Waiving the requirement for informed consent?

When is it permissible to waive or alter the usual rules of informed consent in human subjects research?  It is a testament to the success of the modern system of regulating research with humans that such a question will seem odd, even disturbing, to many.  Isn’t informed consent always necessary?

Actually, our current regulations do allow waivers and alterations of informed consent but it is important to know what this means.  It means waiver or alteration of the specific regulatory requirements, rather than of the general ethical concept itself.  And such waivers or alterations must meet strict criteria. The regulations state that:

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

 (1) The research involves no more than minimal risk to the subjects;

 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

 (3) The research could not practicably be carried out without the waiver or alteration; and

 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Until recently, there has been relatively little discussion about how to apply these criteria. Perhaps this is because most of the time the waivers were used for medical records research which most people do not either know about or would agree to anyway. But with the increasing interest in comparative effectiveness research, there has been a steady rise in calls for allowing waivers in settings that have not usually seen such waivers, namely, randomized clinical trials.

My colleague Frank Miller and I have been somewhat skeptical of this trend.  We just published a new paper on this topic.  In it, we use the principle of respect for persons as a way interpreting these criteria for waiver or alteration of informed consent.



Decisionally impaired persons in clinical research

Here’s a recent talk I gave at the University of Minnesota.  I can say without false modesty that a talk given by Carl Elliott was a bit more compelling.