Nova Southeastern University

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• Adverse Events / Unanticipated Problems
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"The IRB works with investigators from across the university to protect the individuals who participate in research conducted by members of the NSU community."

The following policies have been approved by quorum of the IRB and are promulgated to the university community in addition to this manual:

Part I – IRB General Information

• Federal Wide Assurance
• IRB Authority
• IRB Membership
• Interim Director Policy

Part II – IRB Meetings and Operations

• IRB Record Requirements
• IRB Meeting Operations
• IRB Lead Reviewers
• IRB Levels of Review and Decisions
• Appeal of IRB Actions/Determinations
• Monitoring of Approved Research, Approval Duration, and Continuing Review
• Suspension and Termination of Research
• Unanticipated Problems and Adverse Event Reporting
• Amendments to Research
• Verification of Compliance with Approved Protocols From Sources Other Than Investigators
• Further Review/Approval of IRB Actions
• Changes to Policies
• Non-Compliance Policy
  
• Emergency Use of Unapproved Drugs and Biologics
• Emergency Use of Unapproved Medical Devices

Part III – Investigator Responsibilities

• General Responsibilities of the Principal Investigator
• Informed Consent
• Financial Conflict of Interest Policy

Part IV – Education and Training

• Human Subjects Research Training

Part V – General Research Items

• Research with Children
• Research with Prisoners
• Research with Pregnant Women, Neonates, and Fetuses
• Student Research
• Research Conducted with Students as Subjects

Part VI - HIPAA

• HIPAA Research Policy No. 1: General
• HIPAA Research Policy No. 2: IRB Waiver of HIPAA Authorization
• HIPAA Research Policy No. 3: De-identified and Decedent Information
• HIPAA Research Policy No. 4: Reviews Preparatory to Research
• HIPAA Research Policy No. 5: Accounting of Disclosure
• HIPAA Research Policy No. 6: Guidance on Research at Outside Entities

Note: The above HIPAA policies were presented by the NSU Office of Corporate Compliance and approved by the NSU IRB. All questions regarding the HIPAA policies should be directed to the Office of Corporate Compliance.