loyola aids day 2004 Clinical HIV Vaccine Trials in the U.S. and Sub Saharan Africa

Clinical HIV Vaccine Trials in the U.S. and Sub-Saharan Africa: The Same Scientists, Types of Research, and Funding Sources, but Different Ethical Protections Ruqaiijah Yearby, J.D., M.P.H. Assistant Professor, Institute for Health Law Loyola University Chicago School of Law One East Pearson, Suite 300 Chicago, IL 60611 312.915.6446 ryearby@luc.edu Introduction Sub-Saharan Africa is the region most affected by the HIV pandemic and where HIV is the leading cause of death. In fact, out of the 36.1 million HIV infections worldwide, 25.3 million, seventy-percent, are in Sub-Saharan Africa. Clinical Trials A clinical trial consists of a research study that uses human subjects to evaluate the efficacy of new drugs and treatments. Justice and Clinical Trials Who Bears the Burden? Who receives the Benefit? Belmont Report Justice demands that all individuals be treated equally and that development of therapeutic devices and procedures provide equal advantages to the poor and the rich.  The Justice principle prohibits the use of vulnerable populations as research subjects when the recipients of the benefits of the research are the rich. Progression of HIV Infection HIV enters the body Immune System sends cells to kill HIV HIV reproduces and changes Cells take HIV to healthy cells Immune System sends cells to kill infected cell Immune System cells no longer recognize HIV HIV reproduces and infects entire body Immune System Failure and progression to AIDS Clinical HIV Vaccine Trials Types of Vaccine:  Prophylactic  Therapeutic Sub-Saharan countries participating in trials:  Botswana  South Africa  Uganda Justice and Clinical HIV Vaccine Trials Who Bears the Burden? Who receives the Benefit? US Sub-Saharan Africa Conclusion According to the legal, moral, and ethical principles used to protect human research subjects, if the same scientists, types of research, and funding sources are used then the benefit for all populations should be the same.