Related Pages Protecting Participants in Clinical Trials A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study. Protecting Human Research Participants This free tutorial is for physicians, nurses, and other members of clinical research teams. If you are an extramural researcher obtaining Federal funds, check with your institution to determine if this is the training they use to fulfill the NIH requirement for education on the protection of human research participants. This course is offered by the NIH Office of Extramural Research.

If you and your physician have found a clinical trial that is of interest to you and for which you are eligible (that is, you meet requirements such as type and stage of cancer, age, treatment history, overall health, and others), you will need information in order to make a decision about whether to participate in the trial. Making a decision about participating in a research study involves understanding the potential risks and benefits as well as your rights and responsibilities. The presentation and discussion of these important issues are part of the process called informed consent. This guide will tell you what to expect during the informed consent process, explain its importance to clinical research participants, and describe how it fits into a larger system that protects the welfare of people who take part in clinical trials.

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