Expanding Approved Stem Cell Lines in Ethically Responsible Ways

This executive order directs HHS and NIH to intensify research on pluripotent stem cells derived from sources that do not involve creating or destroying human embryos. It requires a 90-day implementation plan and annual reporting, while renaming the Human Embryonic Stem Cell Registry to reflect broader cell sources.

Federal Register Open PDF 72 FR 34591

Impact dates

Dec 31, 2008
Second annual report to President on activities under this order
Sep 18, 2007
HHS Secretary issues implementation plan after NIH Director consultation

Key directives

HHS Secretary shall conduct and support research on non-embryo-destroying pluripotent stem cell techniques
Within 90 days: HHS Secretary, after NIH Director consultation, shall issue implementation plan including RFPs, RFAs, program announcements
Plan must specify which techniques need additional basic/animal research before human cell use
Plan must prioritize research with greatest potential for clinical benefit
Plan must take into account President's Council on Bioethics techniques and other appropriate techniques
Rename 'Human Embryonic Stem Cell Registry' to 'Human Pluripotent Stem Cell Registry'
Add new qualifying stem cell lines to renamed registry
Not later than December 31 of each year: Secretary reports to President on past fiscal year activities

Who is ordered

Timeline

Immediate

EO takes effect upon signing
Secretary of HHS authorized to begin research support activities

Near term (90d)

HHS Secretary must issue implementation plan with NIH Director consultation
Registry renaming from 'Human Embryonic Stem Cell Registry' to 'Human Pluripotent Stem Cell Registry'

Long term

Annual reports to President due each December 31
Ongoing research prioritization based on clinical benefit potential
Continuous addition of new ethically-derived stem cell lines to registry

Risks & tensions

Technological feasibility: Alternative pluripotent stem cell sources (e.g., induced pluripotent stem cells were still emerging in 2007) may not have been mature enough to match embryonic stem cell research potential
Funding tension: 'Subject to availability of appropriations' clause may limit actual resource commitment
Regulatory boundary: Vague whether some techniques 'clearly meet' the non-harm standard; 45 CFR 46.204(b) reference creates interpretive dependency
Political context: EO explicitly preserves but does not expand 2001 Bush policy on existing embryonic stem cell lines, creating dual-track system with potential resource competition
Definition uncertainty: 'Human embryo' definition using 'not protected as human subject under 45 CFR 46' creates circular reference to regulatory status at signing date