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01-03-2021 | COVID-19 | Scientific Contribution

Back to WHAT? The role of research ethics in pandemic times

Authors: Jan Helge Solbakk, Heidi Beate Bentzen, Søren Holm, Anne Kari Tolo Heggestad, Bjørn Hofmann, Annette Robertsen, Anne Hambro Alnæs, Shereen Cox, Reidar Pedersen, Rose Bernabe

Published in: Medicine, Health Care and Philosophy | Issue 1/2021

Abstract

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

For a differentiation between three different forms of uncertainty, see next paragraph below and Table 1.

Table 1

Covid-19 and three forms of uncertainty (risk, strict uncertainty and ignorance)

Risk^a,b,c,d (known outcomes and known probability distributions)	Test accuracy (sensitivity, specificity, predictive values) for the various tests in different contexts Effects and side effects of new treatments Prevalence of disease The risk of healthcare workers versus the risk of non-essential workers testing positive for COVID-19
Strict uncertainty^e,f,g,h (known outcomes and unknown probability distributions)	Basic reproduction number (R) Case fatality rate/infection fatality rate The precise interval during which an individual with SARS-CoV-2 infection can transmit infection The pathogenic effect of the SARS-CoV-2 in different age groups The extent to which transmission occurs from a-symptomatic or pre-symptomatic subjects and how much it contributes to the pandemic Whether all infected patients mount a protective immune response and how long any protective effect will last Reinfection How long SARS-CoV-2 can persist on surfaces Whether pre-existing immune responses impact the risk or the severity of COVID-19 and whether they will influence SARS-CoV-2 vaccine responses Long-term sequelae and late-stage consequences of COVID-19
Ignorance^i,j,k,l (unknown outcomes and unknown probability distributions)	Mutations Treatment options Unexpected obstacles to vaccine development and production

^aGoldstein and Burstyn (2020)

^bSethuraman et al. (2020)

^cMutambudzi et al. (2020)

^dMcIntosch et al. (2020)

^eHofmann (2020)

^fMcIntosch et al. (2020)

^gYelin et al. (2020)

^hEuropean Group in Ethics in Science and Technology (2020)

ⁱMcIntosch et al. (2020)

^jHofmann (2020)

^kYelin et al. (2020)

^lKalil (2020)

BMA (2001, p. 205).

BMA (2001, p. 210).

Stoeklé and Hérve (2020).

Hellmann et al. (2020).

Outka (2020).

Wynne (1992), Rørtveit and Strand (2001), Nielsen and Sørensen (2017) and Hofmann (2020).

https://www.ohchr.org/en/udhr/pages/udhrindex.aspx.

United States vs. Karl Brandt, et al. (Case No. 1) Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Superintendent of Documents, U. S. Government Printing Office Washington D.C. Volume I (Nuremberg Military Tribunals) pp. 181–182.

Callaway (2020), Eyal (2020), Eyal et al. (2020), Jamrozik and Selgelid (2020a, b), Plotkin and Caplan (2020), Schaefer et al. (2020), Shah et al. (2020), Singer and Chappell (2020), WHO (2020) and Wolemonwu (2020).

Singer and Chappell (2020).

WHO (2020).

Shah et al. (2020).

Jamrozik and Selgelid (2020a).

United Nations International Covenant on Civil and Political Rights. Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966, entry into force 23 March 1976, in accordance with Article 49.

UN Doc A/2929 pp. 87–88. United Nations General Assembly Tenth Session. Draft International Covenants on Human Rights. Annotation Prepared by the Secretary General. 1 July 1955.

Ibid p. 88.

UN Human Rights Committee (HRC), CCPR General Comment No. 20: Article 7 (Prohibition of Torture, or Other Cruel, Inhuman or Degrading Treatment or Punishment), 10 March 1992, para. 3, available at: https://www.refworld.org/docid/453883fb0.html [accessed 5 June 2020].

The Academy of Medical Sciences (2018, p. 3).

The International Alliance for Biological Standardization (2019), Jamrozik and Selgelid (2020a), Eyal (2020).

Shah et al. (2020).

Singer and Chappell (2020).

WHO (2020) and Jamrozik and Selgelid (2020a).

Eyal (2020), Eyal et al. (2020), Jamrozik and Selgelid (2020a, b), Plotkin and Caplan (2020), Schaefer et al. (2020), Shah et al. (2020), Singer and Chappell (2020), WHO (2020).

In a recent paper reviewing and synthesizing available evidence on asymptomatic SARS-CoV-2 infection, subclinical lung abnormalities was found even among asymptomatic persons (For this see Oran 2020).

This additional form of uncertainty is admitted by Jamrozik and Selgelid (2020a, p. 4).

Jamrozik and Selgelid (2020a, p. 4) briefly address the question whether “the permissibility of high-risk human challenge studies” would increase if researchers used themselves as research participants, but they warn against this, and notably for the reason that “clinical and research staff might feel pressure to participate”.

WHO (2016).

WHO (2016, pp. 8–9).

WHO (2016, p. 9).

Lynch (2020).

Cohen (2020)—For this, see also Guarino and Johnson (2020).

Elliott (2020).

Macklin (2020).

Elliott (2020).

Ibid.

Jamrozik and Selgelid (2020a). This concern is also raised by Deming et al. (2020), and by Schaefer et al. (2020).

Shah et al. (2020).

Shah et al. (2020), WHO (2020, note 27, p. 13).

Ward et al. (1958) and Krugman and Giles (1973).

Goodman and McElligott (2003, p. 125).

Krugman (1971, pp. 966–967).

These figures are mentioned in Southam’s letter to Mandel dated July 5, 1964. For this letter, see next note.

Letter from Chester M. Southam, M.D., to Emanuel Mandel, M.D.—July 5, 1963. In: Katz (1972, pp. 10–11).

Arras (2008, p. 75).

This presentation of the interview with Southam, is taken from E. Langer’s article. Human Experimentation: Cancer Studies at Sloan-Kettering Stir Public Debate on Medical Ethics. Science, New Series, Vol. 143, No. 3606 (Feb. 7, 1964), pp. 551–553.

«Direct evidence» was Southam’s own wording in the letter to Mandel.

Southam in his letter to Mandel.

Ibid.

A CHI-study in 197 healthy volunteers contributed to the development and licencing of the Live Oral Cholera Vaccine CVD 103-HgR study in 1993. For this, see: Roestenberg et al. (2018, p. 4).

In 2015, the first malaria vaccine allegedly achieved through the use of CHI-studies gained EMA approval. For this, see Roestenberg et al. (2018, p. 4). For this, see also: European Medical Agency: https://www.ema.europa.eu/en/documents/medicine-outside-eu/mosquirix-summary-public_en.pdf.

For such a study, see: Graham et al. (2004).

Miller and Grady (2001, p. 1032).

Ibid., p. 1032.

CIOMS (2016, p. 10).

The International Alliance for Biological Standardization (2019, p. 88).

Ibid., p. 88. For a similar verdict concerning a Zika CHI-trial, see Recommendation 2 in Shah et al. (2017, p. 27): “Whether a Zika virus human challenge trial has sufficient social value to proceed depends on the reasons for doing it and whether there are alternative ways to obtain the information. The most compelling rationale for conducting a Zika virus human challenge trial, given the risks and uncertainty, would be if field trials were prohibitively difficult to conduct in light of a waning epidemic. This rationale is not currently met, but it could come to pass in the future. Another valuable reason to conduct a challenge trial would be to accelerate the development of a vaccine that could prevent congenital Zika infection. This rationale must be accompanied with strong evidence that results from a Zika virus human challenge trial would be used by stakeholders (e.g., indication from regulatory agencies that finding a correlate would speed up the licensing of a vaccine). The committee did not hear sufficient evidence that this rationale is currently met. Finally, using a challenge trial solely to learn about the pathogenesis and natural history of Zika infection is unlikely to justify the risk involved given the alternative ways to obtain similar information”.

Jamrozik and Selgelid (2020a, p. 4).

WHO (2020, p. 14).

Goodman and McElligott (2003, p. 125).

Shah et al. (2020, p. 2). For the scientific merit argument, see also Bambery et al. (2020, pp. 93–94), Shah et al. (2017, pp. 20–22), Jamrozik and Selgelid (2020b, pp. 602–603), and Wolemonwu (2020, p. 2).

Krugman (1971, p. 966).

Shah et al. (2020, p. 2).

Singer and Chappell (2020). For this argument, see also Eyal et al. (2020, p. 1754), Menikoff (2020, p. 81), Schaefer et al. (2020).

Singer and Chappell (2020), Shah et al. (2020, p. 1), WHO (2020, p. 1), Jamrozik and Selgelid (2020a, p. 1).

The International Alliance for Biological Standardization (2019, p. 86): “Performing CHI is a way to learn and test, while minimizing the number of subjects”.

Krugman (1971).

Jamrozik and Selgelid (2020a, p. 3).

WHO (2020, p. 9). For this argument, see also Eyal et al. (2020, pp. 1754–1755), and Eyal (2020, p. 26).

Krugman (1971, p. 967).

Shah et al. (2020, p. 2).

WHO (2020, p. 9). Also Eyal (2020, p. 26) highlights the importance of Covid-19-CHI-trial participants having “access to standard-of-care life-sustaining treatments”.

Krugman (1971, p. 967).

WHO (2020, p. 8). For the immunity argument, see also Eyal (2020, p. 30).

Jamrozik and Selgelid (2020a, p. 3). A slightly different version of this argument reads thus: “In short, if researchers conducting challenge trials act as recommended, admittedly, the probability of getting infected would remain larger inside a challenge trial than either outside any trial or in a standard efficacy trial; but the probability of death or disability is likely to be much smaller inside a challenge trial than in these alternative scenarios. Overall, a × b could be smaller for any individual inside the challenge trial than either outside any trial or in a standard efficacy trial. What the individual would lose in the probability of averting infection (with that probability rising) she could gain in better protection from death” (Eyal 2020, p. 27).

Krugman (1971, p. 967): informed consent by proxy; Shah et al. (2020, p. 3): “Robust consent”; Jamrozik and Selgelid (2020a, p. 4): “proper” or “adequate consent”; WHO, 220, p. 15: “SARS-CoV-2 challenge studies must involve rigorous informed consent”. For this, see also Bambery et al. (2020, pp. 97–98), Eyal (2020, p. 29), Plotkin and Caplan 2020, p. 3987), Schaefer et al. (2020), and Wolemonwu (2020, p. 3).

Shah et al. (2020, p. 3): «Sites should be selected for sound scientific reasons while avoiding especially vulnerable populations”; WHO (2020, p. 13): “Those whose background risk is high as a result of social injustice should be excluded from participation because their inclusion could be considered unethical exploitation (i.e., taking advantage of those who have already been wrongly disadvantaged. Any prospective participants who could reasonably be perceived to be vulnerable in other ways that would undermine their consent or put them at greater risk (for example as a result of the mental health strain of inpatient isolation during the study) should also be excluded”.

Jamrozik and Selgelid (2020b, p. 11).

https://www.cirp.org/library/ethics/helsinki/.

Singer and Chappell (2020).

London and Kimmelman (2020, pp. 476–477).

Ibid., p. 476.

Ibid, p. 477.

Doroshow et al. (2020).

Ioannidis (2020).

Retraction Watch. Retracted coronavirus (COVID-19) papers. https://retractionwatch.com/retracted-coronavirus-covid-19-papers/.

Mehra et al. (2020a).

Mehra et al. (2020b).

University of Oxford. Dexamethasone reduces death in hospitalised patients with severe respiratory complications of COVID-19. June 16, 2020. Accessible at: https://www.ox.ac.uk/news/2020-06-16-dexamethasone-reduces-death-hospitalised-patients-severe-respiratory-complications. On October 16, 2020, WHO reported that “dexamethasone is the only effective drug for coronavirus”. This information is accesible at: https://www.aa.com.tr/en/latest-on-coronavirus-outbreak/who-dexamethasone-only-effective-drug-for-coronavirus/2009114.

The expression “doing science by press release” we have borrowed from an interview about the study with Dr. George Anesi, director of the Medical Critical Care Bioresponse Team at the Hospital of the University of Pennsylvania. Accessible at: https://www.nbcnews.com/health/health-news/science-press-release-doctors-view-covid-19-drug-results-excitement-n1231183.

NBC News. Doctors view dexamethasone results on COVID-19 with excitement and skepticism. Accessible at: https://www.nbcnews.com/health/health-news/science-press-release-doctors-view-covid-19-drug-results-excitement-n1231183.

Macklin (2020).

Acosta et al. (2015).

Langmuir (1979, p. 660).

Sencer and Millar (2006).

Reference is here made to: Department of Health and Human services. Annex 11: Pandemic influenza response and preparedness plan. Washington: The Department; 2003 Aug 26.

100

FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19, 19.03, 2020. Accessible at: https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19; and, FDA is allowing two drugs to be used for ‘compassionate use’ to treat the coronavirus. Here's what that means. Accessible at: https://www.businessinsider.com/chloroquine-remdesivir-compassionate-use-coronavirus-what-it-means-2020-3?op=1&r=US&IR=T.

101

US FDA. Expanded Access. https://www.fda.gov/news-events/public-health-focus/expanded-access. For this, see also, European Medicines Agency. Compassionate use. Accessible at: https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use.

102

Borysowski et al. (2017).

103

Ibid.

104

Ibid.

105

https://www.centerwatch.com/articles/12702-new-mit-study-puts-clinical-research-success-rate-at-14-percent.

Angus (2020).

WMA (2013).

UNESCO (2005).

‘CIOMS’ stands for Council for International Organizations of Medical Sciences. For this, see CIOMS (2016).

110

Ibid.

111

Editorial in Nature. Everyone wins when patents are pooled. Nature, 2020; 581: 240.

112

AJ Impact/Europen Union (2020).

NOVAVAX (2020).

CNBC (2020a).

CNBC (2020b).

DutchNews.nl (2020).

Lazarus (2020).

Hoen (2020).

COVID-19 technology access pool, 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool.

120

Ibid.

121

Emanuel et al. (2020).

122

Bergens tidende: Accessible at: https://www.bt.no/nyheter/lokalt/i/70vxd4/26-av-30-doede-var-sykehjemsbeboere.

123

BBC News. Accessible at: https://www.bbc.com/news/world-europe-52704836.

124

The Guardian. Accessible at: https://www.theguardian.com/society/2020/jun/07/more-than-half-of-englands-coronavirus-related-deaths-will-be-people-from-care-homes.

125

The differentiation between vulnerability and being vulnerated is important to distinguish between on the one hand persistent and on the other variable forms of vulnerability (Solbakk 2011, pp. 228–238). The persistent form of vulnerability we all share, is part of the human condition, while the second form of vulnerability is context-dependent, in the sense that some people because of disease, poverty, lack of freedom etc. are vulnerated, i.e. harmed or wounded. This distinction points to the need for a differentiation between at least two distinct regimes of protection. Firstly, a human rights-based regime aimed at protecting persistent or universal vulnerability. This regime requires negative action on the part of the State, in the sense that its responsibility is to guarantee basic liberties by securing a just social order that gives equal protection to the vulnerability of each citizen. These protective measures are, however, in need of being supplemented by additional measures of protection—of affirmative action—to cope with accidental states and situations when human vulnerability is no longer intact. “Fallen vulnerability” is a metaphor that has been suggested to designate such situations (Kottow 2004, p. 281).

126

UN Human Rights Committee (HRC), CCPR General Comment No. 20: Article 7 (Prohibition of Torture, or Other Cruel, Inhuman or Degrading Treatment or Punishment), 10 March 1992, para. 7, available at: https://www.refworld.org/docid/453883fb0.html [accessed 5 June 2020].

127

Heggestad et al. (2013).

128

Guillemin and Gillam (2004). Guillemin, M., & Gillam, L. (2004). Ethics, Reflexivity, and “Ethically Important Moments” in Research. Qualitative Inquiry, 10(2), 261–280. https://doi.org/10.1177/1077800403262360.

129

European Group in Ethics in Science and Technology. Statement on European Solidarity and the Protection of Fundamental Rights in the COVID-19 Pandemic, April 2, 2020. Accessible at: https://ec.europa.eu/info/sites/info/files/research_and_innovation/ege/ec_rtd_ege-statement-covid-19.pdf.

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Title: Back to WHAT? The role of research ethics in pandemic times
Authors: Jan Helge Solbakk
Heidi Beate Bentzen
Søren Holm
Anne Kari Tolo Heggestad
Bjørn Hofmann
Annette Robertsen
Anne Hambro Alnæs
Shereen Cox
Reidar Pedersen
Rose Bernabe
Publication date: 01-03-2021
Publisher: Springer Netherlands
Keyword: COVID-19
Published in: Medicine, Health Care and Philosophy / Issue 1/2021
Print ISSN: 1386-7423
Electronic ISSN: 1572-8633
DOI: https://doi.org/10.1007/s11019-020-09984-x

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Back to WHAT? The role of research ethics in pandemic times

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Keynote webinar | Spotlight on medication adherence

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Abstract

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