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.
Before hitting the examples, however, let’s step back a minute and answer the question of what IBC minutes should contain in principle, based on the committees’ obligations under the Guidelines, fulfillment of which the minutes should reflect.
In one of the few public actions it has ever taken in response to IBC noncompliance, back in the 2000s the NIH Office of Science Policy first published a Frequently Asked Questions (FAQ) document on IBC minutes. The FAQ indicates the content of minutes that NIH expects. Here I will focus on that content that is about research protocols under review.
NIH’s FAQ says the following:
With respect to the review of proposed recombinant or synthetic nucleic acid research, the NIH Guidelines cite a number of matters that IBCs should consider as appropriate. These matters are described in Section II-A-3 and Section III of the NIH Guidelines and include:
• Agent characteristics (e.g. virulence, pathogenicity, environmental stability)
• Types of manipulations
• Source(s) of the nucleic sequences (e.g., species)
• Nature of the nucleic acid sequences (e.g., structural gene, oncogene)
• Host(s) and vector(s) to be used
• Whether and [sic] attempt will be made to obtain expression of a foreign gene, and if so, the protein that will be produced
Other information that should be documented includes:
• Principal Investigator (PI) name
• Project title
• Verification that the PI and laboratory staff performing the research have been appropriately trained in the safe conduct of the research
• Applicable section of the NIH Guidelines the research falls under (e.g. Section III-D-1, Section III-E-1, etc.)
• Containment conditions to be implemented (biosafety level and any special provisions)
In general, the IBC meeting minutes should offer sufficient detail about the discussion of these matters to document the committee’s rationale for particular decisions.
While that’s not everything minutes should contain – IBCs have more responsibilities than reviewing protocols – protocol review is a big part of their job and usually the largest part of well-kept minutes.
Above it can be seen that NIH OSP has laid out a list of about a dozen elements that should be found in minutes, with obvious minor variations. For example, if the research does not involve a pathogen, there’s no need information on virulence. Or if there’s no oncogene involved, then no need for that either.
Since IBCs have clear direction on what their minutes should contain, evaluating whether minutes comply with requirements is a fairly straightforward task. Are the elements there or not? The situation today is better than what I confronted in the early 2000s, when I had to develop my own criteria for minutes evaluation because, at that time, NIH had never described what the minutes should be.
But the catch is that relatively few institutions actually follow NIH OSP’s guidance. In fact, minutes that consistently contain the necessary elements are few and far between.
And … wait for it, as this is going to be a refrain at this website … NIH doesn’t care that the IBCs that it “oversees” ignore its guidance. But we’ll hold off on that issue for this post.
Being Beaten About the Head Makes Minutes Better
The University of Texas at Austin is one of the few institutions whose minutes consistently provide the information required. They are well-drafted and reflect the elements that they should. Like these two pages extracted from the minutes of a January meeting:
The UT Austin minutes, all 187 pages of recent ones that I have, consistently reflect the vast majority of necessary elements. Except the Principal Investigator’s name, which a close reader might have noticed. That’s really inexcusable given what the IBC system is. But NIH OSP has repeatedly been clear on this point (an anomaly!), and I have little doubt that eventually, after I complain enough, NIH’s glacially slow fingers can be moved to send UT an email asking them to fix the problem.
UT Austin didn’t start doing this voluntarily. I had to hit them over the head with a baseball bat.
In the 2000s we fought over an ill-documented lab accident with recombinant highly pathogenic avian flu. UT’s senior leadership sought to avoid questions about what seemed like a cover-up, while the biosafety officer called me late at night to leave long rambling messages purporting to inform me of what actually happened. People that worked in the lab next door also reached to me. To try to find out what was happening, because UT wasn’t letting them know.
Later we clashed over a grad student who handled pathogens and was found with a lot of UT lab property in his car trunk when he was arrested for DUI. There was more UT lab equipment at home. The PhD student was said to be setting it up to do something, the police apparently never quite figured out what.
The University of Texas System and I wound up in court more than once in litigation related to the Texas Public Information Act and I notched up two major wins against their lawyers.
At one point, UT Austin hired a new safety director, a military physician, who reached out to me and started a dialog. A happy ending was in sight. But the Research Chancellor fired him when he organized a safety symposium and invited me, among other “offenses” the doctor committed for the cause of safety.
Now for the ugly…
Northwestern University’s minutes should be good. The deeply resourced private* university’s programs have a good reputation. The behind-the-scenes bureaucrat at NIH OSP that has run the NIH Guidelines for years was formerly Northwestern’s biosafety officer.
Those things should bode well for Northwestern’s IBC minutes, but the reality is a disconcerting horror:
I can’t be brought to call this useless document “minutes” as almost every element of the information required is not there. Northwestern’s biosafety officer sent 77 pages of this junk. To add to the insult, Northwestern actually redacts these pages, as if they held useful information in the first place.
On some pages, apparently randomly selected protocols will include a short table, sometimes with just one entry, that appears to be cut and pasted from some other information system. That table is titled “viruses in use”. Never bacteria. Or any other organism or construct. Or if such organisms are the source, or recipient of genes, or what role they have in the experiments, which are themselves completely undescribed. Roll these minutes up and hang them on the wall of your bathroom.
In my review of Northwestern’s 77 pages of refuse, it occurred to me that these “minutes” sometimes do not even seem to reflect actual committee meetings. That is, my suspicion is that they are, at least in part, fabricated. Fake minutes that allege to reflect fictitious meetings would not be a novelty. I encountered this in my research in the 2000s (paging Utah State).
A cynic might say that Northwestern is simply working to perpetuate the academic tradition of blowing off the NIH Guidelines, but I say if NIH is serious about its rules it should be coming down on Northwestern like a ton of bricks.
So it’s pretty simple. To evaluate the quality of minutes, one only has to compare them to NIH’s list of elements. If that list is properly fulfilled, then a pretty good picture of the research emerges and justification for the IBC’s decisions are apparent. And that’s how it is supposed to work.
I mentioned earlier that reviewing protocols isn’t the only task of IBCs. So there are other things that should appear in IBC minutes, such as a record of discussion of accidents, serious lab inspection problems, review of training programs, etc. … a range of activities that IBCs should direct or, at least, be appraised of and discuss. A number of these items will come up in future posts.
*Remember, the NIH Guidelines apply to private entities as well, if they accept federal funds for research involving rDNA.