Institutional Review Boards

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 Institutional Review Board 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 investigator 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 reviews the safety monitoring of the trial. Researchers are required to submit regular reports about the progress of trials and to inform the IRB about any side effects that trial participants experience. The IRB has the authority to shut down a trial if serious unexpected side effects occur or if the trial is not run properly.

Independent Data and Safety Monitoring Boards (DSMBs) may also review trials. When members of a DSMB review the data from a trial, 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. Additionally, if the trial demonstrates that the research treatment is so effective that it would be unethical to deprive others access to this new treatment, they may work to bring the treatment to practice as quickly as possible.

There are extensive guidelines in place that protect your privacy as a study participant. These will be explained in the informed consent form and by a member of the research team.