http://dailynews.yahoo.com/h/abc/20010723/hl/wnt_medicalresearch010723_1.html

Monday July 23 09:00 PM EDT

Is Medical Research Safe For Volunteers?

By Lisa Stark ABCNEWS.com

If you volunteer as a test subject for research, what assurances do you have that it's safe? Not enough, some experts caution.

There are thousands of medical studies underway at any given time in the United States, involving hundreds of thousands of people.

The recent death of Ellen Roche, 24, a volunteer in an asthma research study at Johns Hopkins University, prompted an investigation, and led to new questions about just how safe people are when they become research subjects.

Federal regulators and the university today reached an agreement that allows research to resume at the university with certain exceptions. Regulators had ordered a halt to enrollment of new participants in research studies at Johns Hopkins.

Oversight System Called Overburdened

For the most part, leading researchers insist, studies are conducted correctly and ethically.

"There are many safeguards in place all of which are intended to ensure that patients who volunteer to participate in these trials are protected," says Dr. Richard Schilsky, director of the University of Chicago Cancer Research Center.

But a government report three years ago warned that the system to oversee medical studies is seriously strained.

"The oversight system in the country at present is broken," says attorney Alan Milstein, representing Dawanna Robertson, who feels she was mistreated in a study when she was pregnant. "It's a disaster."

Independent review of research involving human participants in the United States primarily has been a local matter since its inception. Each institution has a review board that oversees human participants in their institution's research.

The boards approve and monitor the studies, and ensure benefits outweigh risks and patients are fully informed. But now, some experts say, the system is overloaded.

"The research ethics committee is supposed to review each protocol to do research that comes before them," says Thomas Murray, a medical ethicist. "In the old days, this committee might have had to deal with a handful. Now they have to do hundreds or thousands a year."

A Loss of Trust

Robertson was pregnant when she took part in an experimental cancer vaccine study at the University of Oklahoma two years ago. Research stopped after more than 40 safety violations.

"He took away all the trust that I had, and he never answered any of the questions that I have," Robertson says of the head researcher of the study. "He put my baby at risk. He lied to me about that."

In the Johns Hopkins trial, the government faulted the review board for not doing its job.

Researchers say the Hopkins case is a wake-up call, that institutions must do better in protecting the safety of research volunteers.

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