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. 2001 Feb;29(2):235-41.
doi: 10.1097/00003246-200102000-00002.

Variability among institutional review boards' decisions within the context of a multicenter trial

H Silverman  1 , S C Hull, J Sugarman
Affiliations

Variability among institutional review boards' decisions within the context of a multicenter trial

H Silverman et al. Crit Care Med. 2001 Feb.

Abstract

Background: Institutional review boards (IRBs) are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research.

Objective: To determine the extent of the variability among different IRBs on their approved research practices and informed consent forms within the context of a multicenter trial that used a common protocol.

Design: Descriptive analysis of survey information and informed consent forms.

Setting and participants: Sixteen IRBs from the institutions participating in a multicenter trial comparing lower vs. traditional tidal volume ventilation in patients with acute lung injury.

Measurements: Analysis of survey information on IRBs' approved research practices. Analysis of informed consent forms for the presence and the adequacy of description of each basic element of informed consent specified in the federal regulations. Reading levels of informed consent forms.

Main results: Surveys and IRB-approved consent forms were obtained from all of the contacted IRBs (n = 16). Variability was observed among several of the research practices; one IRB waived the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled. Three consent forms contained all of the basic elements of informed consent outlined in the federal regulations, and 13 forms had varying numbers of these elements absent (six forms without one element, four without two, one without three, and two without four). Reading levels of the consent forms ranged from grades 8.2 to 13.4 (mean +/- sd was 11.6 +/- 1.2 grade level).

Conclusions: Within a multicenter trial, IRBs reviewing a common protocol varied in several of their approved research practices and in the extent to which the basic elements of informed consent were included in their consent forms.

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Figure 1
Reading grade levels of informed consent forms.
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References

    1. 45 CFR 46: Protection of Human Subjects. Rev. 1991 Jun 18;
    1. 21 CFR 50 and 56: Protection of Human Subjects and Institutional Review Boards. Rev. 1991 Aug 19;
    1. The 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: Federal Register Document 79-12065. 1978 Apr 18; - PubMed
    1. Institutional Review Boards. Their Role in Reviewing Approved Research. Washington, DC: Office of the Inspector General; 1998. Jun 11,
    1. Acute Respiratory Distress Syndrome Clinical Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000;342:1301–1308. - PubMed

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