101
Policies and Procedures Management
102
Training and Education
103
Management of IRB Personnel
104
IRB Authority and Signatory Authority
105
Non-Federally Funded Research
106
Implementation of the Final Rule
201
Management of IRB Personnel
202
Duties of IRB Members
301
Research Submission Requirements
302
Administrative Review and Distribution of Materials
303
IRB Review of Submissions
304
IRB Convened Meeting Administration
305
Documentation of IRB Discussions, Decisions, and Findings
306
Ad Hoc Consultant Reviewers
307
Expiration of Approval
401a:
Non-Human Subjects Research
401b
Research Activities Exempt from IRB Review
403
Initial Review - Criteria for IRB Approval
405
Review of Amendments to Research Studies
406
Final Project Reports
407
IRB Actions to Approve or Disapprove Research
408:
Medical Case Reports
409
Alternate IRB Review Arrangements and Agreements
410
Appeal of IRB Decisions
501
Vulnerable Populations in Research
502
Clinical Research Involving Investigational Drugs and Devices
505
Research Materials in Participants' Medical Records
506
Emergency Use of a Test Article and Planned Emergency Use
601
Screening, Recruiting, and Advertising for Participant Enrollment
602
Payment for Participation in Research Studies
701
General Requirements of Informed Consent
702
General Requirements of Documentation of Consent
703
Waiver or Alteration of Consent
802
Privacy and Confidentiality
803
Research Related Injury
901
Unanticipated Problems Involving Risks to Participants or Others
903
HRPP and Non-Compliance
904
Administrative Hold, Suspension and Termination of Approved Research
905
Institutional Reporting Procedures
906
Protection of Research Participants
907
Research Complaints and Concerns
908
Routine and For-Cause Audits
909
Institutional Review Board (IRB) Community Outreach
