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Failing the vulnerable: Three new consent norms that will undermine health research with children
Submitted: 12 December 2014 | Published: 23 May 2014
About the author(s)
Ann Strode, University of KwaZulu-Natal and HIV/AIDS Vaccines Ethics Group, Durban, South Africa, South AfricaMarlise Richter, International Centre for Reproductive Health, Department of Obstetrics and Gynaecology, Ghent University, Belgium; School of Public Health and Family Medicine, University of Cape Town, South Africa; African Centre for Migration and Society, University of the Witwatersrand, Johannesburg, South Africa
Melissa Wallace, Desmond Tutu HIV Foundation, University of Cape Town, South Africa
Jacintha Toohey, HIV/AIDS Vaccines Ethics Group, Durban, South Africa
Karl Technau, Empilweni Services and Research Unit, Department of Paediatrics and Child Health, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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The South African National Health Act (No. 61 of 2003) provides a legal framework for the regulation of the health system across the country. Within the Act, section 71 introduces a number of legal norms relating to research or experimentation with human subjects, including research on HIV prevention and treatment. These norms have been criticised for the negative impact they will have on research involving children. This article describes three of the new consent requirements in section 71 of the Act. It shows, using a range of case studies, how important HIV-related research will be halted or undermined if the current provisions are implemented. The article argues that the new consent requirements are out of step with other statutory provisions and ethical guidelines, and as a result they will exclude a large population group – children in diverse settings – from much-needed evidence-based healthcare interventions. The article concludes with a clarion call for support of advocacy on this issue with the Minister of Health and the Health Portfolio Committee.
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