Biomedical research includes studies designed primarily to increase the scientific base of information about normal or abnormal physiology and development, and studies primarily intended to evaluate the safety, efficacy or usefulness of a medical product, procedure or intervention.
Behavioral research refers to studies of the behavior of individuals or behavior of aggregates.
A. Criteria for Approval of Research . Federal guidelines strongly advise all IRBs to consider specific issues when reviewing these types of research and to alert Principal Investigators to address these issues in their application for IBRA approval. Most of these special considerations relate to study design and informed consent, and are discussed in further detail in Sections V and Sections VI of the Investigator Guide . I. Studies Performed for Scientific Interest. The FDA does not require an IND for a study of a marketed drug for off-label uses, when the drug is administered in the practice of medicine.