Expanded principles of ethics and its implementation during COVID-19 vaccine trials: A scoping evidence based research synthesis

References

• Bell BP, Romero JR, Lee GM. Scientific and ethical principles underlying recommendations from the advisory committee on immunization practices for COVID-19 vaccination implementation. JAMA. 2020;324(20):2025–26. doi:10.1001/jama.2020.20847.
   PubMed Web of Science ®Google Scholar
• Tsatsakis A, Petrakis D, Nikolouzakis TK, Docea AO, Calina D, Vinceti M, Goumenou M, Kostoff RN, Mamoulakis C, Aschner M, et al. COVID-19, an opportunity to reevaluate the correlation between long-term effects of anthropogenic pollutants on viral epidemic/pandemic events and prevalence. Food Chem Toxicol. 2020;141:111418.
   PubMed Web of Science ®Google Scholar
• World Health Organization. A coordinated global research roadmap. Geneva, Switzerland: WHO; 2019.
   Google Scholar
• Rancich AM, Perez ML, Morales C, Gelpi RJ. Beneficence, justice and lifelong learning expressed in medical oaths. J Contin Educ Health Prof. 2005;25:211–20. doi:10.1002/chp.32.
   PubMed Web of Science ®Google Scholar
• Orr RD, Pang N, Pellegrino ED, Siegler M. Use of the Hippocratic Oath: a review of twentieth century practice and a content analysis of oaths administered in medical schools in the U.S. and Canada in 1993. J Clin Ethics. 1997;8:377–88.
   PubMedGoogle Scholar
• Gabel S. Ethics and values in clinical practice: whom do they help? Mayo Clin Proc. 2011;86(5):421–24. doi:10.4065/mcp.2010.0781.
   PubMed Web of Science ®Google Scholar
• Zeiger H. Coronavirus vaccine ethics. The Center for Bioethics & Human Dignity, Trinity International University, USA. 2021. p. 1–3.
   Google Scholar
• Owonikoko TK. Upholding the principles of autonomy, beneficence, and justice in phase I clinical trials. Oncologist. 2013;18(3):242–44. doi:10.1634/theoncologist.2013-0014.
   PubMed Web of Science ®Google Scholar
• Varelius J. The value of autonomy in medical ethics. Med Health Care Philos. 2006;9(3):377–88. doi:10.1007/s11019-006-9000-z.
   PubMedGoogle Scholar
• Keren A, Lev O. Uncertainty, error and informed consent to challenge trials of COVID-19 vaccines: response to Steel et al. J Med Ethics. 2020;46(12):813–14. doi:10.1136/medethics-2020-106793.
   PubMed Web of Science ®Google Scholar
• Cardozo T, Veazey R. Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. Int J Clin Pract. 2020;28:e13795.
   Google Scholar
• McNamara D Three major COVID vaccine developers release detailed trial protocols. Medcape [Internet] 2020; 2020 .[accessed 2021 Jun 02]. https://wwwmedscapecom/viewarticle/937845.
   Google Scholar
• Vissers MFJM, Cohen AF, Van Gerven JMA, Groeneveld GJ. The impact of the global COVID-19 pandemic on the conduct of clinical trials: return to normalcy by considering the practical impact of a structured ethical analysis. Br J Clin Pharmacol. 2020;87(3):837–44. DOI:10.1111/bcp.14480.
   PubMed Web of Science ®Google Scholar
• Eyal N, Lipsitch M, Smith PG. Human challenge studies to accelerate coronavirus vaccine licensure. J Infect Dis. 2020;221(11):1752–56. doi:10.1093/infdis/jiaa152.
   PubMed Web of Science ®Google Scholar
• Katib A. Research ethics challenges during the COVID-19 pandemic: what should and what should not be done. J Ideas Health. 2020;3:185–87. doi:10.47108/jidhealth.Vol3.IssSpecial1.49.
   Google Scholar
• Vashishtha V, Kumar P. Emergency use authorization of Covid-19 vaccines: an ethical conundrum. Indian J Med Ethics. 2021;6:1–4. doi:10.20529/IJME.2020.122.
   Google Scholar
• Wibawa T. COVID-19 vaccine research and development: ethical issues. Trop Med Int Health. 2021;26(1):14–19. doi:10.1111/tmi.13503.
   PubMed Web of Science ®Google Scholar
• Horstmann E,  McCabe M, Grochow L, Yamamoto S, Rubinstein L, Budd T, Shoemaker D, Emanuel EJ, Grady C. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352:895–904. doi:10.1056/NEJMsa042220.
   PubMed Web of Science ®Google Scholar
• Roberts T, Goulart B, Squitieri L, Stallings S, Halpern E, Chabner B, Stallings SC, Halpern EF, Chabner BA, Scott Gazelle G, et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA. 2004;292::2130–40. doi:10.1001/jama.292.17.2130.
   PubMed Web of Science ®Google Scholar
• Reuters CDC probing heart inflammation in a few young vax recipients. The economic times [Internet]; 2021 May. Health:1. [accessed 2021 Jun 02]. https://health.economictimes.indiatimes.com/news/industry/cdc-probing-heart-inflammation-in-a-few-young-vax-recipients/82897113.
   Google Scholar
• Liu Y, Salwi S, Drolet BC. Multivalue ethical framework for fair global allocation of a COVID-19 vaccine. J Med Ethics. 2020;46(8):499–501. doi:10.1136/medethics-2020-106516.
   PubMed Web of Science ®Google Scholar
• Carter S. Over half of Americans delay or don’t get health care because they can’t afford it- these 3 treatments get put off most. CNBC [Internet]; 2019 [accessed 2021 Jun 02]. cnbc.com/2018/11/29/over-half-of-americans-delay-health-care-becasue-they-cant-afford-it.html/.
   Google Scholar
• Avasthi A, Ghosh A, Sarkar S, Grover S. Ethics in medical research: general principles with special reference to psychiatry research. Indian J Psychiatry. 2013;55(1):86–91. doi:10.4103/0019-5545.105525.
   PubMed Web of Science ®Google Scholar
• Jamrozik E, Selgelid MJ. COVID-19 human challenge studies: ethical issues. Lancet Infect Dis. 2020;20(8):e198–e203. doi:10.1016/S1473-3099(20)30438-2.
   PubMed Web of Science ®Google Scholar
• Kass N. An ethics framework for public health. Am J Public Health. 2001;91:1776–82. doi:10.2105/AJPH.91.11.1776.
   PubMed Web of Science ®Google Scholar
• McClung N, Chamberland M, Kinlaw K, Bowen Matthew D, Wallace M, Bell BP, Lee GM, Talbot HK, Romero JR, Oliver SE, et al. The advisory committee on immunization practices’ ethical principles for allocating initial supplies of COVID-19 vaccine - United States, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(47):1782–86. doi:10.15585/mmwr.mm6947e3.
   PubMed Web of Science ®Google Scholar
• Yunus M, Donaldson C, Perron JL. COVID-19 vaccines a global common good. Lancet Healthy Longevity. 2020;1(1):e6–e8. doi:10.1016/S2666-7568(20)30003-9.
   PubMedGoogle Scholar
• Chung YH, Beiss V, Fiering SN, Steinmetz NF. COVID-19 vaccine frontrunners and their nanotechnology design. ACS Nano. 2020;14(10):12522–37. doi:10.1021/acsnano.0c07197.
   PubMed Web of Science ®Google Scholar
• Branswell H. FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines. STAT News. 2020;1–5.
   Google Scholar
• Thiagarajan K. Covid-19: India is at center of global vaccine manufacturing, but opacity threatens public trust. BMJ. 2021;372:n196. doi:10.1136/bmj.n196.
   PubMedGoogle Scholar
• Bharat Biotech. Bharat Biotech announces phase 3 results of COVAXIN: India’s first COVID-19 vaccine demonstrates interim clinical efficacy of 81%. Hyderabad, India: Bharat Biotech; 2021.
   Google Scholar
• Sapkal G, Yadav P, Ella R, Deshpande G, Sahay R, Gupta N, Krishna Mohan V, Abraham P, Panda S, Bhargava B. Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum. 2021;1–7.
   Google Scholar
• Sariola S. Intellectual property rights need to be subverted to ensure global vaccine access. BMJ Glob Health. 2021;6(4):e005656. doi:10.1136/bmjgh-2021-005656.
   Web of Science ®Google Scholar
• McMahon. A global equitable access to vaccines, medicines and diagnostics for COVID-19: the role of patents as private governance. J Med Ethics. 2020;47:142–48. doi:10.1136/medethics-2020-106795.
   Web of Science ®Google Scholar