United Press International - Wednesday, September 22, 2004
Dee Ann Divis, ddivis@upi.com

At least twice, local biosafety officials have recommended dropping the procedure for liability and ethical reasons, scientists told a research safety committee meeting in Bethesda, Md., Tuesday.

The procedure, called serial serum sampling, involves taking regular blood samples from staff and storing them in a serum bank for future reference. Blood contains antibodies -- cells created to fight infection. Because specific antibodies are made for each type of infection, the samples would indicate what illnesses that person had experienced up to that time. Samples generally are collected annually and stored.

By testing after someone is accidentally exposed, and then comparing that sample to the earlier one, doctors may be able determine more quickly if a new infection has occurred, explained Ralph Baric of the University of North Carolina at Chapel Hill. Baric is using genetic techniques to study SARS. His lab does do serum sampling.

"If it allows you to diagnose three or four days earlier ... that could save your life. I'm all for it," Baric told United Press International.

Yosihiro Kawaoka, a researcher at the University of Wisconsin in Madison, told meeting attendees that his lab did not take serum samples because he had been advised not to.

Kawaoka is using reverse genetics to research the strain of influenza that killed 30 to 40 million people in a world-wide pandemic in 1918. He spoke to a Tuesday meeting of the Recombinant DNA Advisory Committee about his research and the safety precautions taken in his lab. The RAC, sponsored by the National Institutes of Health, is drafting safety guidelines for recombinant DNA research on pathogenic viruses.

Robert Webster, who spoke at the meeting about his research on highly contagious avian influenza, said he, too, had been advised not to take samples. Some of the influenza viruses Webster is studying could be select agents to which anti-terrorism measures would apply.

"I argued with our biosafety officer not to let them remove this from my facility," said Webster, who works at St. Jude Children's Research Hospital in Memphis. "My argument was that my staff was willing to have this and not have their names associated with it. Let's do it. It's absolutely essential from my point of view that this is done."

Webster, whose lab does serum sampling, said they needed the tests to be confident safety precautions were working.

"This is information that is vital," he added.

It is, however, up to the institution to decide if it wants to do serum banking. The National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" state it is the responsibility of the institution to "determine the necessity for health surveillance of personnel involved in connection with individual recombinant DNA projects; and if appropriate, conduct a health surveillance program for such projects."

The "maintenance of serial serum samples for monitoring serologic changes that may result from the employees' work experience" would be a component of such a program.

The NIH guidelines also point to certain types of research in biosafety-level-3-rated labs as the sort where serum sampling should be considered. Both Webster and Kawaoka are studying potentially dangerous, possibly genetically modified, viruses in BSL-3 labs.

Such testing is not a requirement, however, confirmed Deborah Wilson, chief of the occupational safety and health branch at the NIH Office of Research Service.

It is widely recommended, however, she noted.

"It was a surprise to hear that there was a difference of opinion," Wilson told UPI,

She said the Recombinant DNA Advisory Committee likely would recommend serum sampling for projects using genetic recombination to study viruses.

The reasons institutions might resist keeping serum banks have to do with ethics and liability both Webster and Kawaoka said they were told.

"It was the ethics of privacy ... privacy and liability," Webster said.

One concern was that private information -- the HIV status of a person, for example -- might be inappropriately revealed by the tests. One attendee suggested that staff may resist serum sampling because a positive test showing someone had been infected would reflect badly on his or her work habits.

A serum bank may also cause liability problems, at least in part, because of storage and record-keeping requirements.

James Gaut, director of environmental health and safety at St. Jude, gave two hypothetical examples of liability issues an institution could face.

Someone may be accused of a crime, he said, where the blood sample could prove guilt or innocence. Or, someone could sue over exposure to a disease and want to use the sample to prove their case. In such instances, he said, the institution would be on the hook to prove the sample was properly stored, recorded and controlled.

"We would have to have rigorous controls in terms of how we obtained our samples and stored our samples -- to show chain of custody -- to establish that the samples we had weren't compromised," Gaut told UPI.

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