Researchers must follow the same ethical and legal codes they follow during routine care. Certain federal regulations also apply specifically to clinical research. The process starts with a study protocol, which is a plan that must meet certain safety standards to be approved by Duke’s Institutional Review Board (IRB). Potential risks must be balanced against potential benefits, and the safety of participants must be safeguarded. Risks must be minimized and benefits must be maximized to the extent possible. Our IRB requires researchers to report back at least annually throughout the course of the research to ensure patient safety. The IRB also carefully reviews the consent form for the study to ensure that it meets all the criteria of the federal regulations that govern health research.
The U.S. government regulates clinical research that involves human beings, and all studies are required to protect your privacy and safety. Just like when you visit your provider, health information collected about you in a clinical research study is kept private. The research study follows a carefully controlled study plan that details what researchers can and will do in the study, including what they must do to protect your safety and privacy. As a clinical research study progresses, researchers report the results of the study to various oversight groups, and decisions may be made about whether to continue with the study. You will be kept informed of any changes that may affect your willingness to continue participating.
Study records that identify you will be kept confidential as required by law. Federal privacy regulations provide safeguards for your privacy and security. Except when required by law or for your care, you will not be identified by name, Social Security number, address, telephone number, or any other direct personal identifier in study records disclosed outside of Duke University Health System. For records disclosed outside of DUHS, you will be assigned a unique code number that will be used on your study results or health data when they are sent outside of Duke. The key to that code will be kept secure at Duke. When researchers publish the results of the trial, your name will never be disclosed.