Reform within the Common Rule?


  • Tom Puglisi

  • To m Puglisi, “Reform within the Common Rule?” Ethical Oversight of Learning Health Care Systems


In their papers in this supplement, Ruth Faden and colleagues conclude that research ethics and regulation must change to accommodate a changed and changing health care environment. The reality, however, is that the widely understood and accepted ethical framework embedded in the regulatory requirements known as the Common Rule, and recent proposals to modify the Common Rule have become stalled, at least for the foreseeable future, if not permanently. Meaningful systemic modernization of the Common Rule is not likely to occur any time soon. All the same, modernization of the Common Rule is desperately needed. In the short term, the agencies responsible for implementing it must be willing to develop practical guidance for implementing the current regulatory requirements in a way that promotes clarity and understanding and allocates human and fiscal resources based on the level of risk to subjects. To this end, the Veterans Health Administration recently implemented policy to address the research-practice distinction—a distinction that is especially relevant to VHA's current challenges and that the authors of the “ethical framework” articles have identified as particularly outmoded.