PART 431—PROTECTION OF HUMAN SUBJECTS

Table of Contents

Sec. 
431.101To what does this policy apply?
431.102Definitions for purposes of this policy.
431.103Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
431.104Exempt research.
431.105-431.106[Reserved]
431.107IRB membership.
431.108IRB functions and operations.
431.109IRB review of research.
431.110Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
431.111Criteria for IRB approval of research.
431.112Review by institution.
431.113Suspension or termination of IRB approval of research.
431.114Cooperative research.
431.115IRB records.
431.116General requirements for informed consent.
431.117Documentation of informed consent.
431.118Applications and proposals lacking definite plans for involvement of human subjects.
431.119Research undertaken without the intention of involving human subjects.
431.120Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
431.121[Reserved]
431.122Use of Federal funds.
431.123Early termination of research support: Evaluation of applications and proposals.
431.124Conditions.

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).

Source: 82 FR 7270, Jan. 19, 2017, unless otherwise noted.