Is there “Therapeutic Misconception” in HIV/AIDS and Clinical Research in Western Kenya?

Abstract

In research ethics community, the ‘bright line’ between health care and health research continues to be emphasized as important. While this distinction may be clear for many health researchers and practitioners, it may not be clear to research participants. In the case of HIV/AIDS care in resource-limited settings where healthcare is not affordable, individuals and communities are burdened with high rates of infectious diseases, inadequate health conditions, and insufficient or inaccessible medical care. Under these circumstances people are desperate to access better healthcare through any possible means. Participating in clinical research may be seen as one way of accessing care. Even though measures are taken to ensure that participants in health research get into this activity only after a consenting process, some may enter into research for the purpose of accessing treatment or health care. The objective of the study was to investigate specific reasons why participants engage in ongoing IREC/ IRB-approved international HIV research in Western Kenya. The main reasons given for participating in research were contextual: the HIV/AIDS condition, access to better healthcare, and financial poverty were identified. Clinical researchers indicated that their research projects had provisions for healthcare and better services and facilities than in the standard healthcare in terms of individual attention and follow up. Study participants in ongoing research in Western Kenya believe that their participation in HIV/AIDS research enables them to access better healthcare. In the context of limited resources and HIV/AIDS, patients’ beliefs, extra-medical attention and follow up translate into better healthcare. These observations suggest that in practice there may not be a bright line between research and clinical care (no “therapeutic misconception”) and suggest the need for more stringent efforts to make this distinction clear in processes of informed consent in such settings.