This paper describes the role of the Office of Research Integrity (ORI), a component of the Public Health Service (PHS), in defining scientific misconduct in research supported with PHS funds and in establishing standards for responding to allegations of misconduct. The principal methods by which ORI exercises its responsibilities in this area are defining what types of behaviors undertaken by research investigators constitute misconduct, overseeing institutional efforts to Investigate and report misconduct, and recommending to the Assistant Secretary for Health (ASH) PHS administrative actions when misconduct is identified. ORI also takes affirmative steps to promote research integrity through education, training, and other initiatives. The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts but, as the employer of research investigators and front-line manager of the research, the institution has a greater opportunity to promote the highest standards of integrity in the day-to-day conduct of research. Finally, legal precedent established through civil litigation has played an important role in defining the standards that apply in determining when a breach of research integrity has occurred.
Get full access to this article
View all access options for this article.
References
1.
Office of Science and Technology Policy.Proposed federal policy on research misconduct to protect the integrity of the research record. Federal Register64:55722-55725, 1999.
2.
U.S. Department of Health and Human Services (USDHHS).Review group report on research misconduct and research integrity. Washington. DC: USDHHS, 1999.
3.
Office of the Assistant Secretary for Health.PHS statement of organization, functions, and delegations of authority. Federal Register57:24262, 1992.
4.
Office of Public Health and Science.Statement of organization, functions, and delegations of authority. Federal Register60:56605-56606, 1995.
5.
Office of the Secretary.Statement of organization, functions, and delegations of authority. Federal Register61:21470, 1996.
6.
Office of the Secretary; Office of Public Health and Science.Statement of organization, functions, and delegations of authority. Federal Register65:30600-30601, 2000.
7.
Office of Research Integrity.ORI handbook for institutional research integrity officers. Rockville, MD: Department of Health and Human
8.
Services, Public Health Service, Office of Research Integrity, pp9-10, 1997.
9.
Responsibilities of awardee and applicant institutions for dealing with and reporting possible misconduct in science (hereafter PHS misconduct regulation), 42 CFR § 50.102 (1999).
10.
SharmaRK.Ruling on respondent motion to dismiss. Department of Health and Human Services Appeals Board (DAB) (No. A-93-50 at 14–15), May 10, 1993.
PascalCB.Scientific misconduct and research integrity: Federal definitions and approaches. Professional Ethics7:9-32, 1999.
28.
PHS misconduct regulation, 42 CFR § 50.103(d)(6).
29.
PHS misconduct regulation, 42 CFR § 50.104(a)(6).
30.
Office of Research Integrity.Administrative actions: Range, rationale, implementation described. ORI Newsletter4:4, 19%.
31.
Office of Research Integrity.ORI addresses ten issues in inquiries and investigations (ORI position paper #2). Rockville, MD: Department of Health and Human Services, Public Health Service, Office of Research Integrity, 1998.
32.
Shovlin v. University of Medicine and Dentistry of New Jersey, 50 F. Supp. 2d 297, 314 (D. N.J. 1998), aff'd per curiam (3rd Cir. May 28, 1999).
33.
Office of Research Integrity.Institutions elaborate PHS definition of misconduct. ORI Newsletter3:5, 1995.
34.
National Academy of Sciences.Responsible science: Ensuring the integrity of the research process. Washington, DC: National Academy Press, Vol I:28, 1992.
35.
DustiraAK.The federal role in influencing research ethics education and standards in science. Professional Ethics5:139-156, 1996.
36.
Office of Research Integrity.Managing integrity in research. Summary of a conference co-sponsored by ORI and the University of Michigan. Rockville, MD: Department of Health and Human Services, Public Health Service, ORI, 1998.
37.
Department of Health and Human Services.Report of the Commission on Research Integrity: Integrity and misconduct in research. Rockville, MD: Department of Health and Human Services, Public Health Service, ORI, p35, 1995.
Office of Research Integrity.Emerging challenges for the responsible conduct of research [On-line]. Available: http://www.ori.dhhs.gov/page1.htm, 2000.
40.
Public Health Service.Statement of organization, functions, and delegations of authority. Federal Register59:2856, 1994.
41.
Office of Research Integrity.Workshop program revitalized. ORI Annual Report. Rockville, MD: Department of Health and Human Services, Public Health Service, ORI, pii, 1998.
42.
DavidTP, ed. Management of biomedical research laboratories: National Conference Proceedings, University of Arizona, Tucson, 1999.
43.
Office of Research Integrity.Consequences of whistleblowing for the whistleblower in misconduct in science cases: Final report prepared by the Research Triangle Institute for ORI. Rockville, MD: Department of Health and Human Services, Public Health Service, Office of Research Integrity, 1995.
44.
Office of Research Integrity.Survey of accused but exonerated individuals in research misconduct cases: Final report prepared by the Research Triangle Institute for ORI. Rockville, MD: Department of Health and Human Services, Public Health Service, Office of Research Integrity, 1996.
45.
PHS misconduct regulation42CFR § 50.105.
46.
Faculty of Medicine, Harvard University. Faculty policies on integrity in science [On-line]. Available: http://www.hms.harvard.edu/integrity, 1996.
47.
Harvard Medical School, Harvard Dental School, and Harvard School of Public Health.At the Ombuds office: Some appropriate concerns [On-line]. Available: http://www.hms.harvard.edu/ombuds, 1999.
48.
SchwartzJP.NIH gets an ombudsman. NIH Catalyst5:4, 1997.
49.
National Institutes of Health.NIH Office of the Ombudsman: The Center for Cooperative Resolution [On-line]. Available: http://www4.od.nih.gov/ccr, 1999.
50.
Office of Research Integrity.ORI guidelines for institutions and whistleblowers: Responding to possible retaliation against whistleblowers in extramural research. Rockville, MD: Department of Health and Human Services, Public Health Service, Office of Research Integrity, 1995.
51.
University of Michigan.Research responsibility program [On-line]. Available: http://www.research.umn.edu, 1999.
ShermanSE.The False Claims Act. Public Health Reports110:784, 1995.
54.
United States ex rel. Berge v. University of Alabama, 104 F.3d 1453 (4th Cir. 1997), cert. denied, 522 U.S. 916 (1997).
55.
United States ex rel. Condie v. University of California, (No. 89–3550 FMS (N.D. Cal.)).
56.
Office of Research Integrity.Scientific misconduct charges and false claims act suit settled. ORI Newsletter2:1, 1994.
57.
United States ex rel. Milam v. University of California, 912 F. Supp. 868 (D. Md. 1995).
58.
Angelides v. Baylor College of Medicine, (No. 95–24248 (11th D.C. Harris County, Tex.)).
59.
Angelides v. Baylor College of Medicine, 117 F. 3rd 830 (5th Cir. 1997).
60.
AngelidesKJ.Department of Health and Human Services Appeals Board (DAB) Decision No. 1677, February 5, 1999.
61.
Arroyo v. Rosen, 102Md. App. 101, 648 A. 2d 1074 (Md. Ct. App. 1994).
62.
Office of Research Integrity.The whistleblower's conditional privilege to report allegations of scientific misconduct (ORI position paper #1). Rockville, MD: Department of Health and Human Services, Public Health Service, Office of Research Integrity, 1993.
63.
Shen v. Regents of the University of Minnesota, (No. EM 96–12703, Slip op. (County of Hennepin, Minn., May 4, 1998)).
64.
United States v. Arora, 860 F. Supp. 1091 (D. Md. 1994), aff'd per curiam, 56 F. 3d 62 (4th Cir. 1995).
