Tests Continue at Fort Detrick

April 03, 1994|By ANN LoLORDO

Today, the Army's infectious disease research institute in Frederick is still using soldiers to test new vaccines for malaria, hepatitis, dengue fever and other exotic diseases.

But the human testing program is subject to greater review than its predecessor of 20 years ago.

Since 1975, when the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick revived its human testing program, there have been about 120 medical research projects with a need for an estimated 2,520 volunteers, according to Carol Linden, director of research plans and programs at the agency, known by its acronym, "USAMRIID."

The men and women who are willing to participate in a medical research project at Fort Detrick have only one requirement -- attendance at the meetings that explain a study.

Soldier volunteers have helped test vaccines for diseases that the Army fears may be used against its troops in biological warfare and for other fevers endemic to the far corners of the world where America's military serves.

The list reads like a who's who of exotic illnesses: anthrax, plague, Ebola virus, Congo Crimean hemorrhagic fever, Lassa fever and others. The program does not use humans to test diseases for which there is no treatment.

The agency also contracts with universities, research facilities and private firms to do similar research involving human subjects. In the past, both the University of Maryland and the Johns Hopkins University have done Army-funded infectious disease research.

The Army's work in disease research predates World War II. Fort Detrick's use of human volunteers, however, began in the mid-1950s when the Army recruited Seventh-day Adventists for Project Whitecoat, which operated there between 1954 and 1973.

The program, unlike other government-sponsored human testing programs now in the news, briefed volunteers on the risks of participating and sought their consent in writing.

The Army didn't adopt formal regulations on use of human

subjects in research until 1962. With the enactment of federal regulations on the use of research subjects in the mid-1970s, the Army created local review panels in 1975 to oversee and protect the rights of volunteers.

"Our consent process is a lot stricter than what goes on in the civilian community," said Maj. Dale G. Vander Hamm, head of the Human Use Review and Regulatory Affairs Division of the Army Medical Research and Development Command.

The review process is multitiered. A proposed research study is reviewed by three panels, including a board that reports to the Army surgeon general. Areas of review include the project's scientific validity, risk to volunteer subjects and level of informed consent.

Some of the projects have been modified as a result of those multiple layers of scrutiny.

An explanation of a study may be written in plainer language; a researcher may be asked to include more test subjects; the process of inoculating volunteers may be staggered to reduce exposure to volunteers, officials said.

The consent forms describe a project, from possible health risks to the amount of blood to be drawn.

If the prospect of possibly contracting an exotic disease or being stuck with a needle daily for a week sounds unappealing, the soldier volunteers can decline to participate in a project. And if in the midst of a project they want to quit, they can do that, too.

"With no questions asked," said Col. Ernest T. Takafuji, the physician who commands USAMRIID.

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