Ethical aspects of clinical studies
Clinical studies are conducted on patients but also on healthy people. Research obtained from clinical studies is the basis for all medical progress and allows the development of new and innovative therapies. Clinical studies have always been and will continue to be an essential part of the drug development process.
But how can it be ensured that clinical studies will be conducted with the lowest possible risk for the participating subjects?
The ethics of “Research involving human subjects and clinical studies” is an area of public interest. Ethical conduct in clinical studies is based on the Declaration of Helsinki (Declaration of the World Medical Association on ethical principles for medical research involving human subjects), an ethical standard adopted in 1964. Ever since, standards, regulations and codes of ethics have been developed and introduced worldwide, in order to ensure that patient safety is paramount in clinical studies.
For patient groups aged 0–17 years it is of particular importance that the medication used has been tested in clinical studies designed especially for this age group. This is the only way to systematically determine the doses in which medication needs to be administered and what effects they can have in children and adolescents, as the organism of a child still in development clearly differs from that of an adult.
By testing medication on the right group of subjects, evidence-based information can be obtained to help reduce uncertainties associated with the use of drugs in this patient group.
It is the task of the ethics committee to review whether research projects involving human subjects are ethically acceptable. Ethics committees are bodies set up at (private) universities and universities of applied sciences where applied research involving human subjects is reviewed or critically assessed.
As it includes representatives from a wide range of interest groups in the medical field, the ethics committee can ensure a high level of professional competence when reviewing research projects. For the study participants involved, this review guarantees that a study has been approved as flawless in terms of ethics and thus allows early access to improved medical treatments.
In general, the patients’ consent is required for participation in a study at all times and without exception. In case of children and adolescents, parental consent is required, however, always combined with age-appropriate information provided directly to the young patient, as well as the latter’s consent. In contrast to clinical studies involving adults, it is not permitted to offer financial incentives for the participation of children in a study. This higher level of legal protection for paediatric clinical studies ensures an ethically correct approach.