Medical progress is not possible without testing new drugs and therapies on humans. The area of conflict between the desire for medical progress on the one hand and the protection of the physical integrity of the test participants and patients on the other hand, requires a continuous ethical assessment, especially when test participants take on burdens and cannot expect any direct benefit from the research project in question. This applies in particular when research is carried out on people in developing and emerging countries.
In July 2012, the European Commission presented a proposal to facilitate drug testing on humans within the EU. Within this context, it is considered particularly worrying that the Commission’s plans would lower protection standards within the EU. In addition, the current debate needs to consider the conduct of drug testing in developing and emerging countries where less stringent research and ethical standards apply.
Together with experts from various disciplines, the German Ethics Council aimed to draw attention to this issue and to promote a nuanced public discourse by taking into account the following aspects:
- How are the current ethical principles and legal regulations for research on humans in Germany and Europe implemented and are they sufficient?
- What are the ethical and legal advantages and disadvantages of the planned new EU regulations for research on humans?
- Do the existing ethics committees protect the test participants in the required manner and, if so, does the new EU regulation jeopardize this protection?
- Can uniform global standards for research on humans be justified, and if so, what can be done to ensure that they are legalized, enforced and complied with?
- To what extent are industrialised countries responsible to comply with ethical standards when they benefit from research conducted on humans in developing and emerging countries?