CRS-28 likelihood of many more prosecutions is slim because it would be difficult to prove that fabricated data had hurt someone.^7 Would criminal prosecution be a greater deterrent then being found guilty of serious misconduct and losing Federal funding? Opinions on this differ. Loss of funding means that the researcher cannot do research in the public sector. Even though the private sector remains open to him, his reputation as a researcher may have been irreparably harmed as a result of a public disclosure of his misconduct. Options For Detecting Misconduct Detection appears to be the weakest link in a more comprehensive program to deal with the issue of scientific misconduct. IOM, reflecting the opinion of the majority of scientists, believes that data audits are inappropriate for basic research. In addition, recommendations do not fully spell out protections for whistleblowers. Presumably, the need for detection mechanisms can be reduced if effective preventative strategies are implemented. Assuming detection is still needed, however, the following detection mechanisms have been suggested. Data Audits Some Members of Congress as well as officials at DHHS suggest the use of random or systematic data audits to detect occurrences of misconduct in research. In addition, such a mechanism could also function as a method of quality control, as well as a deterrent. Currently, the Food and Drug Administration (FDA) audits selected clinical trials of products like drugs, vaccines, and medical devices. Generally, the selected trials are those which assess the safety and efficacy of the product because such trials form the basis of FDA product approval. These trials may be commercially sponsored, NIHsponsored, or sponsored by an individual. In addition, FDA conducts "forcause audits.48 An FDA audit involves on-site visits and a review of documentation. Among other things, the audit determines whether the researcher has (1) adhered to a mutually agreed upon, predefined research protocol for the trial, (2) accurately documented the clinical conditions of patients, the 47 Ibid. "Kelsey, Frances. Director of the Division of Scientific Investigations, Center for Drugs and Biologics, FDA. Personal communication, May 23, 1989. CRS-29 administration of medication, and other data, and (3) submitted case reports to the trial's sponsor which accurately reflect the data collected."9 Most scientists object to the use of an FDA-type of audit in the field of basic research. Some of the reasons for their objection are as follows: (1) Basic research by nature is exploratory and loosely structuredprotocol can change daily in accordance with new insights which develop as the data are collected; hence someone with a lot of expertise in the field would be needed to assess the relationship between the raw data and the reported results or the appropriateness of a change in protocol. (2) Scientists fear that auditing will stymie creativity and ingenuity. Most scientists hypothesize that the potential loss in creativity along with the perceived financial cost of implementing an audit program would be too high a price to pay given the absence of proof that misconduct or fraud in science is widespread. To respond to these criticisms of an FDA-like audit, it might be possible to implement a less rigorous, technically-demanding, and costly system--a system designed to detect the more serious cases of misconduct. Such an option is inferred in the comments of a deputy editor of the Journal of the American Medical Association who has said that "even the most cursory audit would have unmasked the fabrications of whole collections of patients and experiments" (emphasis added) by some of the researchers who have been found guilty of serious misconduct.60 Whistleblower Legislation Public Sector Employees. The Civil Service Reform Act of 1978 (CSRA) is the key statute that provides protection from retaliation to those employees who engage in whistleblowing or public disclosures. The CSRA defines whistleblowers as ... [T]hose employees or applicants who expose practices which they reasonably believe to be a violation of law, rule, or regulation, or which they believe constitute 49 Shapiro, Martin and Robert Charrow. The Role of Data Audits in Detecting Scientific Misconduct: Results of the FDA Program. Journal of the American Medical Association, May 5, 1989. p. 2506. 60 Rennie, Drummond, Editors and Auditors. Journal of the American Medical Association, May 5, 1989. p. 2543-2545. CRS-30 mismanagement, gross waste of funds, abuse of authority, The intent of the legislation was to encourage the public disclosure of misconduct so as to increase the effectiveness and efficiency of the Government. However, whistleblowing activities allegedly still result in dismissals, punitive or unacceptable transfers, denials of promotion, and negative performance evaluations for the employees who make accusations. The statuary provisions of the CSRA have protected whistleblowers, generally, in the executive branch and in the Senior Executive Service. But: ... confidential, policy-determining, policy-making, or The Office of Special Council (OSC) was created to facilitate the reporting by Federal employees of alleged misconduct and to be the "protector of whistleblower [sic] and, by virtue of that protection, the propagator of further disclosures. The CSRA charged the OSC with providing "... a safe channel for disclosing information evidencing government wrong-doing without fear of retaliation and with the assurance that their [whistleblowers] identities are not disclosed without consent."64 The OSC was to also investigate and prosecute agencies that engaged in prohibitive personnel practices against whistleblowers.66 The OSC's performance in relation to 61 Introducing the Civil Service Reform Act. Washington, U.S. Govt. Print Off., Oct. 13, 1978. p. 8. 82 62 U.S. Library of Congress. Congressional Research Service. Overview of Whistleblower Protection in Federal Law. Report No. 86-1018 A, by Jack H. Maskell. Washington, 1986. p. 4. 69 Parker, R. A. Whistleblowing Legislation in the United States: A Preliminary Appraisal. Parliamentary Affairs, Jan. 1988. p. 153. "Office of Special Council, Annual Report, 1979. p. 2. 665 U.S.C. 2302 (b) lists eleven prohibitive personnel practices of which reprisals against whistleblowing is only one. CRS-31 whistleblowing allegations has been described by critics as ineffective, inefficient, restricted, and punitive toward whistleblowers.66 The OSC has even been charged with harassing rather than protecting employees alleging misconduct by their employers. Many believe the lack of support provided whistleblowers by the OSC, including the need for confidentiality, has prevented many Government employees from disclosing cases of misconduct. A 1984 study by the Merit Systems Protection Board indicated that approximately 34 percent of Government employees with knowledge of misconduct were hesitant to make public disclosures.67 66 The present Whistleblower Protection Act of 1989, P.L. 101-12, signed into law on April 10, 1989, strengthens the protection available to Federal employees against prohibited personnel practices. One of the fundamental changes in the law redirects the OSC to its primary mission of protecting individual Government employees from reprisals. Another major structural change in the current law is that it reduces the burden of proof clause in which a whistleblower alleging retaliation must show evidence of a link between the disclosure of information and a prohibitive personnel practice. Prior to this law, whistleblowers had to show substantive evidence that their disclosure activities resulted in adverse personnel actions (The burden of proof clause had been a major problem for the whistleblower and the OSC.) With less arduous requirements, whistleblowers now need only show that their public disclosures were a contributing factor in personnel reprisals. In turn, relevant agency management would have to prove, unequivocably, that adverse personnel action would have occurred even if the employee had not engaged in whistleblowing activities. Another salient change in the legislation permits whistleblowers to appeal allegations of reprisals directly to the Merit Systems Protection Board. Equally important, during the entire investigative process, whistleblowers would be given greater assurances of confidentiality. P.L. 101-12 also removes the OSC from the Merit Systems Protection Board and makes it an independent agency. Allegations of misconduct relating to health and safety constitute only a small fraction of the whistleblowing cases arising under the CSRA, the dominating cases are of waste, fraud, and abuse. There are various other 66 Parker, R. A., p. 155. 67 U.S. Merit Systems Protection Board. Office of Merit Systems Review and Studies. Blowing the Whistle in the Federal Government: A Comparative Analysis of 1980 and 1983 Survey Findings. Washington, U.S. Govt. Print. Off., 1984. p. 69. 68 Public Law 101-12, Sec. 2(b). CRS-32 Federal statutes that protect whistleblowers in the fields of health and safety. These are set forth in table 6. Private Sector Employees. The breadth of Federal statutes protecting private sector whistleblowers is significant. There are various categories in the legislation, including those affecting the nuclear and transportation industry, mining, environmental issues, and all other areas of industrial activity. Because of the language of the various statutes, one allegation of misconduct may involve multiple statutes. The expansiveness of the legislation protecting private sector employees who allege misconduct in health and safety is set forth in table 7. Options For Investigating Allegations of Misconduct Most of the parties involved in the issue of scientific misconduct, e.g., scientists, NIH and NSF officials, and the legislators who drafted section 493 of the Health Research Extension Act (P.L. 99-158), believe that universities should have the primary responsibility for investigating allegations of misconduct in science. Indeed, universities have assumed primary responsibility in this area. Yet, critics and supporters of this policy, alike, have pointed to deficiencies in the way universities have handled these investigations. Among other things, universities have had difficulty with conducting fact-finding missions, insuring confidentiality when appropriate, handling conflict of interest issues, or conducting timely investigations. There are at least three possible sources for these shortcomings. Universities: (1) lack guidance in the area; (2) lack experience in the area; or (3) are reluctant to investigate allegations of scientific misconduct. Regarding the matter of guidance, the Framework document, the anticipated PHS/NIH regulations on the matter, and the establishment of an Office of Scientific Integrity will provide additional guidance. However, some degree of guidance has been available since 1982, with the publication of AAMC's The Maintenance of High Ethical Standards in the Conduct of Research. In addition, PHS guidelines for dealing with allegations have been |