The Ethical Case to Consider:

A mother reports that her youngest child is 18-years-old and she has two adult children who are 23- and 28-years-old. The adolescent and two young adults are healthy and inform the mother that they have signed up for the latest COVID-19 ‘vaccine challenge’ study announced today. The researchers, conducting the ‘vaccine challenge’ study, are planning to enroll healthy individuals between the ages of 18-years- and 30-years-old in a COVID-19 vaccine clinical trial.  Each participant will receive a dose of the virus to cause them to become ill with COVID-19.  Then, each participant will receive a dose of a newly developed vaccine to determine the effectiveness of the COVID-19 vaccine in these individuals. The parent is very concerned about her children and their decision to participate in this study and contacts the Ethics Committee. The Ethics Committee is now reviewing the request to conduct the study and the letters of concern from medical professionals, and community members whose children are talking about participating in the study.

Ethics Committee Considerations

The nurses on the ethics committee must consider the ethical principles established by the American Nurses Association. Each research participant must have the capacity to consent to the research with a full understanding of the study, the potential for side effects and adverse outcomes, including, in this case pandemic, death as a result of study participation. Committee members and researchers must assume responsibility to prevent harm, minimize harm, and promotes good to all research participants. In addition, the committee members must ensure the ethical integrity of the research process.¹

Ethics Committee Deliberations

Based on the American Nurses Association’s principles of conducting ethical research, deliberations must focus on these major concerns:

• Consent: The age of the participants begins as young as 18-years old. Will every 18-year old have full capacity to consent to be a study participant?
  • How will it be determined if the 18-year old has the ability to consent?
• COVID-19: Each study participant will receive a dose of the virus.
  • THE FACTS FOR CONSIDERATION:
    
    • Outcomes for those who have contracted COVID-19 are unpredictable.
    • Long-term consequences are currently being identified in some individuals and there has been no time to study the lasting effects or long-term outcomes.
    • COVID-19 results in death and it is unpredictable as to who will get seriously ill and die
    • There are no known evidence-based treatments for COVID-19
    • Vaccines remain in early stages of development and the safety and effectiveness of the vaccines have not been determined.

What is your decision?

You, the reader, are now a member of this Ethics Committee and after considerable personal deliberation and meeting with the Ethics Committee members, it is time to make your decision.

Share your opinion. Tell us in the comments below your stance: 

• Yes, I support allowing individuals 18 and 30 years old to participate in this study
• No, I do not support allowing individuals 18 and 30 years old to participate in this study

References

1. American Nurses Association. Code of Ethics for Nurses with Interpretive Statements.Silver Spring, MD: American Nurses Association; 2015.

Donna Hallas PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN is a certified as a pediatric nurse practitioner and pediatric primary care mental health specialist. She is a Clinical Professor and Director of the PNP program at New York University Rory Meyers College of Nursing. She has presented nationally and internationally on numerous research and clinical topics with the overall goal of improving health care outcomes for infants, children, adolescents and young adults. 

Her first book, Behavioral pediatric healthcare: A growth and developmental approach to intercepting abnormal behaviors, earned the prestigious American Journal of Nursing 2018 Book of the Year Award earning first place for Psychiatric and Mental Health Nursing and third place for Child Health.

Dr. Hallas is a digital editor for Contemporary Pediatrics and writes a monthly commentary which focuses on applying information in one or more journal articles to pediatric clinical practice. Here is a link to the PNP corner www.contemporarypediatrics.com/pnp-corner.

Dr. Hallas’ most recent research focuses on vaccine hesitancy. She and colleagues designed a web-based intervention study using the concepts of informed decision making and the influence of social media. The study was conducted using two populations: pregnant women  and mothers of newborns and young infants to determine the effectiveness of population-specific web-based interventions to reduce the incidence of vaccine hesitancy (Hallas, Altman, & Fletcher, 2018). The study was statistically significant for prenatal women and approached statistical significance for mothers of newborns and young infants. 

Please click on this link for a brief discussion by Dr. Hallas on vaccine hesitancy and the most recent measles outbreak: https://www.nyu.edu/about/news-publications/news/2019/october/one-question–why-do-some-parents-hesitate-to-vaccinate-their-ch.html.