Clinical trials review urged Dying, disadvantaged are unwitting subjects, Hopkins ethicist says

Scrutiny, safeguards sought

Patient consent forms are called little more than a formality

November 07, 1997|By Diana K. Sugg | Diana K. Sugg,SUN STAFF

Charging that the signing of consent forms for clinical trials is little more than a formality, one of the country's leading bioethicists called yesterday for national scrutiny of the way that seriously ill or disadvantaged people become subjects in medical research.

The issue has been spotlighted recently in the controversy over how American researchers conduct AIDS drug trials in Africa. But it affects millions of people in the United States.

At Johns Hopkins Hospital alone, about 270 clinical trials are being conducted, at a cost of $286.1 million. The National Cancer Institute has more than 416,000 people enrolled in clinical trials. The federal government invests $3.5 billion annually in research involving human subjects.

This includes the dying and desperate for hope, people who can't get routine health care, and the homeless. Often, studies show, these people trust their doctors so much that they don't consider the potential harm they might suffer from the experimental treatment. Or they're willing to be guinea pigs because they'll get a few nights in a warm hospital.

"When is this a humane effort to improve the lot of the disadvantaged? When is it nothing more than exploitation?" asked Ruth R. Faden, director of the Johns Hopkins University Bioethics Institute. She addressed about 700 bioethicists meeting this week in Baltimore.

"We have to deal with the realities of human psychology and human emotions. We have to recognize where the person is, realize how vulnerable they may be."

At the federal level, an independent group charged with examining research involving human subjects, the National Bioethics Advisory Commission, is trying to devise research protections for people with cognitive impairments. None exists even though these subjects -- who have a mental illness or brain injury from an accident -- are hampered in decision-making.

A federal policy called the "common rule" provides the regulatory oversight for research involving human subjects. Despite this framework, gaps have become apparent.

The Advisory Committee on Human Radiation Experiments, a national panel headed by Faden that investigated past and present problems in research, found that consent forms suggested greater potential benefits than investigators described elsewhere. Some consent forms did not present potential disadvantages, such as quality-of-life issues, at all.

The committee reviewed 125 descriptions of projects funded by the U.S. government between 1990 and 1993. About half raised "serious ethical issues," according to the physician who did the analysis, Dr. Jay Katz, a professor emeritus of law, medicine, and psychiatry at the Yale University School of Law.

The panel also interviewed nearly 1,900 patients at medical institutions across the country to find out their motives and experiences in various kinds of clinical trials. Some who were subjects didn't know they had been, while others wrongly thought they were being studied.

Almost all said they participated because they thought research offered them their best chance of getting better and because their physicians recommended it. Others felt they had no choice. They had tried everything else, and they were dying.

Faden said the groups that oversee research, called institutional review boards, or IRBs, need to spend less time "word-smithing" consent forms and more time scrutinizing other aspects of the research.

One such troubling aspect is the practice of paying poor women $40 to participate in an experiment, said Dr. Sidney Wolfe,

director of Public Citizen's Health Research Group, a consumer advocacy group. He described the IRBs as "flawed mechanisms" that need revamping, adding that they're biased toward their own researchers and need the funds those researchers bring in.

At the University of Maryland School of Medicine, the chairman of the institutional review board, Dr. Paul Fishman, said the groups are acutely aware that they are policing their own. His panel is split into two subcommittees that review about 500 proposals each year, half of which are mostly survey projects and the other half are treatment proposals.

About 20 percent of the proposals go through without a hitch, Fishman said. About 75 percent receive provisional approval requiring the researchers to answer questions and make modifications. The remainder are rejected.

"We're not being lax in our duties because a lot of the things we get are of fairly high quality," said Fishman. But he supports the sort of dialogue Faden seeks.

"Most people on the street have no idea what the research process is about," he said. "There are a lot of public suspicions and hostility toward research, which may not be in their best interest."

Still, getting into an experiment is usually the result of a conversation between doctor and patient, where the physician walks a fine line between supporting a patient's hope and being honest.

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