University of California, Other Health Groups Seek More ‘Leeway’ in Consent Requirements for Medical Research
The University of California, the American Heart Association, California chapters of the Alzheimer's Association and other health groups have started lobbying state lawmakers to pass legislation that would give medical researchers "more leeway" to enroll patients who are incapable of giving their own consent to participate in medical studies, the Los Angeles Times reports. A bill (AB 2328) that recently passed in the Assembly and could be considered by the Senate as early as today would create a list of relatives who could grant consent for an incapacitated patient. Advocates of the bill are seeking more flexibility to find treatments for serious diseases and injuries. In addition, advocates are asking for clarification of the federal law, which currently says that a "legally appointed representative" can give consent but leaves the definition of such a representative up to individual states. As a result, the law is "open to interpretation," the Times reports. Separate UC campuses have interpreted the law differently; in April, the University of California-Los Angeles, acting on legal advice, issued a moratorium barring researchers from enrolling patients who cannot give consent themselves, while other UC campuses allow research involving incapacitated patients if a relative consents.
Critics of the bill say that the UC system, which has had "previous lapses in protecting human research subjects in medical experiments," does not deserve more flexibility, the Times reports. But officials from the American Stroke Association, a "strong advocate" of the bill, say that getting incapacitated patients the "most up-to-date treatment" is crucial. "When a patient presents at the emergency room, the most appropriate treatment for that patient is often still in an experimental state," Marc Burgat, a legislative advocate for the stroke association, said, adding, "We would like to have the law very specifically clarified" (Ornstein/Trounson, Los Angeles Times, 8/7).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.