Informed consent refers both to the process of describing clearly to research participants specific elements related to research participation and the document signed by a research participant that serves as documentation of the participant’s voluntary consent to participate in research. The informed consent process used for human subjects is governed by federal law, and both national and international standards and regulations exist that protect research participants. It is important for researchers who are working with individuals, couples, or families to understand informed consent. There are laws, policies, and ethical codes governing research with human subjects and institutional review boards (IRBs), that help ensure that participants understand any potential risks and benefits of participating in research and are participating voluntarily. This entry outlines the elements of ...

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