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  • Inclusion of adolescents and pregnant women in HIV prevention research

    On the 16th of March CAPRISA co-hosted an ethics symposium on the inclusion of adolescents and pregnant women in HIV prevention research in partnership with the National Institutes of Health (NIH) and the South African Research Ethics Training Initiative (SARETI) and the University of KwaZulu-Natal. The workshop was co-chaired by Professors Quarraisha Abdool Karim, Doug Wassenaar and Daya Moodley.

     

         Professor Abdool Karim started the day by painting a detailed picture of the HIV epidemic in sub-Saharan Africa, highlighting the vulnerability of adolescent girls, young women and pregnant women and the urgent need for all these groups of women to be included in HIV prevention research. She underscored that adolescent girls and young women can be pregnant or not and the ethics of delays in access to products need to be considered. 

     

         The morning session was devoted to adolescents and the first presenter was Dr Christine Grady who discussed the ethics of inclusion of adolescents in research from an international perspective stressing that exclusion from research can be harmful, she furthermore advocated for a need to justify exclusion rather than motivate for inclusion. An additional important point she highlighted was the need to balance protectionism with reducing vulnerability.  The revised Council for International Organisations of Medical Sciences (CIOMS) guidelines in fact ask for a justification if adolescents are excluded from research.

    Local perspectives on the ethical and legal considerations of adolescent inclusion in research were provided by Cathy Slack and Ann Strode. They highlighted the possible tensions between the intricacies of the South African legal system and ethical considerations. They also indicated the possible conflicts between parental consent and adolescent privacy. 

     

         The afternoon sessions were chaired by Professor Daya Moodley.   The challenges of including or excluding pregnant women in research and balancing the vulnerability of pregnant women vs minimising risk to the unborn foetus. Professor Joseph Millum challenged the notion of pregnant women as vulnerable populations in the traditional sense and stressed the fact that ‘sick women get pregnant and pregnant women get sick’ and in both cases there needs to be safe, efficacious treatment made available.  However, the exclusion of pregnant women in research had less to do with the mother and everything to do with potential harm to the foetus.  

     

         Lively discussions followed, highlighting the relevance of this conversation and reminding panellists that although they are rarely included in clinical research trials, adolescents and pregnant women receive treatments that, for the most part, have not been tested specifically for them.  The discussions also underscored the other factors that impact decisions to exclude this population including regulatory authorities; pharmaceutical companies reducing risk of litigation; package insert labelling. 

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Centre for the AIDS Programme of Research in South Africa

CAPRISA was created in 2001 and formally established in 2002 under the NIH-funded Comprehensive International Program of Research on AIDS (CIPRA) by five partner institutions; University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National Institute for Communicable Diseases, and Columbia University in New York. CAPRISA is a designated UNAIDS Collaborating Centre for HIV Prevention Research. The main goal of CAPRISA is to undertake globally relevant and locally responsive research that contributes to understanding HIV pathogenesis, prevention and epidemiology as well as the links between tuberculosis and AIDS care.