Skolnick B E
Department of Neurology, Pennsylvania Hospital, Philadelphia 19107, USA.
Adv Neurol. 1998;76:253-62.
IRBs provide an important role in the protection of research subjects/patients. Research investigators have an inherent potential conflict of interest as health care professionals; as physicians, they are dedicated to promoting the welfare of individual patients, whereas as researchers, they seek knowledge that can be generalized and is applicable to persons other than the individual patient under study. The second goal may be in conflict with the first. IRBs have the paramount responsibility of protecting the rights and welfare of human research subjects. Although the IRB system is not perfect, conscientious IRBs reassure the public that the rights and welfare of human subjects are seriously considered by people who do not have a vested interest in the outcome of the research. By exercising their responsibilities, IRBs promote the protection of human subjects. IRB approval provides a significant affirmation of the scientific and ethical qualities of research, and therefore offers important validation to research and research investigators. IRBs, acting in accordance with the guiding principles of the Belmont Report and within the regulatory guidelines of 45.CFR.46, are intended to provide balance between society's interest in advancing scientific knowledge and the mandate to protect the rights and welfare of human subjects.
机构审查委员会在保护研究对象/患者方面发挥着重要作用。作为医疗保健专业人员，研究人员存在内在的潜在利益冲突；作为医生，他们致力于促进个体患者的福祉，而作为研究人员，他们寻求能够普遍适用且适用于所研究个体患者之外其他人的知识。第二个目标可能与第一个目标相冲突。机构审查委员会肩负着保护人类研究对象的权利和福祉的首要责任。尽管机构审查委员会制度并不完美，但尽责的机构审查委员会让公众放心，即研究结果没有既得利益的人会认真考虑人类对象的权利和福祉。通过履行职责，机构审查委员会促进对人类对象的保护。机构审查委员会的批准对研究的科学和伦理品质给予了重要肯定，因此为研究及研究人员提供了重要的认可。机构审查委员会按照《贝尔蒙报告》的指导原则并在45.CFR.46的监管准则范围内行事，旨在在社会推进科学知识的利益与保护人类对象的权利和福祉的使命之间取得平衡。
