Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
Semin Perinatol. 2009 Dec;33(6):364-71. doi: 10.1053/j.semperi.2009.07.003.
The future health of infants and children is dependent on the performance of clinical research in which infants participate. Achieving a proper balance between this social good and the obligation to protect infants who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with infants. For research to satisfy ethical and legal requirements it must be scientifically sound and significant, subject selection must be fair, approaching families for enrollment must avoid pressure, the risks to participants cannot be excessive and must be minimized, risks must be justified by the benefits of the research, valid and voluntary informed consent must be obtained, enrolled subjects must be respected, and the protocol must have obtained approval of an independent ethical review board.
婴儿和儿童的未来健康取决于临床研究的开展，而婴儿是临床研究的参与者。在实现这种社会效益和保护参与研究的婴儿的义务之间取得适当平衡是一项重大挑战。在设计和实施研究方案时，研究者应了解规范婴儿研究的伦理和法律要求。为了使研究满足伦理和法律要求，它必须具有科学性和重要性，研究对象的选择必须公平，招募家庭时不能有压力，参与者的风险不能过高，必须最小化，风险必须由研究的益处来证明，必须获得有效的、自愿的知情同意，入组的受试者必须受到尊重，方案必须获得独立伦理审查委员会的批准。
