title: Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.
abstract: BACKGROUND
  Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent.
  
  
  METHODS
  Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views.
  
  
  RESULTS
  Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention.
  
  
  CONCLUSIONS
  Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Joseph Mumba
authors.initials: JM
authors.lastname: Zulu
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Mpala Mwanza
authors.initials: MM
authors.lastname: Lisulo
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Ellen
authors.initials: E
authors.lastname: Besa
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Patrick
authors.initials: P
authors.lastname: Kaonga
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Caroline C
authors.initials: CC
authors.lastname: Chisenga
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Mumba
authors.initials: M
authors.lastname: Chomba
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Michelo
authors.initials: M
authors.lastname: Simuyandi
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia.
authors.forename: Rosemary
authors.initials: R
authors.lastname: Banda
authors.affiliation: Departments of Community and Internal Medicine, University of Zambia (School of Medicine), Lusaka City, Lusaka Province, Zambia; Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Kelly
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000941:ethics* / Q000592:standards*; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008875:Middle Aged; D009042:Motivation; D036301:Qualitative Research; D035842:Research Subjects; D011795:Surveys and Questionnaires; D035502:Trust; D055815:Young Adult