Title: Research Related Injuries in HIV Vaccine Study

Author: Anji Wall

Description: Participants receiving a vaccination for HIV at a higher rate than those receiving the placebo.

Keyword(s): Disclosure of Study Results, Medically Vulnerable Persons, Post-Trial Access, Public Health Research, Undervalued/Stigmatized Group or Condition, Randomized Controlled Trials (Placebo), Research Related injuries

Case: A pharmaceutical company has developed and tested a potential vaccine for HIV. The vaccine easily passed through Phase I and II testing but has met some obstacles in Phase III trials. Initial outcomes from the Phase III trials showed no significant difference in the rate of infection of those who have received the experimental vaccine versus those who have received the placebo. Because of these results, researchers have discontinued the trial, but decided to continue monitoring participants for HIV infection rates. After six months of monitoring, researchers found that participants who received the experimental vaccination were becoming infected with HIV at a higher rate than those who received the placebo vaccination.

      1. Do the researchers have an obligation to unblind the study and inform participants of whether or not they received the experimental vaccine? Should they tell them higher infection rates have been detected among those who received the vaccine?
      2. Do the researchers or trial sponsors have any obligation to provide post-trial medical care for those participants who contracted HIV? If there is a duty to provide post-trial care, does the duty extend to everyone who contracted HIV or just those who got the experimental vaccine?

Source: Timberg, C. (2007). Warning Is Sent to AIDS Vaccine Volunteers. Retrieved 8/14/18, from http://www.washingtonpost.com/wp-dyn/content/article/2007/10/24/AR2007102402514.html