See Assurance, Institutional Assurance of Protection for Human Subjects . Black or African American A person having origins in the black racial groups of Africa. Certification, IRB See IRB Certification . Child A person under age 21. Clinical Research Research conducted on human subjects or on material of human origin identifiable with the source person.
Policy covers large and small-scale, exploratory, and observational studies.
Clinical Trial For applications submitted to NIH, a prospective study of human subjects designed to answer questions about biomedical or behavioral interventions, e.g., drugs, treatments, devices, or new ways of using known treatments, to determine whether they are safe and efficacious. Phase II studies the intervention in a larger group of people, usually several hundred, to determine efficacy and further evaluate safety. Phase III studies the efficacy of the intervention in large groups of several hundred to several thousand subjects by comparing it to other standard or experimental interventions and monitor adverse effects and collect information that will allow the intervention to be used safely. Often the aim is to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy.