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Informed Consent on a Complicated Path for Patients

Kirsch, Bob

doi: 10.1097/01.EEM.0000754804.69302.4a
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    informed consent, ethics, best practice

    Medical researchers frequently abandon informed consent and are essentially guilty of experimentation when they do, according to an ethicist who said Americans are systematically denied the right to refuse participation in risky medical research, like the studies that have been legally conducted on trauma victims without their consent or sometimes their knowledge.

    Harriet A. Washington, the author of Carte Blanche: The Erosion of Medical Consent, recently spoke at a panel on consent and vulnerable people presented by a Columbia University imprint, Columbia Global Reports. She is a lecturer in bioethics at the university, and also wrote Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, which won a National Book Critics Circle Award.

    A case in point: Capt. John Buck, MD, an emergency physician at Keesler Air Force Base in Biloxi, MS, refused to take the anthrax vaccine because he said he had treated patients for whom the vaccination led to fatigue, joint pain, and autoimmune disorder symptoms. His refusal ended with him being charged with disobeying a command, sentenced to 60 days of base restriction, and fined $21,000.

    All soldiers were subject to the compulsory vaccination order, and Ms. Washington said in her book that forcing the vaccine on members of the Air Force amounted to a violation of their rights. The problem is more acute for Black members of the armed forces, she said, who then constituted 12.3 percent of the U.S. population but 24.5 percent of the troops sent to the Gulf in 1991 and 26.2 percent of Army reservists in 2001.

    The trend toward overrepresentation of minority groups in nonconsensual research is a major theme in Ms. Washington's book, and she told Emergency Medicine News that EPs can help reverse that trend. “Emergency physicians bear a huge responsibility, for it is often their medical and moral decisions that will determine how well informed consent is respected in research,” she said.

    Optimal for Patients

    Carte Blanche considers what Ms. Washington called the semantic manipulations used in the deteriorating consent process. She wrote about the eroding distinction between patient and research subject, noting that a patient's treatment seeks to “maximize that specific patient's health and well-being” while a study can determine drug selection and dosage that may not be optimal for the patient.

    Ms. Washington also said the phrase medical experiment has given way to medical study, a term that conveys a message of greater safety and security. She questioned the use of language in places where experimental ventures are characterized as being treatments, and pointed to research that claimed to tell patients they may withdraw at any time, when this could, in fact, be impossible. Patients in a body-cooling study, for example, were unconscious and never informed that they were enrolled.

    Ms. Washington examined instances where emergency treatment was said to have been sanctioned by community notification. Researchers of a PolyHeme study, for example, substituted community notification meetings for informed consent, making a miniscule sample of the affected population a proxy for a larger population. The information presented at meetings focused on medical urgency that Ms. Washington said confused attendees about the experimental nature of the study and failed to mention the troubling findings of an earlier acute normovolemic hemodilution study that documented death and illness in patients given PolyHeme.

    Food and Drug Administration records indicated that community residents attending the meetings saw slides saying, “In clinical trials to date, PolyHeme has demonstrated no ‘clinically relevant’ adverse effects.” The commander of the Army Institute of Surgical Research also advocated for clinical trials of PolyHeme, telling local communities, “Up to now, PolyHeme has not caused any clinically bad problems.”

    Pressure on Researchers

    Olajide Williams, MD, the founder of Hip Hop Stroke and Hip Hop Public Health, said research can create pressure to cut corners or just ignore consent procedures. Medical research is “filled with physician conflicts,” he added, noting that he is responsible for recruiting patients and obtaining consent while a portion of his salary comes from funding he receives for studies. “You're under tremendous pressure to meet these milestones, and the current IRB human subjects' protections may not go far enough,” said Dr. Williams, also the chief of staff of neurology, the director of acute stroke services, and a professor of neurology at Columbia University.

    The current approach to securing informed consent involves “a sometimes illogical division of labor,” he said. “Why would you make a person who is at risk for these conflicts of interest responsible for objectively educating a potential research subject about the risks and benefits of the research study when these unconscious conflicts, as we know from other implicit biases, have a way of creeping into our actions?”

    Patients are also in a vulnerable position, Dr. Williams said, because of the hierarchy between patients and physicians, which puts the relationship on an uneven playing field. “We need to spend more time empowering patients about these issues so that they have the confidence to ask questions about concerns they may have without fear of upsetting a physician they may need in the future,” he said. “This is not always easy to do, especially if the patient is a member of a vulnerable population among whom empowerment levels around these issues tend to be low.”

    He advocated for independent education from neutral parties for research subjects so that anyone considering entry into a clinical trial learns the risks and benefits from an independent source.

    Autonomy and Responsibility

    Ms. Washington noted in her book that the trend is moving away from evaluation by university-based IRBs in her book with for-profit contract research organizations assuming a larger role. She recommended changes to IRB composition and function, which is supported by a 1998 U.S. Department of Health and Human Services report that found IRB members were subject to conflicts of interest, inadequately trained, and overwhelmed by too many responsibilities.

    Ms. Washington also said 80 percent of corporate studies are now conducted in developing countries, and she cited instances of African volunteers who were paid but had no idea they were research subjects and other cases where consent forms went missing. The World Medical Association's Declaration of Helsinki governs the conduct of research in developing areas, but she said “the standard of care is nothing” in many of these countries.

    “Informed consent is much more than a piece of paper,” Ms. Washington wrote, noting that it is intended to help enforce principles of autonomy, beneficence, justice, and responsibility to communicate specific information.

    Mr. Kirschwrites on medicine and health for multiple audiences, focusing on clinical medicine, communication in health care, policy, and health disparities. He is a past president of the Metro NY chapter of the American Medical Writers Association.

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