What Treatments are “Satisfactory?” Divining Regulatory Intent and an Ethical Basis for Exception to Informed Consent for Emergency Research

Interpretation of the Federal regulations governing exception to informed consent (21 CFR 50.24) is difficult, in part, because relatively little guidance has been given to institutional review boards (IRBs) in defining the regulation’s terms. Exception to consent is only permitted, for example, when the available treatments for the lifethreatening condition being investigated “are unproven or unsatisfactory,” but how does one define unsatisfactory in this context? Kipnis et al. argue that the in-hospital phase of the PolyHeme ©R Hemorrhagic Shock trial (of PolyHeme ©R , Northfield Laboratories, Inc., Evanston, IL) does not meet the regulatory requirements for research performed using exception to informed consent for emergency research because they believe that the control therapy in that phase, blood transfusion, is “proven and satisfactory” (Kipnis, King and Nelson 2006). We are concerned that this definition of “unsatisfactory” is too narrow and cannot be justified. We present an alternative definition, developed and put forward by a recent consensus conference on resuscitation research and exception to consent (Watters 2005), that has a more satisfactory ethical basis and that we think is more consistent with the regulatory intent. We are concerned about the effect of the narrow definition on all emergency research and on the patients affected by emergency conditions. We critique this definition of “satisfactory” and then explain the reasoning and definition developed by the consensus conference.