October 10, 1997.

Chronicle of Higher Education.

Panel wrestles with thorny issue of protecting human research
by Paulette Walker Campbell. p. 36

Psychiatric patients testify to ethical violations and examples of abuse in experiments at academic health centers.

For the second time in nearly 20 years, a federal commission is trying to write regulations that govern research involving adults who are unable to understand and consent to the risks of participating in the study. No other type of research raises more ethical dilemmas.

Scientists argue that research on patients who have an illness that prevents their informed consent is necessary if the consequences of their condition are to be understood and effective treatments developed. But ethicists say the idea of such research goes against the central tenet of the government’s policy governing studies involving human subjects, which states that the voluntary consent of the subject is essential. With the mentally ill, obtaining informed consent is difficult, if not impossible.

At its meeting here last month, members of President Clinton’s National Bioethics Advisory Commission said special regulations are needed if research on cognitive impairments is not to be impeded or worse, carried out without appropriate safeguards..

.Advocates for the mentally ill increasingly are demanding that the government do more to protect the interests of psychiatric patients in clinical research: “The absence of adequate protections has led to widespread violations of human rights,” said Vera Hassner Sharav, director of the New York City-based Citizens for Responsible Care in Psychiatry and Research.

“The ordeals that these people have suffered may have served the interests of the investigators and their academic institutions, but they clearly undermined the best medical interests of the subjects.”

Shalmah Lee Prince, who is manic depressive, said her experience as a patient and research subject at the University of Cincinnati Hospital (now called University Hospital, Inc.) illustrated all that was wrong with the system. She went to the hospital emergency room in 1983, complaining of mood swings and sleeplessness. Upon discovering that Mrs. Prince had no medical insurance, a nurse suggested that she take part in a study to search for biological markers that identify patients who are responsibe to lithium, an antidepressant.

“I agreed to be in it not knowing what it meant,” Mrs. Prince said. “I asked, “Can you help me?” and they said they could if I agreed to be in a Îwashout.’ I did not know what one was, but it sounded like a cleansing procedure.”

A drug washout is a controversial research design that is used so scientists can observe the effects of drug withdrawal and possible relapse, [to] determine whether patients can maintain drug-induced improvements without medication or at a lower dose, or guage the effectiveness of an experimental drug.

Mrs. Prince had been taking lithium since 1981. But because she was assigned to the control group in the study, she was taken off the drug for five days. When she became violent and suicidal, doctors placed her in leather restraints. On the fifth day she was given apomorphine – a drug that has led to sterility in some women – and was finally given lithium when her condition did not improve.

In 1994, she sued two of the researchers, charging that they had violated her civil rights by not informing her of the risks associated with the study. (The case was dismissed earlier this year because the statute of limitations had run out.)..