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Standard Operating Procedures (SOPs) & Policy

The IRB Office is revising and updating current policies in order to reflect recent changes to the Common Rule. All policies will be approved by quorum of the convened IRB. Once approved they will be communicated to the university community and added to this manual.

Purview and Responsibilities

1-1. IRB Jurisdiction and Authority

1-2. IRB Membership, Roles, and Responsibilities

1-3. Investigator Responsibilities

1-4 Conflicts of Interest (CoI) [revisions in progress]

1-5. IRB Reliance Agreements [revisions in progress]

1-6. IRB Office SOPs [revisions in progress]

1-7. Generation, Use, and Revisions of Standard Operating Procedures

Review Mechanisms and Outcomes

2-1. IRB Authorized Reviewers, Levels of IRB Review, and Decisions

2-2. Protocol Revisions, Annual Status of Research, and Study Closure

2-3 Unanticipated Problems, Adverse Events, and Investigational New Drug Safety

2-4 Non-Compliance and the Suspension/Termination of Approved Research

2-5 Appeals of IRB Actions or Determinations

IRB Meeting Operations

3 Conduct of IRB Meetings

Special Requirements

4-1 Informed Consent

4-2 Translations for Studies conducted in a Language other than English

4-3 Protection of Vulnerable Populations

4-4 Research Involving Deception

4-5 Humanitarian Use Devices (HUD) [revisions in progress]

4-6 Emergency Use [revisions in progress]

4-7 Recordkeeping and the Privacy/Confidentiality of Research Records

Post-Approval Monitoring

5 Post-Approval Monitoring of Research

Other Regulatory Requirements

6-1 FDA Drugs and Device Policy

Banking of Biospecimens/Data Guidance Sheet [revisions in progress]

Return of Research Results [revisions in progress]


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 Health Care Compliance and approved by the NSU IRB. All questions regarding the HIPAA policies should be directed to the NSU Office of Health Care Compliance.

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