Division of Medical Ethics, New York University Langone Medical Center, 227 East 30th Street, #753, New York, NY, 10016, USA.
Sci Eng Ethics. 2019 Apr;25(2):621-629. doi: 10.1007/s11948-018-0027-3. Epub 2018 Feb 5.
A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here we describe four areas of research misconduct (RM) regulations governing Public Health Service funded research that are empirically and/or ethically questionable. Policies for human subject protection, RM and conflict of interest are not harmonized, making it extremely difficult to deal with complex cases which often contain allegations in all of these areas. Second, detection of RM has depended entirely on whistleblowers in spite of evidence of significant under-reporting. Third, the scientific record is far from cleansed of the effects of falsified/fabricated work through current mechanisms of retraction. Finally, lack of fairness in the regulations may reflect lack of a Belmont Report-like document to guide ethics of RM policy. These issues are likely common in other countries. RM regulations should be harmonized with related regulations and their effectiveness tracked, open access to data for independent replication and improved statistical tests are an essential supplement to whistleblowers, correction of the scientific record will require a major effort, and further ethical analysis and guidance are as important as is empirical study for the improvement of RM regulations. Further consideration should be given to assigning current regulations for human subjects protection, RM and conflict of interest to a single authority and to the further development of a Belmont-like report of essential principles, for RM.
最近，美国国家科学院的一份关于研究诚信的报告指出，政策缺乏证据基础，没有任何正式机构负责解决这一缺陷。在这里，我们描述了公共卫生服务资助的研究中管理研究不端行为（RM）的四个方面的规定，这些规定在经验和/或伦理上存在疑问。涉及人类受试者保护、RM 和利益冲突的政策没有协调一致，这使得处理涉及所有这些领域的复杂案件变得极其困难。第二，尽管有大量证据表明报告不足，但 RM 的检测完全依赖于举报人。第三，通过当前的撤回机制，伪造/捏造工作的科学记录远未得到清理。最后，监管规定的不公平可能反映出缺乏类似于《贝尔蒙报告》的文件来指导 RM 政策的伦理。这些问题在其他国家可能也很常见。RM 规定应与相关规定协调，并跟踪其有效性，开放数据供独立复制，并改进统计检验，这是对举报人不可或缺的补充，纠正科学记录将需要付出巨大努力，进一步的伦理分析和指导与实证研究一样重要，有助于改善 RM 规定。应进一步考虑将目前涉及人类受试者保护、RM 和利益冲突的规定分配给一个单一的权威机构，并进一步制定类似于《贝尔蒙报告》的基本原则报告，以管理 RM。
