[Today includes discussion of a sewage spill at USDA’s Ames, Iowa lab, and an interesting incident of the biosafety staff at a major northeastern institution rebelling against an IBC reluctant to report problems.]
You’d be forgiven for thinking that this post is about a tuberculosis lab accident. It’s not. At least not exactly. It’s about many of them, and what they mean, and don’t mean, as best as I can determine at this point in time.
For the past several months I’ve had FOIA pending with NIH for reports of lab accidents. In some cases, I am also requesting such reports directly from the institutions themselves. At this point, neither process is complete, so my observations are based on incomplete data.
The potential for accidents, and here I include unintended but potentially dangerous outcomes, is the single biggest reason for the existence of the Guidelines. And the potential for those accidents to have (human, animal, or plant) health, economic, and reputational impacts on the public is the biggest reason for the existence of the Guidelines’ Public Access Provisions.
There are a lot of issues to unpack and discuss about lab accidents and their reporting. This first look is only an overview. This is not a post about any specific lab accident, although you can expect such posts in the future.
One of the purposes of this website is to document a few things I’ve learned from years of tracking Institutional Biosafety Committees using the Public Access Provisions of the NIH Guidelines. The aim is to be useful to others who will file future requests. In addition to talking about the intersection of the Guidelines and laws, this post is a bit of a walk through of an NIH Guidelines request that may help you not fall into traps that I learned about the hard way.
A few days ago, the question of how the Guidelines relate to state open records laws first came up in reference to the dysfunctional situation at the University of Tennessee. This post goes further into the Guidelines’ status vis-à-vis FOIA and state records laws, because it is a really quite an important issue. If you don’t know how these different obligations relate to one another, and don’t relate to one another, the sociopathic but clever lawyers at universities and other labs will use your ignorance to screw you left, right, and center.
Until recently, the Recombinant DNA Advisory Committee (RAC) served as the country’s highest level review body for novel biotech research safety questions. But NIH disbanded it last year. That leaves, in most circumstances, the frequently dysfunctional local Institutional Biosafety Committees (IBCs) to be the first – and last – line of defense against really stupid ideas and screw ups.
The Texas Biomedical Research Institute (TBRI) is a strange and secretive institution whose large, roughly triangular facility sits at a major intersection on San Antonio’s I-410 highway loop. The folks buttering their cornbread and sipping sweet tea across the road at Cracker Barrel probably have little idea what happens there, and that’s a good thing for appetites.
The fences that ring TBRI are unlike those at San Antonio’s many military installations. Rather than keeping intruders out, the ring around TBRI is primarily to keep the inhabitants in. Specifically, about 2500 primates, including more than 50 chimpanzees and the world’s largest colony of captive baboons, who are probably pretty pissed off about what is done to them in TBRI’s labs, which include one of the nation’s maximium containment biosafety level four (BSL-4) facilities.
The quality of biosafety committee meeting minutes ranges from being quite good (rare) to abysmal (not so rare). In future posts at this website, I will make reference to the quality of disclosure by IBCs in their minutes and other records.
So here at the outset it’s a good time to discuss what IBC minutes should and shouldn’t be. To do that, today’s victims are the University of Texas at Austin and Northwestern University in Evanston, Illinois.
Some universities try to use state laws to prevent release of records under the federal NIH Guidelines. This problem most frequently occurs in states with lousy open records rules. The worse the state law, the more likely the university will try to use it against requests for IBC records.
But state laws have nothing to do with the NIH Guidelines and cannot be used to undermine the Public Access Provisions. That doesn’t stop the universities from trying, however, and they are effectively encouraged to do so because of the NIH Office of Science Policy’s (OSP) extreme reluctance to enforce its own rules.
The Public Access Provisions of the NIH Guidelines, as they apply to records, are short and simple. Consisting of a single paragraph, they say that Institutional Biosafety Committees (IBCs) must release to the public their meeting minutes and all other related records that their funders are required to release. Like so:
Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. If public comments are made on Institutional Biosafety Committee actions, the institution shall forward both the public comments and the Institutional Biosafety Committee’s response to the Office of Science Policy, National Institutes of Health ... – NIH Guidelines at Section IV-B-2-a-(7)
In simple terms, what this obviously means is that, in addition to minutes, if the institution holds other records* related to rDNA research that can be obtained from a government agency under the Freedom of Information Act (or other law), then the IBC has to release those records on request. And that such records exist is effectively always the case, because nobody gets a federal grant or contract without paperwork.
I am a student of history, but I don’t profess to be a historian of the NIH Guidelines nor of biotech research in the United States. Although I do hope that if a history of this obscure topic is one day written that I will earn at least some mention for the work I’ve put in, on and off for twenty years, to preserve the public right to know about the research that it funds at American universities, research institutes and, sometimes, private companies.
The starting point is, really, a deal that was cut over a period of years in the mid to late 1970s between the US government, represented mainly by the National Institutes of Health (NIH), and an assortment of leading biologists representing their disciplines. The deal was about how to govern the safety of genetic engineering experiments, which were starting to happen in earnest at the time.