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IRB Policies and Procedures
GENERAL ADMINISTRATION
102 ACTIVITIES REQUIRING IRB REVIEW
102A HUMAN SUBJECT REGULATIONS DECISION CHARTS
103 POLICY AND PROCEDURE MAINTENANCE
103A SOP REVISION WORKSHEET
103B SOP REVISION LOG
103C SOP TEMPLATE
103D NOTIFICATION OF SOP CHANGE
104 TRAINING AND EDUCATION
104A CHECKLIST AND DOCUMENTATION-MEMBERS
104B CHECKLIST AND DOCUMENTATION-STAFF
105 MANAGEMENT OF IRB PERSONNEL
105A ASSOCIATE VICE PRESIDENT FOR RESEARCH FUNCTIONS
105B IRB COORDINATOR FUNCTIONS
105C SECRETARY FUNCTIONS
106 CONFLICTS OF INTEREST
106A CONFLICT OF INTEREST FORMS
IRB ORGANIZATION AND STRUCTURE
201 COMPOSITION OF THE IRB
201A IRB MEMBER ROSTER FIELDS
203 DUTIES OF IRB MEMBERS
203A REGULAR MEMBER RESPONSIBILITIES
203B ALTERNATE MEMBER RESPONSIBILITIES
203C CHAIRPERSON RESPONSIBILITIES
203D VICE CHAIRPERSON RESPONSIBILITIES
203E REVIEWER DUTIES
203F SUBCOMMITTEE MEMBER RESPONSIBILITIES
203G SUBCOMMITTEE CHAIRPERSON RESPONSIBILITIES
FUNCTIONS AND OPERATIONS
301 RESEARCH SUBMISSION REQUIREMENTS
302 IRB MEETING ADMINISTRATION
303 ADMINISTRATIVE REVIEW AND DISTRIBUTION OF MATERIALS
304 DOCUMENTATION AND DOCUMENT MANAGEMENT
REVIEW OF RESEARCH
401 EXEMPT REVIEW
401A EXEMPT CERTIFICATION FORMS
402 EXPEDITED REVIEW
402A EXPEDITED REVIEW CATEGORIES
402B HUMAN SUBJECTS REVIEW FORM
402C IRB CHECKLIST
403 INITIAL REVIEW - CRITERIA FOR IRB APPROVAL
403A DIRECT ADVERTISEMENT GUIDELINES
403B PAYMENT, REIMBURSEMENT, COMPENSATION GUIDELINES
404 PROTOCOL CHANGES
404A PROTOCOL CHANGE FORM
405 CONTINUING REVIEW - CRITERIA FOR IRB APPROVAL
405A RESEARCH PROJECT REVIEW AND PROGRESS REPORT
406 STUDY COMPLETION OR TERMINATION
406A RESEARCH PROJECT TERMINATION FORM
408 NON-COMPLIANCE WITH IRB POLICIES AND PROCEDURES
410 SUSPENSION AND TERMINATION OF IRB APPROVAL
411 ADVERSE EVENT AND/OR UNANTICIPATED PROBLEMS
411A ADVERSE EVENT AND/OR UNANTICIPATED PROBLEM REPORT
412 INVESTIGATIONAL DRUG AND DEVICE
413 RESEARCH PARTICIPANT CONCERNS/COMPLAINTS
REVIEWS REQUIRING SPECIAL CONSIDERATION
501 RESEARCH INVOLVING SPECIAL POPULATIONS: PREGNANT WOMEN, HUMAN FETUSES, & NEONATES
501A CHECKLIST REQUIREMENTS FOR RESEARCH INVOLVING PREGNANT WOMEN, FETUSES AND NEONATES
502 RESEARCH INVOLVING SPECIAL POPULATIONS:PRISONERS
502A CHECKLIST REQUIREMENTS FOR RESEARCH INVOLVING PRISONERS
503 RESEARCH INVOLVING SPECIAL POPULATIONS: CHILDREN
503A CHECKLIST REQUIREMENTS FOR RESEARCH INVOLVING CHILDREN
504 CATEGORIES OF RESEARCH
504A RISK DETERMINATION FOR DEVICES
504B SIGNIFICANT RISK AND
NONSIGNIFICANT
RISK MEDICAL DEVICE LIST
505 RESEARCH INVOLVING PARTICIPANTS UNABLE TO CONSENT - SURROGATE CONSENT
505A COGNITIVELY IMPAIRED PERSONS OR PERSONS UNABLE TO CONSENT
505B CHECKLIST FOR PERSONS UNABLE TO CONSENT
IRB COMMUNICATION AND NOTIFICATION
601 PRINCIPAL INVESTIGATORS AND INVESTIGATIVE STAFF
INFORMED CONSENT
701 GENERAL REQUIREMENTS AND DOCUMENTATION
701A INFORMED CONSENT CHECKLIST
701B INFORMED CONSENT TEMPLATE - NON MEDICAL
701C INFORMED CONSENT DOCUMENT GUIDELINES AND SAMPLE - TISSUE, BLOOD STORAGE, AND POSSIBLE FUTURE USE
701D GLOSSARY OF MEDICAL TO LAY TERMS
702 WAIVERS
702A DECISION CHART-WAIVER OR ALTERATION OF INFORMED CONSENT
702B WAIVER OR ALTERATION OF INFORMED CONSENT REQUIREMENTS
704A INFORMED CONSENT TEMPLATE - NON MEDICAL ASSENT
RESPONSIBILITIES OF INVESTIGATORS
801 IRB - REQUIRED INVESTIGATOR ACTIONS
QUALITY ASSURANCE
901 QUALITY ASSURANCE/QUALITY IMPROVEMENT PROGRAM
902A FDA SITE INSPECTION PREPARATION CHECKLIST
HIPAA COMPLIANCE
1001 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
1001A HIPAA COMPLIANCE APPLICATION
1001B HIPAA AUTHORIZATION
1001C RESEARCH ON DECEDENTS