What is scientific misconduct, who has to (dis)prove it, and to what level of certainty?

Medicine and Law

Volumn 26, Issue 3, 2007, Pages 493-510

  Spece, Roy G ^a   Bernstein, Carol ^a  

^a UNIVERSITY OF ARIZONA   (United States)

Author keywords

Office of Science Technology Policy; Recklessness; Research misconduct; Standard of proof; U.S. Public Health Service

Indexed keywords

ARTICLE; CRIMINAL LAW; GOVERNMENT; HEALTH CARE POLICY; MEDICAL RESEARCH; PROBABILITY; PUBLIC HEALTH; SCIENTIFIC MISCONDUCT; UNIVERSITY;

ARIZONA; FEMALE; HUMANS; ORGANIZATIONAL CASE STUDIES; ORGANIZATIONAL POLICY; SCIENTIFIC MISCONDUCT; UNITED STATES; UNITED STATES PUBLIC HEALTH SERVICE; UNIVERSITIES;

EID: 35448995266     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (59)

1. Federal Policy on Research Misconduct, 65 Fed. Reg. 76260 (Off. of Sci. & Tech. Pol'y Dec. 6,2000)(initially published for public comment at 64 Fed.Reg. 55722-25, (Oct. 14,1999). This Policy uses the term "research misconduct" and that term and "scientific misconduct" will be treated as equivalent in this article. We will also frequently use "misconduct" to refer to scientific or research misconduct.
2. Although this paper focuses on the PHS regulations and does not attempt to survey and compare various agencies' regulations, the same infirmities are likely to inform other agencies' regulations because each agency is required to conform its regulations to the UFP also discussed in the text. That Policy defines misconduct and the standard of proof applicable to it.
3. For brief descriptions of this case and references to other materials relating to the case see Roy G. Spece & John J. Marchalonis, What Should the Standard of Proof Be in Scientific Misconduct Proceedings Relating to Public Health Service-Funded Research? 49(4) CELLULAR & MOLECULAR BIOLOGY 565,567-70 (2003) [hereinafter Spece & Marchalonis, Standard of Proof] (see note 38infra for a better indication of the standard of proof in each state based on the Federation of State Medical Board's yearly direct board surveys); Roy G.. Spece & John J. Marchalonis, Fourth Amendment Restrictions on Scientific Misconduct Proceedings at Public Universities, 11 HEALTH MATRIX 571, 581-585, 622-26 (2001) [hereinafter Spece & Marchalonis, Fourth Amendment Restrictions]. The authors of this and the cited articles were all outspoken critics of the University of Arizona Administrations' handling of the Kay case.
4. See note 1 supra.
5. Id.
6. Id. at 76262.
7. Id. at 76260.
8. D. Parrish, Research Misconduct And Plagiarism, 33 J.C. & U.L. 65, 68 n.29 (2006).
9. 69 Fed. Reg. 20778 (Apr. 16, 2004).
10. Id. at 20779, 20780.
11. Id. at 20780.
12. Id. at 20790, proposed 42 C.F.R. § 93.106.
13. Id. at 20791, proposed 42 C.F.R. § 93.220.
14. Id. at proposed 42 C.F.R. § 93.221.
15. 70 Fed. Reg. 28370 (2005) (to be codified at 42 C.F.R. pts. 50 & 93).
16. Id. at 28386.
17. See text at supra note 10.
18. R. Dresser, Defining Scientific Misconduct: The Relevance of Mental State, 269 JAMA. 895, 896 (February 17, 1993).
19. Id. at 896. Dresser also suggested that mere negligence be included within the ken of "misconduct," albeit with lesser sanctions. We believe this to be ill-advised because "misconduct" carries with it a stigma too pungent to apply to merely negligent professionals, including scientists. In fact, it is our impression that virtually all professionals are negligent on rare occasions. It is an exaggeration to characterize infrequent lapses as "unprofessional." It is beyond the scope of this article to fully explore either that point or our further belief that "recklessness" too does not merit the characterization of unprofessional conduct unless it is further defined to require conscious disregard of serious danger to important interests. We invite others to consider these issues.
20. Restatement (Third) of Torts: Liability for Physical Harm cmt. c (Proposed Final Draft) (2005) (describing differences among the MPC, on the one hand, and the Restatement (Second & Proposed Third) of Torts, on the other hand).
21. City of Columbus v. Black, Nos. 76AP-262 and 76AP-263, 1976 WL 190088 (Ohio Ct. App. Aug. 3, 1976) (Code section prohibiting solicitation to engage in sexual activity when the offender knows such solicitation is offensive to the other person or is reckless in that regard apparently found violative of both the First Amendment and the Due Process Clause of the Fourteenth Amendment). See also State v. Boyer, 512 S.E.2d 605 (Ga. 1999) (Sears, J. joined by Fletcher, J., dissenting) (reckless conduct statute that was specified to penalize conscious disregard of substantial and unjustifiable risk or harm to others unconstitutionally vague as applied to day care center employee who addressed a twelve-month-old child who would not sleep at nap time as follows: "Boyer lifted the child and 'plopped her on her belly' and dragged the child's sleeping mat a short distance; and that when the child 'kind of popped up again ... Boyer pushed her down by the back'"; the Justices felt the statute failed to give the defendant fair notice and encouraged arbitrary and selective enforcement).
22. See, e.g., Annotation, Statute Prohibiting Reckless Driving: Definiteness and Certainty, 52 A.L.R. 4th 1161, § 2[a] (1987) and authorities collected therein.
23. Responsibilities of Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science, 54 Fed. Reg. 32,446 (Aug. 8, 1989 (to be codified at 42 C.F.R. § 50.102).
24. See text at supra note 6.
25. 65 Fed. Reg. 76260, 76262 (Dec. 6, 2000).
26. 69 Fed. Reg. 20778, April 16, 2004 at proposed 42 C.F.R. § § 93.106(a) & 93.516 (c).
27. Id. at proposed § 93.221.
28. (a) C.J.S. Evidence § 1304 (2000).
29. In re Winship, 397 U.S. 358, 361-62 (1971).
30. 42 CFR Parts 50 and 93, 70 Fed. R eg. 28370, 28372, 28378.
31. 480 U.S. 228 (1997).
32. Id. at 231-232.
33. Id. at 230-234.
34. Id. at 233.
35. See supra text at notes 6 & 15-16.
36. Id. and text at note 23 supra.
37. Dresser, supra note 18, at 897.
38. R. Spece and J. Marchalonis, Sound Constitutional Analysis, Moral Principle, And Wise Policy Judgment Require A Clear And Convincing Standard Of Proof In Physician Disciplinary Proceedings, 3. Ind. Health L. Rev. 107, 114 (2006).
39. 424 U.S. 319, 335 (1976).
40. M. Mello and T, Brennan, Due Process in Investigations of Research Misconduct, N Engl. J. Med 349; 13, May 23, 2007 at page 1280, 1284.
41. 997 F. Supp. at 672 (D.Md. 1998); cited id. at note 11.
42. 997 F. Supp. at 677.
43. 997 F. Supp. at 678-79.
44. Mello & Brennan, supra note 40, at 1284.
45. Spece & Marchalonis, Standard of Proof, supra note 3, at 570.
46. Id. at 570-74.
47. 65 FR 76260, 76262 (Dec. 6, 2000).
48. Charles Toutant, Clear and Convincing Evidence Is Standard of Proof for Legal Fraud; But Latest Federal Ruling Notes Sharp Division of Opinion Among Courts, 169 N.J.L.J. 706 (2002).
49. Spece & Marchalonis, Standard of Proof, supra note 3, at 573-74.
50. Spece & Marchalonis, supra note 38, at 118-19.
51. Id. at 118.
52. Addington v. Texas, 441 U.S. 418 (1979) (clear and convincing standard required in civil commitment); Santosky v. Kramer, 455 U.S. 745 (1982) (clear and convincing standard required in parental termination proceedings);
53. Spece & Marchalonis, supra note 38 at 111-35; Spece & Marchalonis, Standard of Proof, supra note 3, at 567-70.
54. See text at supra note 3.
55. See text at supra note 8.
56. See text at supra note 20.
57. See text at supra notes 23-36.
58. See our companion piece in this theme issue, text at notes.
59. See text supra at notes 23-36.