There are many factors that ensure a participant’s protection during clinical studies including the U.S. Food and Drug Administration (FDA), Institutional Review Boards (IRB), Informed Consent documents and procedures following the Health Insurance Portability and Accountability Act (HIPAA).There is also monitoring of studies by industry or private sponsors as well as oversight and reporting by investigators and their staff.
- The FDA sets safety guidelines for researchers to follow in order to ensure participant safety. The FDA also performs inspections of study sites.
- An IRB is composed of at least 5 members including scientists, doctors and a lay person who review the proposed study, identify the risks, suggest improvements, consider inclusion/exclusion eligibility criteria for participants, review the adequacy of the informed consent document and approve clinical trials.
- The Informed Consent document includes the study’s details including potential risks and benefits, is presented to the participant in their native language, provides information throughout the study and is signed if the participant chooses to enroll in the study. The participant is allowed to withdraw consent at any time during the study.
- The HIPAA Privacy Rule provides federal protection of personal health information and creates guidelines that health care providers must follow regarding personal information. For example, the clinical research study data sent to the study sponsor cannot include the participant’s name or other identifying information.
- www.clinicaltrials.gov is an interactive online database that contains detailed information about federally and privately supported human clinical research trials and contact information for each study. It is managed by the National Library of Medicine and regularly updated.