ABRV (or Abbrevobabble Revisited)
Interdisciplinary Communication; Language; Research/standards; Biomedical Research/standards; Peer Review; Abbreviations as Topic; Periodicals as Topic/standards
Brumback RA
Journal Of Child Neurology
2009
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1177/0883073809340922" target="_blank" rel="noreferrer">10.1177/0883073809340922</a>
Variability among institutional review boards' decisions within the context of a multicenter trial
Humans; United States; decision making; Questionnaires; Respiration; Informed Consent; Organizational Policy; Empirical Approach; Biomedical and Behavioral Research; Multi-site Ethics; Educational Status; Respiratory Distress Syndrome; Organizational; Randomized Controlled Trials as Topic/standards; Research/standards; Professional Staff Committees/organization & administration; National Institutes of Health (U.S.); Artificial/methods; Adult/therapy; Clinical Protocols/standards; Multicenter Studies as Topic/standards; Tidal Volume
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.
2001
Silverman H; Hull SC; Sugarman J
Critical Care Medicine
2001
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1097/00003246-200102000-00002" target="_blank" rel="noreferrer">10.1097/00003246-200102000-00002</a>
Why are so few randomized trials useful, and what can we do about it?
Humans; RDF Project; Randomized Controlled Trials as Topic/standards; Research Design/standards; Research/standards
2006
Zwarenstein M; Oxman A; Pragmatic Trials in Health Care Systems (PRACTIHC)
Journal Of Clinical Epidemiology
2006
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/j.jclinepi.2006.05.010" target="_blank" rel="noreferrer">10.1016/j.jclinepi.2006.05.010</a>