A Researcher’s Guide to Federally Funded Human Embryonic Stem Cell Research in the United States

Abstract

The issuance of the first grant awards for human embryonic stem (hES) cell research by the National Institutes of Health (NIH) in 2002 represents a milestone in this emerging field of biomedical investigation. Based on a policy announced on August 9, 2001 by President George W. Bush, scientists can now apply for and receive federal funds for research to use certain hES cell lines in their laboratory investigations. This chapter provides information often sought by researchers regarding federal policies, regulations, procedures, and opportunities for pursuing studies using hES cells. Although research that results in the creation or destruction of human embryos is prohibited from receiving federal support, there are no legal restrictions on performing these research activities with private sources of funding. In 1998, a research group led by Thomson published their privately funded studies on hES cells, which were obtained after removal of the inner cell mass from an early blastocyst (1). Also in 1998, Gearhart and co-workers published their privately funded studies on human embryonic germ (hEG) cells, which were derived from the primordial ridge of early-gestation fetal tissue (2). Even though hES and hEG cells are isolated from distinctly different stages in human development, both cell lines were found to have the capacity for infinite proliferation in an undifferentiated state and development into specialized cells with properties similar to those found in many different types of tissues. Both hES and hEG cells are described as “pluripotent,” inferring that the undifferentiated cells are capable of developing into cells typically found in specialized tissues representing all three germ layers (the endoderm, mesoderm, and ectoderm) in the course of normal development of an organism.a These discoveries sparked intense interest among the scientific community because of the enormous potential for basic research and development of cell-based therapies, and they led to the establishment of policy for the use of public resources for hES cell research. It is important to note that the presidential decision of August 9, 2001 dealt strictly with hES cell research and did not directly affect the existing guidelines pertaining to the use of federal funds for hEG cell research (3). The main objective of this chapter is to discuss conditions whereby research with hES and hEG cells can be supported by the federal government, and it focuses primarily on the regulations that apply to obtaining funding from the NIH. Other important issues such as those involving patents and intellectual property are addressed in the next chapter.KeywordsHuman Embryonic Stem CellStem Cell ResearchHuman Pluripotent Stem CellHuman Fetal TissueInstitutional Review Board ReviewThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.