Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-23T17:25:33.989Z Has data issue: false hasContentIssue false
  • English
  • Français

COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations

Published online by Cambridge University Press:  29 June 2021

Sara Gerke ,
Gali Katznelson ,
Dorit Reiss  and
Carmel Shachar
Get access Rights & Permissions [Opens in a new window]

Abstract

Employers and governments are interested in the use of serological (antibody) testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.

Keywords

Antibody TestingCOVID-19EmploymentEthicsLawFDAADA
Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 2: Race and Ethnicity in 21st Century Health Care , Summer 2021 , pp. 293 - 302
Copyright
© 2021 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Forgey, Q., “Fauci: Coronavirus Immunity Cards for Americans are ‘Being Discussed,’” Politico, April 10, 2020, available at <https://www.politico.com/news/2020/04/10/fauci-coronavirus-immunity-cards-for-americans-are-being-discussed-178784> (last visited April 14, 2021); J. Bartlett, “Chile’s ‘Immunity Passport’ Will Allow Recovered Coronavirus Patients to Break Free from Lockdown, Get Back to Work,” Washington Post, April 20, 2020, available at <https://www.washingtonpost.com/world/the_americas/chile-coronavirus-immunity-passport-antibody-testing-card/2020/04/20/8daef326-826d-11ea-81a3-9690c9881111_story.html> (last visited April 14, 2021); D. Roland and D. Gauthier-Villars, “Coronavirus ‘Immunity Passport’ Stumbles in U.K,” Wall Street Journal, April 12, 2020, available at <https://www.wsj.com/articles/coronavirus-immunity-passport-stumbles-in-u-k-11586705619> (last visited April 14, 2021).+(last+visited+April+14,+2021);+J.+Bartlett,+“Chile’s+‘Immunity+Passport’+Will+Allow+Recovered+Coronavirus+Patients+to+Break+Free+from+Lockdown,+Get+Back+to+Work,”+Washington+Post,+April+20,+2020,+available+at++(last+visited+April+14,+2021);+D.+Roland+and+D.+Gauthier-Villars,+“Coronavirus+‘Immunity+Passport’+Stumbles+in+U.K,”+Wall+Street+Journal,+April+12,+2020,+available+at++(last+visited+April+14,+2021).>Google Scholar
Eder, S., Twohey, M., and Mandavilli, A., “Antibody Test, Seen as Key to Reopening Country, Does Not Yet Deliver,” New York Times, April 19, 2020, available at <https://www.nytimes.com/2020/04/19/us/coronavirus-antibody-tests.html> (last visited April 14, 2021).+(last+visited+April+14,+2021).>Google Scholar
“‘Immunity passports’ in the Context of COVID-19,” World Health Organization, April 24, 2020, available at < https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19> (last visited April 14, 2021).+(last+visited+April+14,+2021).>Google Scholar
Studdert, D. M. and Hall, M.A., “Disease Control, Civil Liberties, and Mass Testing —Calibrating Restrictions During the COVID-19 Pandemic,” New England Journal of Medicine 383, no. 2 (2020): 102-104, doi: 10.1056/NEJMp2007637.CrossRefGoogle ScholarPubMed
Wang, T.L., Jing, L., and Bocchini, J.A., “Mandatory Influenza Vaccination for All Healthcare Personnel: A Review on Justification, Implementation and Effectiveness,” Current Opinion in Pediatrics 29, no. 5 (2017): 606-615.CrossRefGoogle ScholarPubMed
Abbasi, J., “The Promise and Peril of Antibody Testing for COVID-19,” JAMA 323, no. 19 (2020): 1881-1883, doi:10.1001/ jama.2020.6170.Google ScholarPubMed
Aschwanden, C., “Antibody Tests Were Hailed as Way to End Lockdowns. Instead, They Cause Confusion,” Kaiser Health News, May 28, 2020, available at <https://khn.org/news/anti-body-tests-were-hailed-as-way-to-end-lockdowns-instead-they-cause-confusion/> (last visited May 4, 2021).+(last+visited+May+4,+2021).>Google Scholar
“Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised),” U.S. Food and Drug Administration, May 11, 2020, available at < https://www.fda.gov/media/135659/download> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
Federal Food, Drug, and Cosmetic Act, § 564(c).Google Scholar
“Determination of Public Health Emergency,” United States Department of Health and Human Services. February 4, 2020, available at < https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-02496.pdf> (last visited May 13, 2021).+(last+visited+May+13,+2021).>Google Scholar
“EUA Authorized Serology Test Performance,” U.S. Food and Drug Administration, available at < https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance> (last visited May 13, 2021).+(last+visited+May+13,+2021).>Google Scholar
See U.S. Food and Drug Administration, supra note 8.Google Scholar
See U.S. Food and Drug Administration, supra note 8.Google Scholar
See U.S. Food and Drug Administration, supra note 8.Google Scholar
“Important Information on the Use of Serological (Antibody) Tests for COVID-19: Letter to Health Care Providers,” U.S. Food and Drug Administration, last modified April 17, 2020, available at <https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers?> (last visited April 15, 2021); See also U.S. Food and Drug Administration, supra note 11.+(last+visited+April+15,+2021);+See+also+U.S.+Food+and+Drug+Administration,+supra+note+11.>Google Scholar
Greely, H.T., “COVID-19 Immunity Certificates: Science, Ethics, Policy, and Law,” Journal of Law and the Biosciences 7, no. 1 (2020), available at <https://doi.org/10.1093/jlb/lsaa035> (last visited April 15, 2021); M.A. Hall and D. M. Studdert, “Privileges and Immunity Certification During the COVID-19 Pandemic,” JAMA 323, no. 22 (2020): 2243-2244, doi:10.1001/jama.2020.7712; O.S. Kates, “Show Me Your Passport: Ethical Concerns About Coivd-19 Antibody Testing as Key to Reopening Public Life,” Bioethics Forum Essay, May 5, 2020, available at < https://www.thehastingscenter.org/show-me-your-passport-ethical-concerns-about-covid-19-antibody-testing-as-a-key-to-reopening-public-life/> (last visited May 13, 2021); A.L. Phelan, “COVID-19 Immunity Passports and Vaccination Certificates: Scientific, Equitable, and Legal Challenges,” The Lancet 395, no. 10237 (2020): 1595-1598, doi: 10.1016/S0140-6736(20)31034-5; N. Kofler and F. Baylis, “Covid-19 Immunity Testing: A Passport to Inequity,” Issues in Science and Technology, April 29, 2020, available at <https://issues.org/covid-19-immunity-testing-passports/> (last visited April 15, 2021); N. Kofler and F. Baylis, “Ten Reasons Why Immunity Passports are A Bad Idea,” Nature 581, no. 7809 (2020): 379-381, doi: 10.1038/d41586-020-01451-0; O.F. Norheim, “Protecting the Population with Immune Individu-als,” Nature Medicine 26, no. 6 (2020): 823–824, doi: 10.1038/ s41591-020-0896-2; G. Persad and E.J Emanuel, “The Ethics of COVID-19 Immunity-Based Licenses (‘Immunity Pass-ports’),” JAMA 323, no. 22 (2020): 2241-2242, doi:10.1001/jama.2020.8102.Google ScholarPubMed
Valent v. Bd. of Review, Dept. of Labor, 91 A.3d 644 (N.J. App. 2014); Robinson v. Children’s Hosp. Bos. No. 14-10263-DJC Civ., 2016 WL 1337255.Google Scholar
Anikeeva, O., Braunack-Mayer, A., and Rogers, W., “Requiring Influenza Vaccination for Health Care Workers,” American Journal of Public Health 99, no. 1 (2009): 24-29; A. Caplan, “Time to Mandate Influenza Vaccination in Health-Care Workers,” The Lancet 378, no. 9788 (2011): 310-311.CrossRefGoogle ScholarPubMed
Day Care Facilities: Immunizations: Exemptions. SB-792 (Ca. 2015-2016).Google Scholar
Hagar, S., “‘COVID Parties’ Hurt Everyone,” Union Bulletin, May 4, 2020, available at <https://www.union-bulletin.com/news/health_fitness/coronavirus/covid-parties-hurt-everyone/article_71f95001-a936-5098-8973-65d20b212c31.html> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
See Caplan, supra note 18.Google Scholar
45 CFR § 164.105 (2011).Google Scholar
“Employees,” U.S. Department of Transportation, last modified April 15, 2020, available at <https://www.transportation.gov/odapc/employee#drugalcohol> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
“State Immunization Laws for Healthcare Workers and Patients,” Centers for Disease Control and Prevention, last updated November 19, 2014, available at <https://www2.cdc.gov/vaccines/statevaccsApp/> (last visited May 13, 2021).+(last+visited+May+13,+2021).>Google Scholar
“Job Flexibilities and Work Schedules – 2017-2018 Data from the American Time Use Survey,” U.S. Bureau of Labor Statistics, last modified September 24, 2019, <https://www.bls.gov/news.release/pdf/flex2.pdf> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
“Leisure and Hospitality,” U.S. Bureau of Labor Statistics, May 2020, available at <https://www.bls.gov/iag/tgs/iag70.htm#workforce> (last visited April 15, 2021); “Financial Activities,” U.S. Bureau Labor Statistics, May 2020, available at <https://www.bls.gov/iag/tgs/iag50.htm> (last visited April 15, 2021).+(last+visited+April+15,+2021);+“Financial+Activities,”+U.S.+Bureau+Labor+Statistics,+May+2020,+available+at++(last+visited+April+15,+2021).>Google Scholar
See “Leisure and Hospitality,” supra note 26.Google Scholar
Yasenov, V., “Who Can Work from Home?” IZA Discussion Paper No. 13197 (2020), available at <https://ssrn.com/abstract=3590895> (last visited April 15, 2021).CrossRef+(last+visited+April+15,+2021).>Google Scholar
See Hall and Studdert, supra note 16.Google Scholar
Cohen, I.G., Shachar, C., Silvers, A., Stein, M.A., eds. Disability, Health, Law, and Bioethics (New York NY: Cambridge University Press, 2020).10.1017/9781108622851CrossRefGoogle Scholar
ADA, Section 12102(1)(A).Google Scholar
Bragdon v. Abbott. 524 U.S. 624 (1998).Google Scholar
Id.Google Scholar
Id. at 638.Google Scholar
Id. at 635.Google Scholar
Cook v. Rhode Island Department of Mental Health, Retardation, and Hospitals, 10 F.3d 17, 23 1st Cir. 1993.Google Scholar
Id. at 25.Google Scholar
29 C.F.R. pt. 1630, app. A § 1630.2(l)(2012) (citing 154 Cong. Rec. 144, S8346 (2008), H.R. Rep. No. 110-730 at 17 (2008)).Google Scholar
“Pandemic Preparedness in the Workplace and the Americans with Disabilities Act,” Equal Employment Opportunity Commission, last modified March 21, 2020, available at <https://www.eeoc.gov/laws/guidance/pandemic-preparedness-work-place-and-americans-disabilities-act> (last visited May 13, 2021).+(last+visited+May+13,+2021).>Google Scholar
“What You Should Know About COVID-19 and the ADA, the Rehabiliation Act, and Other EEO Law: Technical Assistance Questions and Answers,” Equal Employment Opportunity Commission, last modified September 8, 2020, available at <https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
“Interim Guidelines for COVID-19 Antibody Testing,” Centers for Disease Control and Prevention, last modified August 1, 2020, available at <https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html> (last visited April 15, 2021).+(last+visited+April+15,+2021).>Google Scholar
Opel, D.J., Sonne, J.A., and Mello, M.M., “Vaccination Without Litigation — Addressing Religious Objections to Hospital Influenza-Vaccination Mandates,” New England Journal of Medicine 378, no. 9 (2018): 785-788.10.1056/NEJMp1716147CrossRefGoogle ScholarPubMed
Trans World Airlines, Inc. v. Hardison, 432 U.S. 63 (1977).Google Scholar