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You have the right to be fully informed about the study, and to have all of your questions answered before you agree to participate. Among the people who can answer your questions are: Study Coordinator - This is the researcher (usually a nurse) who is in charge of the day-to-day running of the research study. Principal Investigator - The Principal Investigator (usually a physician or Ph.D.) is the researcher who set up the study and has overall responsibility for how it is run. Institutional Review Board - This is the local research ethics committee, who can answer questions about your rights as a research volunteer. Institutional Review Boards (IRBs) are made up of researchers, physicians, and community representatives. All research that involves human volunteers, and that is funded by the federal government or is regulated by the FDA, must be approved by a local IRB before the study can begin. In addition, most places that do research with human volunteers make sure all studies are approved by an IRB, regardless of who has funded it. The IRB makes sure that the research does not pose unnecessary risk to the volunteers, and that volunteers will be fully informed about the research before they agree to be in the study. Before agreeing to
be in a medical research study, make sure you have all the information
you need to make your decision. Take the time to talk it over with
your physician or other health care provider, your family, and trusted
friends. Whatever your decision, make it an informed one. |
