title: Improving participant comprehension in the informed consent process.
abstract: OBJECTIVE
  To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies.
  
  
  METHODS
  Integrative review of literature.
  
  
  METHODS
  The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals.
  
  
  RESULTS
  Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it.
  
  
  CONCLUSIONS
  Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.
authors.affiliation: School of Nursing/Adelphi University, Garden City, New York 11530, USA. cohn@adelphi.edu
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cohn
authors.forename: Elaine
authors.initials: E
authors.lastname: Larson
mesh_terms: D032882:Comprehension; D007258:Informed Consent / Q000523:psychology*