title: Preconsent education about research processes improved African Americans' willingness to participate in clinical research.
abstract: OBJECTIVE
  To determine whether preconsent education about research processes and protections affects the willingness of African Americans to participate.
  
  
  METHODS
  This study examined the willingness of 192 African American outpatients (stratified by age, gender, and education) to participate in a hypothetical clinical study under varying consent conditions: phase I participants underwent a typical informed consent process and were asked to indicate whether they would be willing to participate in the hypothetical clinical study and the reasons for their decision; their responses were used to develop a preconsent educational digital video disk (DVD). Phase II participants viewed the DVD before the consent process. We compared the proportion of those who stated they were willing to participate in the clinical study using Fisher's exact tests and used qualitative methods to analyze open-ended responses.
  
  
  RESULTS
  When the consent process included education about research processes and protections, significantly more patients reported willingness to participate in the hypothetical clinical study (43% vs. 27%; P=0.002). Patients receiving preconsent education were significantly less likely to cite mistrust, fear of side effects, lack of perceived benefits, and privacy as reasons for not participating.
  
  
  CONCLUSIONS
  Preconsent education may improve the willingness of African Americans to participate in clinical research and may address important concerns about research participation.
authors.affiliation: Department of Family & Preventive Medicine, Emory University School of Medicine, 1256 Briarcliff Road NE, Atlanta, GA 30322, USA.
authors.forename: Anne L
authors.initials: AL
authors.lastname: Dunlop
authors.forename: Zanie C
authors.initials: ZC
authors.lastname: Leroy
authors.forename: Kristi M
authors.initials: KM
authors.lastname: Logue
authors.forename: Karen
authors.initials: K
authors.lastname: Glanz
authors.forename: Boadie W
authors.initials: BW
authors.lastname: Dunlop
mesh_terms: D000328:Adult; D001741:Black or African American / Q000523:psychology*; D001294:Attitude to Health; D035843:Biomedical Research / Q000379:methods*; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology / Q000706:statistics & numerical data*; D017322:Clinical Trials, Phase II as Topic / Q000523:psychology / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires