By Lisa Seachrist

Washington Editor

WASHINGTON - Before there was Dolly or human embryonic stem cells to consider, the president's National Bioethics Advisory Commission (NBAC) was charged with developing guidelines for using stored tissues for research.

Two and a half years later, NBAC has produced a draft report encompassing 16 recommendations for bolstering privacy protections and ensuring ethical use of the wealth of tissues that have been stored in this country following routine medical procedures.

However, several industry and academic organizations have problems with the direction the commission has taken in order to achieve its goals.

"Although we agree with the necessity to protect human subjects and their privacy, and appreciate the huge effort put forth by the NBAC, we are disappointed with some of the draft recommendations," said Mark Sobel, vice president of the American Society for Investigative Pathology (ASIP). "We are gravely concerned that the commission has grossly overestimated the potential dangers in the use of coded samples, and in so doing has come up with a series of recommendations that will place obstacles in the way of worthy pursuits of the biomedical research community."

NBAC estimates that at least 280 million specimens have been stored in hospitals and research facilities in the U.S. Those tissues, which include DNA, blood, bone, muscle, skin and connective tissue, have been collected from patients who have undergone any one of a number of medical procedures or autopsy. Stored tissues are accumulating at a rate of 20 million per year.

These stored tissues have served as a rich resource for a variety of biomedical research, including the development of new drugs, genetic tests, pharmacogenetic research and epidemiology. The problem is that most people don't know that, when they sign consent forms to have biopsies and surgeries, they often agree to have the samples stored not only as a reference for their care, but also for parts of those stored tissues to be used in research.

'Identifiable' Definition Big Issue For BIO

This lack of informed consent, as well as the advent of genetic technologies that allow each of those samples to deliver an enormous amount of information about a person, led to NBAC's charge to tackle the subject.

The commission states early on in its draft report that genetic information is simply one form of medical information. Suzanne Tomlinson, bioethics counsel for the Biotechnology Industry Organization (BIO), found that statement less than conclusive, and urged the commission "to clarify in a separate recommendation that no special oversight is required for genetic information, because it is a subset of medical information."

In the recommendations set forth in the draft report, NBAC recommended that research conducted on existing and available human biological samples be exempt form regulatory oversight only when the samples are either unidentifiable, or rendered unidentifiable by someone other than the researcher.

As NBAC sees it, coded samples are considered identifiable and thus fall under the scrutiny of the institutional review board (IRB).

Tomlinson, who expressed objections to 14 of the 16 recommendations in the report, said this definition of "identifiable" is the source of most of the problems with the report.

"Clearly, the definition of 'identifiable,' and the definition of coded samples as identifiable, are our biggest issues with the report," she said. "We are very concerned about protecting subjects' privacy. We think coded samples could be used to protect patients. We think that NBAC needs to reevaluate the issue of coding and justify why they don't see it as a solution."

NBAC commissioner Steve Holtzman, CFO for Millennium Pharmaceuticals Inc., of Cambridge, Mass., agreed that the case of considering coded samples identifiable needs more justification and support.

"If using coded samples has resulted in harms, we should state that," Holtzman said. "We just don't have the evidence yet."

R. Alta Charo, NBAC commissioner and University of Wisconsin at Madison law professor, said that the major reason that the commission used the definition is that they wanted independent oversight to determine risks for research with samples that are directly traceable - and having a code makes them traceable.

But industry and academic research organizations don't necessarily see it that way. They point out that risks to human subjects occur not through the gathering of information by research, but through the misuse of that information.

"Information in itself is not bad," said Gillian Woollett, associate vice president for biologics and biotechnology for the Pharmaceutical Research and Manufacturers of America (PhRMA). "It's the fact that there are good and bad uses for that information."

Woollett and Tomlinson maintain that NBAC should instead consider coded samples unidentifiable and provide penalties for the improper use of the information by persons who have access to the coding key.

In addition, PhRMA, BIO and ASIP have concerns about recommendations that researchers go back to patients whose samples have been used for research with relevant clinical information gained from that research. The organizations oppose such a plan, because much of the research has not been validated, and the results in a clinical setting have no meaning.

NBAC has not looked at the public comments made on this report, and will be discussing those in future meetings. n

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