Trauma Care Patients: Exceptions to the Informed Consent Rule

Informed consent, the heart of the Nuremberg Code, is no longer applicable to certain trauma care patients receiving treatment in the U.S. The Nuremberg Code states unequivocally that:

the voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision.

Rules were changed in 1996 to allow emergency research physicians the option of intervening with experimental therapies. The following directives, under 21 CFR 50.24, currently govern trauma care research:

• The research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate.

• In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient.

• Furthermore, studies must be held to the highest ethical standards. These clinical trials undergo multiple independent rigorous reviews to ensure that they meet these standards.

• Before any patients are enrolled, communities are consulted about participation and made aware that informed consent will not be obtained for most study participants, as required by law.

• Surviving patients and/or their authorized representatives need to be informed about the trial as soon as feasible after the intervention has been given.

Emasculating the Nuremberg Code to serve scientific agendas is significant for it is the only principle protecting citizens from predatory research practices .

It is acknowledged that clinical trial subjects are vital resources for the research industry. But is there a valid defense for testing experimental products and procedures on unconscious, non-consenting patients?

The following three examples illustrate the conflict between the Nuremberg Code and scientific interests in the matter of Exception from Informed Consent rules.

PolyHeme , an artificial blood substitute [ hemoglobin based oxygen carrier— HBOC ], was tested on an unknown number of emergency room entrants from 1991 to 2009. Phase III PolyHeme studies , involving 720 hemorrhagic shock victims in 32 trauma centers, were concluded in 2007. The FDA notified the manufacturer, Northfield Laboratories, after the close of Phase III that:

the administration of PolyHeme places the patients at a higher risk of significant adverse events, and therefore, in the absence of clinical benefit, the risk: benefit assessment of the product in trauma is unfavorable.

The Emergency Research Waiver granted to Northfield was controversial for many reasons but specifically because patients were denied whole blood transfusions, the standard course of treatment.

Hemopure, a HBOC product derived from bovine red blood cells, was tested both in the U.S. and South Africa. The Hemopure trials were halted due to high fatality rates. A 2008 analysis from the Journal of the American Medical Association found that HBOCs are potentially deadly and should not be tested in humans. The critical Journal study prompted a firestorm of complaints from the Naval Medical Research Center, other related parties and the manufacturer. One of the coauthors of the JAMA critique said the FDA's concerns are moot because the Navy will advance plans for using Hemopure in likely to die patients.

Patients entering the University of Pittsburgh Medical Center suffering from significant blood loss are being enrolled, also without consent, in a unique clinical trial. It is called emergency preservation and resuscitation [EPR]. If the presumed dying individual meets criteria, trauma surgeon Samuel Tisherman and his team will place the patient in a type of suspended animation. This is accomplished by exsanguinating the patient's remaining blood and replacing with freezing salt water. The researchers hope that this procedure will provide a window of opportunity to stabilize cardiac arrest patients. To test the theory, researchers will select ten subjects and apply EPR, another ten will receive conventional cardiopulmonary resuscitation treatment.

Terminally injured and diseased patients are subject to the Emergency Research Consent Waiver at any juncture during course of treatment because of the influence of the Declaration of Helsinki. The World Medical Association, an international research consortium, determined in 1964 under Helsinki that informed consent was not a mandatory code of conduct. Language was altered to secure consent "if at all possible" and by proxy consent was approved.

The World Medical Association was a favored U.S medical ethics trendsetter until 2000. The reasons for the schism are discussed here .

Modifications to the Helsinki guidance document in 1975 set the stage for the concept of independent medical research committees as overseers of clinical trials. Institutional Review Boards have managed clinical studies in the United States since 1981.

In the World Medical Association's opinion:

In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering.

Contravening the Nuremberg Code and due process rights to achieve scientific prowess is necessary argue those who advocate for expedient clinical trials.

It should be remembered that it was Dr. John C. Cutler, director of the Guatemala syphilis trials and participant in the Tuskegee experiment who said, "Unless the law winks occasionally, you have no progress in medicine."

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Comments

Informed consent and medicine

I was not aware of this situation. A lot of what you wrote went over my head, but i know that informed consent is vital to the safety and care of patients.

Martha Brock