Will I Be Safe If I Participate in a Study?
The Food and Drug Administration (FDA) is the regulatory agency that oversees all clinical research conducted in the United States. It is their responsible to protect the rights and as much as possible, the welfare of subjects participating in clinical trials. They ensure that data collected from clinical trials is of the highest quality and they are the agency that determines whether a new treatment should be sold in the US. Several organizations and individuals are governed by FDA regulations including clinical investigators, sponsors (the companies developing the treatments), Contract Research Organizations (companies that help conduct the studies), and Institutional Review Boards (groups that are responsible for ensuring the safety and welfare of study participants).
Good Clinical Practice (GCP) guidelines are another safeguard implemented to protect the safety of subjects. These guidelines encompass federal regulations and industry-accepted standards that govern clinical trials on humans. These regulations and standards apply to the conduct of the studies, record keeping, informed consent of subjects, collection of scientific data, and submission of information needed for the FDA to determine whether a new treatment should or should not be sold in the US. All companies must follow these guidelines when conducting clinical research.
An Institutional Review Board (IRB) is a committee that is formally tasked by an institution to review, approve, and monitor research involving human subjects. IRBs ensure that the risks to subjects are minimized; that subjects are adequately informed about the trial and the implications it will have on their treatment; that study protocols are modified, when necessary, to ensure safety; that risks are reasonable in relation to the anticipated benefits and the importance of the knowledge to be gained; that subject selection is equitable and that no classes of patients are discriminated against; that informed consent is obtained; that there is a provision for safety monitoring in the research plan; and that here are adequate provisions for the privacy and confidentiality for subjects and the data collected.