As COVID-19 vaccinations have ramped up, there has been a parallel surge in discussion of the legality, ethics, and practicality of so-called vaccine passports: systems or processes that require COVID-19 vaccination in order for a person to participate in certain activities. On the SBER Network, a PRIM&R Online Community, discussion emerged about whether institutions could mandate that anyone wishing to participate in research be vaccinated, what role IRBs might play in that conversation, and the principles we should take into account as we consider the question. Below, we share key points from that conversation and some further discussion from the participants:
- Nicole Ferrari, IRB Administrator at Central Connecticut State University
- Curt Naser, Chief Product Officer at Axiom Mentor
- An IRB Administrator working in public health, participating anonymously (IRB Administrator)
- An IRB Director working in public health, participating anonymously (IRB Director)
The discussion is broken into two parts. In this post, we’ll address whether it’s appropriate to require vaccines for study participants (and what the downsides might be). In a later post, our participants will address the core principles behind these decisions, and what IRBs should do when presented with these challenging questions at their institutions.
The views presented are those of our featured participants, and shouldn’t be understood as positions taken by their institutions or PRIM&R as a whole.
Is it appropriate for an institution to require COVID-19 vaccination for study participation?
IRB Director: When considering the question of whether to require COVID-19 vaccination, you need to weigh state/local laws, institutional policies and individual freedoms. At this point, I'm not sure most people are ready to resume pre-pandemic interactions, even if they are vaccinated. The IRB may want to see how the issue plays out in the broader social context (and in their home organizations) before jumping in with hard and fast rules. Vaccination is only one of several methods for protecting participants against COVID-19. The CDC is still recommending PPE and social distancing precautions for most people, even after vaccination. So, vaccine availability hasn’t yet replaced other precautions. I think this will become a huge issue in the coming months, and I wouldn’t be surprised if it hits the court dockets
Nicole Ferrari: I agree that educational access based on vaccine status may become an issue for the courts, and that some other access issues still need to play out in other contexts. However, as far as research participation goes, I see that as a different (though closely related) question. We do ask for health information to screen for other studies, so if vaccine status is considered out-of-bounds from a privacy perspective, then that would make me question the appropriateness of a lot of other health-related screening criteria regularly used by our IRB. For example, many exercise science studies have health-related screening questions (such as heart conditions, pregnancy, etc.). I'm wondering from a legal standpoint how vaccine status differs from this type of health information? It’s a difficult issue to ignore from a risk/benefit perspective when evaluating the safety of researchers and research participants during in-person research interactions.
I think it is difficult to require anyone to be vaccinated for research participation purposes if significant benefits are being withheld (such as required research participation for students)—especially in a situation where a product has not been fully approved by the FDA. But I think it is justifiable to use vaccine status as a screening tool for safety purposes to lower the risk of study participation for everyone involved so long as that medical information is not shared, other opportunities for research participation are presented, and the research does not involve any type of coercion related to obtaining a vaccine.
Curt Naser: I think it is appropriate to ask for vaccination status and even to require COVID-19 vaccination to enroll subjects in research. With regard to asking for vaccination status, I would only recommend this if the information was germane to the research itself. That is, the research needs that information as part of the data it will analyze. But I think the primary question here is asking for COVID-19 vaccination status as an inclusion criterion in the study. Of course, if there is a methodological reason for seeking to include those vaccinated or even exclude those that are vaccinated, then the criterion likely has a direct justification. It is when vaccination status does not relate to the research question(s) but instead is required as a matter of public health and safety. This is where I think the controversy lies.
The IRB’s first responsibility is to protect the welfare of human subjects. Secondarily, it has some institutional responsibility to protect the researchers, or at least ensure that there are adequate measures in place to keep researchers safe. Many IRBs oversee student research and research conducted by faculty or staff who may not have the working knowledge for maintaining adequate protection when interacting with subjects who may carry infectious diseases. This issue is less of a concern in the hospital setting since hospital staff are trained specifically in the use of PPE and other infection control measures and practice them on a daily basis. In non-health care settings, there is likely less of a PPE culture and other infection control measures and thus there is greater likelihood of error and non-compliance and thus of viral transmission. Not that it can’t be done, but it would require adequate education and training. Since the goal of researcher use of PPE is to both protect their research subjects and themselves, I see no reason not to require researchers to be vaccinated unless they have a medical reason for not doing so (in which case I would question whether they should be involved in face to face contact with research subjects, but that would likely be a medical judgment).
The primary issue for the IRB is protecting human subjects. I think the IRB or the institution itself may require COVID-19 vaccination in order to participate in research. Unvaccinated subjects are a risk of spreading the virus to the researcher or possibly other subjects if subjects are gathered together. There is strong evidence, even without full FDA approval of the vaccines, that they are highly effective at preventing symptomatic disease and reducing the transmission of the virus. We know, generally, the probabilities and magnitudes of harms that result from COVID-19 infection (though we continue to find new risks, e.g. asymptomatic infections resulting in longer term harms) and we have sufficient evidence to know that risks of vaccination are miniscule by comparison (even if a significant minority of the population believes otherwise). We also know that the vaccines are not perfectly effective, and it is still possible for vaccinated individuals to transmit the virus and possible that they become infected. In a public health crisis, every step we can take to minimize transmission is beneficial to those directly involved in the research and to the public at large.
Requiring subjects to be vaccinated will, at least in the short run, result in a selection bias for some research purposes. In the case of research that does not present the possibility of direct benefit to subjects, we would have to weigh the overall possible benefits of the research (knowledge gained) against the immediate heightened risks to subjects and researchers should non-vaccinated subjects be enrolled. It is possible that the research presents general benefits that outweigh the risks of viral transmission, but I would have to evaluate that on a case-by-case basis. If the research does not present significant benefit overall, then I would argue against enrolling non-vaccinated subjects in face-to-face research. In this case, I don’t see that the balance of risk of spread of the virus outweighed by the personal (educational and scholarly) needs of the researchers. Even a small risk of infecting a research subject when there is no possibility of direct benefit to that subject is still a risk to the subject that can easily be avoided by simply not enrolling that subject. We can’t protect everyone all the time, but we can do our part to avoid creating situations where the virus can be transmitted.
IRB Administrator: I feel it is not appropriate to ask participants/subjects to be vaccinated to participate in research unless it is a specific study that encompasses the vaccination or is COVID-19-related. It is a discriminatory question and that excludes a large group of viable participants/subjects that may not be able to be vaccinated due to medical or religious reasons. Research should be inclusive and generalized to the public. There is no scientific reason to ask individuals to be excluded from research simply because they are unvaccinated unless it is directly related to the study’s aims. If a PI is worried about transmission, then they should be following the CDC and their local health department’s guidance to ensure all precautions and personal protective equipment are in place to minimize the risk of transmission. It is a requirement for any PI to minimize the risk as much as possible to participants/subjects for any research study and the IRB’s responsibility to ensure that has been done. I have been fortunate to be working for an agency that has been at the forefront of this pandemic. Research has continued and PIs have become creative in continuing their research projects including all participants/subjects without discriminating all the while protecting themselves, their research staff, and their participants/subjects from the transmission of COVID-19 prior to the vaccine being available.
What, if any, might be the downsides of requiring COVID-19 vaccination?
Curt Naser: It will be likely that higher education institutions will require vaccination of their students as a condition of returning to campus in the fall. I think this is a good thing, but can’t make a judgment about legality, other than that these institutions have been requiring all sorts of other vaccinations for many years. If that is the case, then it will be a moot point of whether students can participate in research for credit (as is typical in psychology departments). But even if the institution does not require COVID-19 vaccination, I think it is on the IRB to make its own determination about the safety and risk of involving students in face-to-face research. Arguably, such research would not raise risk above the normal risk of college students on campus and is likely to be safer than the activities students engage in on their own time. But I don’t see any obstacle to the IRB making its own requirement based on its assessment of safety and risk. The IRB has sole purview of making the risk/benefit determination (with any consultation it wishes to seek). A decision to deny approval based on such a determination is unappealable. It would be interesting to see what the legal system would do with that statement in the regulations in a case like this.
IRB Administrator: The downside to excluding participants from the study that are not vaccinated would be the results would not be generalizable to the public. You are excluding a large group of viable participants/subjects that may not be able to be vaccinated due to medical or religious reasons or those that just want to wait and see if the science is true. How is the principal investigator (PI) going to ensure equity in the participants/subject population? What is the scientific justification for excluding the unvaccinated for a social/behavioral research project? These are just a few of the questions that the IRB should be asking if a PI presents a study with exclusion criteria of unvaccinated individuals. Researchers should be asking how excluding this group will impact their research and if it is a necessary exclusion and have their justification clearly explained.