Code of Federal Regulations
Department of Health and Human Services
PROTECTION OF HUMAN SUBJECTS
* * *
Revised January 15, 2009
Effective July 14, 2009
Basic HHS Policy for Protec-
tion of Human Research
46.101 To what does this policy apply?
46.103 Assuring compliance with this
policyâ€”research conducted or
supported by any Federal Depart-
ment or Agency.
46.107 IRB membership.
46.108 IRB functions and operations.
46.109 IRB review of research.
46.110 Expedited review procedures for
certain kinds of research involving
no more than minimal risk, and for
minor changes in approved re-
46.111 Criteria for IRB approval of
46.112 Review by institution.
46.113 Suspension or termination of
IRB approval of research.
46.114 Cooperative research.
46.115 IRB records.
46.116 General requirements for in-
46.117 Documentation of informed
46.118 Applications and proposals lack-
ing definite plans for involvement
of human subjects.
46.119 Research undertaken without
the intention of involving human
46.120 Evaluation and disposition of
applications and proposals for re-
search to be conducted or sup-
ported by a Federal Department or
46.122 Use of Federal funds.
46.123 Early termination of research
support: Evaluation of applica-
tions and proposals.
Additional Protections for
Pregnant Women, Human Fe-
tuses and Neonates Involved
46.201 To what do these regulations
46.203 Duties of IRBs in connection
with research involving pregnant
women, fetuses, and neonates.
46.204 Research involving pregnant
women or fetuses.
46.205 Research involving neonates.
46.206 Research involving, after deliv-
ery, the placenta, the dead fetus or