Michael J. Selgelid’s research while affiliated with McMaster University and other places

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Publications (131)


TB Matters More
  • Chapter

January 2024

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5 Reads

Michael J. Selgelid

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Paul M. Kelly

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Tuberculosis (TB) is the second leading infectious cause of mortality worldwide and arguably the most important neglected topic in bioethics. This chapter: (1) explains the ethical importance of TB, (2) documents its neglect in bioethics discourse, (3) maps the terrain of ethical issues associated with TB, and (4) advocates a moderate pluralistic approach to ethical issues associated with TB.



Quantifying the impact of individual and collective compliance with infection control measures for ethical public health policy

May 2023

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13 Reads

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7 Citations

Science Advances

Daniel Roberts

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George S Heriot

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[...]

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Infectious disease control measures often require collective compliance of large numbers of individuals to benefit public health. This raises ethical questions regarding the value of the public health benefit created by individual and collective compliance. Answering these requires estimating the extent to which individual actions prevent infection of others. We develop mathematical techniques enabling quantification of the impacts of individuals or groups complying with three public health measures: border quarantine, isolation of infected individuals, and prevention via vaccination/prophylaxis. The results suggest that (i) these interventions exhibit synergy: They become more effective on a per-individual basis as compliance increases, and (ii) there is often substantial "overdetermination" of transmission. If a susceptible person contacts multiple infectious individuals, an intervention preventing one transmission may not change the ultimate outcome (thus, risk imposed by some individuals may erode the benefits of others' compliance). These results have implications for public health policy during epidemics.


Reconciling Regulation with Scientific Autonomy in Dual-Use Research

February 2022

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21 Reads

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9 Citations

Journal of Medicine and Philosophy

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional design principles and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy.


Ethics review of COVID-19 human challenge studies: a joint HRA/WHO workshop
  • Article
  • Full-text available

February 2022

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103 Reads

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9 Citations

Vaccine

This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO’s international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA’s approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.

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Figure 1: The probability a single infected individual entering a completely susceptible population causes an epidemic, assuming no other introductions. The offspring distribution follows either a Poisson distribution or a negative binomial distribution with a dispersion parameter of 0.16.
Figure 3 The expected number of averted infections, () c , due to a single infected individual isolating after infection and not transmitting, after accounting for overdetermination. The result is independent of the specific offspring distribution. This depends only on the average, c . Note the divergence to  as the reproduction number 1 c → , and the decay to 0 as c decreases towards 0 or increases towards  .
Figure 4: The distribution of the number of infections averted if a single individual isolates after infection. Calculated for Poisson and Negative binomial distribution (with dispersion parameter 0.16). For 1 c = the result is a power law distribution. If c is larger or smaller than 1, the distribution falls off quicker. For a given c , both distributions have the same mean, but the Negative binomial distribution results in a more heterogeneous outcome.
Figure 5: Measuring the effectiveness of many individuals isolating. Left The average impact assuming that others interventions set a starting value of c , but in addition to that an additional fraction of the infected individuals isolate. Calculations are done in the limit of an infinite population. As the fraction of infections isolating increases, the size of the epidemic decreases. Eventually a larger fraction isolating translates to a smaller absolute number isolating due to the smaller epidemic. When enough isolate to drive the resulting c close to 1 almost all infections are averted while only a small fraction of the total population isolate, so the number of infections averted per isolating individual diverges. Beyond this threshold (white region), epidemics are impossible and the number of infections averted per infected individual is infinite. Right The marginal benefit of one more infected individual isolating. That is, given the fraction isolating and the initial c , this gives the number of infections averted if one additional infected individual who would not isolate is successfully identified and isolated.
Figure 6: The expected number of infections averted by an individual taking sufficient action (such as a vaccine or prophylactic medication) to prevent her own infection (top blue curve). This is partly from the probability that she prevents her own infection [bottom orange curve, equal to () c ]. The difference between the two curves (shaded yellow) is ( ) ( ) cc ,

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Quantifying the impact of individual and collective compliance with infection control measures for ethical public health policy

December 2021

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75 Reads

Compliance with infectious disease control measures can benefit public health but be burdensome for individuals. This raises ethical questions regarding the value of the public health benefit created by individual and collective compliance. Answering such questions requires estimating the total benefit from an individual's compliance, and how much of that benefit is experienced by others. This is complicated by "overdetermination" in infectious disease transmission: each susceptible person may have contact with more than one infectious individual, such that preventing one transmission may have no net effect if the same susceptible person is infected later. This article explores mathematical techniques enabling quantification of the impacts of individuals and groups complying with three types of public health measures: quarantine of arrivals, isolation of infected individuals, and vaccination/prophylaxis. The models presented suggest that these interventions all exhibit synergy: each intervention becomes more effective on a per-individual basis as the number complying increases, because overdetermination of outcomes is reduced, Thus additional compliance reduces transmission to a greater degree.






Citations (71)


... Additionally, environmental factors, socioeconomic conditions, and access to healthcare contribute substantially to disease transmission dynamics (4). One major challenge in modeling infectious diseases, given the aforementioned epidemiological factors, is understanding how these factors interact and influence each other. ...

Reference:

PREPARE: PREdicting PAndemic's REcurring Waves Amidst Mutations, Vaccination, and Lockdowns
Quantifying the impact of individual and collective compliance with infection control measures for ethical public health policy
  • Citing Article
  • May 2023

Science Advances

... The WHO, in its aforementioned guidance, also mentions the need to have CHIM protocols reviewed by ethics committees with specific training, expertise and resources to conduct a rigorous and relevant review [2] and, where necessary, to call upon another independent ethics body (for pathogens carrying specific risks, for example). A speech at the recent workshop on ethical approval for Controlled Human Infectious Models (CHIM) clinical trial protocols in Brussels (30--31 May 2023) reported that in the United Kingdom, where a CHIM trial with SARS-COV 2 was authorised, the public authority considered that some ethics committees in the United Kingdom were already used to examining this type of protocol but that it was necessary to form a specific committee for the first trials with this new pathogen, given the public interest during a pandemic and the need to have a completely transparent process without any real or perceived conflict of interest [28]. ...

Ethics review of COVID-19 human challenge studies: a joint HRA/WHO workshop

Vaccine

... Third, the issue of dual-use research is often framed as a dilemma between security and freedom of research (see, e.g. Ehni, 2008;Evans, 2013;Evans et al., 2022;Salloch, 2018). In philosophy, too, there have been both recent and historical debates about alleged restrictions on academic freedom on the grounds that a scholar's research is perceived to be harmful to certain groups. ...

Reconciling Regulation with Scientific Autonomy in Dual-Use Research
  • Citing Article
  • February 2022

Journal of Medicine and Philosophy

... Colonization can be defined as the asymptomatic presence of a pathogen in the human body. It is the first step toward an overt disease of the colonized patient, with more or less severity, and also one of the main contributors to infection outbreaks in healthcare settings [11]. Indeed, some studies showed that between 36% and 39% of patients colonized by AMR Enterobacteriaceae develop a subsequent infection [12,13]. ...

Invisible epidemics: ethics and asymptomatic infection

Monash Bioethics Review

... The members of the Round Table, after vigorous discussions, have agreed on a conventional understanding according to which compensation (which never refers to fees within the terms of French law,) cannot be intended to cover the risks taken by the volunteers [34]. It compensates for the costs incurred and the constraints suffered. ...

Should practice and policy be revised to allow for risk-proportional payment to human challenge study participants?

Journal of Medical Ethics

... Public involvement is encouraged by international and Australian authorities. In 2020, the WHO released criteria for the ethical acceptability of a human challenge trial of SARS-CoV-2 [11]. One criterion included public consultation and engagement, including the incorporation of the views of challenge study participants or those who have expressed an interest in participating [11]. ...

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group

Vaccine

... Environmental factors, such as water sources, air quality, and surface cleanliness, may also affect the spread of resistant bacteria. Infection control strategies, including hand hygiene, isolation measures, and appropriate disinfection and cleaning protocols, are crucial to reducing the spread of resistant bacteria; strengthening infection monitoring and control policies can help limit their transmission 23 . ...

Drug-Resistant Infection: Causes, Consequences, and Responses

... Pathogens, in particular bacterial pathogens, do coexist with our microbiome in our digestive, respiratory, urogenital tracts and skin; in many cases human hosts are simply their carriers [21]. This condition, however, may change and the asymptomatic carrier can develop disease that sometimes can be serious with those who develop it becoming at high risk of death or recurrent damaging morbidity [21,22]. ...

Surveillance and Control of Asymptomatic Carriers of Drug-Resistant Bacteria

... Although there is a growing initiative to implement CHIMs in endemic settings [27], most CHIMs have been conducted in high income countries, often where the pathogen under investigation is not endemic [28]. This study explores a relatively novel setting of a neglected tropical disease endemic in a high-income setting. ...

Ethical issues surrounding controlled human infection challenge studies in endemic low‐and middle‐income countries

Bioethics

... Not surprisingly, as research was sped up and scaled up to address the pandemic, ethical questions arose about whether to continue non COVID-19-related studies (Bierer, et al. 2020); how much funding to allocate to research (as opposed to clinical care and public health interventions) (Bierer, et al. 2020;Bunnik and Smids 2021); and how to treat research participants. With respect to the latter, there were questions about whether usual consent and privacy provisions could be waived for some kinds of research (Singh, Cadigan, and Moodley 2022;Tosoni, et al. 2022); how much risk was acceptable for research participants (Jamrozik, Heriot, and Selgelid 2020;Menikoff 2020); and what degree of scientific and clinical uncertainty were needed to justify conducting clinical trials or continuing them as data emerged and clinical and epidemiological circumstances changed (Lenzer 2020). ...

Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks

Journal of Bioethical Inquiry