Responsible conduct of radiology research. Part IV. The boundary of research and practice.
The purpose of this series of articles is to explain the ethical and legal basis for responsible conduct of radiology research and the rules that an investigator must follow. Part four of this series explains special situations that commonly arise during human research in radiology. The boundaries of research and innovative care or quality improvement often are not clear. When human research activities are or become subject to regulation, they must be reviewed and approved by an institutional review board. Therefore, physicians performing innovative care or conducting quality improvement should have a low threshold for seeking institutional review board guidance. Physicians performing innovative care should also consider their ethical obligation to future patients to conduct research to prove the validity of such innovative care.
Cooper
Jeffrey A
JA
Association for the Accreditation of Human Research Protection Programs, Washington, DC 20005-2315, USA. jcooper@aahrpp.org
D035843:Biomedical Research / Q000941:ethics* / Q000592:standards*; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics* / Q000592:standards*; D006801:Humans; D011356:Product Labeling; D011871:Radiology / Q000941:ethics* / Q000592:standards*; D012107:Research Design; D017749:Total Quality Management; D014481:United States; D014486:United States Food and Drug Administration