EBHC Library > Methodology of Research > Clinical Research > Etichs of Research

Page last update: 29/09/2012

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• General
  • Steinbrook R. Standards of ethics at the National Institutes of Health. N Engl J Med 2005;352:1290-2
  • Jamrozick K. Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004;329: 286-7.
    • Warlow C. Clinical research under the cosh again. BMJ 2004;329:241-2.
  • Miller FG, Rosenstein DL. Reporting of ethical issues in publications of medical research. Lancet 2002;360:1326-8.
  • Kahn JP, Mastroianni AC. Moving from compliance to conscience: why we can and should improve on the ethics of clinical research. Arch Intern Med 2001;161:925-8.
  • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11.
  • Marquis D. How to resolve an ethical dilemma concerning randomized clinical trials. N Engl J Med 1999;341:691-3.
  • Joseph KS. Ethics in clinical research: searching for absolutes. CMAJ 1998;158:1303-5.

• Special topics
  • Parker M, Ashcroft R, Wilkie AO, et al. Ethical review of research into rare genetic disorders. BMJ 2004;329:288-9.
  • Miller FG, Emanuel EJ, Rosenstein DL, Straus SE. Ethical issues concerning research in complementary and alternative medicine. JAMA 2004;291:599-604.
  • Agrawal M, Emanuel EJ. Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA 2003;290:1075-82.
  • Are large clinical trials in rapidly lethal diseases usually unethical?
  • Horrobin DF. Are large clinical trials in rapidly lethal diseases usually unethical? Lancet 2003;361:695-7.

• Integrity of Research
  • Korn D, Ehringhaus S. Principles for strengthening the integrity of clinical research. PLoS Clin Trials 2006;1:e1.
  • [No authors listed]. The next step: ensuring integrity of scientific research. Lancet 2002;360:499
  • Smith R. US calls for research into research integrity BMJ 2000;321:1369B.
  • Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Trial registration, transparency and less reliance on industry trials are essential. Med J Aust 2005;182:549-50.
  • Rennie D. Dealing with research misconduct in the United Kingdom. An American perspective on research integrity. BMJ 1998;316:1726-8.
  • Miller FG, Rosenstein DL, DeRenzo EG. Professional integrity in clinical research. JAMA 1998;280:1449-54.
  • Huston P, Moher D. Redundancy, disaggregation, and the integrity of medical research. Lancet 1996;347:1024-6
  • Lowry F. Create culture of integrity to defeat research fraud, funding agencies say. CMAJ 1995;152:1507-8.

• Special studies
  • Djulbegovic B, Clarke M. Scientific and ethical issues in equivalence trials. JAMA 2001;285:1206-8.

• Sample size
  • Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA 2002; 288: 358-362.
  • Edwards SJL, Lilford RJ, Braunholtz D, et al. Why "underpowered" trials are not necessarily unethical. Lancet. 1997;350:804-807

• Placebo
  • Rief W, Avorn J, Barsky AJ. Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med 2006;166:155-60.
  • Stang A, Hense HW, Jockel KH, et al. Is it always unethical to use a placebo in a clinical trial? PLoS Med 2005;2:e72.
  • Holbrook A, Goldsmith C. Innovation and placebos in research: a new design of clinical trial. Lancet 2003;362:2036-7.
  • Horng S, Miller FG. Is placebo surgery unethical? N Engl J Med 2002;347:137-9.
  • Miller FG, Shorr AF. Unnecessary use of placebo controls: the case of asthma clinical trials. Arch Intern Med 2002;162:1673-7.
  • Lewis JA, Jonsson B, Kreutz G, et al. Placebo-controlled trials and the Declaration of Helsinki. Lancet 2002;359:1337-40.
  • Weijer C. Placebo trials and tribulations. CMAJ 2002;166:603-4.
    • [No authors listed] The better-than-nothing idea: debating the use of placebo controls. CMAJ 2002;166:573.
  • Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002;136:471-6.
  • Emanuel EJ, Miller FG. The ethics of placebo-controlled trials--a middle ground. N Engl J Med 2001;345:915-9.
    • Huston P, Peterson R. Withholding proven treatment in clinical research. N Engl J Med 2001;345:912-4.
  • Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344:1594-602
    • Bailar JC 3rd. The powerful placebo and the Wizard of Oz. N Engl J Med. 2001;344:1630-2.
  • Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med 2000;133:464-70.
  • Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 2000;133:455-63.
    • Reynolds T. The ethics of placebo-controlled trials. Ann Intern Med 2000;133:491.
    • Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatment exists? Ann Intern Med 2000;133:474-5.
  • Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med 1999;341:992-6.
  • Tramer MR, Reynolds DJ, Moore RA, et al. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1998;317:875-80.
  • Senn S. Are placebo run ins justified? BMJ 1997;314:1191-3.
  • Rothman KJ. Placebo mania. BMJ 1996;313:3-4.
  • Baer N. Debate about placebos points to issue surrounded by many shades of grey. CMAJ 1996;155:1475-6.
  • Aspinall RL, Goodman NW. Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials. BMJ 1995;311:844-6.
    • Collier J. Confusion over use of placebos in clinical trials. BMJ 1995;311:821-2.
  • Johnson AG. Surgery as a placebo. Lancet 1994;344:1140-2.
  • Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331:394-8.
  • Kluge EH. Placebos: some ethical considerations. CMAJ 1990;142:293-5.
  • The Powerful Placebo and the Wizard of Oz. N Engl J Med 2001;

     

• The ethics of participating in research

Varie etica

• Lievre M, Menard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001;322:603-5

• Marquis D. How to resolve an ethical dilemma concerning randomized clinical trials. N Engl J Med 1999;341:691-3

• Edwards SJ, Lilford RJ, Hewison J. The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. BMJ 1998;317:1209-12

• Edwards SJ, Lilford RJ, Braunholtz DA, et al. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess 1998;2(15):i-vi, 1-132

• World Association of Medical Editors (WAME)

  • Web Resources on Publication and Research Ethics

  • Bibliografia varia