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The Institutional Review Board (IRB) is a committee which reviews the ethics and safety of the research studies in which children take part and protects their rights and welfare. The Director/CEO of St. Jude appoints this committee yearly. The IRB is made up of a diverse group of dedicated individuals including scientist, nonscientist and community members responsible for ethical and regulatory oversight of all research involving human participants. The IRB follows the ethical principles in the Belmont Report. These principles include Respect for Persons: people are to be treated as independent and capable of making decisions, Beneficence: making the most of possible benefits and reducing risk of harm, and Justice: treating people fairly. The IRB reviews research according to the Federal Code of Regulations Title 45 CFR 46 and Title 21 CFR 50,11,56,312,600,812.
St. Jude has a Research Participant Advocate (RPA) who supports research participant’s rights. The Research Participant Advocate will help you find answers to any questions or concerns you may have about taking part in clinical research studies. The RPA also serves as a contact with St. Jude doctors and other staff members. This person is a member of the IRB and reviews informed consent documents for all studies. The advocate serves as a third party in consent discussions to facilitate communication between prospective participants, their families, and the research team. This person can advise you about the informed consent process that is a part of every clinical research study and they may be asked to be with your family during the informed consent process.
When should you call the Research Participant Advocate?
Contact Research Participant Advocate Diane Brand at 901-595-4644 or 901-857-6848, e-mail: firstname.lastname@example.org, pager: 901-595-3578 #1101. Outside the Memphis area, toll free 1-866-JUDE-IRB (1-866-583-3472).