Topic: Case Study
A childhood vaccine for pneumococcal disease, one of the most important causes of child deaths in the developing world, has been developed by a European pharmaceutical company and tested at a site in Africa. The goal of the trial was to determine how many children would be protected from the disease before the age of 3 years. In this community, and in the region overall, approximately 90% of the childhood deaths caused by pneumococcal disease occur in children younger than 3 years. After community consultation and extensive efforts to obtain meaningful informed consent, 20 000 infants were enrolled in the vaccine trial. Participants were randomized and half received the trial vaccine. After 3 years, 90% of those who were vaccinated remained free of the disease. Those in the control group had infection and mortality rates comparable to those that prevailed in recent years in this population.
Ordinarily, vaccines and other interventions which are proven effective in a randomized placebo-controlled trial are offered to all participants in the control group soon after the conclusion of the trial. Some of the scientists in this study, however, became reluctant to follow that practice in this trial. Their concern was that the study provided a unique opportunity to determine whether the vaccine protected children who were older than 3 years; if the controls were vaccinated at the conclusion of the trial, an ongoing study in older children would have no controls. The same considerations applied to longer-term monitoring of adverse post-trial events. Both of these issues – protection of children older than 3 years, and long-term safety – might play a role in determining whether the vaccine would be widely used in the future, and many children’s lives might depend on the result. Moreover, if (as turned out to be the case) the results of the first trial were definitive for children aged 3 years and younger, it might be impossible to conduct any further controlled trial of the vaccine. This was, in the view of these scientists, a unique opportunity. Their concerns, however, were not incorporated into the study design, and all controls received the vaccine at the conclusion of the trial.
Adapted from a case study contributed by Dr. Brooke Ronald Johnson, World Health Organization
Questions
- Were the dissenting scientists correct to urge that controls should not be vaccinated? If the parents had agreed to this condition in the informed consent, would this justify not vaccinating the control group at the conclusion of the study?
- If the randomized, placebo-controlled trial design was justified, why would it be unjustified to decline to vaccinate the controls?
- Would any further test of the effect of these vaccines on children older than 3 years, and of long-term safety, be justified?
- It is vital when conducting research that all ethical principles of the Belmont Report are considered and the researcher seek approval from an Internal Review Board (IRB) to ensure safety and ethnicity of the research project. The Belmont Report assures protection of human subject during research thought the ethical principles of respect for person, beneficence, and justice (Office for the Secretary, et al., 1979). The three ethical principles provide a framework of safety for human participants in research studies. The scientist where unethical in their approach to not vaccinate the control subjects after benefit was determined. This is in direct violation of the ethical principle of beneficence, in that the human subjects would be harms by not receiving the treatment once benefit was determined. This is a central ethical theme for medications and randomized control trials. Ovosi, et al. (2017) finds the use of placebos can possibly harm patients as not receiving treatment through increase morbidity or mortality for the primary purpose of scientific advancement. Therefore, it is unethical and not justifiable to request that parents do not vaccinate their child at the end of the study. Furthermore, this was not part of the study design and is not covered under the IRB approval. A second research design would need to be proposed to continue the study of long-term effects of the vaccination with IRB approval. However, this research study design is more ethical as it is not directly violating any ethical principles of the Belmont Report.
this is another example
Were the dissenting scientists correct to urge that controls should not be vaccinated?
No, because according to the case study, those in the control group had infection and mortality rates comparable to those that prevailed in recent years in this population.
If the parents had agreed to this condition in the informed consent, would this justify not vaccinating the control group at the conclusion of the study?
No, Based on this case study, the same considerations applied to longer-term monitoring of adverse post-trial events, protection of children older than 3 years, and long-term safety play a role in determining whether the vaccine would be widely used in the future, and many children’s lives might depend on the result.
Would any further test of the effect of these vaccines on children older than 3 years, and of long-term safety, be justified?
No, After 3 years, 90% of those who were vaccinated remained free of the disease
Reviewing the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct is vital. Relevant original publications form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.
This is also a good example
Ethics, relating to human subjects, is a broad discussion area and depends on maintaining human rights principles (Anabo et al., 2019). The dissenting scientists were incorrect to urge that controls should not be vaccinated. At the end of the randomized control trial, all participants in the control group should have had the opportunity to receive the vaccination, especially since the vaccine’s success proved to prevent mortality and prevent the disease from occurring. The parents should have been notified, informed, and allowed for their children to be vaccinated.
Because the randomized, placebo-controlled trial design was justified, and this would make it unjustifiable to decline to vaccinate the controls. This fact is so because the case study points out that children who were greater than three years old, if provided the vaccine, will need an ongoing study. These children would be without a control group since the trial had ended with considerations applicable to extended surveillance of adverse post-trial events that would not be in place for monitoring. Guidelines were developed to ensure that research would be performed with specific ethical principles such as respect for people, beneficence, and justice (Adashi et al., 2018).
Any further test of the effect of these vaccines on children older than three years and of long-term safety would not be justified because the case study reports that “approximately 90% of the childhood deaths caused by pneumococcal disease occur in children younger than three years old. Research performed on children that did not provide a direct advantage was considered immoral because it utilized the child exclusively as a means for research purposes only (Ross, 2020).
References
Adashi, E. Y., Walters, L. B., & Menikoff, J. A. (2018). The Belmont Report at 40: Reckoning with time. American Journal of Public Health, 108(10), 1345–1348. https://doi-org.libauth.purdueglobal.edu/10.2105/AJPH.2018.304580
Anabo, I. F., Elexpuru-Albizuri, I., & Villardón-Gallego, L. (2019). Revisiting the Belmont Report’s ethical principles in internet-mediated research: Perspectives from disciplinary associations in the social sciences. Ethics & Information Technology, 21(2), 137–149. https://doi-org.libauth.purdueglobal.edu/10.1007/s10676-018-9495-z
Ross, L. F. (2020). The ethical limits of children’s participation in clinical research. The Hastings Center Report, 50(4), 12–13. https://doi-org.libauth.purdueglobal.edu/10.1002/h…
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