is governed by its own set of federal laws and regulations, and any hES cell research that involves insertion of hES cells or their derivatives into animals is already subject to animal welfare protections. The Animal Welfare Act constitutes congressional policy to ensure the most humane use of animals in research. Some animals that might be used by hES cell investigators are not covered by the act, but most are covered.11 In addition, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires that each institution receiving PHS support for an activity involving any live vertebrate animals establish an appropriate institutional animal care and use program, including an Institutional Animal Care and Use Committee (IACUC) with specific responsibilities as described in the PHS policy.12

Laboratory Practice

In addition to special regulations governing recombinant DNA research and research that uses animals, the federal government has regulations pertaining to the management of laboratories where products that might ultimately be introduced into humans (as in a clinical trial) are being developed. FDA’s Good Laboratory Practice (GLP) regulations establish standards for nonclinical laboratory studies. These do not include basic exploratory studies performed to determine whether a test article has any potential utility or to determine its physical or chemical characteristics but they do encompass in vivo or in vitro experiments in which test articles are studied to determine their safety—an activity that would be characteristic of the preclinical phase of hES cell research. Failure to conform to GLP regulations, although not itself a violation of law, would render any hES cells less useful in the future if they were considered for clinical trials of tissue transplantation or other cell-based therapies.13

Recommendation 11:

Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care. Institutions should consider adopting Good Laboratory Practice standards for some or all of their basic hES cell research.

REGULATION OF CLINICAL RESEARCH WITH CELL LINES AND DIFFERENTIATED TISSUE

Clinical research aimed at obtaining FDA approval or new labeling of drugs, devices, or biologics is subject to regulation by FDA. It must be conducted in

11  

Animal Welfare Act (as amended), 7 USC §§ 2131-56.

12  

http://grants.nih.gov/grants/olaw/references/phspol.htm.

13  

http://www.fda.gov/ora/compliance_ref/bimo/7348_808/part_I.html.



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