A Model Designed to Enhance Informed Consent: Experiences From the HIV Prevention Trials Network

Abstract

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

“…CABs were used as often as surveys/questionnaires. Five methods were used by only one study each: concept mapping 35, cognitive mapping 77, crowdsourcing 72 (having a group participate in solving a problem and then sharing the solution with the public), participatory mapping 102 and dramatic performances 112. All five of these studies were published from the year 2005 onward, suggesting more recent diversification of stakeholder engagement methods.…”

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries

“…In most settings in Africa due to cultural barriers, truly voluntary, valid informed consent may be problematic and difficult, and it may even preclude ethical research conduct (Annas & Grodin, 1998). In such cases counsellors might be more effective in communicating and providing information regarding the research (Fitzgerald, Marotte, Verdier, Johnson & Pape, 2002;Muthuswamy, 2005;Woodsong & Karim, 2005).…”

“…Respecting the community and its values is essential: the research protocol should start and end with the community (Crigger et al., 2001). Woodsong and Karim (2005), based on their experience with the HIV Prevention Trials Network, outlined a full model designed to enhance the informed consent process. The model focused on both individual and community concerns and included three stages:…”

Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee

“…A few interventions in resource-poor countries have been successful, including dividing the consent process over several sessions (Fitzgerald, Marotte, Verdier, Johnson, & Pape, 2002) and using a context-specific informed consent approach that includes local explanations and analogies (Corneli et al, 2007;Corneli, 2003). A conceptual framework for improving participants' understanding has also been proposed (Woodsong & Karim, 2005). The need to assure subjects' informed consent is even more urgent in light of the finding that REC members consider stigmatization from association with an HIV/AIDS trial to be so pervasive (Goldin, 1994).…”