Ethical Conduct of Research
We will conduct our research with integrity and intellectual honesty, and show the greatest care for human or animal subjects-
This means that each member of the campus community to whom this standard applies
- Protects the rights of human subjects
Perspective: A Real World Illustration
A July 2002 San Francisco Chronicle newspaper article reported on a public university located in California violating federal guidelines by not obtaining the consent of emergency room patients in conducting a study of experimental breathing support techniques.
In the study involving patients too sick to give consent for themselves, the researchers improperly persuaded relatives to approve their participation after a mere phone call, without first providing them any written description of the study and its risks, according to two federal reports.
The findings were made by investigators from the U.S. Department of Health and Human Services, who responded to an anonymous complaint made in 2000.
For years university lawyers have maintained the law can be interpreted to allow such consent by surrogates, and the medical research center continues to permit clinical trials on incapacitated people when researchers can get a relatives' consent. The problems that cropped up with getting relatives' consent in the university study illustrate the often unavoidable conflict between the search for medical advances and patient protection.
The 105 university patients were part of a nationwide study on 861 people to find out whether routine ventilator settings to support breathing in patients with pneumonia or other serious lung damage could be harming them by over-stretching their lungs.
The study, which ended in 1999, apparently proved the researchers' hunch: Lower ventilator settings decreased the death rate by 22 percent. Subjects in the nationwide study on average had a lower death rate than the usual 40-50 percent for patients with acute respiratory distress in ordinary medical practice. University officials said they were aware of no claims that subjects had been injured by the study.
Federal investigators found that at least in some circumstances, the scientists, who enrolled patients at the university's medical center and another hospital, violated guidelines for protecting patients' rights.
Family members had nothing in writing describing the clinical trial and its risks when they gave the go-ahead over the phone, the investigators wrote. Neither did emergency room patients who agreed to the study on their own with only a "nodding gesture," since they were too sick to speak or hold a pen.
Consent documents given to relatives who granted permission in person did not adequately inform them of the possible hazards of the experimental treatment, which included breathing difficulties and a potentially life threatening jump in blood sodium levels, the federal investigators concluded.
The university's practices came to light at the same time it was pressing state lawmakers to pass legislation that would relax state protections for human subjects.
That legislation, if approved, would address the larger issue of whether it is proper to obtain consent from relatives in the first place. While federal guidelines govern most areas of human subject protection at the university, state law controls who can give proxy consent.
A spokesperson from the Alliance for Human Research Protection based in New York said that the university violations show that informal methods of proxy consent are prone to abuse. "I think it demonstrates why you must not have this backdoor approval process," she said. "It invites exploitation of incapacitated people."
Last Revised 5/23/2006