SAN FRANCISCO – Federal investigators have found University of California, San Francisco researchers did not follow federal guidelines to obtain consent from emergency room patients for a study on breathing support techniques.
The researchers often got approval to use patients who were too sick to give consent themselves with just a phone call to relatives, without providing any written description of the study or its risks, according to two federal reports obtained by the San Francisco Chronicle.
An anonymous complaint in 2000 prompted investigators from the Office of Human Research Protections, an agency of the U.S. Department of Health and Human Services, to take a closer look at the study, which was completed in 1999.
UCSF recruited 105 emergency room patients for the nationwide study on 861 people to look at whether routine ventilator settings used to help patients with lung damage could be harming the patients by over-stretching their lungs.
The study found that lower settings on ventilators were better for the patients, cutting the death rate by 22 percent.
But many of the patients were required to make a decision about participating in the study within minutes of being told about it, and some of them could only nod, as they were too sick to speak or hold a pen, the report found.
UCSF lets researchers conduct clinical trials on incapacitated people when researchers get a relative’s consent, which the university’s lawyers say the law allows.
But at least three other UC campuses have found that state law prohibits research on patients unless researchers have gotten permission from a court-recognized representative, not just a relative.
Pulmonary specialist Dr. John Luce, with San Francisco General Hospital, helped conduct the research and acknowledged that errors were made in obtaining consent. But he said the university has modified its policies as a result of the federal inquiry.
The university’s practices come at a time the UC is pressing state lawmakers to relax protections for human subjects and allow researchers to get proxy consent from a prioritized list that starts with patient-appointed representatives and ends with relatives such as a spouse, adult child or sibling.
UC is urging support for legislation on proxy consent, because researchers say the current law is holding up work on Alzheimer’s disease.