Center for Clinical and Organizational Ethics, Inova Health System, Falls Church, Virginia, USA.
Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Intern Med J. 2020 Dec;50(12):1583-1587. doi: 10.1111/imj.15117.
Innovative practice involves medical interventions that deviate from standard practice in significant ways. For many patients, innovative practice offers the best chance of successful treatment. Because little is known about most innovative treatments, clinicians who engage in innovative practice might consider including extra procedures, such as scans or blood draws, to gather information about the innovation. Such information-gathering interventions can yield valuable information for modifying the innovation to benefit future patients and for designing scientific studies of the innovation. However, existing guidelines do not say when or whether it is appropriate to add potentially risky information-gathering interventions for these purposes. As a result, clinicians may assume that information-gathering interventions are ethically inappropriate and should not be used in innovative practice. This assumption can lead to seriously negative consequences, such as increasing the likelihood that harmful or ineffective innovations will be adopted and creating new barriers to the development of genuinely beneficial treatments. We argue that health care institutions need to promote the responsible use of information-gathering interventions as an adjunct to innovative practice, and that these interventions are not clinical research and should not be subject to research oversight.
创新实践涉及到与标准实践有重大差异的医疗干预措施。对于许多患者来说，创新实践提供了成功治疗的最佳机会。由于大多数创新治疗方法知之甚少，因此从事创新实践的临床医生可能会考虑增加额外的程序，如扫描或血液抽取，以收集有关创新的信息。这些信息收集干预措施可以为改进创新以造福未来患者和设计创新的科学研究提供有价值的信息。然而，现有的指南并没有说明何时或是否适合出于这些目的增加潜在风险的信息收集干预措施。因此，临床医生可能会认为信息收集干预措施在伦理上是不适当的，不应在创新实践中使用。这种假设可能会导致严重的负面后果，例如增加采用有害或无效创新的可能性，并为真正有益的治疗方法的发展制造新的障碍。我们认为，医疗机构需要促进负责任地使用信息收集干预措施作为创新实践的辅助手段，并且这些干预措施不属于临床研究，不应受到研究监督。
