ALZHEIMER'S PATIENTS TARGETED FOR MEDICAL IMPLANT EXPERIMENTATION

On February 22, 2007, the VeriChip Corporation and Alzheimer's Community Care, Inc. announced their plan to conduct a medical study involving the implantation of 200 Alzheimer's patients with a VeriChip microchip implant. The device will be injected into the patients' flesh for a two-year experiment to study the effectiveness and safety of the implants.

Alzheimer's Community Care officials have indicated that the microchip implantation could begin as soon as May.

Medical experimentation on Alzheimer's patients raises profound issues of informed consent. We strongly believe that cognitively impaired individuals should not be used in medical experimentation of this type.

Not only is injecting potentially harmful microchips into people who cannot say "no" ethically problematic, it is in direct violation of VeriChip's longstanding position that no one should be involuntarily implanted with their product. In its press release, VeriChip acknowledges that the patients being implanted "cannot speak for themselves."

Since cognitively impaired individuals are unable to give informed consent, their use in medical experiments is highly controversial. When medical research is conducted on human beings in conjunction with a university or research institution, an institutional review board (IRB) is charged with ensuring that the research meets appropriate ethical and safety guidelines. There is no such oversight in this case.

The need for medical researchers to obtain informed consent from individuals involved in medical experimentation was first established in 1947 by the Nuremberg Code. Since that time, guidelines have been developed to ensure that no one is experimented upon against their will.

The National Bioethics Advisory Committee has developed guidelines and recommendations on the use of human subjects with cognitive impairment in medical research studies. Here are some of their recommendations:

• "An IRB should not approve research protocols targeting persons with mental disorders as subjects when such research can be done with other subjects."

• "Because of [the cognitively impaired] population's potential vulnerability, we should prohibit research targeting them if that research can be conducted equally well with other subjects. At least two reasons support this prohibition. First, it is important, on grounds of justice and fairness, to discourage any tendency to engage these persons in research simply because they are in some sense more available than others. Second, this prohibition would further reinforce the importance of informed consent in human subjects research. The principles of justice and respect for persons jointly imply that IRBs should not approve research protocols targeting persons with decisional impairments due to mental disorders when the research does not, by design, require such subjects."

• "Even when decisionmaking capacity appears to be severely impaired, respect for persons must prevail over any asserted duty to serve the public good as a research subject. Hence, a potential or actual subject's objection must be heeded, regardless of the level of risk or potential benefit, just as it would in the case of an individual who clearly retains decisional capacity. Respect for persons requires that we avoid forcing an individual to serve as a research subject, even when the research offers the possibility of direct medical benefit to the individual."

• "No person who has the capacity for consent may be enrolled in a study without his or her informed consent. When potential subjects are capable of making informed decisions about participation, they may accept or decline participation without involvement of any third parties... A third party, such as a relative or friend, may not override the informed decisions of capable people. This is an implication of respect for persons, including their autonomous choices."

Additional Resources:

The Ethics Of Research With Subjects Who Have Dementia http://onlineethics.org/reseth/mod/ADreseth.html

The National Bioethics Advisory Commission's report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity http://onlineethics.org/reseth/nbac/mindex.html

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