The possibility federal research dollars for life science research will be linked to rules aimed at thwarting terrorists looks more serious.

Mary Groesch, senior adviser for science policy within the National Institutes of Health's Office of Biotechnology mentioned just such a link when she described to a college audience recently how the new National Science Advisory Board on Biosecurity would work. She also floated the possibility new regulations could be extended to research that is not federally funded.

The still forming NSABB will develop a code of conduct for scientists and lab workers conducting dual-use life sciences research -- research with legitimate purpose that could also help bioterrorists if misused. Examples include experiments demonstrating how to render a vaccine ineffective or to increase the virulence of a pathogen.

The NSABB also is tasked with developing a set of guidelines for the nation's roughly 400 Institutional Biosafety Committees to use in evaluating such research. Under the guidelines, experiments in specific key areas would have to be reviewed before being published or perhaps even undertaken. Advance reviews are well established for recombinant DNA research, but have not been installed in such a broad way for biological or other life sciences research.

As things stand, however, the code and guidelines lack teeth. Under the NSABB charter, signed last March, the board is only empowered to advise agencies supporting such research.

What (the NSABB) might recommend (as an initial priority) is how to give themselves some teeth, said Stephanie Loranger, biology issues director for the Federation of American Scientists. The recombinant DNA advisory committee is an advisory committee, but the (National Institutes of Health) tied those guidelines to funding. The NSABB could recommend something similar or the NIH could do something similar.

Indeed, it appears the Department of Health and Human Services, under which NIH operates, may be inclined to establish such a link.

In describing the board, Groesch told a meeting of Student Pugwash USA in Washington last week: Basically, the government would say, 'OK, this is a rule now.' Everyone that receives government money for life sciences research has to be trained or be told about this code of conduct and they need to follow it.

She noted worries within the science community that privately financed labs would not be required to adhere to the rules.

There are concerns because these guidelines will be implemented for laboratories that receive federal funding, Groesch said. "That could leave a lot of private industry out of the loop and they wouldn't be subject to any of these biosecurity policies. Some people think we need to have regulations that reach out to all sectors that are engaged in biosciences research.

I think we are just going to have to see how it goes, Groesch said. If new laws or regulations are needed we'll have to address that.

Whatever the final decision on regulating private labs, linkage to federal funding makes the rules -- and the composition and operation of the board crafting the rules -- much more important.

Unfortunately, formation of the NSABB is, well, a bit behind schedule.

With a first meeting planned for sometime this fall, staff, including the executive director, remain to be hired. No voting board members have been named.

About 40 nominations for membership have been submitted by the public and the deadline for federal agencies to nominate members was July 14 -- though names from the agencies are still trickling in, Groesch told United Press International.

Some progress has been made. The 15 federal agencies with an interest in life sciences research have each selected someone to represent them as a non-voting, ex-officio member. Groesch's office will work with the ex-officio members to prepare an initial slate. That list will go to HHS, which will screen the nominees for conflicts of interest and make the final selections.

Just this process, however, is going to take a while. The newly selected board members, and the 13 members of the NSABB staff, also are going to have to obtain a secret-level security clearances. Though such clearances are fairly common they can be time consuming to obtain.

At this point it is difficult to imagine how the NSABB is going to get up and running, much less hold its first meeting, before the November election. Should the current administration lose, the entire NSABB process will likely fall into political limbo. It would be months, if not a year or more, before the new administration sorted itself out, selected agency personnel and then, eventually, named members to NSABB.

A new administration also could just decide to forgo an NSABB. Ultimately the board is still just a federal advisory committee. It has no authority in law, explained one expert who asked not to be named. If a new president is elected, or the Bush administration changes its mind, the NSABB could simply be disbanded.

Whatever happens there are risks -- risks that the board will change the way researchers work -- or else -- and risks that terrorists might get help no one wants them to have. There also are risks if the board does nothing.

In my mind the worst thing that could happen is that there would be another bioterrorist attack before any kind of guidelines are recommended Loranger said. I worry that Congress would overreact to another terrorist attack.

With so much at stake, one might think scientists would pay more attention.

My opinion is that the (life sciences) community actually isn't really aware of this, Loranger told UPI. I am not really sure that they have any idea of what is going on.

Dee Ann Divis is UPI's Senior Science & Technology Editor. E-mail [email protected]