Search tips
Search criteria 


Logo of bmjThe BMJ
BMJ. 1996 November 30; 313(7069): 1390–1393.
PMCID: PMC2352884

Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability.


The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data collection.

Full text

Full text is available as a scanned copy of the original print version. Get a printable copy (PDF file) of the complete article (943K), or click on a page image below to browse page by page. Links to PubMed are also available for Selected References.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Koopmans PP. Registration of drugs for treating cancer and HIV infection: a plea to carry out phase 3 trials before admission to the market. BMJ. 1995 May 20;310(6990):1305–1306. [PMC free article] [PubMed]
  • Mulrow CD. The medical review article: state of the science. Ann Intern Med. 1987 Mar;106(3):485–488. [PubMed]
  • Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA. 1992 Jul 8;268(2):240–248. [PubMed]
  • Oxman AD, Guyatt GH. The science of reviewing research. Ann N Y Acad Sci. 1993 Dec 31;703:125–134. [PubMed]
  • Assendelft WJ, Koes BW, Knipschild PG, Bouter LM. The relationship between methodological quality and conclusions in reviews of spinal manipulation. JAMA. 1995 Dec 27;274(24):1942–1948. [PubMed]
  • Moher D, Olkin I. Meta-analysis of randomized controlled trials. A concern for standards;. JAMA. 1995 Dec 27;274(24):1962–1964. [PubMed]
  • Baum ML, Anish DS, Chalmers TC, Sacks HS, Smith H, Jr, Fagerstrom RM. A survey of clinical trials of antibiotic prophylaxis in colon surgery: evidence against further use of no-treatment controls. N Engl J Med. 1981 Oct 1;305(14):795–799. [PubMed]
  • Lau J, Schmid CH, Chalmers TC. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. J Clin Epidemiol. 1995 Jan;48(1):45–60. [PubMed]
  • Freedman Benjamin. Scientific value and validity as ethical requirements for research: a proposed explication. IRB. 1987 Nov-Dec;9(6):7–10. [PubMed]
  • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987 Jul 16;317(3):141–145. [PubMed]
  • Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992 Jul 23;327(4):248–254. [PubMed]
  • Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med. 1994 Aug 11;331(6):394–398. [PubMed]
  • Shapiro MF, Charrow RP. Scientific misconduct in investigational drug trials. N Engl J Med. 1985 Mar 14;312(11):731–736. [PubMed]
  • Shapiro MF, Charrow RP. The role of data audits in detecting scientific misconduct. Results of the FDA program. JAMA. 1989 May 5;261(17):2505–2511. [PubMed]
  • Denny WF. The use of placebo controls. N Engl J Med. 1995 Jan 5;332(1):61–62. [PubMed]
  • Henry D, Hill S. Comparing treatments. BMJ. 1995 May 20;310(6990):1279–1279. [PMC free article] [PubMed]
  • Scherer RW, Dickersin K, Langenberg P. Full publication of results initially presented in abstracts. A meta-analysis. JAMA. 1994 Jul 13;272(2):158–162. [PubMed]
  • Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986 Oct;4(10):1529–1541. [PubMed]
  • Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet. 1991 Apr 13;337(8746):867–872. [PubMed]
  • Gøtzsche PC. Reference bias in reports of drug trials. Br Med J (Clin Res Ed) 1987 Sep 12;295(6599):654–656. [PMC free article] [PubMed]
  • Egger M, Smith GD. Misleading meta-analysis. BMJ. 1995 Mar 25;310(6982):752–754. [PMC free article] [PubMed]
  • Jacobsen G, Hals A. Medical investigators' views about ethics and fraud in medical research. J R Coll Physicians Lond. 1995 Sep-Oct;29(5):405–409. [PubMed]
  • de Melker HE, Rosendaal FR, Vandenbroucke JP. Is publication bias a medical problem? Lancet. 1993 Sep 4;342(8871):621–621. [PubMed]
  • Vandenbroucke JP. De Cochrane Collaboration en 'evidence-based medicine'. Ned Tijdschr Geneeskd. 1995 Jul 22;139(29):1476–1477. [PubMed]
  • Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990 Mar 9;263(10):1405–1408. [PubMed]
  • Moher D. Publication bias. Lancet. 1993 Oct 30;342(8879):1116–1116. [PubMed]
  • Pearn J. Publication: an ethical imperative. BMJ. 1995 May 20;310(6990):1313–1315. [PMC free article] [PubMed]
  • Roberts J, Smith R. Publishing research supported by the tobacco industry. BMJ. 1996 Jan 20;312(7024):133–134. [PMC free article] [PubMed]
  • Chalmers I. Publication bias. Lancet. 1993 Oct 30;342(8879):1116–1116. [PubMed]
  • Herxheimer A. Clinical trials: two neglected ethical issues. J Med Ethics. 1993 Dec;19(4):211–218. [PMC free article] [PubMed]
  • Oxman AD, Sackett DL, Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993 Nov 3;270(17):2093–2095. [PubMed]
  • Milne R, Chambers L. Assessing the scientific quality of review articles. J Epidemiol Community Health. 1993 Jun;47(3):169–170. [PMC free article] [PubMed]
  • Milne R, Donald A, Chambers L. Piloting short workshops on the critical appraisal of reviews. Health Trends. 1995;27(4):120–123. [PubMed]
  • Dickersin K. Why register clinical trials?--Revisited. Control Clin Trials. 1992 Apr;13(2):170–177. [PubMed]
  • Harlan WR. From the National Institutes of Health. JAMA. 1994 Jun 8;271(22):1729–1729. [PubMed]
  • Chalmers I, Gray M, Sheldon T. Handling scientific fraud. Prospective registration of health care research would help. BMJ. 1995 Jul 22;311(6999):262–262. [PMC free article] [PubMed]
  • Stamler Jeremiah, Elliott Paul, Dyer Alan R, Stamler Rose, Kesteloot Hugo, Marmot Michael. Commentary. BMJ. 1996 May 18;312(7041):1285–1287. [PMC free article]
  • Delamothe T. Whose data are they anyway? BMJ. 1996 May 18;312(7041):1241–1242. [PMC free article] [PubMed]
  • Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation unfulfilled. CMAJ. 1995 Jun 15;152(12):1973–1980. [PMC free article] [PubMed]
  • Protecting and promoting the human research subject: a review of the function of research ethics boards in Canadian faculties of medicine. NCBHR Commun. 1995 Winter;6(1):3–32. [PubMed]
  • Riordan F, Thomson AP. How to get patients' consent to enter clinical trials. Reports of trials should state proportion of people who refuse to participate. BMJ. 1996 Jan 20;312(7024):185–186. [PMC free article] [PubMed]
  • Gilbert C, Fulford KW, Parker C. Diversity in the practice of district ethics committees. BMJ. 1989 Dec 9;299(6713):1437–1439. [PMC free article] [PubMed]
  • Alberti KG. Local research ethics committees. BMJ. 1995 Sep 9;311(7006):639–640. [PMC free article] [PubMed]
  • Middle C, Johnson A, Petty T, Sims L, Macfarlane A. Ethics approval for a national postal survey: recent experience. BMJ. 1995 Sep 9;311(7006):659–660. [PMC free article] [PubMed]
  • Garfield P. Cross district comparison of applications to research ethics committees. BMJ. 1995 Sep 9;311(7006):660–661. [PMC free article] [PubMed]
  • While AE. Ethics committees: impediments to research or guardians of ethical standards? BMJ. 1995 Sep 9;311(7006):661–661. [PMC free article] [PubMed]
  • Rachels J. Active and passive euthanasia. N Engl J Med. 1975 Jan 9;292(2):78–80. [PubMed]

Articles from The BMJ are provided here courtesy of BMJ Publishing Group