Risky Research Review Bill
"On reading," by Simon Wain-Hobson, is a weekly discussion of scientific papers and news articles around gain of function research in virology.
Since January 2024, Dr. Wain-Hobson has written weekly essays for Biosafety Now discussing risky research in virology. You can read his entire series here.
Virology is alive and well post COVID. There is one “really tiny part” of virology that needs looking at. And that is GOF/DURC/Risky Research that readers are aware of.
Self-governance regularly fails when the stakes are high. Vested interests get in the way. This happens so often it’s amazing how some still believe in self-governance. A 2013 study showed that scientists tend to overestimate the benefits of their work and underestimate the risks involved which has added a special twist to GOF/DURC controversy in virology.
The opposite of benefit is hazard. Risk is the probability of the hazard arising. In the case of GOF/DURC/hazardous bird flu research, the hazard is a novel pandemic following a researcher walking out the virus following a lab accident. The risk may be small, but the hazard is humongous. Which is why this “really tiny part” of virology needs oversight.
Whatever you may think of the origins of the COVID virus, the pandemic killed over 20 million while the economic cost is $20 trillion or more as the virus is still circulating and killing people. Under any circumstances its normal for governments to get involved.
The Risky Research Review Bill was introduced by Senator Rand Paul (R, Kentucky) and has worked its way through committee stage and will now be put to the US Senate floor for a vote. Despite the highly polarized climate in US politics, the draft bill passed the Homeland Security Committee with a clear bipartisan 8 to 1 majority.
What does it propose?
An independent oversight committee. The President, by and with the advice and consent of the Senate, shall appoint, without regard to political affiliation, 9 individuals who are citizens of the United States to serve as members of the Board for not more than 2 terms of 4 years each, including— ‘‘(A) the Executive Director appointed under section 7903(a); ‘‘(B) 5 nongovernmental scientists in a life sciences field; and ‘‘(C) 2 nongovernmental national security experts.
As the DURC field in the life sciences is broad indeed, the issue of expertise arises. No doubt they will bring in ad hoc reviewers just as scientific journals – who don’t have the requisite knowledge – reach out to researchers for expert opinions. And as every journal editor knows, you’re looking for the one reviewer who finds the weak spot – assuming there is one.
Who oversees the committee? The Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Oversight and Accountability of the House of Representatives, so totally independent of the funding agencies. The legislation is limited to 2x4 years so at the end we’ll see if the virologists (mainly) have understood the need to discuss openly.
The mission of the Board shall be to issue an independent determination as to whether an agency may award Federal funding for proposed life sciences research, which shall be binding upon the agency. Its powers are considerable. Worthy of note is review any classified research conducted or funded by any agency to determine whether the research would be considered high-risk life sciences research. This is logical as you can’t let off the hook another branch of government. And if civilian labs have accidents involving microbes, then the military is confronted by the same problem. Excellent.
The Board may pause the life sciences research in progress; and ultimately stop it.
Under ‘Considerations’ there is a list of eleven criteria the first two being
(A) whether the research poses a threat to public health;
(B) whether the research poses a threat to public safety;
Obvious. The crunch is (J) whether the reasonably anticipated benefits outweigh the reasonably anticipated risks. We’re back to the ill-defined risk/benefit ratio. It will be interesting to learn how they will do this but it’s unavoidable and something nobody has done in a succinct and pragmatic manner. At least IMHO. Oh, derivatives of the word ethic are not to be found. Once again very pragmatic.
The American Society of Microbiology (ASM) came out with a short statement on the proposed Bill.
There is far greater risk from some areas outside the U.S. where there is less stringent oversight or lax enforcement. For them, the U.S. should serve as a model.
New regulatory barriers will be of little use absent investments [sic] in the network of the nation’s aging biocontainment labs and specialized workforce training to ensure that ongoing work is being conducted in the safest way possible. Such investments will have an important real-world impact on biosafety and biosecurity.
So what if there is a far greater risk from elsewhere? The US doesn’t have jurisdiction elsewhere. Apparently, the idea is that there is no need to clean up at home while lax enforcement exists elsewhere. This flies in the face of the old maxim about first setting your own house in order. It is also at odds with the words the US should serve as a model just downstream. No doubt a cut and paste issue like the other.
The second paragraph mentions aging biocontainment labs. Wow, and this from the ASM which has pushed back on all attempts to rein in GOF virology. Obviously, it's a call for more money, but thanks for being blunt about the aging biocontainment labs.
Others have criticized the limited size of the Board fearing that this and that expertise will be underrepresented. This is an unrelenting and exaggerated critique with subtitles like The Good, The Bad and The Ugly. Too much, too late. With a $30M annual budget, the proposed Board is not short of convening power and can solicit opinion as they see fit. This article goes on to say It is unclear what the bill means by “work with which poses a significant risk of deliberate misuse.” This is astounding. The fact is the dual use side of research of concern covers deliberate misuse.
Ever since 2005 and the resurrection of the Spanish flu virus, which was nice to have but not essential (1918 and all that), the NIH has had plenty of time to think about DURC and even act. In addition, it had the excellent 2005 Fink report to work with but it provided no guidance. Worse, concerning the bird flu virus work, it took the remarkable initiative of telling the world in a Washington Post Op Ed that it was a risk was worth taking, before virologists could examine the work which had not been published at the time of the Op Ed (Chilled virology).
The fact is that the virologists and the NIH underperformed and surrendered the role they traditionally had. Governmental oversight is the inevitable corollary. As noted above, the proposed Board will have an 8 year lifespan. Let’s hope the life sciences will address the DURC issue and the inherent dangers in one “really tiny part” of virology.
The Bill is necessary and should be supported by life scientists. Support it reluctantly even; but admit our track record hasn’t been good. Self-governance hasn’t worked, so it’s not surprising Government wants to step in.
There is cause for a little optimism, however. The recent call for a ban on Mirror Life research in the top journal Science shows that some scientists can think responsibly (Mirror life). On reading implores fellow virologists to read the Mirror Life paper and support the Risky Research Review Bill, work with the Board and find a modus operandi within the next few years to the benefit of all.
Oh yes; as viruses don’t respect borders, other countries should tackle the DURC problem too. There is no reason why the US should do all the foot work.
Aside 1
On January 19 Dr. Paul issued subpoenas to fourteen agencies regarding COVID-19 origins and risky gain-of-function research.
Aside 2
Re the ‘unrelenting’ critique, the authors forgot the showdown where The Good took down The Bad after having taken the bullets from the revolver of The Ugly. Forethought and pragmatism rolled into one, something unfortunately absent from the NIH re the GOF research.
Thank you. Timely, and wonderfully written.
Congress needs to get a spine, and connect a brain to it.
- Add deterrence to the bill, prosecution of any persons that defy a ruling of the oversight agency. It takes some minimal imagination, but the possibility of prison time is a powerful behavior influencer.
- The downside of creating pandemic viruses isn’t just humongous, the stakes make it unacceptable under any circumstances. Even the slightest give on this allows for the mentality of “safe” which has no possible fixed meaning in this case.
- To say that a lab must be upgraded says that it is assumed that that lab can and will be used to violate this unacceptability standard. “Houston, we have a problem.”
- The public outnumbers those with skin in the game with respect to this sort of research hundreds of thousands to one, and overwhelmingly want it stopped completely.
- Congress is failing because of conflicts of interest, and because the public is asleep (because of conflicts of interest by media and groupthink blindness.)
Thanks for keeping this discussion going forward. Respectfully