Why did the researchers avoid enrolling substance abusers who were HIV+, the concomitant disease of interest?
IRB members questioned whether HIV+ individuals were not a more appropriate subject population for this study. That is, why not simply enroll subjects who were already taking both meds or were scheduled to begin one or the other in the near future? This concern is based on the ethical principle of Justice, balancing risks and benefits so as not to subject one group to risks for the benefit of a different group. IRB Decision This issue was resolved by noting that almost all HIV+ individuals being treated with anti-retroviral drugs are taking several such medications at the same time. Monotherapy with Kaletra would be considered beneath the standard of medical care for this disease at this time and would thus prevent anyone who is HIV+ from enrolling in the study. It would also be unethical to require HIV+ individuals to revise their standard therapy to Kaletra alone, just to meet study inclusion criteria. With regard to adverse events in the study as proposed, all such occurrences could
