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Cornell Provost Michael Kotlikoff rolls the COVID dice with (from left to right) Lisa Nishii, Peter Frazier, Gary Koretzky, Madelyn Wessel, and Martha Pollack looking on. Photoshopped by Jonathan Ochshorn.

Administrators at Cornell University are going to extraordinary lengths to mitigate the negative impacts of viral transmission as they plan for an in-person start to the fall 2020 semester. They have created a Behavioral Compact that will require students engaged in in-person instruction to follow various safety protocols and to submit to asymptomatic testing once or twice per week. By reducing the density of classrooms and requiring social distancing and mask wearing, the expected number of infections, while still quite large, is considered by the University to be acceptable and manageable.

I am not arguing against the steps Cornell has proposed in order to bring students back on campus. Rather, my complaint is that Cornell administrators are being disingenuous when they claim to be “following the science” to minimize negative health impacts. Their basic argument, reiterated recently by Cornell President Pollack, can be summarized as follows:

• Cornell is “relying on the best available science” to “limit the spread of the coronavirus, on our campus and across the Ithaca region.”
• An online semester, “counterintuitive though it may be,” would have worse outcomes than an in-person semester.
• The reason for this paradoxical result is that “Cornell has no legal authority” over the conduct of registered students taking courses online.

Cornell’s “science” derives from the work of faculty in Operations Research and their PhD students, led by Prof. Peter Frazier, who have created a model—constantly being updated—that measures the amount of COVID-19 infections under various scenarios. It is beyond my expertise to critique this model, but it is also unnecessary. Even assuming that all the “scientific” or “medical” assumptions underlying the model are correct, there are flaws in the nonscientific and nonmedical assumptions imported into the interpretation of the model’s results.

Cornell’s “counterintuitive” decision to hold in-person instruction is justified by Frazier in the July 17 “Addendum” to his original June 15, 2020 report, entitled “COVID-19 Mathematical Modeling for Cornell’s Fall Semester.” For the online-only scenario to significantly outperform the in-person scenario, Cornell would need to test “at least 20% of the [Ithaca-based online] population per day, which seems out of reach with optional testing.”

This is actually an incredible admission: Frazier states unequivocally that implementing an online semester would “significantly [outperform] the residential scenario” if testing of Ithaca-area students occurred at a rate comparable to the rate already envisioned for the in-person scenario, for which adequate testing capacity is available. An online semester was rejected, even though it would “significantly outperform” the in-person scenario, not because there would be inadequate testing capacity. Rather, it was rejected based on the contention that “Cornell has no legal authority” over the conduct of online students and—even if they had the authority—Cornell could not adequately enforce a testing regime on students living in the Ithaca area and taking courses online. We’ll examine these arguments in turn, starting with the claim that “Cornell has no legal authority” to mandate asymptomatic testing of online students, a claim for which no legal evidence has been provided.

Finding myself at this impasse, I wrote to Madelyn F. Wessel, Cornell University Counsel and Secretary of the Corporation, and asked: “Why wouldn’t Cornell have the authority to block an Ithaca-based student’s access to online course participation if that student failed to comply with Behavioral Compact stipulations for asymptomatic COVID-19 testing?” The University Counsel’s reply, dated August 11, 2020, focused not on the question of authority, but on the practicality of implementation and enforcement, which we will discuss later. Only in the last paragraph of her long email she did finally acknowledge that Cornell has the authority to require testing of online-only students in the Ithaca area, contradicting statements made by the President and by Frazier: “Bottom line, yes,” she wrote, “we could exhort online students living locally to engage with the university’s significant health and safety protocols; we could probably make public statements to the effect that we were requiring testing and related compliance.”

Therefore, the only remaining questions concern practicality and enforcement. The following excerpts from Counsel Wessel’s email response are representative of the arguments made also by Cornell’s Provost and by Prof. Frazier; they are followed by my commentary in italics.

“Our assessment was that identifying which online students were ‘local’ and which were not would be exceptionally difficult to establish with specificity.” Cornell has already identified which students are local and which are remote, simply by requiring them to provide the address at which they are residing. This is not rocket science.

“And, any student who wished to evade university controls could easily do so by not disclosing their return to Ithaca.” Cornell could require that students provide proof of their residency—this could take many forms but would not be difficult to devise or implement. And, as in Jeremy Bentham’s panopticon, merely the threat of verification would be sufficient to deter infringement. It’s simply not reasonable to conclude that many students would go to all this trouble and risk disciplinary action, while simultaneously forging proof of residency documents, all to avoid asymptomatic testing. 

“Additionally, to penalize – through academic disenrollment – an online student living in private housing in the Ithaca region, but not an online student living privately beyond whatever radius was necessarily established for the behavioral and testing regime, did not seem to us to be either practical or fair.” This argument has two parts: in terms of practicality, it would be easy to establish a boundary within which students are considered to be in the Ithaca area and subject to asymptomatic testing. Cornell is doing a lot of things to prepare for this upcoming semester that are far more complex. In terms of fairness, there is no ethical issue raised by protecting the Ithaca community from spread of this virus: this is, in fact, exactly what Cornell intends to do with in-person instruction. The idea, in both scenarios, is to reduce the health impact of instruction within the local Ithaca community—not within the entire planet. This ethical premise doesn’t change by altering the mode of instruction.

“It is precisely because Cornell is conditioning access to our physical campus, eateries, libraries, classrooms, dorms, student activities and more … that enables the university to require that they register their local address, adhere to testing, sign the behavioral compact, get their student ID activated for campus access, and become subject to the behavioral compact we are enforcing on Ithaca area residential students.” It is hardly necessary that students physically attend classes or use facilities in order to require adherence to a behavioral compact. Nor does enforcement require physical access to campus facilities; it would be quite simple to revoke online access if online-only Ithaca-based students did not comply with the testing protocol.

I therefore reach the following conclusions:

• The “science” developed by Frazier et al. suggests that asymptomatic testing of Ithaca-area students during an online-only semester could create health outcomes that “significantly outperform” those of an in-person semester.
• There are no practical, legal, or ethical barriers to enforcing a testing protocol on Ithaca-area students during an online-only semester.
• Therefore, if Cornell administrators claim to be following “the science,” they should move immediately to an all-online semester.
• Alternatively, if Cornell administrators feel that there is value in having an in-person semester that outweighs the health benefits of an online-only semester, then they should tell the truth: specifically, they should acknowledge that their decision not to follow “the science” puts more people at risk of infection, hospitalization, and even death, but that they will attempt to minimize those health risks in order to gain what they feel are benefits of in-person instruction.

Links to all my Cornell-COVID writings are here.

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Cornell Provost Kotlikoff takes a chance bowling with COVID while Operations Research Professor Frazier provides the expertise and President Pollack looks on with approval. Photoshopped image by Jonathan Ochshorn.

I’m not arguing against Cornell’s decision to reopen with in-person instruction for the fall 2020 semester (although it does seem like an incredibly dangerous strategy), but rather against their public relations campaign spinning this decision as something “based on the science.” The “science” turns out to be a study undertaken by Operations Research Professor Peter Frazier and his graduate students that models health outcomes resulting from various scenarios defined, as they must be, by making numerous assumptions. Aside from the uncertainty intrinsic to such models, the basic flaw in this pandemic restart analysis is that only two options are studied—(1) opening up Cornell and offering in-person instruction with required asymptomatic testing; or (2) closing down the campus and offering online instruction but without any asymptomatic testing for any students, even those in the Ithaca area.

It seems clear to me that a third option should have been considered: to close down the campus, offer virtual instruction, and require asymptomatic testing for students in the Ithaca area. It seems likely that this third option would result in the fewest COVID-19 cases, for the following reasons:

The model created by Frazier doesn’t mention the threat of superspreader events, which research suggests are extremely important in understanding how this virus spreads. Cornell’s protocols may reduce, but will not necessarily prevent such events, since students are tested only every five days (1/5 of the students get tested the first day, 1/5 the second day, and so on). Because such testing produces up to 40% false negatives even four days after infection, a student could become infected, say, three days before their scheduled test, receive a (false) negative diagnosis, and become extremely infectious four days later, before their next scheduled test. During this extremely infectious period, the student may well remain asymptomatic while attending classes over the course of two or three days (depending on the timing of the onset of extreme infectiousness) and potentially infecting many others. By the time the student is tested, and the results become available, and contact tracing begins, a superspreader event could already have materialized and metastasized. [Update, Aug. 14, 2020: An Addendum to the original report by Frazier et al. adjusts testing frequency to once or twice per week, depending on the assumed risk. So, undergraduates may well be tested twice per week rather than every five days. Even so, it is still possible that an infected student can pass undetected through two asymptomatic tests and come to class highly infectious. Frazier also counters that superspreader events are built into the model, which is based on “real-world” numbers. However, the model still discounts classrooms as special sites of potential superspreader events; in fact, because of the 6-foot distance between chairs, classmates of positive-testing students will not be considered close contacts, and will not be subject to contact tracing!]

In fact, a recent Harvard-Yale study suggests that testing every two days, not every five days, would be necessary to adequately control infections in college settings. But even that scenario creates enormous complications (and expenses): “The greater difficulty lies in managing the overwhelming number of false positives that will inevitably result from repeated screening for low-prevalence conditions. False-positive results threaten to overwhelm isolation housing capacity, a danger whose gravity increases with screening frequency.” In more recent communications, Cornell says that “students … will be tested either once or twice a week,” which is slightly better—or slightly worse—than the 5-day frequency originally modeled.

And this is precisely why the third option would likely have better results than an in-person model with testing every five days or every week: with virtual instruction, it is not possible to have in-class superspreader opportunities. Of course, people can still behave badly and break the rules outside of the classroom, but such misbehavior would apply equally to all the other scenarios as well. The main difference—that was not considered in Frazier’s model—is precisely the risk of superspreading events in classrooms, especially in those classrooms without operable windows and with modern HVAC systems that are designed to minimize the amount of fresh air (in order to be more energy-efficient). Cornell has not released detailed building-by-building assessments of ventilation systems in all its classrooms, so we cannot know how serious they are about providing adequate fresh air changes per hour (ACH), and whether their HVAC systems can even reach optimal ventilation targets. And Cornell has not even stated what their ventilation targets are.

Evolving research on the efficacy of mask wearing indicates that wearing anything other than N-95 respirators, while better than nothing, is not nearly as effective: “The general public should be educated about mask use because cloth masks may give users a false sense of protection because of their limited protection against acquiring infection.” And six-foot social distancing guidelines, while helpful, are also not necessarily adequate when aerosol transmission in indoor settings is factored in. None of these contraindications are considered in Frazier’s model.

Cornell is already requiring all students, whether taking classes in-person or virtually, to sign a behavioral compact and provide their Ithaca address, if they have one. Yet Cornell refuses to consider the option of testing such students taking online courses in the same way that they test students taking in-person courses: “Frazier said the university still could choose to ask [online-only] students where they are living and attempt to enforce asymptomatic testing for those living in Ithaca. But students could misrepresent where they are residing, and the spotty enforcement could result in outbreaks. The model assumes students in Ithaca are entirely outside the university’s testing purview.” It is this assumption—that “students could misrepresent where they are residing”—that is offered without evidence; i.e., pulled out of thin air. And it is on this shaky foundation that Cornell’s entire conclusion about the superiority of in-person instruction rests.

Cornell clearly wanted to reach this conclusion even before Frazier’s report was published. Just read what Provost Michael Kotlikoff emailed to the entire Cornell Community at the end of April, 2020, two months before Cornell’s announcement of its re-opening based on “science” and one and a half months before Frazier’s report was completed: “As we engage in detailed planning, we are very mindful of the ways in which residential experiences are a hallmark of campus life and provide students with crucial opportunities for formative personal growth. Significant efforts are being devoted to planning aimed at enabling our residence halls to reopen in the fall. As President Pollack noted in her message from last week, the university has established four planning committees to help us to determine the best path toward reopening. We remain hopeful that, working with public health and other scientific experts, we will be able to resume campus operations and welcome students back to our campuses for the start of the fall semester.”

Links to all my Cornell-COVID articles are here.

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Example of human subject research (smog chamber breathing) at the Stanford Research Institute in 1956 (photo by Jack Carrick).

Cornell University is organizing an enormous research project involving human subjects that appears to violate its own guidelines—based on the so-called Common Rule promulgated by the U.S. Department of Health and Human Services (HSS)—as well as principles embedded in the Nuremberg Code of 1947 and the Belmont Report of 1979.

Specifically, Cornell is bringing together thousands of students, faculty, and staff during a global pandemic and subjecting them to in-person instruction where the risk of contracting and spreading the SARS-CoV-2 virus are high. Cornell acknowledges the risk and likelihood of serious consequences: President Pollack wrote, in her June 30, 2020 announcement of Cornell’s reactivation plans that “there is simply no way to completely eliminate risk, whether we are in-person or online; even under the best-case projections, some people will become infected with the SARS-CoV-2 virus, and some will develop the severe form of the COVID-19 disease.” The Nuremberg Code directly prohibits such activity, stating: “No experiment should be conducted where there is a priori reason to believe that death or disabling injury will occur.”

Cornell’s own Institutional Review Board for Human Participant Research (IRB) would, in principle, evaluate such “experiments” with human subjects, but the Board has come to the conclusion that no such evaluation is required. Why? Because they claim that Cornell’s proposal to expose its human subjects to these known risks is not “research.” In an email to me on July 30, 2020, the IRB justified this conclusion as follows:

The regulatory definition of “human subjects research” has two components: the “human subjects” piece and the “research” piece.  While Cornell will be obtaining information and biospecimens from living individuals through intervention and interaction (so, meeting that “human subjects” piece of the definition), the activities are not being performed for the purposes of research. Here is the “research” definition from 45 CFR 46 (the “Common Rule”): 

• 46.102(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Cornell’s surveillance activities are not designed to develop or contribute to generalizable knowledge, but rather, to track the transmission and prevalence of SARS-CoV-2 and COVID-19 in the Cornell community, and develop practices to help curb that transmission. In addition, there is a public health surveillance activities carve-out from the Common Rule (i.e., deemed not to be research):

• 46.102(l)(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

The HHS Office for Human Research Protections also published guidance on COVID-19 this past spring, which might interest you.

I hope this helps clarify our determination that Cornell’s current proposed surveillance activities do not meet the definition of “human subjects research.”

In other words, the IRB argues (1) that Cornell’s activities are not “research” because they are not “designed to develop or contribute to generalizable knowledge,” and (2) that public health surveillance activities are, in any case, exempted from review. Both of these arguments, however, can be challenged. On the question of whether Cornell’s proposed activities constitute research, compare the HSS definition of research to Cornell’s own research statement, embedded in its reactivation plan, in which Cornell describes behavioral surveillance and surveying strategies that are designed to “provide valuable insight on subsequent guidance that could be provided to students to reduce transmission”:

Behavioral surveillance is an important tool for monitoring compliance with these directives. A standard survey instrument will be developed to observe adherence in public places (only) on campus, such as classrooms, libraries or dining facilities. In addition, Cornell will monitor infections on a daily basis. In collaboration with TCHD, Cornell Health will receive identified information of positive students and will determine activities or practices associated with becoming COVID-19 positive. Using this information, the university will be able to correlate clusters of infections in individuals sharing residences, classrooms or other activities. This may allow for the identification of places or behaviors associated with an increase in risk of transmission and provide valuable insight on subsequent guidance that could be provided to students to reduce transmission.

In an email reply to the IRB on July 30, 2020, I argued that Cornell’s intended surveillance and survey activities do constitute “research” and that the HSS public health exemption does not apply to these research activities:

First, it seems to me that Cornell’s surveillance and surveying activities are designed to develop or contribute to generalizable knowledge. In their reactivation plan document, Cornell draws upon the results of research conducted elsewhere (for example, Cornell writes that “experiences at other institutions of higher education indicate that there will likely be individuals positive for COVID-19 among those returning to campus” — p.4). In the same way, it can be safely assumed that the results of Cornell’s surveillance and surveying will not merely be used internally but will also be disseminated. This is, by definition, a contribution to generalizable knowledge.

Second, the public health exemption does not seem to apply to Cornell’s research since Cornell’s activities are not “conducted, supported, requested, ordered, required, or authorized by a public health authority.” Cornell is collaborating primarily with Cayuga Medical Center, which is not a public health authority. It is true that Cornell is coordinating some of its reactivation planning with the Tompkins County Health Department (and TCHD is a public health authority), but this relationship is not connected to Cornell’s research on human subjects: TCHD will provide counseling to students who test positive (p.5), TCHD is conducting its own independent “syndromic surveillance system among outpatient providers in Tompkins County” (p.13), and, per state law, TCHD will conduct contact tracing. Similarly, Cornell has consulted with the NYS Department of Health Wadsworth in order to use the Animal Health Diagnostic Center (AHDC) at the College of Veterinary Medicine to expand PCR testing capabilities in Ithaca (p.3). But such ad hoc contact with public health authorities is entirely separate from the independent research—the behavioral surveillance and surveying of their human subjects—that Cornell is undertaking. And these independent research activities are not “conducted, supported, requested, ordered, required, or authorized” by TCHD or by any other public health authority.

The OHRP Guidance exception for “actions taken for public health or clinical purposes” does not seem to apply to the research activities Cornell is undertaking on its human subjects. The example given, of a hospital implementing “mandatory clinical screening procedures related to COVID-19 for all people who come to that institution” is clearly not research, as its purpose is simply to identify patients carrying the virus. Cornell’s surveillance and surveying, on the other hand, is undertaken as research, to enable “identification of places or behaviors associated with an increase in risk of transmission and [to] provide valuable insight on subsequent guidance that could be provided to students to reduce transmission.”

Third, the OHRP Guidance document, in response to this global health emergency, states: “Given the current circumstances, the research community is encouraged to prioritize public health and safety.” Yet Cornell is not reacting to a health emergency, as it was when shutting down the campus last spring. In the present case, Cornell is actually creating the public health emergency for which it has organized its research program with human subjects. The campus was shut down, and Cornell has decided to open it back up knowing that infection, disease, and—possibly—death will inevitably follow. This was a choice Cornell made, not one forced upon it. Other universities have opted not to engage in in-person instruction.

But this should not be a debate about whether Cornell made the right decision, or whether other options would have an even worse outcome. The only question here is whether Cornell’s research on human subjects should be evaluated by the IRB. I believe that the facts and definitions cited above show that Cornell’s planned activities constitute research and that this research involves human subjects.

On July 31, 2020, the IRB sent me the following reply:

The IRB staff have discussed this together with the IRB Chair, and using our collective knowledge of U.S. human subjects research regulations and the compliance community’s accepted interpretation of them, we have determined that Cornell’s surveillance activities are not research, as defined by the Common Rule. As I noted in an earlier email, if any human subjects research is proposed in conjunction with or using data from these surveillance activities, those research projects will require an IRB review.

In other words, the IRB is willing to let Cornell expose its human subjects to a highly contagious and dangerous virus, knowing that—in President Pollack’s words— “some people will become infected with the SARS-CoV-2 virus, and some will develop the severe form of the COVID-19 disease”; is willing to let Cornell implement behavioral surveillance and surveying tools that, in Cornell’s own words, are intended to “provide valuable insight on subsequent guidance that could be provided to students to reduce transmission”; but does not consider any of this to be worthy of IRB review unless the data gathered from these activities are used in what the IRB determines is human subject research, i.e., after Cornell’s human subjects have already been exposed to a virus that is likely to cause severe disease or even death in some of the human subjects. To repeat, the Nuremberg Code states: “No experiment should be conducted where there is a priori reason to believe that death or disabling injury will occur.”

There is certainly some potential ambiguity between what constitutes research and what constitutes ordinary practice, and Cornell’s behavioral surveillance and surveying may well fall into this gray zone. However, it is precisely this ambiguity that makes IRB review essential. As argued in the Belmont Report cited above: “The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.”

Links to all my Cornell-COVID articles are here.