concludes with a finding of misconduct, ORI will review the finding and the supporting evidence as well as any sanctions recommended by the institution. ORI will then forward its recommendations for sanctions to the HHS Assistant Secretary for Health (ASH), who will issue a final decision regarding the proposed sanctions. Such sanctions may include one or more of the following: correction of the scientific literature; special plan of supervision to ensure integrity of the scientific research; certification of the accuracy of the scientific data; certification of the accuracy of sources and contributions for scientific ideas and writings; prohibition against service on PHS advisory committees or as a consultant; and a recommendation for debarment from receipt of federal funds. These actions are for specified durations, depending on the nature and seriousness of the misconduct.

If the ASH makes 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). Throughout this process, the accused scientists may have counsel, and the ORI will represent the Department. Each hearing panel of the DAB will include two scientists to ensure that the views of the scientific community are well represented during the appeals process. If the ASH makes a recommendation of debarment, the HHS Debarring official (the Deputy Assistant Secretary for Grants and Acquisition Management) has sole responsibility for imposing debarment. An accused scientist may appeal a proposed debarment to the DAB.

PROTECTING ALL PARTICIPANTS

The HHS scientific misconduct regulation provides protection for respondents (the accused) and complainants in scientific misconduct cases. Institutions are required to protect the confidentiality of the individuals involved. 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 these individuals who make allegations of scientific misconduct in good faith.

HHS RESOURCES

Office of Research Integrity (ORI): ORI is responsible for overseeing the collaborative system for promoting research integrity in PHS-supported research programs. With a budget of more than $4 million, ORI has eight scientist-reviewers, four attorneys, and other professional and support staff. This staff responds to more than 100 allegations of scientific misconduct received each year, as well as engaging in activities related to whistleblower protection, institutional compliance with regulatory requirements, and public education, research and evaluation, and technical assistance.

Since it was established in 1992, ORI has dealt with more than 1,500 allegations of misconduct. About 20 percent required a formal inquiry. ORI has found misconduct in more than 100 cases. ORI has set a goal of closing cases within one year of receipt. Approximately 35 cases are currently pending.

Departmental Appeals Board: The DAB provides independent review of disputed decisions by HHS operating components under HHS grant programs, as well as hearings in cases involving appeals of remedies imposed on health care providers. The DAB has handled a total of 15 appealed findings of scientific misconduct since the mid-1980's. The Board Chair and Board Members are adjudicators who are non-political appointees of the Secretary, assisted by DAB attorneys and support staff. In cases involving appeals of scientific misconduct findings, the Board Chair appoints Research Integrity Adjudication Panels, which may be composed of Board Members, Administrative Law Judges, and scientists. Generally, the DAB seeks prominent scientists outside HHS acceptable to both ORI and the scientist accused of misconduct.

RECOMMENDATIONS FOR CHANGE

The NIH Revitalization Act of 1993 mandated that a Commission on Research Integrity be created to review the system for protecting against scientific misconduct. This Commission, chaired by Dr. Kenneth Ryan of Harvard University, delivered its report to the Secretary of Health and Human Services in November 1995. The Commission made 33 recommendations, including a re-definition of research misconduct and a Whistleblower Bill of Rights. These recommendations have been implemented on a selective basis in accordance with an HHS analysis prepared during 1996.

In 1996, the HHS Secretary convened the Review Group on Research Misconduct and Research Integrity to examine the system under which the Department handles allegations of research misconduct, which included a review of the issues addressed by the Commission. In October 1999, the review group issued its recommendations, which were accepted by the Secretary. Under the proposals agreed to:

• The Department will adopt through rulemaking a new definition of research misconduct that focuses on improper behaviors related specifically to the conduct of research. The definition, proposed by the National Science and Technology Council, will also be adopted by other federal agencies engaged in research.

• Institutions that administer PHS-supported grants will maintain responsibility for conducting initial inquiries and investigations when allegations of misconduct are made. However, when further fact finding is required by the federal government, it will be carried out by the OIG rather than the ORI, as previously was the case.

• Inquiries and investigations into potential research misconduct will be separated from the decision making process of determining if misconduct occurred. The ORI will recommend findings and sanctions to the Assistant Secretary for Health, who will make the final decisions regarding misconduct, subject to appeal.

• The Departmental Appeals Board (DAB) will continue to hear appeals from individuals who contest findings of misconduct. Each DAB appeals panel will include 2 scientists, and the appeals process will be streamlined with clarified procedures and rules for conducting hearings.

• The Department will require research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds. This expands an existing NIH requirement that applied only to research trainees.

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Note: For other HHS Press Releases and Fact Sheets pertaining to the subject of this announcement, please click here (www.os.dhhs.gov/news/press/) for our Press Release and Fact Sheet search engine at: www.os.dhhs.gov/news/press/.