Teaching medical students to discern ethical problems in human clinical research studies

Academic Medicine

Volumn 80, Issue 10, 2005, Pages 925-930

  Roberts, Laura Weiss ^a   Warner, Teddy D ^b   Hammond, Katherine A Green ^b   Brody, Janet L ^c   Kaminsky, Alexis ^b   Roberts, Brian B ^a  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

^b UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^c OREGON RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; EVALUATION; FEMALE; HUMAN; LEARNING; MALE; MEDICAL ETHICS; MEDICAL PRACTICE; MEDICAL STUDENT; PRIORITY JOURNAL; TECHNIQUE;

EID: 25444479397     PISSN: 10402446     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001888-200510000-00012     Document Type: Article

References (36)

1. Centerwatch. Welcome to the Center watch clinical trials listing service 〈http://www. centerwatch.com〉. Accessed 1 July 2005.
2. Lemonick MD, Goldstein A. At your own risk. Time. 2002;46-56.
3. Evaluation of NIH implementation of Section 491 of the Public Health Service Act, mandating a program of protection for research subjects. Bethesda: Office of Extramural Research, National Institutes for Health, 1998.
4. Kaplan A. Ensuring the continuation and growth of clinical research. Psychiatr Times. 2000;17:60-62.
5. Kelch RP. Maintaining the public trust in clinical research. N Engl J Med. 2002;346: 285-87.
6. Roberts LW, Brody JL, Warner TD, Horwitz RH, Roberts BB. Impacts on biomedical research. In: Bennahum DA (ed). Managed Care. Cleveland: Pilgrim Press, 1999:106-28.
7. Meyer M, Genel M, Altman RD, Williams MA, Allen JR. Clinical research: assessing the future in a changing environment; summary report of conference sponsored by the American Medical Association Council on Scientific Affairs, Washington, DC, March 1996. Am J Med 1998;104:264-71.
8. Roberts LW, Warner TD, Brody JL. Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation. Am J Psychiatry. 2000;157:67-74.
9. Roberts LW, Warner TD, Anderson CT, Smithpeter MV, Rogers MK. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing. Schizophr Res. 2004;67:283-91.
10. Warner TD, Roberts LW, Nguyen K. Do psychiatrists understand research-related experiences, attitudes, and motivations of schizophrenia study participants? Compr Psychiatry. 2003;44:227-33.
11. Cho MK, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts of interest at US universities. JAMA. 2000;284:2203-8.
12. Karlawish JH, Hougham GW, Stocking CB, Sachs GA. What is the quality of the reporting of research ethics in publications of nursing home research? J Am Geriatr Soc. 1999;47: 76-81.
13. Moreno J, Caplan AL, Wolpe PR. Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group. JAMA. 1998; 280:1951-58.
14. Kopelman LM. Children as research subjects: a dilemma. J Med Phil. 2000;25:745-64.
15. Levine RJ. Ethics and Regulation of Clinical Research. Baltimore: Urban & Schwartzenberg, 1986.
16. Roberts LW. Ethical dimensions of psychiatric research: a constructive, criterion-based approach to protocol preparation. The Research Protocol Ethics Assessment Tool (RePEAT). Biol Psychiatry. 1999;46:1106-19.
17. Faden RR. Human-subjects research today: final report of the Advisory Committee on Human Radiation Experiments. Acad Med. 1996;71:482-83.
18. Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274:1354-60.
19. Rothman DJ. Ethics and human experimentation. Henry Beecher revisited. N Engl J Med. 1987;317:1195-99.
20. Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, The fragile foundation of contemporary biomedical research. Hastings Cent Rep. 1996;26:25-29.
21. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317: 141-45.
22. Gallin JI, Smits HL. Managing the interface between medical schools, hospitals, and clinical research. JAMA. 1997;277:651-54.
23. Lieberman JA. Ethical dilemmas in clinical research with human subjects: an investigator's perspective. Psychopharmacol Bull. 1996;32:19-25.
24. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Government Printing Office, 1979.
25. Wenger NS, Korenman SG, Berk R, Berry S. The ethics of scientific research: an analysis of focus groups of scientists and institutional representatives. J Investig Med. 1997;45:371-80.
26. Rosenstein DL, Miller FG, Rubinow DR. A curriculum for teaching psychiatric research bioethics. Biol Psychiatry. 2001;50:802-8.
27. Gluck JP, Dipasquale T, Orlans BF. Applied Ethics in Animal Research: Philosophy, Regulation, and Laboratory Applications. Purdue University Press, 2002.
28. Jasanoff S. Innovation and integrity in biomedical research. Acad Med. 1993;68:S91-95.
29. Chen DT. Curricular approaches to research ethics training for psychiatric investigators. Psychopharmacology (Berl). 2003;171:112-19.
30. Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA. 2001;285:1201-5.
31. Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M. Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol. 1992;10:1810-16.
32. Erlen JA. Clinical research: what do patients understand? Orthop Nurs. 2000;19:95-99.
33. Sponholz G. Teaching scientific integrity and research ethics. Forensic Sci Int. 2000;113: 511-14.
34. Roberts LW, Warner TD, Brody JL, Nguyen K, Roberts BB. What is ethically important in clinical research? A preliminary study of attitudes of 73 psychiatric faculty and residents. Schizophr Bull. 2003;29:607-13.
35. Roberts L, Roberts B. Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness. Biol Psychiatry. 1999;46:1025-38.
36. Patton MQ. Qualitative Evaluation and Research Methods. 2nd ed. Newbury Park, CA: Sage Publications, 1990.