How do I know that negative research stories from the past won’t happen again?

Click on the video below to hear about safety and ethics in clinical trials.

Today, clinical trials are conducted under strict guidelines, with oversight from the Food and Drug Administration (FDA).Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which explains what the trial will do, how the study will be carried out, and why each part of the study is necessary.

Your rights and safety are further protected by:

  • Institutional Review Board (IRB), which ensures researchers follow all ethical guidelines and laws.
  • Federal regulations, which requires that clinical trials are done ethically and you rights and safety are protected
  • Informed consent in which you learn important information about the clinical trial to help you decide whether to participate; you can leave the study at anytime. 
  • Ongoing monitoring  by research teams and study sponsors

 

Learn more of what the government and researchers do to protect participants today:

 

Gain understanding into research mistakes of our past:

  • Tuskegee Study (1932-1972) researchers did not tell participants all the study information. By today’s standards, participants could not join a study without all the information. The Tuskegee Study also withheld medical treatment from participants. Today, research studies can’t prevent high quality medical care.

 

  • Henrietta Lacks received a medical procedure in 1951. Medical research staff did not inform her about using a sample of cells from the procedure. Today, a study cannot use someone’s cells unless they consent to the research plan.