IRB Policies and Procedures


GENERAL ADMINISTRATION
101	AUTHORITY AND PURPOSE
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
107	SIGNATORY AUTHORITY
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IRB ORGANIZATION AND STRUCTURE
201	COMPOSITION OF THE IRB
	201A	IRB MEMBER ROSTER FIELDS
202	MANAGEMENT OF THE IRB
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
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FUNCTIONS AND OPERATIONS
301	RESEARCH SUBMISSION REQUIREMENTS
302	IRB MEETING ADMINISTRATION
303	ADMINISTRATIVE REVEIW AND DISTRIBUTION OF MATERIALS
304	DOCUMENTATION AND DOCUMENT MANAGEMENT
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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 RENEWAL
	405A	RESEARCH PROJECT REVIEW AND PROGRESS REPORT
406	STUDY COMPLETION OR TERMINATION
	406A	RESEARCH PROJECT TERMINATION FORM
407	CATEGORIES OF ACTION
408	NON-COMPLIANCE WITH IRB POLICIES AND PROCEDURES
409	REPORTING REQUIREMENTS FOR UNANTICIPATED PROBLEMS, NON-
	COMPLIANCE AND/OR SUSPENSION OR TERMINATION OF IRB APPROVAL
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
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REVIEWS REQUIRING SPECIAL CONSIDERATION
501	RESEARCH INVOLVING SPECIAL POPULATIONS: PREGNANT WOMEN,
	HUMAN FETUSES, & NEONATES
	501A	CHECKLIST REQUIREMENTS FOR REEARCH INVOLVING PREGNANT
		WOMEN, FETUSES AND NEONATES
502	RESEARCH INVOLVING SPECIAL POPULATIONS: PRISONERS
	502A	CHECKLIST REQUIREMENTS FOR RESARCH 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
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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
703	DOCUMENTATION
704	ASSENTS
	704A	INFORMED CONSENT TEMPLATE - NON MEDICAL ASSENT
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RESPONSIBILITIES OF INVESTIGATORS
801	IRB - REQUIRED INVESTIGATOR ACTIONS

QUALITY ASSURANCE
901	QUALITY ASSURANCE/QUALITY IMPROVEMENT PROGRAM
902	AUDITS
	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
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Institutional Review Board

Grand Forks, ND

IRB Policies and Procedures

Institutional Review Board

Grand Forks, ND

IRB Policies and Procedures