The dilemma stems from a conflict between two leading ethical principles. In the medical context, that means allowing people to refuse medical treatment, even lifesaving therapy. The other ethical principle, beneficence, directs physicians and hospitals to maximize benefits and minimize harms in caring for patients.
This article has been cited by other articles in PMC. Obviously, new, more cost-effective and improved vaccines are needed today and in the future. Vaccines have some distinct features than drugs. Unlike therapeutic molecules, vaccines have preventive role against specific infectious diseases.
The target population is healthy people, mostly children and infants; as a result, tolerability of adverse events is less. Additionally, vaccines are highly complex substances derived from living microorganisms and their quality and safety needs to be demonstrated on a lot-to-lot basis.
Naturally, these factors have some bearing on the clinical trials of vaccines.
Here we discuss some of the current ethical issues in vaccine clinical trials. Pediatric trials Most of the vaccine studies are conducted in children, some of them in infants and even in newborns because that is where you want to catch them for prevention of an infection.
However, children by themselves are unable to consent, and the vaccinator has to accept a legal guardian's agreement. Also, one would expect children to experience more adverse reactions than adults.
For these and many other reasons, it is generally agreed that vaccine studies are, at least primarily, unethical in children if the relevant investigation can be done among adults. The main problem here is, however, that many infections are characteristically only pediatric diseases, or at least, those infections are specially harmful to the youngest.
One therefore needs to seek for a difficult balance between the true and ostensible need of a vaccine in the pediatric population. Yet these parents will be called upon to give consent on behalf of their small children, or to explain to their older heirs children what is happening in the trial.
Another concern is consent of an appropriate legal representative in the absence of parental consent. Recently a demonstration project on a vaccine was conducted in India. An investigation was prompted after press reports of some deaths.
Though the deaths were not found caused by the vaccine, consent obtained from hostel wardens in some subjects living in hostels was questioned.
Such a trial would not be justified if the child comes from population in which that particular disease is not a problem. Malaria vaccine cannot be tested soon in Europe or North America. An absolute care must be taken to ensure that socioeconomic inequalities between industrialized and developing countries are not exploited i.
At the same time, research should not be impeded that aims to reduce the inequality of health care and to benefit pediatric populations in need in developing countries.
Selection of control If a good vaccine is already in use in some other country or community which is more or less comparable to site where the trial is planned, that vaccine should be used as the comparator. Placebo controls are ethically acceptable when there is no proven vaccine for the indication for which the candidate vaccine is to be tested.
An alternative to the use of placebo is to give another vaccine that provides comparable benefit against another disease, or more willingly, against similar disease caused by different agents. This was the approach in Finland in the s, when the first vaccines against bacterial meningitis due to Neisseria meningitidis and H.
For some vaccines, the choice is not difficult since there are no effective interventions so far, e. In Indonesia, an exceptional approach was taken on Thus, all children were not in an equivalent position, but the setup was considered justified because in the absence of disease burden data and vaccine efficacy data in the region, the trial was deemed helpful for the decision whether or not to introduce Hib vaccination in Indonesia and the whole region.
For instance, meningococcal C conjugate vaccine in a pneumococcal vaccine trial, or rabies vaccine in a Japanese encephalitis vaccine trial does not restore equipoise but benefit the child who would not otherwise receive that vaccine.
Age de-escalation Age de-escalation means that phase I and II trials are conducted first in adults, then in older children, and finally, if relevant, in small children.
Rotavirus vaccines are good examples in this category. Sometimes adult participants can be used in the first trials, although they are of no help in the efficacy trials. Sometimes there are grounds to use child participants already in phase I trials.CCRE, Center for Clinical and Research Ethics, Responsible Conduct of Research, PI Program, Case Studies, Ethics Educational Programming.
31 rows · Research case country location year summary Psychosurgery: s . Case studies are an established teaching tool. Ethical analyses of such cases demonstrate the relevance of ethics to the actual practice of medical research and provide paradigmatic illustrations of the application of ethical principles to particular research situations.
May 28, · No-consent medical experiments put ethics to test. It's a fact of emergency research: Patients wake up after serious accidents to discover they've become unwitting subjects in medical studies.
Case studies are an established teaching tool. Ethical analyses of such cases demonstrate the relevance of ethics to the actual practice of medical research and provide paradigmatic illustrations of the application of ethical principles to .
Clinical Research Ethics Case Study: Clinical research ethics is the branch of ethics which is supposed to follow the ethical norms in the all sort of medical and clinical trials and experiments. Nowadays, with the development of science clinical research has become a popular activity, because with its help the humanity receives new and new useful and important gifts in the form of the.