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BMJ. Sep 14, 1991; 303(6803): 610–613.
PMCID: PMC1671066

Informed consent: study of quality of information given to participants in a clinical trial.


OBJECTIVE--To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN--About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING--Eight different centres in Sweden. SUBJECTS--43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES--Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS--All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION--Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry. 1982 Aug;39(8):951–958. [PubMed]
  • Stanley B, Guido J, Stanley M, Shortell D. The elderly patient and informed consent. Empirical findings. JAMA. 1984 Sep 14;252(10):1302–1306. [PubMed]
  • Simes RJ, Tattersall MH, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J (Clin Res Ed) 1986 Oct 25;293(6554):1065–1068. [PMC free article] [PubMed]
  • Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896–900. [PubMed]
  • Taub HA. Informed consent, memory and age. Gerontologist. 1980 Dec;20(6):686–690. [PubMed]

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