Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS)

Abstract

Abstract

Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India

“…GPP guidelines may help to augment the previous focus of HIV vaccine preparedness on individual-level factors associated with WTP, with greater attention to structural features of trials that facilitate or impede the conduct of scientifically and ethically valid research. These trial features include access to medical care and HIV treatment if one is harmed or becomes HIV infected during the trial; preventing exploitation, such as enrollment of participants in HIV vaccine trials in low-income countries for the benefit of populations in high-income countries, by guaranteeing access to a free or affordable vaccine locally if proven efficacious [23,27,28]; and the extent to which trials ensure that potential volunteers have sufficient information and understanding about the trial services provided to ensure informed consent is ethically valid [27,29,30].…”

Social and Behavioral Challenges of HIV Vaccines: Implications for Social Work and Social Science

“…These include the effects of globalization on biomedical research (Guenter, Esparza, & Macklin, 2000), particularly challenges raised by poverty (e.g., payments to participants) and low literacy (e.g., comprehension of informed consent forms; Flory & Emanuel, 2004;Lindegger et al, 2006), access to health research and clinical trials (Gifford et al, 2002;Wendler et al, 2006), access to medical care and medications during and after a trial, and access to a trial product if found to be efficacious (Ciaranello et al, 2009;Guenter et al, 2000;Pace et al, 2006;Slack et al, 2005). Significant structural-level challenges to the fair and ethical implementation of HIV vaccine trials are posed by criminalization of behaviors associated with HIV transmission and of evidence-based HIV preventive 318 P. A. Newman interventions (Mills & Singh, 2007), including syringe exchange programs for injecting drug users (IDUs; Lurie & Drucker, 1997), and empowerment and outreach for sex workers (Masenior & Beyrer, 2007) and MSM (Newman, Chakrapani, Cook, Shunmugam, & Kakinami, 2008;Smith, Tapsoba, Peshu, Sanders, & Jaffe, 2009).…”

Nutrition education and counselling as strategic interventions to improvehealth outcomes in adult outpatients with HIV: a literature review

“…Additionally, sponsors could consider ways in which their activities might build up not only research capacity in a host country, but also the capacity to deliver health services (Guenter, Esparza & Macklin, 2000).…”