An antivaxxer is creating his own bogus institutional review board (IRB)

Recently, a longtime reader made me aware of a recent podcast episode in which an antivaxxer about whom I’ve written a number of posts over the years, James Lyons-Weiler, revealed a “surprise” announcement a little over halfway through the podcast that his antivax “research” organization, the Institute for Pure and Applied Knowledge (IPAK), is planning on forming his own institutional review board (IRB). When I learned of this, I knew that I had to write a post about it. Why? Because this is yet another example of the longstanding tactic among quacks who crave scientific legitimacy to ape the trappings of actual science while continuing to engage in pseudoscience and conspiracy theories that I first noticed nearly two decades ago. Also, why wouldn’t Lyons-Weiler form his own compliant IRB? He already has his own fake scientific journal—IMHO, of course— in which he publishes the most deranged antivax nonsense, likely because one of his attempts at antivax “research” published in even the dodgiest of real scientific journals ended up being retracted.

Let’s take a look.

What is an IRB, and why do antivaxxers hate legitimate IRBs?

The function of an institutional review board (IRB) is to protect the welfare, rights, and privacy of human subjects involved in biomedical research. The purview of IRBs includes research ranging from studies that merely use anatomical substances (e.g., blood, urine, biopsies taken as part of science-based medical care, etc.) to what lay people classically consider human subjects research, phase III clinical trials required by the FDA to approve new pharmaceuticals, devices, and biologics for licensure. Basically, IRBs review proposed protocols for human subjects research for issues that might compromise the safety, autonomy, rights, or privacy of the human subjects to be enrolled in the study, Moreover, federal regulations codified in the Common Rule require IRB review of all human subjects research done for the following reasons or by the following entities:

• To obtain FDA approval of a new drug or a new indication for a drug. (FDA regulations are based on the Common Rule, but not the same as the Common rule.)
• By any investigator receiving funding from a federal agency. Most federal agencies that fund research are “Common Rule” agencies, but, in the case of those that are not, many research institutions still choose to apply the Common Rule to all of their human subjects research regardless of funding source.
• By any investigator employed by an organization (e.g., university, foundation, company, or whatever) that receives federal funding, particularly from the NIH.

According to the NIH:

NIH does not require IRB approval before NIH peer review of proposed research; however, the appropriate IRB approval(s) must be in place to implement the research protocol. This review must be conducted by an IRB approved by the HHS Office of Human Subjects Protection; this can include approval by a single or central IRB in the case of multisite studies. Both local and single IRBs must follow the same Federal regulations about human subjects protections provided in 45 CFR 46, Subpart A and 21 CFR Part 50 (for studies that must also meet Food Drug Administration requirements). IRBs also ensure compliance with relevant local and State regulations.

There are a number of research types that do not require formal IRB approval, such as research based on publicly available data without protected health information (PHI), and there are other types of research that are considered “exempt” from IRB oversight, such as studies involving anonymized clinical specimens. The latter, however, generally require a letter from the relevant IRB that the protocol is “exempt.” An investigator can’t just declare a protocol exempt.

As for its composition, federal regulations stipulate:

An IRB must:

1. have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
2. make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
3. include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
4. include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution; and
5. not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Please see the regulations at 45 CFR 46.107 for complete information on all of the required qualifications to properly compose an IRB.

Also, an IRB may appoint non-voting members when deemed appropriate by the chair and membership when specialized knowledge and advice might be required. There are often lay members of IRBs as well, in order to assess the subjects’ perspective.

There’s still a large loophole that should be obvious. Entities that don’t fall into the categories listed above do not necessarily have to obtain IRB approval for human subjects research, although nearly all legitimate companies and entities doing human subjects research still do, if only because, at the very least, it’s good PR. A more generous interpretation is that most researchers engaged in human subjects research want to do the right thing with respect to protection the welfare, rights, and privacy of their research subjects, and subjecting their research to IRB oversight is one way to accomplish this goal.

Antivaxxers, of course, generally misunderstand biomedical research ethics and detest IRBs. Why? Because ethics often tell them why the studies that they want to do are unethical, and IRBs are the mechanism by which ethical oversight is achieved for clinical trials. (Other countries, of course, also mandate ethics committees similar to IRBs but with different names to oversee their human subjects research.)

One example of the antivax lack of concern for clinical trial ethics that I like to cite is the commonly cited claim that many of the vaccines on the CDC’s recommended schedule for childhood vaccines have not been “tested against saline placebo controls” in randomized, double-blinded controlled trials. This is a particularly brain dead antivax trope (most recently promoted again by Robert F. Kennedy, Jr.) that I have deconstructed in depth several times. The short version of why is that it is unethical to deprive children in the control group of such a study of vaccines considered standard-of-care in pediatrics because doing so would leave them susceptible to diseases that the vaccines protect against. Basically, in human subjects research, ethics must always trump perceived scientific rigor. That’s why, for longstanding vaccines, new versions are generally tested against the old version of the vaccine for non-inferiority, which is an ethical research design. Only new vaccines against diseases for which there are not yet approved vaccines face the requirement of a placebo controlled RCT, and even then saline is not the only scientifically valid placebo. Of course, some antivaxxers know that the “no saline placebo-controlled RCT” gambit is deceptive bullshit, but they also know that lay people don’t understand why.

Which brings us to the question: Why would Lyons-Weiler want to form his own IRB?

A fake IRB to go with a fake institute, fake research, and a fake journal?

It’s at around 35:55 in the podcast that Lyons-Weiler drops his bombshell, but only after spending the preceding several minutes complaining about how the “MO” of most journals is to note associations of bad things with vaccines but then find ways to “try to make the association go away.” Of course, this is a longstanding antivax trope that claims that correcting for confounders in epidemiological studies is actually a big conspiracy to make associations with, for example, autism “go away” when it really isn’t. This particular trope is based on a willful misunderstanding that goes back to the Simpsonwood conspiracy theory 20 years ago and was behind the whole “CDC whistleblower” conspiracy theory featured in Andrew Wakefield and Del Bigtree‘s “docuganda” conspiracyfest VAXXED. Lyons-Weiler also declares that he, not they, is a scientist, while referring to the scientists doing proper epidemiology and vaccine science as “shills” and “grifters,” which leads me to respond that he really owes me a new irony meter.

Lyons-Weiler also amused me by admitting that the website for his fake—IMHO—journal, Science, Public Health Policy & the Law, is “horrid,” which is what I’ve been saying all along. Of course, he’s referring only to its aesthetics and design, while I’m referring to its content, such as when the journal laundered MSU Professor Mark Skidmore’s awful study deceptively extrapolating from a survey to claim that COVID-19 vaccines had killed 278,000 people. In any case, yes, the website looks to me like basically just a fairly generic WordPress template, and his “journal” has only a few published “studies.” Meanwhile, Lyons-Weiler touts how he’s “in it to win it” and “change the world forever.” He also notes that the journal’s website will be “completely unrecognizable in a month’s time,” as he has apparently consulted quacks like Drs. Peter McCullough, Ryan Cole, and others about a redesign and overhaul. There will also be an expansion of the editorial board, no doubt to include a wider variety of antivax quacks besides its current membership, which currently includes antivax luminaries such as Russell Blaylock, Christopher Shaw, Brian Hooker, Mary Holland, Rick Jaffe, and Paul Thomas, among others. Of course, slickness ≠ scientific rigor, and to me this redesign will just be pouring old rancid wine from a rotting skin into a shiny new carafe; it won’t change the crappy science one iota, other than perhaps in quantity, which will likely be much greater than before. (Oh, goody.) There will also be advertising, although Lyons-Weiler claims he will cap any one advertiser to $1,000 a year. Also, he’s soliciting donations.

So, if you have what I, in my not-so-humble opinion, consider to be a fake institute, fake science, and a fake journal, why not have a fake IRB as well? Apparently, Lyons-Weilers has already formed one, bragging about how he had emailed 50 people and has had nine months of “secret meetings” of an “IRB formation committee.” (Why were the meetings secret, I wonder?) He further relates that all 50 people have “said yes” and that he now has 36 people, so that he can now have five-person “study sections” to review protocols. Of course, one naturally wonders whether each of those “five person study sections” that Lyons-Weiler touts actually has the appropriate members as stipulated by the Common Rule. Somehow, I doubt it. Come to think of it, if you’re going to form an IRB, then you really need to follow the regulations promulgated under the Common Rule. Will the IPAK IRB do that?

Possibly, but one wonders how well. Lyons-Weiler states that IPAK’s IRB has not yet been registered with the Department of Health and Human Services (HHS) yet, stating that they are “just starting” the process. This worries me, because I really do have to wonder whether HHS is equipped to deal with antivax IRBs registering as though they are legitimate IRBs or know how to spot such IRBs.

What does registering an IRB with HHS entail? The first thing you have to realize is this, taken from an FDA FAQ on IRB registration:

Does registration imply that an IRB is in full compliance with 21 CFR Part 56 or is otherwise meeting a particular standard of competence or expertise?

No. IRB registration is not a form of accreditation or certification by FDA that the IRB is in full compliance with 21 CFR Part 56. While a U.S. IRB that reviews FDA-regulated studies must register to be in compliance with 21 CFR Part 56.106(a), IRB registration does not address issues regarding an IRB’s competence or expertise nor does it require IRBs to meet a particular standard in order to conduct a review.

In other words, only IRBs that review FDA-regulated studies are even required to register with HHS. Basically, registration is just that, registration with HHS. It implies nothing about the competence or expertise of an IRB. I predict, however, that IPAK will represent its registration with HHS as evidence that it is in compliance with all relevant regulations and is therefore a “real” IRB. The problem, of course, is that legally it probably will be “real” IRB, but those of us who know about IPAK and antivaxxers will recognize it for what it is likely to function as. What do I mean? Simple. I’ll explain.

In the interview, Lyons-Weiler inadvertently reveals what is likely to be the true impetus and purpose for his IRB when he points out that states are refusing to release public health data, particularly record-level data, to researchers because they don’t have an IRB-approved protocol. My first thought was: How much do you want to bet that the “researchers” to which Lyons-Weiler refers are antivax “researchers” who want to data mine state public health databases in order to seek “findings” that attribute horrific harms to vaccines, particularly COVID-19 vaccines? In other words, how much do you want to bet that Lyons-Weiler’s IRB will exist to rubber-stamp antivax human subjects research protocols, so that antivax researchers can get their hands on that sweet, sweet state record-level public health data on vaccines? Lyons-Weiler even says that his goal is to increase the amount of publications of what he deludedly calls “objective science,” bragging that he has a journal, a research institute, and now an IRB, leading the interviewer to gush that she’d love to see others follow this model.

At this point, I feel obligated to point out that this IRB is not really necessary if what Lyons-Weiler is doing is actually good research. Even Lyons-Weiler implicitly seems to recognize this—although obviously he frames it as “them” suppressing awesome”objective” science—when, in response to a question about whether publication in his journal will require the use of his IRB, he states that any HHS-registered IRB can approve human subjects research, but that his will just be one that “won’t stab you in the back” or refuse in general to approve protocols involving requests for access to state public health databases. Basically, he straight up says that his IRB will allow antivax “researchers”—obviously he doesn’t call them that—to get access to these databases because state agencies won’t be able to deny them if they have approval by an IRB that did things “by the book.”

To that I would add that there do exist, after all, IRBs that can be used by researchers not affiliated with a university that maintains an IRB. For example, some university IRBs will review protocols from non-faculty members, and there are also independent and/or for-profit IRBs that charge a fee for IRB review and oversight based on the complexity of the protocol, the size of the study, and the number of sites involved. Industry uses such IRBs all the time; even universities sometimes use them. I will concede that I have…issues…with such IRBs, particularly the for-profit ones. After all, one can’t help but wonder how financial incentives affects their review, given that there is definitely an incentive not to be too harsh, lest customers go “IRB shopping” and take their business elsewhere. However, there’s no way that even the most questionable independent IRB can be as bad as IPAK is likely to be, no matter how “by the book” it appears to be, the key word here being “appears.” Lyons-Weiler claims that his IRB will adhere to standards that meet or exceed HHS requirements. I call bullshit, because HHS standards require IRBs to adhere to the highest standards of ethics and science to protect human subjects, and antivax studies adhere to the highest standards of neither of these. Of course, Lyons-Weiler can prove me wrong by rejecting bad and unethical studies, but I predict that his IRB will not reject a single one. Indeed, at one point, he even shows that this IRB will be an opportunity for more grift. What do I mean? He says that investigators of a study rejected for bad science will be offered courses from IPAK to teach them good science to enable them to revise and resubmit their protocol.

Well, maybe not. Here’s where the rubber will hit the road. The interviewer brings up an interesting point, shockingly enough, when she asks whether this IRB will reject any study that doesn’t include “informed consent,” given that regulations were just changed to allow a waiver of informed consent “when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety and welfare of human subjects.” Whatever the merits of this change, antivaxxers have been losing their minds the FDA guidance issued in response to the 21st Century Cures Act that allows such waivers under certain circumstance, for instance when the investigation could not have been feasibly carried out without the waiver or altering informed consent. (I might have to write a post about this soon, but for now suffice to say that there has always been a mechanism in HHS regulations that permit the bypassing informed consent in the case of minimal risk research; what appears to be new is the FDA also allowing it.) Lyons-Weilers, amusingly, dances around the study by misrepresenting what this rule likely means in practice. (Hint: No, the FDA is not likely to let investigators change a blood pressure medication without informed consent.) Then he—correctly, amazingly—notes that retrospective studies of minimal risk might fall under this new guidance.

A refinement of an old quack technique

James Lyons-Weiler, of course, is far from the first quack scientist to have formed his own IRB. For example, nearly two decades ago Mark and David Geier created a fake institute, which they called the Institute for Chronic Illnesses, as a front under which to do their “studies” of Lupron in autistic children. As part of that institute, they formed an Institutional Review Board (IRB) to oversee their “research.” They then stacked that IRB with cronies and true believers in violation of federal regulations. Indeed, they even went so far as having the principal investigator sit as the chair of the IRB overseeing his own research protocols.

Then, a decade ago, I was writing about another dubious IRB, this time belonging to the Burzynski Clinic, which has existed for a long time, at least as far back as 2001, and served as a rubber-stamp for all of Stanislaw Burzynski’s dubious clinical trials with his “antineoplastons,” a treatment that he had come up with in the 1970s and never compellingly demonstrated to be effective against any cancer. This IRB was, unsurprisingly, chaired by a crony of Dr. Burzynski’s, Carlton F. Hazlewood, PhD, who was also on the board of directors of the Burzynski Clinic. As I noted at the time, given that the Burzynski Clinic was trying to commercialize antineoplastons as a treatment for various cancers, this was a profound conflict of interest, which led me to ask: What would Burzynski’s defenders have said if they’d found out that a sitting member of the board of directors of Merck, for example, was serving on the IRB that oversees Merck’s clinical trials? Burzynski’s IRB was doing the same thing, although I did conceded that it wasn’t quite as bad as having the principal investigator of a study chair the IRB overseeing his studies, as Mark Geier did. It was, nonetheless plenty bad, man. One wonders who will chair Lyon-Weiler’s committee when an “investigator” from IPAK submits a protocol to it, one does.

I like to say that in the world of quacks and antivax there is nothing new under the sun. James Lyons-Weiler’s embryonic IRB is just more evidence of that. However, just because there isn’t anything new under the sun in antivax-land doesn’t mean that antivaxxers aren’t learning and refining the tactics that worked for them before. Among those tactics has always been recreating their versions of the trappings of real science, such as research institutes, clinics, and journals—and IRBs as well.