The Sunshine Project
Biosafety Bites (v.2) #20 - 11 December 2006

 

IBC EnFARCEment II: OBA Tackles the Salk Institute

Introduction
"One of the world's premier research communities" boast grant applications from the Salk Institute of La Jolla, California. Founded by Jonas Salk of polio vaccine fame and the home of Francis Crick, the co-discoverer of DNA, from 1977 until his death, the Institute doesn't suffer from a lack of self-confidence.

The US National Institutes of Health (NIH) seems impressed, sending it more than $57 million in federal handouts since 2002. In fact, NIH thinks that Salk is so special that it is not required to obey the rules. Two years after Salk's IBC was demonstrated to be a failure, Salk still hadn't addressed the problems and NIH hasn't imposed any penalty.

When it comes to IBCs, think of the Salk Institute as a sort of Rockefeller University (see Biosafety Bites #5) of the West Coast. There are just too many important people there to worry about a biosafety committee to keep tabs on the research that goes on.

Noncompliance Identified
For an undetermined number of years, the Salk Institute didn't bother to keep a working institutional biosafety committee (IBC). They had a list of names, sure; but an IBC that met and reviewed research? "Too burdensome", Salk's Principal Investigators and management probably whined, perhaps even as they signed yet another legal assurance of compliance to the federal government. Making that safety assurance is, after all, a pesky requirement for receiving each and every one of those 57 million dollars that was for research involving recombinant DNA.

The NIH Office of Biotechnology Activities (OBA) is charged with enforcing IBC rules and making sure those assurances are more than signatures on a piece of paper. But NIH OBA didn't detect the fact that the Salk IBC was effectively nonexistent and did not meet (before August 2004). Instead, Salk and OBA danced along together, OBA in willful ignorance, Salk indulging it, each pretending to know that an IBC existed to oversee the work at Salk's La Jolla labs. It was a charade that suited them both.

Then, in early 2004, the Sunshine Project asked Salk for its IBC minutes. It's Biological Safety Officer, regaled as a leader of his field (seemingly like everything at Salk), replied in June 2004 that Salk couldn't produce any IBC minutes because the IBC didn't meet and Salk didn't conduct any research that needed an IBC's supervision anyway.

But interestingly, it later became apparent, he also convened the first IBC meeting in recent memory a few weeks later (for a single project involving mice and some moderately hazardous microbes).

Salk's Research Portfolio
Salk has not, as far as the Sunshine Project is aware, heavily invested in biodefense or "classical" biotech research with a very high lab biosafety risk. It does, however, have BSL-3 labs, an anthrax toxin project, an animal biohazard suite, and a primate lab. Day in and day out, it is apparent that Salk scientists do a great deal of biotechnology, especially with transgenic animals. For example, Salk is finding genes from the fugu, a famously poisonous kind of pufferfish, that can regulate the central nervous systems in transgenic mice.

Salk has its own synthesis core for short strands of genetic material. And its internal listservers (the archives are public) chatter about ordering oligos (DNA sequences) in addition to the usual "Who took [X] out of my freezer?" and "holiday party next week" fare.

OBA Slouches Into "Action"
Although NIH probably sent annual letters to Salk expressing satisfaction at their "partnership" for biosafety (like OBA does for most IBCs), OBA did not detect noncompliance by Salk because there are no significant reporting requirements for IBCs.

Because Salk could not produce any IBC meeting minutes, the Sunshine Project filed a complaint against it on 1 September 2004. A committee that never meets is obviously not executing its responsibilities. The complaint asked for suspension of Salk's NIH funding, the penalty supposedly levied on institutions that that receive NIH biotechnology funding; but that fail to properly maintain an IBC.

At the end of 2006, NIH OBA is fighting to keep its correspondence with Salk a secret, implausibly claiming a Freedom of Information Act exemption designed to keep current FBI criminal investigation files confidential. But there's no real NIH OBA investigation going on. To compare NIH OBA's investigatory talents and dedication against those of the FBI would be like pitting a toy poodle against a pride of starving lions, i.e. one of the greatest legal and bureaucratic mismatches in history. (A Sunshine Project appeal of OBA's FOIA denial is pending.)

But, ironically, Salk's reply to a 2006 request for its meeting minutes reveals much of what NIH OBA doesn't want the public to know.

No Result from NIH OBA "Enforcement"
Two years after Salk's noncompliance became apparent, the issues remained unresolved. The Salk IBC, as of 13 September 2006, is still effectively non-functional and the Institute's research portfolio has not been reviewed to identify errant research and unreviewed projects.

Yet Salk is paying no penalty for this ongoing noncompliance, which is taking place with the full knowledge of NIH. In fact, from the timing of Salk IBC meetings (a few months after the Sunshine Project requests minutes) it seems that Salk may be more likely to react to Sunshine Project than it is to an "enforcement" letter from NIH OBA.

According the minutes of the second ever Salk IBC meeting, held on 13 September 2006, NIH OBA sent Salk a letter in October 2004. It is very likely that this letter was essentially identical to the one that NIH OBA sent at the same time to The Institute for Genomic Research (now known as the Venter Institute, see Biosafety Bites #19). The letter asked Salk if it had and IBC that was identifying and reviewing research and if it was conducting research that was not being properly overseen.

The answer that Salk gave can be deduced from its 2006 IBC minutes. No, Salk could not claim to have a working IBC and no, it had not properly overseen research. According to the minutes:

"[An IBC member] distributed copies of correspondence that occurred between the Salk Institute and the Office of Biotechnology Activities (OBA) from October 2004 to September 4, 2006. After a review of the correspondence, [the IBC member] informed the committee that the Salk Institute had committed to submit formal written policies and procedures to the OBA as well as complete an inventory of the research portfolio to ensure that all projects subject to the NIH Guidelines have been reviewed and registered by the IBC."

In other words, two years after its noncompliance had become apparent, nothing of substance had been done fix Salk's IBC.

Two Years of Noncompliance with NIH's Full Knowledge
By September 2006, twenty-four months had passed and nobody had assessed Salk's research portfolio to find noncompliant projects that should have been assessed by the IBC before they started. Even the Venter Institute did better. It said that it reviewed its research portfolio within a few months of receiving NIH's letter (notably NIH made no apparent attempt to independently evaluate this claim).

At its September 2006 meeting, the Salk IBC did not review a single project. Instead, it discussed the format of its paperwork, apparently because it has never had any paperwork before, because it hasn't done anything before. The minutes state that interviews with Principal Investigators (to find out what research they are doing) were to begin on 18 September 2006. 

By now, Salk and NIH OBA know that the Sunshine Project is probably going to want to know what happens. And based on prior experience with NIH OBA, that's probably the only reason why any further activity would take place. Under the circumstances, Salk has no incentive to be thorough in its self-investigation; after all, NIH OBA is likely to take anything that Salk says about its research portfolio at face value. And the longer Salk delays, the more time its researchers get to finish or adjust noncompliant projects so that little or nothing about them need be communicated to OBA.

Conclusion: The Quest for Pretty Bits of Paper
For the past two years, it has been business as usual for the Salk-NIH relationship. Salk continues to receive millions in NIH funding, despite its broken biosafety program. More than $20 million granted since NIH OBA found out that Salk doesn't have an IBC that works.

The NIH Office of Biotechnology Activities is willfully ignorant of IBC violations and unwilling to impose penalties on those that break the rules. It is a foregone conclusion that by the time OBA's "investigation" of the Salk Institute ends, OBA will claim that all is well with Salk's IBC. OBA is just waiting, ever so patiently, for Salk to get around to writing down the right things on a piece of paper, never mind what actually happens in the labs, because all that OBA has ever wanted from an IBC was to get a pretty little piece of paper or two every once in a while.