A Comprehensive Look at Clinical Trials
Protecting Your RightsYou may be hesitant to join a clinical trial because you are not sure if a research doctor can be trusted. In the past, there have been human rights abuses made in the name of scientific research. An example that you may be familiar with is the Tuskegee Syphilis Study. The study was conducted in Alabama by the United States Public Health Service to examine the effects of untreated syphilis. It began in the 1930s and continued until 1972. The African-American men who were recruited for the trial were not told about the purpose of the trial. They were also not told about penicillin when it became the standard treatment for syphilis in 1943.
The Tuskegee Syphilis Study was shut down in 1973. To prevent history from repeating itself, the National Research Act was passed in 1974. This Act led to the establishment of Institutional Review Boards (IRBs). IRBs exist to protect the rights of trial participants.
An IRB is a group that consists of people such as doctors, lawyers, community members, and members of the clergy. In order to run a clinical trial at a hospital, clinic, or private doctor's office, the research doctor must submit an application to the IRB at that site or to a central IRB. The application contains detailed information about the trial. The IRB reviews the application to make sure that the trial asks a worthwhile scientific question and that the trial design is ethical. The IRB also checks the safety monitoring of the trial.
The research doctor is required to submit regular reports about the progress of the trial and to inform the IRB about any severe side effects that trial participants experience. The IRB has the authority to shut down a trial that is not run properly.
Trials may also be reviewed by independent Data and Safety Monitoring Boards (DSMBs). When members of a DSMB review trial data, they look for patterns of side effects or treatment benefits. They may suggest changes to the trial design if they find clear benefits or disadvantages to one group in the trial. They might also recommend that a trial be shut down if there are serious safety issues.
This article was provided by AIDS Community Research Initiative of America. Visit ACRIA's website to find out more about their activities, publications and services.