Introduction
Clinical research on medicines is among the most tightly regulated areas of medicine, because commercial interests can conflict with the safety of trial participants. Two foundations govern it: ethics (the Declaration of Helsinki) and Good Clinical Practice.
Ethical principles
The Declaration of Helsinki (World Medical Association, 1964, revised) states that the well-being of the individual research subject must take precedence over all other interests.
- Informed consent: oral and written information on the aims, procedures, risks, inconveniences and possible benefits; the consent form is signed and dated personally (or by a legal representative) before any trial procedure.
- The right to withdraw at any time, without giving a reason and without any disadvantage.
- An independent person should be available to answer questions.
- Special protection of vulnerable groups: children, pregnant women, people who cannot consent, prisoners, dependent persons (students, employees).
- Risks must be justified by the expected benefit; placebo only when no proven treatment exists or there is a compelling scientific reason and no serious harm.
- Confidentiality of personal data; insurance for participants.