Miller F G, Wendler D
Department of Clinical Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892-1156, USA.
J Med Ethics. 2008 Mar;34(3):198-201. doi: 10.1136/jme.2006.019109.
Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from research participants is deceptive, inconsistent with valid informed consent, and a violation of respect for participants' autonomy. The present article examines these arguments, focusing specifically on confidential data monitoring for efficacy. This practice need not be deceptive provided its use is disclosed to prospective research participants. In addition, confidential data monitoring does not make research participants worse off than they would be in the clinical setting and represents an acceptable limitation on the options available to prospective research participants. Taken together, these considerations suggest confidential data monitoring, subject to adequate safeguards, is ethically acceptable.
数据监测委员会经常被用于审查随机对照试验的中期结果。中期结果会被保密，直到数据监测委员会发现它们提供了关于疗效的足够有说服力的证据，这通常是因为它们跨越了预先设定的统计界限，或者引发了对安全性的严重担忧。虽然这种做法对于维护对照试验的科学完整性并从而确保其社会价值至关重要，但它却被批评为不道德。评论者认为，向研究参与者隐瞒中期结果具有欺骗性，不符合有效的知情同意，并且侵犯了对参与者自主性的尊重。本文审视了这些论点，特别关注针对疗效的保密数据监测。只要将其使用情况告知未来的研究参与者，这种做法不一定具有欺骗性。此外，保密数据监测不会使研究参与者的处境比他们在临床环境中更糟，并且代表了对未来研究参与者可选择方案的一种可接受的限制。综合考虑，这些因素表明，在有充分保障措施的情况下，保密数据监测在伦理上是可以接受的。
