Unregulated biomedical research has previously caused untold suffering to humankind. History is full of examples of abuse of animal and human subjects for research. Several codes and instruments have been formulated to regulate biomedical research. In Kenya, the Science, Technology and Innovation Act, 2014, together with the Constitution of Kenya, 2010, provide a fairly robust legal framework. Possible challenges include capacity building, overlap of functions of institutions, monitoring and evaluation, scientific/technological advances, intellectual property rights, funding for research, and dispute resolution. It is hoped that the new legislation will adequately address these challenges.