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Controls tight in mental health research
Nestled behind the crest of Dix Hill on the campus of Dorothea Dix Hospital is a small brick building that is quite different from the rest of the institution.
Only 10 patients live there, in semi-private rooms, and they are watched closely day and night by a staff of two doctors, three nurses and 11 technicians. A sign outside identifies the unit as Edgerton Building.
“It’s a research center and we are used for guinea pigs, so to speak,” said Jane
Smith (not her real name), an Edgerton resident. “But it’s for our own good.”
Mrs. Smith is a manic-depressive, suffering from extreme changes of mood. Along with the other patients at the hospital. she was picked, and consented, to live in the unit and serve as a test subject for a new anti-depression drug.
She actually completed the test years ago. but she has been in and out of Dix since then, and the research unit admits her when she needs to return.
Hundreds of patient volunteers like Mrs. Rollins are used throughout the state men
tal-health system as subjects for research. There have been no complaints of abuse in the research programs and officials say controls are strict. Some sources, however, have questioned whether patients are in a position to give their consent to participating in the research.
But most state mental-health officials say the arrangement benefits both researchers and patients.
“If a patient goes into a research center,” said Dr. Peter N. Witt, chief of mental-health research for the state, “he gets better care than a millionaire patient
gets from his private psychiatrist.” Research patients enjoy better living conditions and are observed much more closely than ordinary patients, he said.
Researchers benefit by having a controlled community on which to experiment. “If we Have a new drug that has been proven to be harmless, not toxic, if we can give it to a large sample of our patients, we can immediately see if the (disease) incidence goes down,” Witt said. “It’s an ideal situation for a researcher.”
See RESEARCH, page 16
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According to state officials, there are 38 research projects currently going on in the mental-health system, including 29 at Dix. Some involve only patient records or histories, Witt said. Others use patients directly-
The research generally takes two forms, he said. One is the intensive kind of program operated in the Edgerton clinical research unit, in which patients are removed from the hospital community and placed under long-term scrutiny.
The other type is a broad-scale project involving a large number of patients whose daily lives are not affected by the program. Dix recently received national attention for one such project in which a new vaccine was shown to be effective in preventing pneumococcal pneumonia.
The role of the 1.300 patients and 100 staff members who participated in the two-year study, according to Dix officials, was merely to receive one shot and then be watched for pneumonia.
Controls over use of patients are tight, Witt said. All proposals must go through a research committee, representing various elements of the hospital community, and must be approved by the hospital director.
Patients or their guardians must sign consent forms that explain in understandable language the benefits and risks of the project. Once in a project, a patient may drop out at any time.
Risks. Witt said, are minimal. “The general rule is that I can take very small risks valuaêlÿ study .St will benefit biiliOhSof people.“ No lives would relier be placed in danger.ehe said.
There have been no complaints about abuses in the research programs, according to the Dix advocate’s office, which looks out for patients’ rights. However, several sources voiced concerns about die consent procedure used in the programs.
“One Dix official who asked not to be identified put the question this way: “Is a mental patient who is confined to an institution really capable of consenting to research procedures?”
John Decker, a legal-aid attorney at Dix who has represented patients in suits against the hospital, said he’d have trouble defending a patient who felt injured by a program.
“Say, for example, a patient comes to me and says. ‘I didn’t understand what was going on.’ but he’d signed all the papers. How would you go about proving that they didn’t understand it? It’s a very difficult burden on the patient, because it places the word of the patient against the staff.”
Decker stressed, however, that he’d heard of no abuses of patient research at Dix.
Among patients, the projects appear to be popular, and there is more demand to get into them than space to accommodate patients. “I told the doctors when I came in, anything that would help me, I’d be more than glad to try,” said a man who lives in Edgerton Hall.
The man. an alcoholic who suffers from depression, said he met his wife in the clinical research unit.
“I’ve been in other biddings at this institution and I’ve never found anyplace where they try to help you as much.“ he said.