Case Example #2: Researchers are recruiting participants from a local hospital to take part in a clinical research trial for a new gene therapy for a genetically based liver disease. All the recruits are currently in the hospital with near-total liver failure. (Although the gene therapy is dangerous, the alternative would be no cure at all.)
One recruit is found to have high ammonia levels during a screening, which poses a fatal health risk in the study. However, participants are difficult to find because this disease is so rare and he seems to desperately want to take part, so the researchers allow him to participate.
This gene therapy had resulted in the deaths of two monkeys (out of several hundred) during the animal testing phase of the trials. Because the deaths of the monkeys are unrelated to human research, and because the number of deaths was so small, the researchers exclude this information from the consent form