U researcher

The Minnesota Board of Medical Practice announced the reprimand of University psychiatry professor Dr. James A. Halikas Tuesday after concluding the researcher violated federal safety and ethical guidelines in an experimental drug study.

The board fined Halikas $3,500 for dispensing a drug that weans addicts off opium without first acquiring written informed consent from eight patients. The board concluded he also gave two of the study's participants doses of the drug that exceeded limits set for the research study. And according to the report, patients who requested methadone after expressing dissatisfaction with the drug were denied the replacement therapy.

The study ended after two months in August 1993, following complaints about Halikas' practices.

The board's action tags his license with practice limitations for a minimum of two years. In addition, Halikas, 56, must report to the board each time he becomes involved in a research study involving human subjects. Halikas may apply to the board to have the conditional terms removed from his license.

In the meantime, Halikas continues to lecture and train University medical school students and residents. Reached at his home Tuesday evening, Halikas responded to the board's announcement.

"Basically, it was the last page of a chapter that was finished five years ago. We have all moved on since then," he said.

Halikas has not conducted research at the University involving human subjects since the conclusion of the 1993 study.

According to the board's reprimand, Halikas eventually received written consent from three participants. The study used an experimental drug, Gamma-Hydroxybutyrate, to treat the recurring opiate addiction problems of Southeast Asian immigrants. According to the complaint, most of Halikas' participants were not proficient in English.

Under federal law and University guidelines, scientists conducting human research must outline the risks and benefits of a study and obtain written consent from participants.

Signatures collected from participants, known as informed consent, demonstrate participants have been told of the study's risks and have agreed to join the research voluntarily.

Halikas terminated the study after co-workers expressed concerns about his conduct during the study. The head of the Department of Psychiatry also told him to stop the study.

The board found Halikas was irresponsible in his dual role as the study's principal investigator and attending physician.

According to the board's complaint, Halikas led more than 20 research studies during the past 15 years in which he administered drugs to patients.

Halikas also served as a member of the University's Institutional Review Board from 1986 to 1993.

The board oversees the school's 5,000 ongoing research studies involving human subjects for compliance with federal ethical and safety standards. Halikas was expelled from the board in 1993, following the conclusion of the drug study.

Respect for an individual's rights to an informed choice is at the heart of the review board's responsibilities, said Moira Keane, director of the Research Subjects' Protection Program, formerly the Institutional Review Board. Keane declined to comment about Tuesday's announcement.

A supervising physician will be required to conduct a random review of Halikas' patients' charts and meet with the psychiatrist monthly.

"The reprimand does not interfere with his teaching," said Dr. Paula Clayton, head of the psychiatry department. "This was a reprimand that involved a research project."