Legislature OKs Bill on Incapacitated Patients

The Legislature gave its final approval Monday to a bill that would give researchers more leeway to enroll incapacitated patients in research studies.

The bill would allow family members to approve participation by patients unable to give their consent. Such patients might include victims of stroke or Alzheimer’s disease or those in comas.

The University of California and several health groups strongly support the bill, which now heads to the desk of Gov. Gray Davis. They contend that more flexibility is needed to improve treatment of life-threatening diseases and injuries.

Supporters of the bill have said current laws governing informed consent are open to interpretation.

Federal law allows any “legally appointed representative” to give consent on behalf of an incapacitated patient, leaving interpretation of that term to individual states. California law is more restrictive, giving authority only to those appointed by the courts or legally approved by the patients before incapacitation.

Critics of the bill said it could place patients at risk for exploitation. Several studies have shown that family members and doctors are poor predictors of what treatments patients want.

In addition, some opponents say that the UC system doesn’t deserve this new authority because of its previous lapses in protecting human research subjects.

In response to critics, the bill’s authors amended their proposal to ban payments to family members who volunteer patients for research.

Assemblywoman Dion Aroner (D-Berkeley), who co-authored the bill, said she’s satisfied with the end product.