Senate Passes Bill To Expand Clinical Trial Participation for Incapacitated Patients
The Senate yesterday voted 24-13 to approve a bill (AB 2328) that would expand the number of individuals who can grant researchers consent to enroll an incapacitated patient in a clinical trial, the San Francisco Chronicle reports. Under current state law, only a court-appointed conservator can grant consent. The bill, sponsored by Assembly member Howard Wayne (D-San Diego), would establish a prioritized list of people who can consent to participation in clinical trials for individuals with Alzheimer's disease and other mental illnesses, emergency room patients or other "mentally incapacitated people." The prioritized list would include those appointed by an incapacitated individual to make health decisions for them, conservators, spouses, domestic partners, adult children, custodial parents, adult siblings, adult grandchildren or adult relatives. Under the bill, a decision to refuse to grant consent by an individual higher on the list "trumps anything a person lower on the list says," and researchers would not receive consent when two individuals of the same priority level disagree. Wayne said that the bill "has reasonable controls to avoid abuses." Opponents, however, said that the legislation "creates no duty on the part of the person who gives consent to act in the patient's best interest," the Chronicle reports (Lucas/Tansey, San Francisco Chronicle, 8/23).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.