The author examines and comments on the individual research-related regulations of the Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine concerning biomedical research. Existing national and international provisions are included in a comparative manner, as well as general legal principles that currently shape biomedical research involving humans in Germany. At the same time, the question is addressed to what extent the research protocol is compatible with constitutional requirements, particularly human dignity and research freedom, as well as the general right to self-determination of research participants, and whether its incorporation into national law can be advocated. Regarding identified conflicts and divergences, potential solutions and regulatory options de lege ferenda are presented.