HHS’s Request for Comments on Regulations for Research Needed to Improve Routine Patient Care

Like many others (see signatures on the submitted statement, “CERIC HHS standard of care interventions 2013-09-09”), I am concerned about our lack of sufficient information about the absolute or relative effectiveness of routine medical care. We need a “learning health system” as my colleagues at the Institute of Medicine describe it: one that benefits from consistent performance data feedback, research, and patient input regarding their care experiences. Research regarding what interventions work, which work best, for whom and under what conditions, is critical to quality care delivery for each individual.

However, ethical research requires careful attention to the appropriate rules and regulations that protect human subjects from harm in the research process. I commend HHS for reaching out and soliciting comments on how to balance the needs of patients to have a better quality health care delivery system grounded in research, with the need for adequate research protections. I offer you the perspective of some notable scholars on this issue and, whatever your position, encourage you to share them with HHS .