Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission

This executive order creates the National Bioethics Advisory Commission (NBAC) to advise on bioethical issues in human research, and requires all executive branch agencies conducting, supporting, or regulating human subjects research to review their protections within 120 days. The commission's first priority is protecting human research subjects and addressing genetic information issues, with a two-year lifespan unless extended.

Federal Register Open PDF 60 FR 52063

Impact dates

Oct 3, 1997
NBAC terminates unless extended
Feb 1, 1996
Agency reports on human subject protection reviews due to NBAC

Key directives

All relevant executive agencies must review human subject protection policies and report to NBAC within 120 days
NBAC established with max 15 presidential appointees
NBAC's first priority: human subject protections and genetic information issues including gene patenting
NBAC shall not review and approve specific projects
Secretary of HHS delegated FACA functions except annual congressional reporting
HHS to provide funding and management support to NBAC
NBAC terminates October 3, 1997 unless extended

Who is ordered

Timeline

Immediate

NBAC established
Agencies directed to begin review of human subject protections

Near term (90d)

Agency reports due to NBAC (120 days from signing, by February 1, 1996)

Long term

NBAC terminates October 3, 1997 unless extended
Ongoing bioethics advisory function if extended

Risks & tensions

Sunset clause creates institutional uncertainty; NBAC's influence depends on presidential extension
Vague 'to the extent practicable and appropriate' language for educational programs weakens enforceability
FACA delegation to HHS Secretary without annual congressional reporting may reduce legislative oversight
Genetic information/gene patenting priority could conflict with commercial research interests