Sunshine Project

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Sunshine Project

http://www.sunshine-project.org

 

Asleep at the Wheel? The NIH Office of Biotechnology Activities

http://www.sunshine-project.org/biodefense/bb.html#11

 

 

Biosafety Bites #11 (3 September 2004)

 

Asleep at the Wheel? The NIH Office of Biotechnology Activities

 

As the Biosafety Bites series nears its close, the Sunshine Project

has filed ten new complaints against US research institutions that do

not maintain institutional biosafety committees as required under the

National Institutes of Health Guidelines on Research Involving

Recombinant DNA Molecules (the NIH Guidelines). The causes for the

complaints range from an IBC that approved dozens of projects without

actually meeting (ever), to IBCs that, despite explicit instructions

from NIH, continue to resist release of records that " shall be made

available " to the public.

 

It remains to be seen if NIH's Office of Biotechnology Activities

(OBA), which is in charge of the NIH Guidelines, will take action in

the new cases. OBA has remained stoically silent over 2004, a

tumultuous year to date. Complaints have been filed against dozens of

the IBCs it oversees concerning serious problems; but OBA refuses to

communicate about its investigations, if the complaints have actually

stirred OBA from its slumber and prompted a serious attempt at federal

oversight.

 

Meanwhile, arms control advocates are increasingly disconcerted with

OBA's imperceptibly slow movement to get the National Science Advisory

Board on Biosecurity (NSABB) up and running - NSABB is the Bush

administration's alleged answer to ensuring safety and good judgment

in dual-use research with biological weapons. Senior administration

officials announced NSABB with much fanfare in early March. But since

Secretary Tommy Thompson's announcement generated a wave of publicity

that gave the impression that the federal government is doing

something about dual-use dangers, NSABB has remained theoretical - a

paper kitten. Even its members remain unappointed.

 

While OBA officials fiddle with job descriptions and extend

application deadlines, hundreds of millions of dollars for research on

biological weapons agents continue to flow out of the National

Institute of Allergy and Infectious Disease (NIAID) and other federal

agencies. NIAID is an NIH agency that does not hold OBA and the NIH

Guidelines in high regard, having repeatedly funded institutions whose

biosafety committees either simply do not exist or which violate

federal biosafety rules in other ways.

 

The following paragraphs provide a brief overview of each of the ten

new complaints that the Sunshine Project has filed with the NIH Office

of Biotechnology Activities. Collectively, these complaints and those

previously submitted demonstrate profound problems with federal

oversight of biotechnology and biodefense research that will require

major actions to correct.

 

Utah State University (Logan, UT)

 

Utah State says that its IBC somehow managed to " approve " at least 48

research protocols before the committee was ever organized. Utah State

could not produce any minutes of meetings of its IBC, except those of

an emergency meeting - its first meeting ever - called after the

Sunshine Project requested its IBC minutes. At its first meeting, Utah

State's IBC leaders thoughtfully provided the committee members with a

list of the projects that the committee had approved over a period of

six and half years - before it actually existed. Utah State University

thought that it was a good candidate to receive a BSL-4 National

Biocontainment Laboratory grant from NIAID and has a virology

institute that actively advertizes its large collection of biological

weapons agents and its knowledge of how to manipulate them.

 

The State University of New York at Stony Brook (SUNY-SB)

 

SUNY-SB conducts a large amount of NIH and DOD-funded biological

weapons research, yet its IBC maintains atrocious records that it

holds for up to a year and a half before release to the public. To top

it off, SUNY-SB has decided to consider its IBC records 'informal' and

'intra-agency', allowing it to invoke New York State open records law

to gut the content of its already poor IBC minutes. In addition to

maintaining inadequate records, SUNY-SB's stance on records access is

in direct conflict with the NIH Guidelines, which require that the

documents be promptly released, that they be formal records, and that

they be public (as opposed to " intra-agency " ).

 

The Salk Institute (La Jolla, CA)

 

The renowned Salk Institute, a major recipient of federal research

money, cannot produce a single page of minutes from any meeting of its

institutional biosafety committee. Salk claims that none of its work

on items such as anthrax toxins, genetically-engineered viruses, and

gene therapy techniques requires review by an institutional biosafety

committee. Salk's moribund IBC is an interesting example of what the

Bush administration calls the 'culture of responsibility' among

institutional biosafety committees.

 

The Donald Danforth Plant Science Center (St. Louis, MO)

 

Like Salk, the Danforth Center is an interesting example of just how

strong the biosafety " culture of responsibility " is among prestigious

institutions. On its Board of Trustees, the Danforth Center counts the

President of the National Academies of Science, the current or former

CEOs of the Monsanto, Merck, and McDonnell Douglas Corporations, and a

fistful of university presidents. The Danforth Center receives funding

from NIH and USDA; but it does not have an IBC that works. It can

produce minutes of only one meeting, a meeting that was called two

weeks after the Sunshine Project requested Danforth's IBC minutes. At

the meeting, IBC members were introduced to concepts such as what an

IBC is, and what its responsibilities are - suggesting that the

meeting was, in fact, the only IBC meeting that has ever taken place.

Danforth's IBC membership does not comply with the NIH Guidelines and

its IBC does not meet to review the safety of biotechnology research

at the institute.

 

Carnegie Mellon University (Pittsburgh, PA)

 

Carnegie Mellon's IBC has, for at least two and a half years, been in

an ongoing state of sporadically trying to organize itself and to

first identify all of the biotechnology research on campus that it

needs to oversee. In 2002, the nascent Carnegie Mellon IBC deferred

approval for a whopping 11 research projects, saying that they needed

to be addressed at the IBC's next meeting. The 11 projects were never

heard from again. At the next meeting, which occurred more than a year

later, there is no mention of them. The Sunshine Project asked

Carnegie Mellon what happened to these projects. The University said

it would respond; but in the end it didn't. It appears that at least

some of the projects were " approved " without actually being reviewed.

 

Medical College of Wisconsin (Milwaukee, WI)

 

The Medical College of Wisconsin (MCW) has more than 4,000 employees,

1200 students, and receives almost $120 million in annual research

grants, many of which come from NIH. Its research includes a wide

variety of biotechnology studies and work with the biological weapons

agents plague and botulinum toxin. MCW cannot produce any meeting

minutes because it says its Institutional Biosafety Committee has

never met.

 

Medical College of Georgia (Augusta, GA)

 

With 750 faculty, over 2000 students, and $169 million in external

funding, the Medical College of Georgia (MCG) also dips into NIH's

coffers for biotechnology research grants. Unlike MCW, MCG can produce

some IBC minutes; but the problem is that its IBC doesn't do its job

of reviewing research projects to ensure safety - not even for BSL-3

projects. MCG says, " Our IBC does not meet as a committee to review

protocols " . In violation of the NIH Guidelines, the MCG IBC has

effectively abdicated responsibility for biosafety and instead devotes

its meetings to discussion of how biosafety paperwork can be made

" very user-friendly " , expedited and simplified.

 

Washington University (St. Louis, MO)

 

The Sunshine Project first complained to OBA about Washington's

refusal to properly release its IBC records in March of this year. In

one of its very few public actions related to the Sunshine Project's

complaints, OBA did direct Washington University and other IBCs to

provide copies of their IBC minutes. But Washington University, which

has hundreds of ongoing NIH-funded projects, is effectively refusing

to obey an explicit order from OBA. (Other institutions, most notably

Iowa State University, are also reluctant to comply.) While Washington

University openly defies OBA and the NIH Guidelines, NIH research

grants continue to flow into its coffers, thus revealing how

extraordinarily weak US government oversight is of laboratory biosafety.

 

University of Kansas Medical Center (Kansas City, KS)

 

The University of Kansas Medical Center (UKMC) refuses to release its

IBC records unless requesters explicitly agree to a set of terms and

conditions that are posted on its website. UKMC's position violates

the NIH Guidelines, which require release of IBC records to the public

upon request.

 

University of Nebraska Medical Center (Omaha, NB)

 

The University of Nebraska Medical Center (UNMC), which entertains

notions of building a biosafety level four laboratory, cannot produce

a single page of minutes from a meeting of its institutional biosafety

committee. After six months of playing e-mail footsie, Nebraska

finally decided that it could come up with documents from alleged

" electronic meetings " of its IBC. Curiously, the records of these

" electronic meetings " are not available in electronic format. Having

ignored the requirements of the NIH Guidelines and delayed its

response, Nebraska has now invoked its state open records law and says

that it can only release the paper version of its electronic records

in return for nearly $100, a prohibitively high cost for almost all

public requesters.