title: Informed consent in Sri Lanka: a survey among ethics committee members.
abstract: BACKGROUND
  Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.
  
  
  METHODS
  We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.
  
  
  RESULTS
  Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.
  
  
  CONCLUSIONS
  The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.
authors.affiliation: Kings College, University of London, Institute of Psychiatry, De Crespigny Park, Denmark Hill, London SE5 8AF, UK. spjuats@iop.kcl.ac.uk
authors.forename: Athula
authors.initials: A
authors.lastname: Sumathipala
authors.forename: Sisira
authors.initials: S
authors.lastname: Siribaddana
authors.forename: Suwin
authors.initials: S
authors.lastname: Hewage
authors.forename: Manura
authors.initials: M
authors.lastname: Lekamwattage
authors.forename: Manjula
authors.initials: M
authors.lastname: Athukorale
authors.forename: Chesmal
authors.initials: C
authors.lastname: Siriwardhana
authors.forename: Joanna
authors.initials: J
authors.lastname: Murray
authors.forename: Martin
authors.initials: M
authors.lastname: Prince
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D017041:Ethics Committees / Q000706:statistics & numerical data*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D013188:Sri Lanka; D011795:Surveys and Questionnaires; D006113:United Kingdom; D014944:World Health Organization