IRB Reference Manual

Chapter	Title
Preface	JURISDICTION, STRUCTURE, AND RESPONSIBILITIES
Chapter 1	GENERAL REVIEW REQUIREMENTS
Chapter 2	SUBMISSION REQUIREMENTS
Chapter 3	CONTINUING REVIEW OF RESEARCH PROTOCOLS
Chapter 4	INSTITUTIONAL REVIEW BOARD - INVESTIGATOR COMMUNICATIONS
Chapter 5	RESEARCH SUBJECT AND PATIENT RECRUITMENT
Chapter 6	SPECIAL SUBJECT POPULATIONS
Chapter 7	RESEARCH PROTOCOL FORMAT AND REQUIREMENTS
Chapter 8	THE INFORMED CONSENT PROCESS AND DOCUMENT - REQUIREMENTS AND FORMAT
Chapter 9	INVESTIGATOR RESPONSIBILITIES
	Appendices
Appendix A	Institutional Review Board Forms
Appendix B	Requirements And Procedures For The Emergency Use Of An Unapproved Investigational Drug, Biologic Or Device
Appendix C	"Off-Label" And Investigational Use Of Approved Drugs And Biologics
Appendix D	The Human Use Subcommittee, Radiation Safety Committee, And The Radioactive Drug Research Committee
Appendix E	Special Considerations For The Collection And Use Of Tissue Samples For Genetic Studies And Other Research Purposes
Appendix F	Investigational Devices
Appendix G	Standard Screening Instruments Not Requiring Submission With Research Protocols
Appendix H	Sample Consent Form for HIV Testing (Word) Sample Addendum Consent to Act as a Participant (Word) Sample Consent Form for MRI Study (Word)
Appendix I	Glossary Of Lay Terms
Appendix J	Abbreviations
Appendix K	Definitions
Appendix L	Data and Safety Monitoring Plans
Appendix M	Obtaining Written Informed Consent of Family Members When Research Involves the Collection of their Private Info
Appendix N	Humanitarian Device Exemption (HDE) Requirements
Appendix O	Research Participant Information Sheet
Appendix P	Coordinating Center Guidance (2/10/05)
Appendix Q	Conflict of Interest Management Plan for Human Subject Research

Institutional Review Board

IRB Reference Manual