ABSTRACT
This chapter examines some of the common challenges facing the global biomedical research community, with emphasis on emerging discussions related to regulatory burden and risk mitigation. It provides a meaningful review of the myriad international differences in how law is developed and enforced in different countries, and the potential challenges of harmonization. Perhaps the biggest challenge, if not threat, to the biomedical and animal science research community in the United States is the varied requirements for oversight and reporting imposed by the different federal agencies that fund research. Federally funded research in the United States is awarded to research universities and research organizations by as many as 13 different government agencies. Regulatory burden in today's research environment is not only caused by government mandates and policies. It is also caused by misinterpretation or over interpretation of rules, regulations, accreditation standards, and best practices by research institutions, ethical review boards, editorial review boards, and other members of the scientific community.
