Due process in investigations of research misconduct

New England Journal of Medicine

Volumn 349, Issue 13, 2003, Pages 1280-1286

  Mello, Michelle M ^a   Brennan, Troyen A ^a,b,c  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALGORITHM; CLINICAL RESEARCH; FORGERY; GOVERNMENT; HOSPITAL BILLING; HUMAN RIGHTS; LEGAL ASPECT; PRIORITY JOURNAL; PROFESSIONAL MISCONDUCT; REVIEW; UNITED STATES; ACCREDITATION; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; HISTORY; HOSPITAL; LEGAL APPROACH; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PERSONNEL; POLICY; PRACTICE GUIDELINE; PUBLIC HEALTH SERVICE; SCIENTIFIC MISCONDUCT; STANDARD; UNIVERSITY;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

ACADEMIES AND INSTITUTES; CREDENTIALING; FRAUD; GUIDELINES; HISTORY, 20TH CENTURY; HOSPITALS; ORGANIZATIONAL POLICY; RESEARCH PERSONNEL; SCIENTIFIC MISCONDUCT; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES; UNITED STATES OFFICE OF RESEARCH INTEGRITY; UNIVERSITIES;

EID: 0141796724     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMhpr035095     Document Type: Review

References (46)

1. Goldner J. The unending saga of legal controls over scientific misconduct: a clash of cultures needing resolution. Am J Law Med 1998;24:293-343.
2. Broad WJ, Wade N. Betrayers of the truth. New York: Simon & Schuster, 1982.
3. Health Research Extension Act of 1985, 42 U.S.C.A. § 289a (West 2003).
4. Responsibility of PHS awardee and applicant institutions for dealing with and reporting possible misconduct in science. Fed Regist 1989;54(151):32446-51.
5. Dr. Rameshwar K. Sharma, D.A.B. decision No. 1431 (1993).
6. Dresser R. Defining scientific misconduct: the relevance of mental state. JAMA 1993;269:895-7.
7. Greenberg DS. Resounding echoes of Gallo case. Lancet 1995;345:639.
8. Mikulas Popovic, M.D., Ph.D., D.A.B. decision No. 1446 (1993).
9. Friedly J. How Congressional pressure shaped the "Baltimore case." Science 1996; 273:873-5. [Erratum, Science 1996;273: 1481.]
10. Thereza Imanishi-Kari, Ph.D., D.A.B. decision No. 1582 (1996).
11. Popovic v. United States, 997 F. Supp. 672 (D. Md. 1998).
12. Popovic v. United States, 175 F.3d 1015 (4th Cir. 1999).
13. Hiserodt v. Shalala, C.A. No. 91-00224 (W.D. Pa. 1994).
14. Abbs v. Sullivan, 756 F. Supp. 1172 (W.D. Wisc. 1990).
15. Needleman v. Healy, 1996 U.S. Dist. LEXIS 21614 (W.D. Pa. May 22, 1996).
16. Committee on Science, Engineering, and Public Policy, Panel on Scientific Responsibility and the Conduct of Research. Responsible science. Vol. 1. Ensuring the integrity of the research process. Washington, D.C.: National Academy Press, 1992-1993.
17. Establishment of Commission on Research Integrity. Fed Regist 1993;58(241): 66009.
18. Report of the Department of Health and Human Services. Rockville, Md.: Office of Research Integrity, 2002. (Accessed September 4, 2003, at http://ori.dhhs.gov/html/news[HHSreview.asp.)
19. Commission on Research Integrity. Integrity and misconduct in research: report of the Commission on Research Integrity. Rockville, Md.: Office of Research Integrity, 1995.
20. Letter from Ralph R, Bradshaw, president, FASEB, to Dr. William F. Raub, Office of Science Policy. May 13, 1996. (Accessed September 4, 2003, at http://www.faseb.org/opar/cristat.html.)
21. Office of Science and Technology Policy. Federal policy on research misconduct: preamble for research misconduct policy: notification of final policy. Fed Regist 2000; 65(235):76260-4.
22. ORI model policy and procedures for responding to allegations of scientific misconduct. Rockville, Md.: Office of Research Integrity, 1995. (Accessed September 4, 2003, at http://ori.dhhs.gov/html/policies/model. asp.)
23. Pascal CB. Scientific misconduct and research integrity for the bench scientist. Proc Soc Exp Biol Med 2000;224:220-30.
24. Office of Research Integrity. Is ORI objective when it investigates alleged misconduct? Vol. 5. No. 1. ORI Newsletter. December 1996:9. (Accessed September 4, 2003, at http://ori.dhhs.gov/html/publications/newsletters.asp.)
25. HHS Departmental Appeals Board information. Rockville, Md.: Office of Research Integrity, 2003. (Accessed September 4, 2003, at http://ori.dhhs.gov/html/misconduct/appeal.asp#.)
26. 42 C.F.R. § 50.103(d)(2003).
27. Andersen RM. The federal government's role in regulating misconduct in scientific and technological research. Harv J Law Technol 1988;3:121-48.
28. CHPS Consulting. Analysis of institutional policies for responding to allegations of scientific misconduct. Rockville, Md.: Office of Research Integrity, 2000. (Accessed September 4, 2003, at http://ori.dhhs.gov/html/publications/polantitle.htm.)
29. Cipriotti v. Board of Directors of Northridge Hospital Foundation Medical Center, 196 Cal. Rptr. 367 (Cal. App. 1983).
30. Greisman v. Newcomb Hospital, 192 A.2d 817 (N.J. 1963).
31. Garrow v. Elizabeth General Hospital and Dispensary, 401 A.2d 533 (N.J. 1979).
32. Wheeler v. Methodist Hospital, 95 S.W. 3d 628 (Tex. Ct. App. 2002).
33. Rea v. Hospital Corporation of America, 892 F. Supp. 821 (N.D. Tex. 1993).
34. Madsen v. Audrain Health Care, Inc., 297 F.3d 694 (8th Cir. 2002).
35. Kalb PE, Koehler KG. Legal issues in scientific research. JAMA 2002;287:85-91.
36. 45 C.F.R. § 76.115 (2003).
37. Gideon v. Wainwright, 372 U.S. 335 (1963).
38. Mathews v. Eldridge, 424 U.S. 319 (1976).
39. Survey of accused but exonerated individuals in research misconduct cases: final report. Washington, D.C.: Research Triangle Institute, June 1996.
40. Steinberg NA. Regulation of scientific misconduct in federally funded research. South Calif Interdisciplinary Law J 2000;10: 39-105.
41. Weiss RB, Rifkin RM, Stewart FM, et al. High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet 2000;355:999-1003.
42. Burk DL. Research misconduct: deviance, due process, and the disestablishment of science. George Mason Indep Law Rev 1995;3:305-50.
43. Wood A, Grady C, Emanuel EJ. The crisis in human participants research: identifying the problems and proposing solutions: paper presented to the President's Council on Bioethics's September 2002 meeting. Bethesda, Md.: National Institutes of Health 2002. (Accessed July 24, 2003, at http://www. bioethics.gov/background/emanuelpaper. html.)
44. Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346: 1425-30. [Erratum, N Engl J Med 2002;346: 1838.]
45. Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trusst, promoting progress - policy and guidelines for the oversight of individual financial interests in human subjects research. Washington, D.C.: Association of American Medical Colleges, December 2001.
46. Establishment of the Office for Good Clinical Practice (OGCP). Press release of the Food and Drug Administration, Rockville, Md., October 26, 2001. (Accessed September 4, 2003, at http://www.fda.gov/oc/gcp/ogcp.html.)