US Federal Guidelines on Human Stem Cell Research

• Abstract
• Characteristics of this policy
• Purpose and process analysis
• Expected outcome
• References

Featured in half-yearly report: Health Policy Developments 9

Abstract

The United States policy regarding stem cell research changed significantly in early 2009. A new Executive Order rescinded earlier policy restricting funding of stem cell research, requested development of new research guidelines by the National Institutes of Health, and affirmed the government’s commitment to scientific inquiry. The National Institutes of Health issued new guidelines that balance ethical concerns with support for sound scientific method.

Recent developments

Under the Bush Administration, federal funding for stem cell research was significantly restricted. A statement by President George W. Bush allowed the National Institutes of Health to fund research using stem cell lines whose derivation was initiated before 9 pm EDT on August 9, 2001, but not research using stem cell lines derived after that date. This statement was supplemented by Executive Order 13435 on June 20, 2007. The restriction limited federally funded researchers to 21 viable stem cell lines. It also limited collaboration and complicated administrative aspects of running and maintaining laboratories. In response to these restrictions most stem cell funding was received from private and state sources. Several legislative attempts to remove this funding restriction were vetoed by President Bush.

President Obama issued Executive Order 13505 on March 9, 2009 to change the way the National Institutes of Health can support and conduct research and to rescind the Bush Administration's restrictive policy. The Executive Order asked the National Institutes of Health to develop new research guidelines under the guidance of strengthening the federal government's commitment to free and open scientific inquiry. The new proposed guidelines issued by the National Institutes of Health attempted to balance ethical concerns with support for sound scientific method. The final guidelines took effect on July 7, 2009.

The guidelines attempt to clarify the separation between privately funded cell-derivation and publicly funded stem cell research and expand funding to research using any stem cell lines created from embryos remaining after fertility procedures and listed in the newly established federal Registry of approved cell lines. In addition, the guidelines require full informed consent from donors of emrybos for use in stem cell research, prevent financial inducements to donate, and require donors to demonstrate they understand that research will not confirm personal benefit. The guidelines also establish an oversight group of scientists and ethicists to review which stem cell lines should be eligible for federal funding based on their derivation. The guidelines continue to prohibit NIH funding of the derivation of stem cells from human embryos, as required by Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09.

 

Degree of Innovation	traditional		innovative
Degree of Controversy	consensual		highly controversial
Structural or Systemic Impact	marginal		fundamental
Public Visibility	very low		very high
Transferability	strongly system-dependent		system-neutral
current    previous

This new policy is a substantial lessening of the Bush Administration's limits on federally funded research for stem cell research. The change was highly visible as one of President Obama's first initatives upon taking office. However, the resulting guidelines are fairly consistent with standards in other countries.

Purpose and process analysis

Current Process Stages

	Idea	Pilot	Policy Paper	Legislation	Implementation	Evaluation	Change
Implemented in this survey?

Initiators of idea/main actors

• Government: The Obama administration supports federally funded stem cell research and NIH expanded the definition of what lines will be eligible for federal funding.

• Patients, Consumers: The public is generally supportive of expanding stem cell research. Disease advocates are extremely supportive of increasing federal funds.

• Scientific Community: Prior to June 2009, the scientific community relied on private and state funds for research on stem cell lines created after 2001. The new federal policy gives them greater acccess to these lines under federal funding.

• Others: Religious organizations and private citizens also registered feedback on the NIH draft guidelines.

• Political Parties

Stakeholder positions

The position of the White House changed with the election of President Obama. The positions of other stakeholders are not thought to have changed subsantially since the last policy update in 2007. The scientific and medical communities, as well as the general public, have increasingly supported expanding funding of stem cell research since the institution of the Bush Administration policy in 2001. Conservatives in Congress and some religious organizations continue to oppose expanded funding and guidelines. The widespread support allowed President Obama to issue his Executive Order revoking Bush Administration policy very early in his tenure. NIH subsequently drafted and finalized guidelines for stem cell research based on feedback from the public.

Actors and positions

Government
Obama Administration	very supportive		strongly opposed
National Institutes of Health	very supportive		strongly opposed
Patients, Consumers
Patients	very supportive		strongly opposed
Patient advocacy groups	very supportive		strongly opposed
Celebrities	very supportive		strongly opposed
Scientific Community
Academic researchers	very supportive		strongly opposed
Scientific societies	very supportive		strongly opposed
Medical organizations	very supportive		strongly opposed
Others
Liberal religious organizations	very supportive		strongly opposed
Conservative religious groups	very supportive		strongly opposed
Private citizens	very supportive		strongly opposed
Political Parties
Congressional Democrats	very supportive		strongly opposed
Congressional Republicans	very supportive		strongly opposed
current    previous

Influences in policy making and legislation

 With the election of President Obama, the role of the White House as barrier to expanding access to stem cell research and funding changed. After issuing the executive order, the National Institutes of Health drafted guidelines and finalized them based on the 49,000 comments recieved from patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, members of Congress, and private citizens. The process by which comments are provided on the draft guidelines is designed to be procedurally just, providing all stakeholders an equal opportunity to provide feedback.  

Legislative outcome

Enactment

Actors and influence

Government
Obama Administration	very strong		none
National Institutes of Health	very strong		none
Patients, Consumers
Patients	very strong		none
Patient advocacy groups	very strong		none
Celebrities	very strong		none
Scientific Community
Academic researchers	very strong		none
Scientific societies	very strong		none
Medical organizations	very strong		none
Others
Liberal religious organizations	very strong		none
Conservative religious groups	very strong		none
Private citizens	very strong		none
Political Parties
Congressional Democrats	very strong		none
Congressional Republicans	very strong		none
current    previous

Positions and Influences at a glance

Adoption and implementation

The NIH guidelines became effective on July 7, 2009 after incorporation of public comments on the draft guidelines. In September, the NIH launched a website for researchers to submit information about human embryonic stem cell lines for approval. Members of a Working Group for Human Embryonic Stem Cell Eligibility Review were also announced, and tasked with ensuring that submitted lines meet the new guidelines. Accepted cell lines will be now eligible for use in federally funded research.

Monitoring and evaluation

With the issuing of Executive Order 13505, the Secretary of Health and Human Services, through the Director of NIH, has been directed to review and update the human stem cell research guidance periodically.

Expected outcome

The new NIH guidelines pleased scientists, advocates, and patients. Research opportunities will expand as human embryonic stem cell scientists are able to access federal funding for their work.

Impact of this policy

Quality of Health Care Services	marginal		fundamental
Level of Equity	system less equitable		system more equitable
Cost Efficiency	very low		very high
current    previous

The Executive Order and new NIH guidelines provide the scientific community with greater access to stem cell lines created after 2001.

References

Sources of Information

•  President George W. Bush. Expanding Approved Stem Cell Lines in Ethically Responsible Ways.; 2007. Available at: http://usgovinfo.about.com/od/healthcare/a/stemcelleo.htm [Accessed September 29, 2009].
• Human Embryonic Stem Cell Policy Under Former President Bush (Aug. 9, 2001-Mar. 9, 2009) [Stem Cell Information]. National Institutes of Health: Stem Cell Information. Available at: http://stemcells.nih.gov/policy/2001policy.htm [Accessed September 29, 2009].
• President Barack Obama. Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.; 2009. Available at: http://stemcells.nih.gov/policy [Accessed September 7, 2009]
• President Barack Obama. Remarks of the President-As Prepared for Delivery-Signing of Stem Cell Executive Order and Scientific Integrity Presidential Memorandum.  2009. Available at: http://www.whitehouse.gov/the_press_office/Remarks-of-the-President-As-Prepared-for-Delivery-Signing-of-Stem-Cell-Executive-Order-and-Scientific-Integrity-Presidential-Memorandum/ [Accessed September 29, 2009].
• Raynard S Kington, M.D., Ph.D. Acting Director, NIH. 2009 Guidelines on Human Stem Cell Research [Stem Cell Information]. National Institutes of Health: Stem Cell Information. Available at: http://stemcells.nih.gov/policy/2009guidelines.htm [Accessed September 29, 2009].
• Guidelines for Human Stem Cell Research:  Memorandum for the Heads of Executive Departments and Agencies. Federal Register. 2009;74(149). Available at: http://edocket.access.gpo.gov/2009/E9-18834.htm [Accessed September 29, 2009].

Author/s and/or contributors to this survey

Krista Harrison and Gerard Anderson

Suggested citation for this online article

Krista Harrison and Gerard Anderson. "US Federal Guidelines on Human Stem Cell Research". Health Policy Monitor, October 2009. Available at http://www.hpm.org/survey/us/b14/4