title: Improving the informed consent process--a booklet on participants' rights in medical research.
abstract: OBJECTIVE
  This paper describes the process undertaken to develop and validate a booklet that informs participants of their rights in clinical studies. A booklet coupled with a shorter study-specific informed consent form may improve informed consent.
  
  
  METHODS
  A booklet was developed in simple clear language, based on information contained in currently used audited informed consent forms and good clinical practice guidelines. 159 people from a broad range of backgrounds with expertise or interest in the consent process were asked to review the booklet and complete a survey. The booklet was modified based on feedback received from 59 respondents.
  
  
  RESULTS
  Feedback was used to improve the booklet and ensure it complied with guidelines, was legally accurate and sensitive to tanga te whenua (Māori/indigenous people). The booklet was easier to read and comprehend compared to equivalent information contained in currently used informed consent forms.
  
  
  CONCLUSIONS
  A broad consultation and revisions improved the booklet and suggested it would be well received if introduced in New Zealand together with shorter study-specific informed consent forms.
authors.affiliation: Cardiovascular Research Unit, Greenlane Cardiovascular Service, Auckland City Hospital, Auckland 1030, New Zealand. Jocelyne.Benatar@adhb.govt.nz
authors.forename: Jocelyne R
authors.initials: JR
authors.lastname: Benatar
authors.forename: Philip
authors.initials: P
authors.lastname: McKibbin
authors.forename: Ralph A H
authors.initials: RA
authors.lastname: Stewart
mesh_terms: D000328:Adult; D000368:Aged; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D003256:Community Participation; D032882:Comprehension; D005260:Female; D006266:Health Education / Q000379:methods; D006304:Health Status; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods*; D028701:Patient Rights; D055815:Young Adult