vaccines; boosters; genetics; consent, COVID-19, ethics review, health care workers
During the emergence of the COVID-19 pandemic in 2020, heath care workers were among the highest risk populations to be infected with SARS-CoV-2.1,2 When COVID-19 vaccines became available in early 2021, the Ministry of Health in a Southeast Asian country began a mass vaccination program and prioritized heath care workers. Later that year, amid waning immunity and increasing risk from emerging COVID-19 variants, the Ministry of Health quickly began administering booster doses to heath care workers, considering them a high-risk group.3,4 At the time, there were no scientific data to support use of the COVID-19 vaccine booster in this geographic region, but studies conducted elsewhere suggested the boosters were safe and effective.
Local researchers were interested in studying the potential role of a genetic variation among Asians that affects immunological response to vaccination.5,6 The research team evaluated genetic characteristics and immunological parameters in heath care workers before and after administration of a COVID-19 vaccination booster dose and then prospectively monitored the risk of breakthrough COVID-19. The researchers recruited heath care workers working in COVID-19 wards who were between 22 and 55 years old, had no chronic co-occurring conditions, had received two COVID-19 vaccine doses, were eligible to receive a booster dose, and tested negative for COVID-19 (via a PCR test). Eligible participants were included in a 1-year prospective surveillance study and had 10 milliliters of blood drawn at 3-month intervals.
The fast-moving COVID-19 pandemic created a sense of urgency for this research, and the Ministry of Health was quickly moving toward administering booster vaccinations for this population. The research team did not have time to obtain a research ethics committee (REC) approval before commencing their activities, fearing they would miss the opportunity to draw prebooster blood samples from heath care workers obtaining the booster shot. The team collected prebooster blood samples under the auspices of a hospital management program, then later submitted a research protocol to an REC for review and approval of a postbooster vaccination 1-year surveillance study.
Questions
Discuss the appropriateness of obtaining and using the prebooster blood samples for research, considering no ethics approval was obtained.7
If you were a member of the research ethics committee that received the protocol for the postbooster vaccination surveillance study and you learned that samples and data collected prior to submission of the protocol were to be used in the study, what would you communicate to the researchers? Would you allow the previously collected data and samples to be used? If so, what would you recommend that the researchers do to ensure participants are sufficiently respected and protected?
What unique ethics and regulatory considerations should the researchers consider given that they will be doing genetic testing with the samples?
What would you recommend research institutions and national authorities do to minimize the likelihood that such a situation arise in the future while helping to support rapid evidence development during a pandemic?
