Responsible Science Ensuring the Integrity of the Research Process: Volume II (1993) / Chapter Skim
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5 Factors Enhancing Acceptance of Federal Regulation of Research
5 Factors Enhancing Acceptance of Federal Regulation of Research
Pages 90-116
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From page 90... ...
The cases included Elias Alsabti, an Iraqi who fabricated his medical and research credentials and who was alleged to have plagiarized almost 60 scientific papers in cancer immunology while working at a half-dozen research centers in the United States; Marc Strauss, an oncologist at Boston University, alleged to have falsified patient records to make patients eligible for clinical trials;2 Vijay Soman, an endocrinologist at Yale Medical School, alleged to have fudged and fabricated data and plagiarized a rival's paper;3 and John Long, a cancer researcher at Massachusetts General Hospital, alleged to have fabricated and falsified data and mislabeled the cell line he was studying.4 These cases raised concerns over the capability of existing mechanisms to handle allegations of misconduct in science and maintain integrity in the research environment. Concerns about misconduct in science persisted throughout the 198Os as more allegations were made public and as reports of poor handling of allegations continued to surface.
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From page 91... ...
(D-TN) , chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, held oversight hearings entitled "Fraud in Biomedical Research.''5 The hearings were motivated by the four widely publicized cases mentioned above, the issuing by NTH of disbarment regulations, and the interest of Representative Gore in ethical issues in science.6 The witnesses were primarily senior spokesmen for science (e.g., Philip Handier, president, National Academy of Sciences [NAS]
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From page 92... ...
This decision was due in part to the testimony given by William Raub of NTH regarding actions then being initiated, in part to the fact that the House Science and Technology Committee has no real legislative jurisdiction over NIH, and in part to the concentration of cases in biomedical research.~° It would be eight years before the oversight subcommittee would hold a second set of hearings. In the intervening years the committee and its staff played a role in the development and passage of the Health Research Extension Act and participated in investigations of individual cases and their resolution, Representative Gore was elected to the Senate, and many of He original staff members assumed other positions.
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From page 93... ...
Institutional Review Boards were created in response to a series of widely publicized cases of abuses in human subjects research. The Congress adopted legislation in the early 1970s that contained new requirements for grantee institutions sponsoring federally funded human subjects research.
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From page 94... ...
The regulations required by the Health Research Extension Act of 1985 were first listed as part of NTH's regulatory agenda in April 1986. Preliminary guidelines were issued in the NIH Guide for Grants Art Contracts in July 1986, and the notice of proposed rulemaking was issued in September 1988.
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From page 95... ...
In discussing reviewers' comments on the article, Benjamin Lewin, editor of CeR, stated, "Although they [the reviewers] had criticisms of the article, the overwhelming consensus was that He article says something important about the way science is done, and that it would be in the public interest to have it published."20 House Committee on Science and Technology Task Force on Science Policy A few months later, on May 14, 1986, Stewart and Feder were among a series of witnesses at hearings on research and publication practices convened by the Task Force on Science Policy of the House Committee on Science and Technology.2i Witnesses at the hearing addressed two issues: (~)
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From page 96... ...
Three separate hearings were convened during 198S, two by the House Committee on Government Operations and one by the House Committee on Energy and Commerce, which has legislative and authorizing jurisdiction for NTH. Witnesses and congressional members participating in the hearings suggested that the science community, in spite of claims to the contrary, had not demonstrated an ability to handle this issue through existing self-regulatory mechanisms, and that government regulation may be necessary.
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From page 97... ...
1988, He Subcommittee on Human Resources and Intergovernmental Relations of the Committee on Government Operations, chaired by Representative Ted Weiss (D-NY) , held oversight hearings titled "Scientific Fraud and Misconduct and the Federal Response."23 This subcommittee has oversight jurisdiction and investigatory authority, but no legislative authority, over the Department of Health and Human Services (DHHS)
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From page 98... ...
House Committee on Government Operations On September 29, INS, Representative Weiss held another set of hearings before the Committee on Government Operations to explore (~) the issue of conflict of interest in U.S.
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From page 99... ...
of the Department of Health and Human Services presented a draft report on misconduct in scientific research.29 The OlG report included the results of its recent study of (~) the extent to which NTH and its grantee institutions have developed policies and procedures to prevent, detect, and handle scientific misconduct cases and (2)
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From page 100... ...
Based on these findings, the DHHS inspector general recommended that the secretary of DHHS establish investigatory and oversight functions independent of the research funding agencies and develop a more formal process to deal with cases of alleged misconduct in science. Other recommendations included additional notification requirements for the awardee institutions and the development of alternative methods of detecting possible misconduct, including spot audits of scientific data and specific reviews by editors of scientific journals.
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From page 101... ...
Following the 1988 hearing held by Representative Dingell, DHHS officials negotiated changes in the NPRM with the Office of Management and Budget (OMB) , and a final rule dealing with misconduct in science was published on August 8, 1989.32 The final rule required each institution applying for PHS research funds to certify by January I, 1990, that it had adopted satisfactory misconduct procedures.
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From page 102... ...
The awardee institutions bear the primary responsibility for handling allegations of misconduct. RECENT HEARINGS House Committee on Energy and Commerce On May 4th and 9th, 1989, Representative Dingell held additional hearings on scientific misconduct before the Committee on Energy and Comrnerce.35 These hearings reopened questions about the NTH investigation of charges of misconduct stemming from the paper published in Cell by Weaver, Imanishi-Kari, Baltimore, and others.
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From page 103... ...
House Committee on Government Operations On June 13, 1989, Representative Weiss held additional oversight hearings before a subcommittee of the Committee on Government Operations, entitled "Is Science for Sale? Conflicts of Interest vs.
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From page 104... ...
In his opening remarks, Representative Roe expressed his belief that the responsibility for maintaining integrity in science belonged primarily to the science community, that it must effectively deal with issues of fraud and misconduct in science, and that Congress had a legitimate concern to see that these issues were resolved because the federal government was funding science at increasing levels. His views were shared by other members of the subcommittee who stated that they hoped the scientific community would effectively deal with issues of fraud and misconduct in science without governmental intervention.
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From page 105... ...
According to Dingell, of concern to the subcommittee was "whether monetary interests are undermining the academic integrity and impairing the ability of scientists to carry out health research for which they are supposedly being paid" and to see "that NIH is able to function efficiently, well, honorably and competently in the public interest." On Monday May 14, 1990, the Subcommittee on Oversight and Investigations, chaired by Representative Dingell, held a fourth hearing on allegations of fraud and misconduct stemming from the paper published in Ced by Weaver, Imanishi-Kari, and Baltimore, among others. Two panels of witnesses presented testimony.40 The first was composed of two forensic experts from the Secret Service, and the second pane!
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From page 106... ...
As Imanishi-Kari did not testify and as there was no one asking questions of the Secret Service investigators on her behalf, the forensic evidence was not challenged. The second pane} consisted solely of Hadley, who had no prepared statement and simply responded to questions from Representatives Ron Wyden (D-OR)
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· House Committee on Government Operations, chaired by Representative Conyers; Subcommittee on Human Resources and Intergovernmental Relations, chaired by Representative Weiss.
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From page 108... ...
of qualified independent experts "to verify the independence and thoroughness of the NIH's own investigation."48 It is expected to be a number of months before this review is complete. The Subcommittee on Human Resources and Intergovernmental Affairs of the House Committee on Government Operations, chaired by Representative Weiss, released a committee report on misconduct in science based on hearings convened by the subcommittee over the past few years.49 The report addresses conflict-of-interest issues, questions concerning substandard research practices and their relevance to misconduct, and the role and plight of whistle-blowers, among other issues.
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contain a subtitle dealing with scientific integrity. The bill would provide legislative authority for the Office of Scientific Integrity (OSI)
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From page 110... ...
has not conducted any studies on fraud or misconduct in science. From time to time, in response to congressional requests, GAO has conducted studies of the peer review system and the distribution of federal research funds.5~ As noted above, legislation pending in the House would direct GAO to study the Office of Scientific Integrity to determine its effectiveness in investigating and preventing scientific misconduct and report by the end of fiscal year 1992 to the House Energy and Commerce and the Senate Labor and Human Resources Committees.
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From page 111... ...
GENERAL OBSERVATIONS This review of congressional activities concerning misconduct in science is characterized by the divergence in perspective between the Congress and the science community regarding the prevalence of misconduct, the competency of the science community versus Congress to judge instances of misconduct, the effectiveness of the institutions of science to implement oversight and investigative mechanisms (i.e., the ability to be self-policing) , and the legitimacy of questions concerning the use and misuse of public funds.
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From page 112... ...
Similar tension has characterized other discussions of congressional oversight or regulation of scientific research. Throughout these discussions Congress and its committees have affirmed their belief in the veracity of scientific research and the importance of the contributions of the research community to the nation.
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From page 113... ...
U.S. Congress, 1983, Health Research Extension Act of 1983, House of Representatives, HR 2350, Part F
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From page 114... ...
42. Chalk, R., 1988, "Survey of current work on scientific misconduct," a background paper prepared for COSEPUP, December.
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From page 115... ...
GOLD 115 50. Littlejohn and Matthews, Scientific Misconduct in Academia, 1989.
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