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Factors affecting the understanding and retention of the informed consent among participants at an antiretroviral clinical trial in a resource limited setting

The misunderstanding of the informed consent has become a major area of concern particularly for participants of clinical trials in the developing regions/countries. This study assessed the understanding and retention of the informed consent among participants in an anti-retroviral clinical trial been conducted in Nigeria; and also the myriad of social, cultural & economical factors affecting their understanding.

A structured questionnaire (QuIC) was administered to participants who signed consent to the lopinavir/ritonavir mono-therapy study, within the previous 12 months. The questionnaire assesses re-call of the basic elements of informed consent specified in federal regulations.

A total of 55 respondents completed the QuIC questionnaire. Majority age distribution was in the 30-49 age group (69.1%), 10.9% had no education, 32.7% were not employed, 69.1% were females. 74.5% didn’t know that the treatments and procedures in the clinical trial are not standard for their HIV management; 18.2% of respondents didn’t know that the trial carried additional risks and discomfort in comparison to standard treatments; 38.2% were unsure if they were offered alternatives to participation; 32.7% were unsure as to who will pay for treatment if they were injured or become ill as a result of participation in this clinical trial. None of the demographics were significantly associated with knowledge scores. In the uni-variate model, none of the socio-economic factors were independently associated with improved knowledge score.

Results suggest misunderstanding/deficiencies in certain important domain areas. This study reiterates the need for intensive studies in the area of therapeutic misconception as it has to do with HIV/AIDS preventive trials in developing countries.

Author information

Correspondence to Donald Salami.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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About this article


  • Informed Consent
  • Basic Element
  • Limited Setting
  • Economical Factor
  • Additional Risk


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