What safeguards are there to protect participants in clinical research?

The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:

  • The Protocol Review Process
  • Informed Consent Procedures

Protocol review. As in any medical research facility, all new protocols must be reviewed and approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.

Informed consent. Your participation in any Research study is voluntary. For every study in which you intend to participate, you will receive a document called “Informed Consent Form” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the research clinic for a final visit and then be advised to return to the care of the doctor who referred them.