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Ethical Conduct of Clinical Research Involving Children
An inactive substance (e.g., a sugar pill) or a sham action (e.g., an injection of sterile water) used with a control group as part of a Phase 3 clinical trial.
A document that describes the purpose, design, methods, organization, and other key features of a research study.
A payment for out-of-pocket expenses directly related to research participation.
A potential harm or the potential of an action or event to cause harm.
Serious adverse event.
An unwanted outcome, which may or may not be related to an experimental intervention, that involves death, hospitalization (new or extended), disability, birth defect, or another major medical event that may jeopardize a research participant and require intervention to prevent one of the above outcomes.
A treatment currently in use that is believed to be effective.
Federal regulations providing for general protections of human subjects in research (the basic policy of the U.S. Department of Health and Human Services for the protection of human research subjects). See also Common Rule.
Federal regulations providing for special protections of child participants in research. The regulations have been adopted only by the U.S. Department of Health and Human Services, the U.S. Department of Education, the Central Intelligence Agency, and the Social Security Administration.
The belief that the purpose of research is to treat a disease or condition rather than to generate scientific knowledge.
A child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with applicable federal, state, or local law (21 CFR 50.3q).