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Subject:   California Law
Date:   2002-09-17

The California State Senate in late August has passed a bill (Assembly Bill No. 2328) that would expand the capacity of medicine to conduct human research on citizens who do not give their personal consent – in experiments that would not be for the direct medical benefit of the patient. We question this expansion of medical power as it abridges the fundamental Nuremberg principle of informed consent by the person undergoing the experiment and the Hippocratic oath to do no harm.

A class of people is being created who are decisionally incapacitated, which could include any citizen who comes into the emergency room with head trauma or heart attack, or a person with a chronic condition such as Alzheimer's or other neurological condition. At this point, persons with mental health diagnosis are specifically excluded, but there is always the danger that the principle would be expanded in the future. If it is appropriate to do a no-benefit, potentially harmful experiment on someone with a brain injury for the purposes of research, why not someone who is in an incapacitating state of schizophrenia – which is (by the medical model) held to be a physical illness?

The bill attempts to offer an assurance of protection by stating that federal law (45 CFR 46) is applicable, but reliance on the federal law for the past ten years has proved inadequate and subject to a wide range of interpetation by a variety of IRB's. More specifically in this arena, federal law provides for a conservator who acts in the interest of the patient, but now the state of California would dilute this provision to include a greater number of people who can give approval and who need not act for the patients direct medical benefit.

The list of persons who can give approval is expansive – not just a spouse or immediate siblings, but the adult relative who is simply closest in kin to the patient if others aren't available. (Persons more related can veto approval by more removed kin) And as mentioned, the legislation – by making no specific limits – allows research that is not for the person's direct medical benefit and so – as side effects are common in such treatments – is likely to do medical harm.

For these reasons, CIRCARE stands opposed to such expansion of powers on groups of vulnerable citizens.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327


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Last Updated: 2006-03-04

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