Additional Guidelines and Regulations 

The National Academies recommended guidelines for research involving human embryonic stem cells, and urges all institutions conducting such research to establish oversight committees to ensure that the new guidelines will be followed. The guidelines are intended to enhance the integrity of privately funded human embryonic stem cell research by encouraging responsible practices.

At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), 1989 (Hong Kong), 1996 (Somerset West, Republic of South Africa) and 2000 (Edinburgh, Scotland).

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research: Respect for persons, Beneficence, and Justice. The Belmont Report explains how these principles apply to research practices. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.

The CIRM is a state agency that was established through the passage of Proposition 71, the California Stem Cell Research and Cures Initiative. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was approved by California voters on November 2, 2004, and called for the establishment of a new state agency to make grants and provide loans for stem cell research, research facilities and other vital research opportunities.

This Measure is known as the "California Stem Cell Research and Cures Act." The Measure establishes the Independent Citizens Oversight Committee (ICOC), which is a 29-member governing board for the CIRM. The ICOC establishes and appoints members to three working groups. Some of the members are ICOC members and some are not connected to ICOC or CIRM. The three work groups are the Scientific and Medical Accountability Standards Working Group, the Scientific and Medical Research Funding Working Group, and the Scientific and Medical Facilities Working Group.

On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research.

EFFECTIVE DATE: These Guidelines are effective on July 7, 2009.