Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting.

ABSTRACT:

Background

Informed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa. Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial. The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent. Cross-sectional study conducted over a 4 month period.

Methods

Consent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntar

SUBMITTER: Minnies D 

PROVIDER: S-EPMC2575196 | biostudies-literature | 2008 Sep

REPOSITORIES: biostudies-literature