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.
(Today’s victim: The USDA National Wildlife Research Center, read on!)
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.
How? Sometimes, FOIA and state laws can be interpreted – often disingenuously – to be more restrictive than the Guidelines. These laws may give institutions that want to deny your request the chance to hide more information, which is the raison d’être of every sad little cubicle ogre. These laws also provide for ways to throw up procedural obstacles – like Tennessee’s residency requirement – and to create long delays answering your request. All of these things are inconsistent with the obligations of Guidelines themselves.
So, here’s one of the biggest rules of requests under the Guidelines:
Never file a Freedom of Information Act Request, or a state open records request for materials available under the Guidelines.
And the corollary:
Refuse to consent, and explicitly object to any move by an institution to convert your request under the Guidelines into a FOIA request or one under a state open records law.
A request under the Guidelines is not a request under FOIA or a state law. Your right to IBC records, “upon request”, is established in the Guidelines themselves. It is not dependent upon FOIA or any state law. It’s a request under the Guidelines, and that’s all you need to cite.
Think about it. If a university or other entity wants to turn your request under the Guidelines into a state or federal FOIA, they are not trying to help you. They are doing it for their own reasons, and chances are very high that those reasons are not in your interest.
You don’t use a hammer to crack an egg, so don’t use the wrong tool for an IBC records request job. The right tool for IBC records are the Public Access Provisions of the NIH Guidelines.
Often the way this plays out is that you properly present a request under the NIH Guidelines, and that would be to the Biosafety Officer (BSO) / Responsible Official (RO) or IBC Chair. If you don’t know who these people are at the institution(s) you are interested in, all you have to do is ask NIH, they will tell you. Sometimes when I can’t find the right person I’ll just send a request to the institution’s director, which might technically not be quite right, but I might not want to wait a day or two for NIH to get back to me.
The BSO / RO or IBC Chair will sometimes provide an initial reply to your request, or forward your request to the snarling cubicle trolls in the legal or “marketing” office. Either way, there is a good chance that you will get a first response that looks something like this:
What’s critical at this juncture is to not take the bait. The institution has signed a contract, or is subject to a regulation, that legally obliges it to follow the Guidelines. And at this point, you have already properly lodged a request under the Guidelines. You have sent an e-mail to the right person that mentions the Guidelines and that reasonably describes the records requested. You have done your part. There should be literally nothing more for you to do except to wait a short and reasonable period for your records.
If you take the bait and submit a request to Mr. Bob Davis or fill out the linked form, chances are high that you’ll be screwed. Your request will become a state law request and the institution will attempt to use all the means it is afforded in that law to try to mess you up and stop release of records, particularly of anything embarrassing, like lab accidents.
An effective way to parry such a reply is as follows:
Any demand for you to file a state open records request (or a federal FOIA request) should be bounced right back at them. Put the IBC and/or BSO – RO back into the loop if they have been taken out. Tell them you refuse to file a state request (or FOIA) because you are not obligated to, but that they are obligated by the Guidelines to send you the records.
Obfuscations about state laws have definitely gotten worse over the years. I have recently started preemptively copying the NIH Office of Science Policy on these sorts of exchanges. At time of writing, the people you should copy are Jessica Tucker (email@example.com) and Kathryn Harris (firstname.lastname@example.org). They, supposedly, enforce the Guidelines.
Hopefully, the resistance ends here, and you get your records. If not, don’t mess with the institution any more. Instead, send an e-mail to the NIH officials above indicating that you are lodging a formal complaint against the offending institution for noncompliance with the NIH Guidelines. Ask that NIH terminate the institution’s rDNA research funding (but don’t hold your breath on that remedy).
If things reach the level of a complaint to NIH, it’s probably a good move to escalate who you copy at the institution. Find the Chancellor of Research if it’s a university, and/or the President or chief compliance officer. Looping in the higher ups causes the institution to have more skin in the game.
But there’s a catch … sort of
There is a complication that I have thus far avoided mentioning in the interest of being extremely clear that you should never mix up your Guidelines requests with state law or FOIA.
And that’s that NIH will allow institutions to process your request using locally applicable open records procedures, i.e. state laws or, for federal labs subject to the Guidelines, FOIA. We’ve established that you don’t have to, and should never use those laws yourself, but institutions can – with important limitations – treat your request like it was a FOIA.
You might now be thinking, “Well, crap, if they can treat it sorta like a FOIA, what’s the point of being so insistent about the Guidelines?”
Well, there are two big reasons, and a number of smaller ones. The big reasons are:
1. Contemporaneous Access
The Guidelines very clearly intend for committee transparency that is contemporaneous with committee actions. To be transparent and accountable as required by the Guidelines, the IBC needs to release its records in a timely manner, so that the public can review them and offer comment or criticism on a reasonably contemporaneous basis. This local accountability is impossible if an IBC’s records take many months or even years to be released.
Some state laws allow institutions to park open records requests, especially requests that they don’t like, for years at a time. I’m looking at you, California. This is also true of practices at some federal agencies’ FOIA offices. I have unanswered FOIA requests to the USDA Agricultural Research Service that date to the Obama administration.
Let’s say that – over your hopefully strident objections – an institution sends your Guidelines request to the FOIA office for a reply. You might still be waiting months later with no records in sight. While the institution might be able to get away with that under FOIA or state law, it cannot under the Guidelines. Or should not. Fight back, because the Guidelines are on your side (if you can get NIH to enforce them).
When facing delays, don’t go to the university and say something like “Well, the California Public Records Act requires you to answer me within two months” or some such typical FOIA plea. The open records offices in California (and some other states), trust me, know how to ostensibly stay within their law but not answer your request until you die or file a lawsuit, if that’s what they really want to do. And you didn’t file a CPRA (or similar) request anyway.
Instead, you go to NIH and lodge a complaint as per the previous section.
2. Disclosure still has to comply with the Guidelines
Even if your request was, regrettably, sent to the cubicle trolls to be treated in large measure as if it were a state request or FOIA, the standard of disclosure that the reply must adhere to is that of the Guidelines. What this means, for minutes, was the subject of a post a few days ago, Good Minutes and Bad “Minutes”.
This is where some of the most interesting action happens – when (alleged) state laws or agency FOIA practices diverge from the requirements of the Guidelines. My first run in with this was in 2004, when the University of Texas Medical Branch (UTMB) claimed that its IBC records were those of a “medical committee” and as such were completely exempt from disclosure under Texas law. They went so far as to get the Texas Attorney General to issue a ruling to that effect, despite the utter falsehood of UTMB’s pretense that IBC minutes relate to medical care and should be treated as if they were patient records.
The gnomes at UTMB and the University of Texas System’s counsel’s office were probably exchanging high fours and breaking out the fried worm snacks in celebration after completely shutting down my requests with the ruling. Until I complained to NIH. Uncharacteristically, NIH responded fairly vigorously to the situation. The University of Texas was apparently informed that its federal funding was in jeopardy and within a few months it legally reconstituted the IBCs at all of its medical institutions in a way designed to specifically to evade the very Attorney General’s ruling that UTMB had begged for and won …. and I got my minutes in the mail.
There is a similar situation to the UTMB showdown that is brewing right now with another major US university system whose flagship campus has ridiculously decided that, under its state open records law, it can entirely withhold any document related to “research”. Stay tuned on that one.
Often it’s less dramatic than a legal showdown. The trolls typically get out their big black pen and start redacting records as if it was business as usual under their state law. “If in doubt, black it out.” But the applicable standard for Guidelines compliance is the Guidelines themselves, not the imaginings of a mean-spirited troll who is rewarded for screwing you.
For example, citing state laws, institutions commonly and impermissibly redact the names of their professors and/or the IBC members from records. They do this despite the fact that professors obviously publish their research, and federal agencies like NIH and USDA also publish the names of grant recipients and summaries of the funded research. And usually the professor’s name is associated with the research on the university’s own website, but still the satanic cubicle minions will black it out in their mindless, ceaseless, depressing war against the very same public that pays their salary.
But fighting back works. Many times have I seen “mandatory” redactions under state laws suddenly disappear – “Oh, did we trolls say that was the law here in Underworld? I’m sorry, that was a bad troll, we ate him.” – when it becomes apparent that they have gone too far and brought what they allege to be their state law into conflict with the Guidelines.
And notably, if we’re talking about a private entity, there is no applicable state law nor FOIA, so the Guidelines provide the only reference point. This is one important reason why the standard has to be national and consistent. More on private entities in the future.
The way to deal with inappropriate redactions pursuant to FOIA or state laws is the same as with delays. Don’t go back to the institution citing open records law, instead remind the institution of the obligations of the Guidelines and tell them to unredact. If they don’t budge, don’t hesitate to escalate to NIH.
Gene Drive Standoff with USDA
The USDA National Wildlife Research Center in Fort Collins, Colorado is not, as some might think, about giving grizzlies a massage or counting Bambi’s spots. They deal with some significant biosafety related issues, like the chronic wasting disease sweeping through the West. And – this may surprise you – it is planning (or may already be conducting) what are arguably some of the most dangerous gene drive experiments undertaken anywhere.
Working with scientists at North Carolina State University and Texas A&M, the Wildlife Research Center’s Toni Piaggio is planning to – or might already have – set gene drive mice loose in a very large and unusual contained habitat at the Center, with the eventual goal of liberating into the wild mice that are engineered with a gene drive so that their offspring that should have been male have shredded Y chromosomes, making them sexless, and causing the population to crash. The idea is to release such animals on islands where mice are invasive and thereby eradicate the rodent population. The problem is what happens if these gene drives get off the island, or escape from the lab.
This makes the biosafety records of the National Wildlife Research Center quite interesting. The facility is unusual and the stakes high. How are they ensuring containment? Is the lab well run? What are the contingency plans? Have there been accidents before? The questions go on and on, because if there was a failure, there could be rather dramatic consequences. Misplaced mice rank high on the scale of common lab mishaps.
While a number of USDA labs have recently responded to my requests for IBC minutes without incident, the National Wildlife Research Center is not one of them. I have been trying to get the minutes of the National Wildlife Research Center’s IBC for months, but Jason Suckow, the Center’s Director, steadfastly refuses to honor requests pursuant to the Guidelines. If you’ve read this far into this post, you probably know why.
Though I have explained the salient points in this post to Suckow, and encouraged him to contact others in USDA, he stubbornly insists that I cannot have his IBC minutes, and am not entitled to learn about the gene drive experiments, unless I file a FOIA request. Then who knows what happens.
Not only is Suckow wrong in point of fact, his position is remarkably arrogant given that the records in question are of obvious public interest. Why would he not want to release such records?
Which now leads to the necessity of lodging a complaint with NIH. NIH, though, has always been quite reticent to intervene when other federal agencies are involved. But, as the keeper of the Guidelines, it should not sit back and permit different standards for different labs. Stay tuned.