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The Unending Saga of Legal Controls Over Scientific Misconduct: A Clash of Cultures Needing Resolution

Published online by Cambridge University Press:  24 February 2021

Jesse A. Goldner
Jesse A. Goldner*
Affiliation:
Saint Louis University School of Law; Saint Louis University School of Medicine; 1969, Columbia University; 1971, Columbia University; 1973, Harvard Law School
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Extract

There are a remarkable number of similarities between science and the law. Each discipline sets as a gold standard a search for precision. For example, scientists utilize the scientific method—a specific set of principles and procedures designed to aid them in a systematic pursuit of knowledge. Following the scientific method involves the recognition and formulation of a problem, the collection of data through observation and possibly experimentation, the formulation of a hypothesis and the testing and confirmation of the hypothesis formulated. The law, in turn, seeks its form of precision through the careful use of words, as in finely crafted statutes or regulations and contractual language that seek to eliminate the possibility of vagueness or confusion. Each discipline utilizes an approach or methodology that strives to minimize or eliminate the possibility of error and to arrive at a form of “truth” that it recognizes as being maximal within the confines of the rules it has established, be they rules of scientific method or legal rules of evidence.

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Articles
Information
American Journal of Law & Medicine , Volume 24 , Issue 2-3 , 1998 , pp. 293 - 343
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1998

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References

1 See WEBSTER's THIRD NEW INTERNATIONAL DICTIONARY 2033 (3d ed. 1961).

2 See Rick Weiss, Proposed Shifts in Misconduct Reviews Unsettle Many Scientists, WASH. POST, June 30, 1996, at A6.

3 See id. (noting that a scientist, although never ultimately charged with misconduct, suffered detrimental effects due to the investigation of his actions).

4 See id.

5 Id.

6 See id.

7 For a discussion of some of these early cases and approaches, see Green, Harold P., Scientific Responsibility and the Law, 20 J.L. REFORM 1009 (1987)Google Scholar; Olswang, Steven G. & Lee, Barbara A., Scientific Misconduct: Institutional Procedures and Due Process Considerations, 11 J.C. & U.L. 51, 54-62 (1984)Google Scholar; Beth Sise, C., Comment, Scientific Misconduct in Academia: A Survey and Analysis of Applicable Law, 28 SAN DlEGO L. REV. 401, 412-27 (1991)Google Scholar. In particular, the issuance of a report by the Association of American Medical Colleges appears to have played a significant role in stimulating discussion and later action in this area by recommending to its members that they adopt procedures to investigate allegations of fraud in a fair and expeditious manner and by recommending guidelines for such policies. See ASSOCIATION OF AM. MED. COLLEGES, THE MAINTENANCE OF HIGH ETHICAL STANDARDS IN THE CONDUCT OF RESEARCH 899-902 (1982).

8 .See, e.g., C. David Bridges, No. 89-207, D.A.B. 1232 (1991), available in 1991 WL 634972 (Dep't of Health and Human Servs. Mar. 7, 1991) (upholding the debarment of a Baylor University diresearcher, but reducing the period of debarment from 5 to 3 years); Robert Edward McCaa, No. 85-178, D.A.B. 823 (1987), available in 1987 WL 419231 (Dep't of Health and Human Servs. Jan. 12, 1987) (upholding the three-year debarment of a researcher from University of Mississippi Medical Center).

9 For a discussion of how universities have fared in investigating scientific misconduct, including reviews of model university programs, see Taubes, Gary, Misconduct: Views from the Trenches, 261 SCIENCE 1108, 1109 (1993)CrossRefGoogle Scholar.

10 For a comparison of National Science Foundation (NSF) and National Institutes of Health (NIH) investigatory procedures, see David Hamilton, OSI: Better the Devil You Know, 255 SCIENCE 1344, 1344^17(1992).

11 Health Research Extension Act of 1985 § 493, 42 U.S.C.A. § 289b(a) (West Supp. 1998); see 45 C.F.R. § 689 (1997). Congress granted similar authority for regulations necessary to administer NSF Grant Programs under the National Science Foundation Act of 1950 § 11, 42 U.S.C.A. § 1870 (1994).

12 42 U.S.C.A. § 289b(b).

13 See Announcement of Development of Regulations Protecting Against Scientific Fraud of Misconduct, 53 Fed. Reg. 36,344, 36,345-17 (1988).

14 Id. at 36,345.

15 See id. at 36,347.

16 See Statement of Organization, Functions and Delegations of Authority, 54 Fed. Reg. 11,081, 11,081 (1989).

17 See id.; Responsibilities of Awardee and Applicant Institutions for Dealing with Reporting Possible Misconduct in Science, 54 Fed. Reg. 32,446, 32,446 (1989) [hereinafter Responsibilities of Awardee and Applicant Institutions].

18 See Responsibilities of Awardee and Applicant Institutions, 54 Fed. Reg. at 32,446.

19 See Anderson, Christopher, The Aftermath of the Gallo Case, 263 SCIENCE 20, 21 (1994)CrossRefGoogle Scholar.

20 See Gibbons, Ann, Advisory Committee Urges Changes at OSI, 254 SCIENCE 1287, 1288 (1991)CrossRefGoogle Scholar.

21 See id.

22 See Statement of Organization, Functions and Delegations of Authority, 57 Fed. Reg. 24,262, 24,262 (1992). This change was later codified in the National Institutes of Health Revitalization Act of 1993 § 161, 42 U.S.C.A. § 289b (West Supp. 1998) (amending the Public Health Service Act of 1944, 42 U.S.C. § 289b(a) (1994)). The Public Health Service Act (PHSA) also required the creation of the Commission on Research Integrity (the Ryan Commission). See id. § 182. PHSA also required the Department of Health and Human Services (DHHS) to promulgate “whistleblower” regulations requiring institutions to establish “standards for preventing, and for responding to the occurrence of retaliation” by the institution. Id. § 163.

23 See Anderson, supra note 19, at 20; Hamilton, supra note 10, at 1346.

24 See id.; infra text accompanying notes 91-110.

25 42 U.S.C.A. § 289b.

26 See Statement of Organization, Functions and Delegations of Authority, 59 Fed. Reg. 2856, 2856(1994).

27 See Statement of Organization, Functions and Delegations of Authority, 60 Fed. Reg. 56,605,56,606(1995).

28 See Responsibilities of Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science, 54 Fed. Reg. 32,446, 32,446-48 (1989). For detailed discussions of the regulatory framework for misconduct investigations, see Howard, Elizabeth, Science Misconduct and Due Process: A Case of Process Due, 45 HASTINGS L.J. 309, 328-32 (1994)Google Scholar; Parrish, Debra, Scientific Misconduct and the Plagiarism Cases, 21 J.C. & U.L. 517, 526-30 (1994)Google Scholar; Sise, supra note 7, at 412-18.

29 56 Fed. Reg. 27,384, 27,385-93 (1991) [hereinafter Policies and Procedures]. These proposed policies and procedures are essentially the same as those adopted on August 29, 1990, for which notice of availability was published in 55 Fed. Reg. 42,490 (1990). When the Public Health Service (PHS) requested that comments on the publication be provided, litigation on the agency's ability to promulgate such policies and procedures without following Administrative Procedures Act (APA) rulemaking requirements ensued and the district court found against the agency. See Abbs v. Sullivan, 756 F. Supp. 1172, 1189 (W.D. Wis. 1990); see also Hamilton, David P., NIH Misconduct Procedures Derailed, 251 SCIENCE 152, 152 (1991)Google Scholar (explaining Abbs’ conclusion—that NIH's investigative procedures violated federal law when they were adopted in 1986 and discussing the case's implications for NIH investigations). Ultimately the lawsuit was dismissed on jurisdictional grounds. See Abbs v. Sullivan, 963 F.2d 918, 918 (7th Cir. 1992). PHS has taken the position that such a document is exempt from APA rulemaking requirements as interpretative rules and within the exception for agency management, general policy or rules of procedure and continues to follow these policies and procedures. See Policies and Procedures, 56 Fed. Reg. at 27,384; see also Opportunity for a Hearing on Office of Research Integrity Scientific Misconduct Findings, 57 Fed. Reg. 53,125, 53,125 (1992) [hereinafter Opportunity for Hearing] (noting the Seventh Circuit's dismissal of the district court's decision in Abbs, which eliminated the need for PHS to exclude the Western District of Wisconsin from coverage by policies and procedures).

30 Public Hearing and Meeting of the Advisory Committee on Scientific Integrity, 57 Fed. Reg. 21,293,21,294(1992).

31 See supra note 22; infra text accompanying note 357.

32 See Opportunity for Hearing, 57 Fed. Reg. at 53,125; infra text accompanying notes 88-110.

33 Letter from Chris B. Pascal, Acting Director, Office of Research Integrity, to institutional officials responsible for implementing PHS regulations related to scientific misconduct (Feb. 24, 1997), reprinted in OFFICE OF RESEARCH INTEGRITY, ORI HANDBOOK FOR INSTITUTIONAL RESEARCH INTEGRITY OFFICERS (visited May 10, 1998) <http://ori.dhhs.gov/other/hb97text.htm> [hereinafter ORI HANDBOOK]. The Office of Research Integrity's (ORI) handbook “is non-binding and is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, officers or employees.” ORI HANDBOOK, supra. Nonetheless, it is the most current description of the position of ORI regarding both its own responsibilities and that of research institutions, and it contains various documents related to the handling of scientific misconduct in PHS-supported research and research training. See id.

34 42 C.F.R. § 50.102 (1997); Policies and Procedures, 56 Fed. Reg. at 27,384 (defining misconduct in extramural scientific research). Commentary to the proposed rule noted that the term “scientific misconduct” rather than “scientific fraud” (the language used by Congress in the enabling statute) was used, but that the meanings were the same. See Announcement of Development of Regulations Protecting Against Scientific Fraud or Misconduct, 53 Fed. Reg. 36,344, 36,345 (1988). The word “fraud” was not used to avoid any equation with common law fraud which required that “the defendant not only knowingly made a false representation to the plaintiff with the intent to induce the plaintiff to rely on that misrepresentation, but also that the plaintiff justifiably relied on the misrepresentation and as a result of that reliance sustained damage.” Id. It was noted that in cases of scientific misconduct it was often difficult to ascertain the individual whom the defendant intended to deceive and that it could also be difficult to establish justifiable reliance and discernible damages. See id. A similar but related definition appears in NSF regulations: misconduct means “(1) falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from activities funded by NSF; or (2) retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.” 45 C.F.R. § 689.1(a)(l)-﹛2) (1997).

35 See ORI HANDBOOK, supra note 33.

36 See 9 C.F.R. §§ 1.1-4.1 (1997); Jesse A. Goldner, An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, 38 ST. LOUIS U.L.J. 63,99-100(1993).

37 See 7 U.S.C. § 2143 (1994); 9 C.F.R. §§ 2.30-.38 (1997); see also Schmahmann, David R. & Polacheck, Lori J., The Case Against Rights for Animals, 22 B.C. ENVTL. AFF. L. REV. 747, 765-68 (1995)Google Scholar (claiming that the Animal Welfare Act codifies the human right to use animals in research).

38 See 45 C.F.R. § 689.3(a).

39 ORI conducts inquiries and investigations of allegations of scientific misconduct at NIH facilities. See 42 C.F.R. §§ 50.102, 50.104(a)(6).

40 See id. § 50.104; cf 45 C.F.R. § 689.3(b) (requiring that NSF be notified immediately in cases of misconduct).

41 See ORI HANDBOOK, supra note 33.

42 See id.

43 42 C.F.R. §§ 50.102, 50.103(d)(1); cf. 45 C.F.R. § 689.3(a) (noting that the awardee institution must investigate misconduct); Policies and Procedures for Dealing with Possible Scientific Misconduct in Extramural Research, 56 Fed. Reg. 27,384, 27,389 (1991) [hereinafter Policies and Procedures] (requiring institutions to conduct inquiries unless the institution is unable or unwilling to conduct the inquiry; in such a case, OSI will conduct the inquiry).

44 See 42 C.F.R. § 50.103(d)(1); cf. 45 C.F.R. § 689.3(b)(4) (noting that NSF should be provided with the final report from any investigation); Policies and Procedures, 56 Fed. Reg. at 27,390 (noting that OSI will receive the results of an institutional investigation).

45 See 42 C.F.R. § 50.103(d)(1); cf. 45 C.F.R. § 689.8(c)(2)(i) (allowing the respondent to submit comments or rebuttal within 30 days for full consideration); Policies and Procedures, 56 Fed. Reg. at 27,388 (providing opportunity to rebut all evidence except if disclosure would violate individual confidentiality).

46 See 42 C.F.R. §§ 50.103(d), 50.104(a) (requiring institutions to report investigations to ORI but saying nothing about requiring institutions to report inquiries); cf. 45 C.F.R. § 689.3 (reporting procedures for allegations of scientific misconduct for NSF-funded research); Policies and Procedures, 56 Fed. Reg. at 27,389 (reporting requirements for institutions that receive financial assistance from PHS). ORI, formerly known as a combination of OSI and the Office of Scientific Integrity Review (OSIR), continues to be known as OSI in the Code of Federal Regulations (CFR). See supra notes 22-24 and accompanying text. Despite CFR's continued use of the term Office of Scientific Integrity, this office is referred to in this Article as ORI.

47 42 C.F.R. § 50.103(d)(6).

48 Id. § 50.102; cf. 45 C.F.R. § 689.1(c) (noting that, in deciding what actions are appropriate to address scientific and engineering misconduct, NSF considers the seriousness of the misconduct); Policies and Procedures, 56 Fed. Reg. at 27,385 (noting the definition of an investigation in the OSI context).

49 See 42 C.F.R. § 50.104(a)(1); cf. 45 C.F.R. § 689.3(b)(1) (noting that in deciding the appropriateness of actions for scientific and engineering misconduct, NSF considers the seriousness of the misconduct); Policies and Procedures, 56 Fed. Reg. at 27,387 (stating that OSI must be notified of possible scientific misconduct).

50 See Policies and Procedures, 56 Fed. Reg. at 27,390. PHS ALERT is a system of records used to disseminate and control information to PHS officials on a need-to-know basis that an individual is under investigation or has been subject to sanction for misconduct. See Abbs v. Sullivan, 963 F.2d 918, 926-28 (7th Cir. 1992) (federal courts have no jurisdiction to review placement of respondent's name in PHS ALERT system before final agency action unless the respondent can show actual harm from being placed in the system); Policies and Procedures, 56 Fed. Reg. at 27,385; PHS to Launch New Scientific Research Oversight System, MED. RES. FUNDING NEWS, June 10, 1992, available in 1992 WL 2796470 [hereinafter New Oversight System]. The effect, of course, is to make it extremely unlikely that such individuals will be awarded government grants and contracts during the pendency of the investigatory proceedings, and being in ALERT could affect the availability of private funds. See New Oversight System, supra; New System of Records, 60 Fed. Reg. 2140, 2140 (1995) (revising New System of Records, 59 Fed. Reg. 36,776, 36,776 (1994)).

51 See ORI HANDBOOK, supra note 33.

52 See 42 C.F.R. § 50.103(d)(7); cf. Policies and Procedures, 56 Fed. Reg. at 27,391 (requiring any comments of the subject(s) to be appended to the OSI report).

53 See 42 C.F.R.§ 50.103(d)(10).

54 See id. § 50.103(d)(14); ORI HANDBOOK, supra note 33.

55 See 42 C.F.R. § 50.103(d)(15); ORI HANDBOOK, supra note 33; cf. 45 C.F.R. § 689.3(b)(4) (stating that NSF must be provided with the final report); Policies and Procedures, 56 Fed. Reg. at 27,392 (noting that OSI must review investigative reports).

56 See 42 C.F.R. § 50.103(d)(8).

57 See id. § 50.103(d)(9).

58 See id. § 50.103(d)(ll); cf. 45 C.F.R. §§ 689.3(b)(iii), 689.7(a) (stating that NSF may take interim measures if its resources are threatened); Policies and Procedures, 56 Fed. Reg. at 27,391 (noting that OSI can take interim measures to prevent the inappropriate use of federal funds).

59 42 C.F.R. §§ 50.103(d)(2), 50.103(d)(13); see ORI HANDBOOK, supra note 33; cf. Policies and Procedures, 56 Fed. Reg. at 27,387-88 (stating that OSI will vigorously protect the rights of informants).

60 See 42 C.F.R. § 50.103(d)(3); cf. Policies and Procedures, 56 Fed. Reg. at 27,387 (detailing a list of policy principles, including safeguarding the interests and rights of respondents in scientific misconduct inquiries and investigations through maintaining maximum feasible confidentiality, conducting prompt and thorough inquiries and investigations, and providing respondent(s) with ample opportunity to suggest witnesses and present evidence).

61 See 42 C.F.R. § 50.103(d)(13); ORI HANDBOOK, supra note 33.

62 See ORI HANDBOOK, supra note 33.

63 See 42 C.F.R. § 50.104(a)(l)-(5); ORI HANDBOOK, supra note 33; cf. 45 C.F.R. § 689.3 (stating NSF rules for institutional investigation reports); Policies and Procedures, 56 Fed. Reg. at 27,392 (requiring the following of guidelines set forth in 42 C.F.R. § 50.104(a)-(b)).

64 See 42 C.F.R. § 50.104(a)(4); ORI HANDBOOK, supra note 33; cf. Policies and Procedures, 56 Fed. Reg. at 27,392 (reiterating that OSI reviews the investigations’ “objectivity, thoroughness, and competence“).

65 See 42 C.F.R. § 50.104(a)(6); ORI HANDBOOK, supra note 33; cf. Policies and Procedures, 56 Fed. Reg. at 27,392 (discussing post-investigational actions).

66 See 42 C.F.R. §§ 50.104(a)(6), 50.105; ORI HANDBOOK, supra note 33; cf. 45 C.F.R. §§ 689.1(f), 689.8(a) (requiring review by the Office of the Inspector General).

67 ORI HANDBOOK, supra note 33.

68 See id.; infra text accompanying notes 88-110.

69 See ORI HANDBOOK, supra note 33.

70 See id.

71 See id.

72 See id.

73 See id.

74 See 42 C.F.R. § 50.104(a)(6) (1997); ORI HANDBOOK, supra note 33.

75 See id.; cf. 45 C.F.R. § 689.8(a) (1997) (noting that NSF may conduct its own inquiries and investigations if the institutional investigation was inaccurate or incomplete); Policies and Procedures for Dealing with Possible Scientific Misconduct in Extramural Research, 56 Fed. Reg. 27,384, 27,388 (1991) [hereinafter Policies and Procedures] (providing similar provision with regard to OSI).

76 See Policies and Procedures, 56 Fed. Reg. at 27,389.

77 See id.

78 See ORI HANDBOOK, supra note 33.

79 See id.

80 See id.

81 See id.

82 See id.; Policies and Procedures, 56 Fed. Reg. at 27,388; cf. 45 C.F.R. § 689.1(d) (1997) (discussing similar provisions with regard to scientific and engineering).

83 See ORI HANDBOOK, supra note 33.

84 See id.

85 See id.; Policies and Procedures, 56 Fed. Reg. at 27,392.

86 See infra text accompanying notes 110, 121-22.

87 See ORI HANDBOOK, supra note 33.

88 See Opportunity for Hearing on Office of Research Integrity Scientific Misconduct Findings, 57 Fed. Reg. 53,125, 53,125 (1992) [hereinafter Opportunity for Hearing]; Hearing Procedures for Scientific Misconduct, 59 Fed. Reg. 29,809, 29,810 (1994) [hereinafter Hearing Procedures].

89 See Anderson, supra note 19, at 20.

90 Gina Kolata, Inquiry Lacking Due Process, N.Y. TIMES, June 25, 1996, at C3.

91 See id.

92 See Hearing Procedures, 59 Fed. Reg. at 29,811; U.S. Dep't of Health and Human Servs., Department Appeals Board Guidelines: Hearings Before the Research Integrity Adjudications Panel (visited Mar. 23, 1998) <http://phs.os.dhhs.gov/phs/ori/other/appeals.htm>; ORI HANDBOOK, supra note 33.

93 See 45 C.F.R. §§ 76.300-.325 (1997); 48 C.F.R. §§ 309.4, 9.405-.470 (1997); Opportunity for Hearing, 57 Fed. Reg. at 53,125.

94 See Hearing Procedures, 59 Fed. Reg. at 29,810. -

95 See Anderson, supra note 19, at 20.

96 See Hearing Procedures, 59 Fed. Reg. at 29,810.

97 See id.

98 See id.

99 See id.

100 See id. Thus, for example, in Hiserodt, only the presiding panel member was present at the hearing. See John C. Hiserodt, No. A-93-117, D.A.B. 1466 (1994), available in 1994 WL 321797 (Dep't of Health and Human Servs. Feb. 25, 1994).

101 See Hearing Procedures, 59 Fed. Reg. at 29,810.

102 See Mikulas Popovic, No. A-93-100, D.A.B. 1446 (1993), available in 1993 WL 762622 (Dep't of Health and Human Servs. Nov. 3, 1993).

103 Id.

104 See ORI HANDBOOK, supra note 33.

105 See id.; Hearings Procedures, 59 Fed. Reg. at 29,811.

106 See Hearing Procedures, 59 Fed. Reg. at 29,811.

107 See ORI HANDBOOK, supra note 33.

108 See Hearing Procedures, 59 Fed. Reg. at 29,811; 45 C.F.R. §§ 76.300-.325 (1997); 48 C.F.R. §§ 9.404-.405 (1997); John C. Hiserodt, No. A-93-117, D.A.B. 1466 (1994), available in 1994 WL 321797 (Dep't of Health and Human Servs. Feb. 25, 1994).

109 See 45 C.F.R. §§ 16.1-.23 (1997).

110 See Hearing Procedures, 59 Fed. Reg. at 29,809-11.

111 See ORI HANDBOOK, supra note 33.

112 See id.; 42 C.F.R. §§ 50.103(d)(14), 50.104(a)(7) (1997).

113 See Policies and Procedures Dealing with Possible Scientific Misconduct in Extramural Research, 56 Fed. Reg. 27,384, 27,393 (1991) [hereinafter Policies and Procedures]; ORI HANDBOOK, supra note 33; cf. 45 C.F.R. § 689.2(b) (identifying factors NSF should consider in determining appropriate action in response to misconduct).

114 See Policies and Procedures, 56 Fed. Reg. at 27,393; ORI HANDBOOK, supra note 33; cf. 45 C.F.R. § 689.2(a) (identifying possible actions to be taken by NSF in response to misconduct).

115 See 45 C.F.R. §§ 74.100-.510; Policies and Procedures, 56 Fed. Reg. at 27,393; cf. 45 C.F.R. § 689.2(a)(3)(i) (discussing NSF sanctions for misconduct).

116 See Policies and Procedures, 56 Fed. Reg. at 27,393; 45 C.F.R. § 52.6(b)(2)-(3).

117 See Policies and Procedures, 56 Fed. Reg. at 27,385; ORI HANDBOOK, supra note 33. Debarment procedures are outlined in 45 C.F.R. § 75 and 48 C.F.R. §§ 9.4, 309.4 (1997). Cf. 45 C.F.R. § 689.2(a)(3)(ii) (stating that NSF may prohibit an individual guilty of misconduct from participating as an NSF reviewer, advisor or consultant).

118 See 45 C.F.R. §§ 76.100-.420; 48 C.F.R. §§ 9.400-.409, 309.403-.470-2.

119 See 48 C.F.R. §9.406-1.

120 See id. § 9.406-4(a)(l); 45 C.F.R. § 76.320(a)(1).

121 Investigations of Scientific Misconduct, 55 Fed. Reg. 52,327, 52,327 (1990); see ORI HANDBOOK, supra note 33; see, e.g., Findings of Scientific Misconduct, 62 Fed. Reg. 49,014 (1997) (notice of scientific misconduct findings); Findings of Scientific Misconduct, 62 Fed. Reg. 44,281 (1997) (same); Findings of Scientific Misconduct, 62 Fed. Reg. 42,558 (1997) (same); Findings of Scientific Misconduct, 60 Fed. Reg. 58,365 (1995) (same); Findings of Scientific Misconduct, 58 Fed. Reg. 33,830 (1993) (same).

122 See ORI HANDBOOK, supra note 33.

123 See 48 C.F.R. § 9.404; ORI HANDBOOK, supra note 33.

124 See 48 C.F.R. § 9.404.

125 See Sise, supra note 7, at 418.

126 See Perzan, Christopher P., Note, Research and Relators: The False Claims Act and Scientific Misconduct, 70 WASH. U. L.Q. 639, 655-56 (1992)Google Scholar; Sise, supra note 7, at 423; see, e.g., Susan E. Sherman, The False Claims Act: Litigating Scientific Misconduct, 110 PUB. HEALTH REP. 784, available in 1995 WL 12475368 (reporting that an institution and its researchers are liable under the False Claims Act).

127 C. David Bridges, No. 89-207, D.A.B. 1232 (1991), available in 1991 WL 634972 (Dep't of Health and Human Servs. Mar. 7, 1991).

128 Kolata, supra note 90, at C3 (quoting attorney Robert Charrow, who assisted in establishing ORI).

129 Paul F. Langlois, No. A-93-30, D.A.B. 1409 (1993), available in 1993 WL 742594 (Dep't of Health and Human Servs. May 6, 1993).

130 See id.

131 See id.

132 See id.

133 See id.

134 See id.

135 See id.

136 See id.

137 See id.

138 See id.

139 Id.

140 Id.

141 Id.

142 Id.

143 See id.

144 See id.

145 See id.

146 See id.

147 See Rameshwar K. Sharma, No. A-93-50, D.A.B. 1431 (1993), available in 1993 WL 742551 (Dep't of Health and Human Servs. Aug. 6, 1993).

148 See id. The role of Dr. Bernadine Healy, who participated in the original investigation of Sharma at the Cleveland Clinic Foundation and then as director of NIH, became a source of controversy at congressional oversight hearings on scientific misconduct. See Anderson, supra note 19, at 20; Hamilton, David P., Can OSI Withstand a Scientific Backlash?, 253 SCIENCE 1084, 1085 (1991)CrossRefGoogle Scholar; Robin Herman, Report Faults Cleveland Clinic in Long-Running Scientific-Misconduct Probe, WASH. POST, Dec. 29, 1992, at A5.

149 See Sharma, 1993 WL 742551.

150 Id.

151 See id.

152 See id.

153 See id.

154 See id.

155 Id.

156 Id.

157 See id.

158 Id.

159 Id.

160 Id.

161 See id.

162 See id.

163 See id.

164 See id.

165 See id.

166 Id.

167 See id.

168 See id. ORI had also unsuccessfully attempted the use of the “knew or should have known” standard in Popovic and Gallo discussed infra Part A.3. See AIDS Researcher Cleared of Charges, 144 SCI. NEWS 383, 383 (1993)Google Scholar.

169 See Sharma, 1993 WL 742551.

170 Id.

171 See id.

172 Mikulas Popovic, No. A-93-100, D.A.B. 1446 (1993), available in 1993 WL 762622 (Dep't of Health and Human Servs. Nov. 3, 1993).

173 See Nicolas Wade, Method and Madness: The Vindication of Robert Gallo, N.Y. TIMES, Dec. 26,1993, at 12.

174 See Cohen, Jon, HHS: Gallo Guilty of Misconduct, 259 SCIENCE 168, 168 (1993)CrossRefGoogle Scholar.

175 See Popovic, 1993 WL 762622.

176 See Hamilton, David P., Healy Returns Fire at Dingell Hearing, 253 SCIENCE 618, 618 (1991)CrossRefGoogle Scholar.

177 See Cohen, Jon, Dingell Rips Healy for “Obstructionism”, 258 SCIENCE 1729, 1729 (1992)Google ScholarPubMed [hereinafter Dingell Rips Healy]; Philip J. Hilts, Health Official Concedes Mishandling of Inquiry, N.Y. TIMES, Aug. 2, 1991, at B6.

178 See Cohen, Jon, Stormy Weather Ahead for OSI's Gallo Report, 255 SCIENCE 914, 914 (1992)CrossRefGoogle Scholar.

179 See id.

180 Leslie Alan Horvitz, Can Scientists Police Themselves?, INSIGHT, May 1994, at 6, 10 (quoting Jules Hallum, former director of OSI).

181 See Cohen, supra note 174, at 168.

182 The panel was appointed “to monitor the investigation and reassure skeptics who doubted NIH's ability to investigate one of its own most prominent researchers.” Hamilton, David P., Scientist- Consultants Accuse OSI of Missing the Pattern, 256 SCIENCE 738, 738 (1992)CrossRefGoogle Scholar; David P. Hamilton & Joseph Palca, Scientists Get Mad at OSI, 252 SCIENCE 1606, 1606(1991).

183 See Cohen, supra note 174, at 168.

184 See Cohen, supra note 178, at 914.

185 See Cohen, supra note 174, at 168; Greenberg, Daniel S., Resounding Echoes of Gallo Case, 345 LANCET 639, 639 (1995)CrossRefGoogle Scholar; Hamilton, supra note 182, at 738; Hamilton, David P., The Richards Panel Tosses a Curve, 256 SCIENCE 23, 23 (1992)CrossRefGoogle Scholar. The text of the Dingell report, entitled Institutional Response to the HIV Blood Test Patent Dispute and Related Matters is available at http://nyx.net/∼wstewart/CelebratedCases/GalloCase/StaRepFolder/StaRepl.html.

186 See Cohen, supra note 174, at 168.

187 See id.

188 See Christopher Anderson, Hearing Process Proves a Challenge for ORI, 260 SCIENCE 1714,1714(1993).

189 See Mikulas Popovic, No. A-93-100, D.A.B. 1446 (1993), available in 1993 WL 762622 (Dep't of Health and Human Servs. Nov. 3, 1993).

190 See id.

191 Id.

192 See Anderson, supra note 188, at 1714.

193 Id.; Popovic, 1993 WL 762622.

194 Popovic, 1993 WL 762622.

195 See id.

196 See id.

197 See id.

198 See id.

199 Id.

200 See id.

201 See AIDS Researcher Cleared of Charges, supra note 168, at 383.

202 U.S. NCI ORI Drops Charges Against Gallo, AIDS WEEKLY, Nov. 29, 1993, available in 1993 WL 2808319 [hereinafter ORI Drops Charges].

203 See AIDS Researcher Cleared of Charges, supra note 168, at 3 83.

204 Id. Gross negligence is defined as “the intentional failure to perform a manifest duty in reckless disregard of the consequences as affecting the life and property of another.” BLACK's LAW DICTIONARY 539 (5th ed. 1989).

205 See Kaiser, Jocelyn, The ‘Gallo Case’ Popovic Strikes Back, 275 SCIENCE 920, 920 (1997)CrossRefGoogle Scholar. See generally Hamilton, David P., Did OS! Rewrite History?, 256 SCIENCE 959 (1992)CrossRefGoogle Scholar (stating that Susan Hadley believed the question of whether the virus was stolen was still open after the OSI report).

206 Kaiser, supra note 205, at 920.

207 See id. at 921.

208 See id.

209 See id.

210 See John C. Hiserodt, No. A-93-117, D.A.B. 1466 (1994), available in 1994 WL 321797 (Dep't of Health and Human Servs. Feb. 25, 1994) (recommendation for debarment).

211 See id.

212 See id.

213 See id.

214 See id.

215 See id.

216 See id.

217 See id.

218 Id.

219 See id.

220 See 1994 ORI ANN. REP. 5 (quoting the decision).

221 See id.

222 See id.

223 See id.

224 Id.

225 See id.

226 See Hiserodt v. Shalala, 65 F.3d 162, 162 (3d Cir. 1995).

227 Tereza Imanishi-Kari, No. A-95-33, D.A.B. No. 1582 (1996), available in 1996 WL 399931 (Dep't of Health and Human Servs. June 21, 1996).

228 Weaver, David et al., Altered Repertoire of Endogenous Immunoglobulin Gene Expression in Transgenic Mice Containing a Rearranged Mu Heavy Chain Gene, 45 CELL 247, 247 (1986)CrossRefGoogle Scholar.

229 See Culliton, Barbara J., A Bitter Battle Over Error, 240 SCIENCE 1720, 1720 (1988)CrossRefGoogle Scholar.

230 See id.

231 See Rick Weiss, Biologist Baltimore to Lead Caltech, WASH. POST, May 14, 1997, at A12.

232 See Fackelmann, K., Appeals Panel Reverses Fraud Finding, 150 SCI. NEWS 4, 4 (1996)Google Scholar.

233 See Marwick, Charles, Appeals Board Exonerates Baltimore, Imanishi-Kari, 276 JAMA 266, 266 (1996)CrossRefGoogle Scholar.

234 See Philip J. Hilts, Researcher Accused of Fraud in Her Data Will Not Be Indicted, N.Y. TIMES, July 14, 1992, at C3.

235 See Noted Finding of Science Fraud is Overturned by a Federal Panel, N.Y. TIMES, June 22, 1996, at 1 [hereinafter Finding of Science Fraud Overturned]. For a detailed explanation of the research and its implications, see Culliton, supra note 229, at 1721.

236 See Testimony of Margot O'Toole (visited May 14, 1998) http://www.nyx.net/∼wstewart/-CelebratedCases/BaltimoreCase.

237 See Hilts, supra note 234, at C3.

238 See id.

239 See Marwick, supra note 233, at 266.

240 See id.

241 The testimony can be found on the Internet at http://www.nyx.net/∼wstewart/main.ssi. The location is the homepage of Walter Stewart who with Ned Feder worked for NIH as a laboratory researcher and grant reviewer, respectively. The two became “self-appointed … monitors of the integrity of science” and advisors to Congressman Dingell, but ultimately they were ordered to return to their purely scientific duties at NIH under a cloud for their possible overzealousness. Phillip J. Hilts, Institutes of Health Close Fraud Investigation Unit, N.Y. TIMES, May 5, 1993, at A21; see Greenberg, Daniel S., Reassignment for NIH's Fraud Hunters, 341 LANCET 1204, 1204 (1993)CrossRefGoogle Scholar. Stewart's homepage contains an extensive collection of original documents related to allegations of scientific misconduct.

242 See Holden, Constance, Whistle-Blowers Air Cases at House Hearings, 240 SCIENCE 38 (1988)CrossRefGoogle Scholar, available in 1988 WL 2614438; Culliton, supra note 229, at 1720.

243 Marwick, supra note 233, at 266; see Culliton, Barbara J., Baltimore Cleared of All Fraud Charges, 243 SCIENCE 727 (1989)CrossRefGoogle Scholar, available in 1989 WL 3069812; When Science Turns Nasty, ECONOMIST, June 1990, at 87, 87.

244 Culliton, supra note 243.

245 See Marwick, supra note 233, at 266; Warren E. Leary, Whistle-Blower Tells Congress of Cost to Scientific Career, N.Y. TIMES, May 10, 1989, at B6.

246 See Leary, supra note 245, at B6.

247 See Thereza Imanishi-Kari, No. A-95-33, D.A.B. 1582 (1996), available in 1996 WL 399931 (Dep't of Health and Human Servs. June 21, 1996); Warren E. Leary, Lab Notes Are False. Secret Service Says, N.Y. TIMES, May 15, 1990, at C5.

248 See Jock Friedly, How Congressional Pressure Shaped the ‘Baltimore Case', 273 SCIENCE 873,874(1996).

249 See id.; Kaiser, Jocelyn & Marshall, Eliot, Imanishi-Kari Rule Slams ORI, 272 SCIENCE 1864, 1865 (1996)CrossRefGoogle Scholar; Anthony Lewis, Tale of a Bully, N.Y. TIMES, June 24, 1996, at A15. For another account of congressional interference in the case, see The Baltimore Vindication, WALL ST. J., July 2, 1996, at A14. But see John D. Dingell, The Elusive Truths of the Baltimore Case, WASH. POST, July 18, 1996, at A27 (responding to criticisms of the scientific misconduct process and offering factual clarifications).

250 Culliton, Barbara J., NIH Misconduct Probes Draw Legal Complaints, 249 SCIENCE 240, 240-41 (1990)CrossRefGoogle Scholar; see Hamilton, David P., A Question of ‘Fitness', 248 SCIENCE 1598 (1990)CrossRefGoogle Scholar, available in 1990 WL 3304059; When Science Turns Nasty, supra note 243, at 87.

251 See Hamilton, supra note 250.

252 Id.

253 See id.

254 Id.

255 See id.

256 Philip J. Hilts, Inquiry Finds a Researcher Faked Work, N.Y. TIMES, NOV. 27, 1994, at 37; see Kaiser & Marshall, supra note 249, at 1865.

257 See Thereza Imanishi-Kari, No. A-95-33, D.A.B. 1582 (1996), available in 1996 WL 399931 (Dep't of Health and Human Servs. June 21, 1996).

258 See id.

259 See id.; Kaiser & Marshall, supra note 249, at 1864.

260 gee Imanishi-Kari, 1996 WL 399931; Kaiser & Marshall, supra note 249, at 1865.

261 See Imanishi-Kari, 1996 WL 399931.

262 See id.; Finding of Science Fraud Overturned, supra note 235, at 1.

263 Imanishi-Kari, 1996 WL 399931.

264 id.

265 See id.

266 See id.

267 See id.

268 See id.

269 Id. (citing Rameshwar K. Sharma, No. A-93-50, D.A.B. 1431 (1993), available in 1993 WL 742551 (Dep't of Health and Human Servs. Aug. 6, 1993)).

270 Id.

271 See id.

272 Id.

273 Id.

274 See id.

275 Id.

276 See id.

277 See id.

278 See id.

279 See id.

280 Id.

281 id.

282 id.

283 u.

284 id.

285 See id.

286 Id.

287 Id.

288 Id.

289 Id.

290 Id.

291 Id.

292 See id.

293 See id.

294 Id.

295 id.

296 Id.

297 See id. It has been alleged that tensions between Congressman Dingell and Dr. David Baltimore “politicized every stage of the long [Imanishi-Kari] inquiry process.” Kolata, supra note 90, atC3.

298 See Imanishi-Kari, 1996 WL 399931. It was later reported that, at a private meeting on July 14, 1989 between Secret Service agents and NIH officials, a Secret Service official talked about ‘“continual conversations’ with Capital Hill ‘in order to keep our job as small as possible’ and because ‘we relied on [Dingell staff] to determine the scientific significance of our findings.'” Weiss, supra note 2, at A6. An NIH official at the meeting worried about Dingell's aide's influence. A transcript of the meeting included the following colloquy:

NIH official: So they did focus you in on what they wanted to see each time. You didn't really do an entirely independent analysis in the sense of choosing random things and going at it.

Secret Service official: We couldn't understand what we were doing.

NIH official: So they're directing you in the direction they want to see the results in. There might have been other things elsewhere or that might have been of equal importance to an overall analysis, but they are providing some direction to you.

Secret Service official: Absolutely.

Friedly, supra note 248, at 874.

299 Imanishi-Kari, 1996 WL 399931.

300 M.

301 Id.

302 Id.

303 Summaries of additional cases, not discussed herein, can be found in ORI annual reports at http://ori.dhhs.gov.

304 See Bernard Fisher Settles Lawsuit with University of Pittsburgh and Federal Government (visited May 10, 1998) <http://www.pgh.auhs.edu/bfisher/press_release2.html> [hereinafter Fisher Settles Lawsuit].

305 See id.

306 See id.

307 See University Apologizes to Cancer Scientist in Research Dispute, L.A. TIMES, Aug. 29, 1997, at Al6.

308 See Rick Weiss, 3-Year Inquiry Exonerates Breast Cancer Researcher, WASH. POST, Mar. 4, 1997, at A13; Editorial, Welcome Apology Dr. Fisher Is Vindicated in Settlement of His Suit, PITT. POST-GAZETTE, Aug. 30,1997, at A8.

309 See Fisher Settles Lawsuit, supra note 304.

310 See id.; Skolnick, Andrew A., Breast Cancer Researchers Cleared of Charges, 277 JAMA 950, 950 (1997)CrossRefGoogle Scholar; Weiss, supra note 308, at A13.

311 See Weiss, supra note 308, at A13.

312 See Fisher Settles Lawsuit, supra note 304.

313 Id.

314 See id.

315 See Accused Cancer Expert Gets Apology, $3 Million, CHI. TRIB., Aug. 30, 1997, at 3.

316 See id.

317 See Angelides v. Baylor College of Med., 117 F.3d 833, 835 (5th Cir. 1997).

318 See id.; 1996 ORI ANN. REP. 34.

319 See Office of Research Integrity, Angelides Appeals ORI Finding, ORI NEWSLTR., June 1997 (visited May 10, 1998) <http//ori.dhhs.gov/newsltr/vol5no3.html> [hereinafter ORI NEWSLTR., June 1997].

320 See id.

321 See id.

322 See Angelides, 117 F.3d at 835; see also 1996 ORI ANN. REP., supra note 318, at iii (reporting that the amicus curiae brief filed by the federal government argued that the defendant's actions were “privileged by the mandatory notification requirements of Federal law“); ORI NEWSLTR., June 1997, supra note 319 (same).

323 See 1996 ORI ANN. REP., supra note 318, at 34.

324 See Angelides, 117 F.3d at 835; 1996 ORI ANN. REP., supra note 318, at 34.

325 See Angelides, 117 F.3d at 835.

326 See id.

327 See ORI NEWSLTR., June 1997, supra note 319.

328 See Angelides, 117 F.3d at 835-36; see also Office of Research Integrity, Appeals Court Sends Baylor Case Back to Texas State Court, ORI NEWSLTR., Sept. 1997 (visited May 10, 1998) <http://ori.dhhs.gov/newltr/vol5no4.html> (reviewing Angelides); 1996 ORI ANN. REP., supra note 318, at 21 (same).

329 See Angelides, 117 F.3d at 836-38.

330 See Ron Grossman, In Academe, the Serfs are Toppling the Lords, CHI. TRIB., Aug. 24, 1997, at 1.

331 See Philip J. Hilts, University Forced to Pay $1.6 Million to Researcher, N.Y. TIMES, Aug. 10, 1997, at 13.

332 See Phinney v. Perlmutter, 564 N.W.2d 532, 543 (Mich. Ct. App. 1997); Gregory Gordon, Misconduct Costs U-M $1 Million, DETROIT NEWS, May 13, 1993, at 1A.

333 See Philip J. Hilts, Scholar Who Sued Wins $1.2 Million, N.Y. TIMES, Sept. 22, 1993, at A23.

334 See Anderson, Christopher, Michigan Gets an Expensive Lesson, 262 SCIENCE 23, 23 (1993)CrossRefGoogle Scholar.

335 See id.

336 See Gordon, supra note 332, at 1A.

337 See Phinney, 564 N.W.2d at 555; Hilts, supra note 331, at 13.

338 See Hilts, supra note 333, at A23.

339 See Phinney, 564 N.W.2d at 541; Gordon, supra note 332, at 1A; Hilts, supra note 333, at A23.

340 See Phinney, 564 N.W.2d at 540; Gordon, supra note 332, at 1A.

341 See Hilts, supra note 331, at 13.

342 See Phinney, 564 N.W.2d at 541; Hilts, supra note 331, at 13.

343 See, e.g., Culliton, supra note 250, at 248 (discussing due process rights); Greenberg, David S., Leaks in the House of Science, 338 LANCET 1195, 1195 (1991)CrossRefGoogle Scholar (discussing leaks in confidential information); Hamilton, supra note 148, at 1084-85 (discussing due process, information leaks, lengthy investigations and the definition of scientific misconduct).

344 See Gibbons, supra note 20, at 1287; Hamilton, supra note 148, at 1085; supra text accompanying notes 164-67, 193-95.

345 See Gibbons, supra note 20, at 1288; Hamilton, supra note 250, at 1598.

346 See Cohen, supra note 178, at 914; Hamilton, supra note 148, at 1084; Hamilton, supra note 176, at 618; Bernadine Healy, The Dangers of Trial by Dingell, N.Y. TIMES, July 3, 1996, at A23.

347 The panel's proposal was that it be defined as “the intentional fabrication or falsification of data, research procedures, or data analysis; plagiarism; or other fraudulent activities in proposing, conducting, reporting or reviewing research.” Gibbons, supra note 20, at 1287.

348 See id.

349 See l NATIONAL ACAD, OF SCI., RESPONSIBLE SCIENCE: ENSURING THE INTEGRITY OF THE RESEARCH PROCESS 5 (1992).

350 See id. at 147 (stating Recommendation Three).

351 See id. (stating Recommendation Four).

352 See irf. at 111.

353 42 U.S.C.A. 289b (West Supp. 1998).

354 See id. § 163. CRI was established on November 4, 1993. See Establishment of Commission on Research Integrity, 58 Fed. Reg. 66,009, 66,009 (1993).

355 COMMISSION ON RESEARCH INTEGRITY, DEP't OF HEALTH AND HUMAN SERVS., INTEGRITY AND MISCONDUCT IN RESEARCH (visited May 10, 1998) <http://www.faseb.org/opar/cri.html> [hereinafter CRI REP.].

356 See id.

357 See Notice of a Regional Public Hearing of the Commission on Research Integrity, 60 Fed. Reg. 4168, 4168 (1995) [hereinafter Regional Public Hearing]; Advisory Committee on Immunization Practices: Meeting, 59 Fed. Reg. 50,605, 50,605 (1994).

358 See Regional Public Hearing, 60 Fed. Reg. at 4168.

359 CRI REP., supra note 355.

360 See Greenberg, Daniel S., Proposed US Misconduct Rules Draw Opposition, 347 LANCET 1475, 1475 (1996)CrossRefGoogle Scholar; Kaiser, Jocelyn, Panels Look for Common Ground: Scientific Misconduct, 272 SCIENCE 476, 476 (1996)CrossRefGoogle Scholar.

361 IMPLEMENTATION PROPOSALS ON RECOMMENDATIONS BY THE COMMISSION ON RESEARCH INTEGRITY (visited May 10, 1998) <http://www.washington-fax.com/pl/doc/ryan2/ryannew2.htm> [hereinafter IMPLEMENTATION PROPOSALS].

362 See supra text accompanying notes 190-95.

363 CRI REP., supra note 355.

364 See id.

365 See id.

366 Id.

367 Id.

368 The Commission provided examples of violations of this obligation. The examples include misappropriating the words or ideas of another without attribution, using information in breach of any duty of confidentiality associated with the review of manuscripts or grant applications, interfering with or impeding the progress of research by taking the research-related property of others and misrepresenting or corrupting the scientific record or compromising the integrity of scientific practices.

See id.

369 Id.

370 Id.

371 Id.

372 Id.

373 See id.

374 See id.

375 See id.

376 See id.

377 See id.

378 See id.

379 Id.

380 See id.

381 See id.

382 See id.

383 See id.

384 Billy Goodman, Scientists are Split over Findings of Research Integrity Commission (visited May 10,1998) <http://www.the-scientist.library.upenn.edu/yrl996/jan/conduct_960122.html>.

385 See Kaiser, supra note 360, at 476.

386 See Goodman, supra note 384.

387 See Letter from Ralph A. Bradshaw, President, Federation of American Societies for Experimental Biology (FASEB), to Dr. William F. Raub, Science Advisor, Office of Science Policy (May 13, 1996) (visited May 10, 1998) <http://www.washington-fax.com/pl/docs/raub.htm>.

388 Id.

389 See id.

390 See id.

391 See id.

392 See id.

393 See id.

394 See id.

395 See id.

396 Letter from the Council of the National Academy of Sciences, to Dr. William F. Raub, Science Advisor, Office of Science Policy (March 15, 1996) (visited May 15, 1998) <http://www2.nas.edu/nas/2102.htm>.

397 See id.

398 Id.

399 Id.

400 Id.

401 Id.

402 Id.

403 See id.

404 The implementation group was appointed by a section of DHHS to develop proposals to implement recommendations. See IMPLEMENTATION PROPOSALS, supra note 361.

405 See id.; Kaiser, Jocelyn, HHS is Still Looking for a Definition, 272 SCIENCE 1735, 1735 (1996)CrossRefGoogle Scholar.

406 See Kaiser, supra note 405, at 1735.

407 See IMPLEMENTATION PROPOSALS, supra note 361; Kaiser, supra note 405, at 1735.

408 See Kaiser, supra note 405, at 1735.

409 See IMPLEMENTATION PROPOSALS, supra note 361.

410 See id.

411 See Public Health Service Standards for the Protection of Research Misconduct Whistleblowers, 62 Fed. Reg. 21,712, 21,712 (1997) (proposing a new 42 C.F.R. § 94 under which covered institutions would have to follow certain requirements for preventing and responding to occurrences of retaliation against whistleblowers). The regulations would be designed to protect both “(1) persons who make a good faith allegation that a covered institution or member engaged in, or failed to respond adequately to an allegation of, research misconduct, and (2) persons who cooperate in good faith with an investigation of research misconduct.” Id.

412 See Dresser, Rebecca, Defining Scientific Misconduct: The Relevance of Mental State, 269 JAMA 895, 895-96 (1993)CrossRefGoogle Scholar.

413 See supra text accompanying note 362 (discussing several CRI language proposals, including FFP).

414 42 CF.R. § 50.102 (1997); Policies and Procedures Dealing with Possible Scientific Misconduct in Extramural Research, 56 Fed. Reg. 27,383, 27,385 (1991).

415 Id.

416 See supra notes 362-63 and accompanying text.

417 See supra notes 344-45 and accompanying text.

418 See supra note 344 and accompanying text.

419 CRI REP., supra note 355.

420 See Jacobellis v. Ohio, 378 U.S. 184, 197 (1964) (Stewart, J., concurring).

421 See supra Part IV.A.2.

422 See supra text accompanying notes 168-71.

423 See supra Part IV.A.3.

424 See supra text accompanying notes 192-96.

425 See supra text accompanying notes 191-92.

426 See supra text accompanying notes 193-95.

427 See supra Part IV.A.5.

428 See supra text accompanying notes 263-64.

429 Rebecca Dresser, Giving Scientists Their Due: The Imanishi-Kari Decision, HASTINGS CENTER. REP., May 1997, at 26,26.

430 Culliton, supra note 250, at 241.

431 See EDWARD W. CLEARY ET AL., MCCORMICK ON EVIDENCE §§ 336,337 (4th ed. 1992).

432 See id. § 337.

433 See Id. §§ 336-337.

434 See id. § 347.

435 See id.

436 See id. §§ 347-348 (discussing Patterson v. New York, 432 U.S. 197 (1977); Mullaney v. Wilbur, 421 U.S. 684 (1975)). The jury in Mullaney was instructed that:

if the prosecution proved that the homicide was both intentional and unlawful, malice aforethought was to be conclusively implied “unless the defendant proved by a fair preponderance of the evidence that he acted in the heat of passion on sudden provocation,” in which event the defendant would be guilty only of manslaughter. The placing of this burden on the defendant was said [by the Supreme Court] to violate the [rule] that the due process clause requires the prosecution to prove beyond a reasonable doubt every fact necessary to constitute the crime charged.

Id. § 347.

437 Kolata, supra note 90, at C3.

438 Id.

439 Weiss, supra note 2, at A6.

440 See Dresser, supra note 412, at 895-97.

441 See id.

442 Id. at 896.

443 See id.

444 See id.

445 CRI REP., supra note 355.

446 See id.; supra text accompanying notes 372-73.

447 CRI REP., supra note 355.

448 See supra text accompanying notes 161-63, 168.

449 See supra text accompanying note 169.

450 See id.

451 See supra text accompanying note 167.

452 See supra text accompanying note 270.

453 See supra text accompanying notes 289-90.

454 Dresser, supra note 412, at 896.

455 Id.

456 Dresser, supra note 429, at 27.

457 Id.

458 See id.

459 Id.

460 42 C.F.R. § 50.103(d)(13) (1997).

461 See 1994 ORI ANN. REP., supra note 220, at 23.

462 See id. at 4.

463 See 1995 ORI ANN. REP. at 4.

464 See ORI HANDBOOK, supra note 33.

465 See 1995 ORI ANN. REP., supra note 463, at 32.

466 See id. at 5.

467 Id.

468 See 1996 ORI ANN. REP., supra note 318, at 38-43.

469 See supra Part IV.B.2.

470 See supra Part IV.B.l.

471 See supra Part IV.B.3.

472 See supra Part IV.A.3.

473 996 ORI ANN. REP., supra note 318, at iii.

474 42 U.S.C. §§ 11101-11152 (1994); see BERNARD D. REAMS, JR., THE HEALTH CARE QUALITY IMPROVEMENT ACT OF 1986: A LEGISLATIVE HISTORY OF PUB. L. 99-660 (1990).

475 See BARRY R. FURROW ET AL., HEALTH LAW §§ 3-20, 10-25, at 114, 670 (1995). The Act establishes a National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners. See id. Insurance companies report to the data bank payments made in malpractice settlements and judgments. See 42 U.S.C. § 11131. State medical and dental licensing boards and various health care entities, such as hospitals and managed care organizations, are similarly required to report disciplinary action relating to professional competence. See 42 U.S.C. §§ 11131- 11134, 11151; 45 C.F.R. §§ 60.2-.14. Entities engaged in medical employment decisions or peer review activity can and often must obtain information from the data bank. See 42 U.S.C. §§ 11135, 11137; 42 C.F.R. § 60.7(b). The Act provides immunity from certain antitrust enforcement actions, given the potential anticompetitive nature of peer review activities conducted by rival health care practitioners. See id.

476 See 42 U.S.C. §§ 11101(5), 11111(a)(1).

477 See 42 U.S.C. § 11111(a)(2).

478 See FURROW ET AL., supra note 475, § 10-25, at 670.

479 See 42 U.S.C. § 11112(a).

480 See 42 U.S.C. § 11112(c).

481 42 C.F.R. § 50.103(d)(3) (1997).

482 ORI HANDBOOK, supra note 33.

483 See id.

484 MODEL RULES OF PROFESSIONAL CONDUCT Rule 3.7 (1990); see also RESTATEMENT (THIRD) OF THE LAW GOVERNING LAWYERS § 168 (Tentative Draft No. 8, 1997) (describing conditions under which a lawyer may and may not testify on matters relating to his representation of a client).

485 See 2 GEOFFERY C. HAZARD JR. & w. WILLIAM HODES, THE LAW OF LAWYERING app. 4, at 1269-70 (Supp. 1998).

486 Culliton, supra note 250, at 240.

487 Id.

488 j n 1990, Representative Robert A. Roe (R-N.J.) was prepared to introduce legislation that would have given universities and scientific publications immunity from litigation in fraud cases, but only if the accused individual had “all the rights that adhere to due process—like the right to see evidence and cross-examine witnesses.” Id.

489 See Office of Research Integrity, ORI Reduces Caseload, ORI NEWSLTR., Mar. 1997 (visited May 10, 1998) <http:www.ori.dhhs.gov/newsltr/vol5no2.html> [hereinafter ORI NEWSLTR., Mar. 1997]

490 See UNITED STATES GEN. ACCOUNTING OFFICE, REPORT TO CONGRESSIONAL REQUESTERS: HEALTH RESEARCH MISCONDUCT (visited May 10,1998) <http://www.frwebgate.access.gpo>.

491 See ORI NEWSLTR., Mar. 1997, supra note 489.

492 See Jock Friedly, ORI's Self Assessment: A Batting Average of .920?, 275 SCIENCE 1255, 1255(1997).

493 See id.

494 Id. (quoting Howard Schachman, a biochemist at the University of California, Berkeley, speaking on behalf of the Federation of American Societies for Experimental Biology).

495 See id. (quoting Howard Schachman and others, as well as data complied by Science).

496 See id.

497 See id.

498 See id.

499 See id.

500 See id. (quoting Howard Schachman: “The cost the American society is paying for a technician [in which] an agreement was reached that he or she will not serve on an advisory committee of the United States government… is just preposterous.“).

501 Philip J. Hilts, Panel Urges Independent Body to Set Ethical Standards in Science, N.Y. TIMES, Mar. 28, 1991, at D3.

502 See Friedly, supra note 492, at 1255.

503 Victoria Slind-Flor, Scientific Fraud and the Law, NAT'L L.J., Oct. 25, 1993, at 1, 1 (quoting Robert P. Charrow, former Principal Deputy General Counsel for DHHS).

504 See Hilts, supra note 501, at D3.

505 See id.

506 See Rennie, Drummond, Survey Tracts Misconduct, To An Extent, 262 SCIENCE 1203 (1993)Google Scholar, available in 1993 WL 12230957.

507 See id.

508 Id. (quoting David Goodstein, physicist and former Vice Provost of the California Institute of Technology).

509 See Friedly, supra note 492, at 1255.

510 See supra Part III.C.

511 See 1996 ORI ANN. REP., supra note 318, at 3.

512 See id. app. H, atH-1.

513 See id.

514 See id.

515 See id.

516 See id.

517 See id.

518 See id.

519 See CRI REP., supra note 355.

520 See, e.g., Abelson, Philip H., Integrity of the Research Process, 256 SCIENCE 1257 (1992)CrossRefGoogle Scholar, available in 1992 WL 11303658; Crigger, Bette-Jane, Perish for Publishing, 18 HASTINGS CENTER REP. 4 (1988)Google Scholar, available in LEXIS, News Library, Asapii File.

521 See Crigger, supra note 520.