Correspondence

Informed Consent and Approval by Institutional Review Boards in Published Reports on Clinical Trials

N Engl J Med 1999; 340:1114-1115April 8, 1999

Article

To the Editor:

Publication of the results of biomedical research is not a mere formality in science. It is the culmination of a long process, and careful attention to every step in that process is important.1 In randomized clinical trials, failing to obtain or forgetting to report informed consent from participants or approval of the protocol by an institutional review board (IRB) might suggest that the authors considered these steps unimportant details, if not obstacles. This is clearly a misconception, because the aim of research is to serve human subjects, not to use them.

We assessed the frequency of reporting of informed consent and IRB approval in all reports of trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association, and the British Medical Journal. We also searched the Medline data base for all trials with at least one author from Spain that were published in other journals during the period from 1993 to 1995. We included all reports of trials involving human subjects that had two or more treatment groups and studies referred to as “clinical trials,” “field trials,” or “randomized trials” by the authors. When information on IRB approval or informed consent was missing in the reports, we mailed a standardized questionnaire to the corresponding authors. After two months, we repeated the mailing for authors who had not responded to the first questionnaire.

Of reports on 767 clinical trials, 543 (70.8 percent) stated that an IRB had approved the research, and 612 (79.8 percent) reported that informed consent had been requested from the participants. Both types of information were included in 64 percent of the reports. The authors explicitly stated that they had not requested the informed consent in 10 reports. In all these trials, the authors reported having obtained IRB approval. Many of these trials were studies of cardiopulmonary resuscitation for patients with cardiac arrest.

The response rate for authors of reports that lacked information on IRB approval was 73.7 percent (165 of 224), and the rate for authors of reports that lacked information on informed consent was 70.3 percent (102 of 145). Thirty-seven of the 165 respondents who did not report on IRB approval (22.4 percent) stated that they had not sought approval, and 21 of the 102 who did not report on informed consent (20.6 percent) stated that they had not requested informed consent.

There were no significant differences in the proportion of reports that included information on IRB approval or informed consent according to the year of the survey or the number of participating centers. We constructed a logistic-regression model with failure to disclose either IRB approval or informed consent as the outcome (Table 1Table 1Failure to Report on Informed Consent or Approval by an Institutional Review Board (IRB), 1993 through 1995.). Among other findings, reports published in the New England Journal of Medicine as compared with other journals, those with authors from European countries (excluding Spain and the United Kingdom) as compared with other countries, and those involving trials funded by the pharmaceutical industry as compared with other sources of funding were more likely to report IRB approval or informed consent.

Similar surveys have been reported elsewhere.2-5 They assessed a smaller number of trials (range, 37 to 279). In general, our survey showed a higher rate of reporting of IRB approval and informed consent than the other surveys did. However, our results suggest that, even in the leading general medical journals, closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

Miguel Ruiz-Canela, B.Pharm., Ph.D.
Miguel Ángel Martínez-González, M.D., M.P.H.
Universidad de Navarra, 31080 Pamplona, Spain

Enrique Gómez-Gracia, M.D., M.P.H.
Joaquín Fernández-Crehuet, M.D., Dr.P.H.
Universidad de Málaga, 29071 Malaga, Spain

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   Nchangwi Syntia Munung, Chi Primus Che, Odile Ouwe-Missi-Oukem-Boyer, Godfrey B. Tangwa. (2011) How Often are Ethics Approval and Informed Consent Reported in Publications on Health Research in Cameroon? A Five-Year Review. Journal of Empirical Research on Human Research Ethics: An International Journal 6:3, 93-97
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   Robert Klitzman, Ilene Albala, Joseph Siragusa, Kristen N. Nelson, Paul S. Appelbaum. (2007) The Reporting of Monetary Compensation in Research Articles. Journal of Empirical Research on Human Research Ethics 2:4, 61-67
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   Amy K. Wagner, Michael L. Boninger, Charles Levy, Leighton Chan, David Gater, R. Lee Kirby. (2003) Peer Review. American Journal of Physical Medicine & Rehabilitation 82:10, 790-802
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