Inappropriate and Inconsistent Consent Policies

An investigator at a large U.S. university was funded to conduct a study of psychosocial responses to the trauma of human rights abuses in a developing country outside the U.S. The investigator, a physician in the medical school, was required by the medical school IRB to use a five-page written consent. The literacy rate in the country at the time was less than 70%. Appeals by the investigator to the medical IRB to shorten the consent form or to change it to an oral consent form were unsuccessful. When the investigator showed the required consent form to his collaborators in country, they immediately responded that the consent form was about protecting the investigator’s university and not about protecting research subjects.

At the same time, another investigator at the same university, in a department in the College of Arts and Sciences, was funded through a different funding agency to conduct a study that also explored psychosocial responses to human rights abuses in the same developing country. His Arts and Science IRB required him to use a half-page oral consent form.