TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS *** Revised June 23, 2005 Effective June 23, 2005 *** Basic HHS Policy for Protection of Human Research Subjects Subpart A – Sec. 46.101 To what does this policy apply? 46.102 Definitions. 46.103 Assuring compliance with this policy research conducted or supported – by any Federal Department or Agency. 46.104- [Reserved] 46.106 [Reserved] 46.107 IRB membership. IRB functions and operations. 46.108 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 research. 46.111 Criteria for IRB approval of research. Review by institution. 46.112 46.113 Suspension or termination of IRB approval of research. 46.114 Cooperative research. 46.115 IRB records. 46.116 General requirements for informed consent. 46.117 Documentation of informed consent. 46.118 Applications and proposals lacking definite plans for involvement of human subjects.
TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS *** Revised June 23, 2005 Effective June 23, 2005 *** Basic HHS Policy for Protection of Human Research Subjects Subpart A – Sec. 46.101 To what does this policy apply? 46.102 Definitions. 46.103 Assuring compliance with this policy – research conducted or supported by any Federal Department or Agency. 46.104- [Reserved] 46.106 [Reserved] 46.107 IRB membership. IRB functions and operations. 46.108 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 research. 46.111 Criteria for IRB approval of research. Review by institution. 46.112 46.113 Suspension or termination of IRB approval of research. 46.114 Cooperative research. 46.115 IRB records. 46.116 General requirements for informed consent. 46.117 Documentation of informed consent. 46.118 Applications and proposals lacking definite plans for involvement of human subjects.