July 26, 2002
The bill, AB 2328, was introduced by Assembly member Howard Wayne in the California State Assembly on February 21, 2002. This amendment would overturn key aspects of the current California Medical Experimentation Act by enabling researchers to obtain "proxy consent" for patients who do not have the capacity to consent or refuse to be research subjects. http://www.leginfo.ca.gov/pub/bill/asm/ab_2301-2350/ab_2328_bill_20020617_amended_sen.html
In New York State proxy consent regulations were struck down by the court in a landmark decision. Justice Edward Greenfield opening statement underscores the gravity of research without personal informed consent:
"The mere mention of experimental medical research on incapacitated human beings - the mentally ill, the profoundly retarded and minor children - summons up visceral reactions with recollections of the brutal Nazi experimentation with helpless subjects in concentration camps, and elicits shudders of revulsion when parallels are suggested. Even without the planned brutality, we have had deplorable instances of overreaching medical research in this country." [TD v NYSOMH,626 N.Y.S. 2d 1015 (Sup. Ct. NY County 1995)
In Maryland the research establishment attempted to legislate proxy consent to research but that effort was aborted by a coalition of human rights activists.
AB 2328 was passed in the Assembly on May 2, 2002. It was withdrawn from the Senate Judiciary committee - thereby circumventing a public hearing. AB 2328 will be voted on by the full California legislature in early August 2002.
April 16, 2002. UCLA announced a "Moratorium on IRB Approval of Surrogate or Proxy Informed Consent for Human Subjects Research" because such consent "is inconsistent with California law." http://www.oprs.ucla.edu/human/NewsLetters/041602.htm]
Most likely, the ARDS experiment on incapacitated patients with acute lung injury and acute respiratory distress syndrome is the catalyst behind efforts to amend the California Medical Research Act, which prohibits conducting experiments on human beings with surrogate consent.
This imminent action could have devastating consequences for the citizens of California and, if adopted in other states, such legislative usurpation of the right to personal informed consent for research will affect us all.
AHRP
Questions Ethics of Acute Respiratory Distress Syndrome (ARDS) Study
Memorandum in opposition to California
AB 2328
Additional documents at: http://www.mninter.net/~lbarry/Voices/2328.html
Trace status of AB 2328: http://www.leginfo.ca.gov/