Policies and Procedures

IRB AUTHORITY AND INSTITUTIONAL COMMITMENT

1.1 Institutional Oversight of Assurance [pdf ]

1.2 Activities Subject to IRB Jurisdiction  [pdf ]

INVESTIGATOR RESPONSIBILITIES

2.1 Investigator Qualifications [pdf ]

2.2 General Responsibilities of Investigators [pdf ]

2.3 Investigator and Key Study Personnel Conflict of Interest [pdf ]

2.4 Data and Safety Monitoring Plans [pdf ]

2.5 Certificates of Confidentiality [pdf ]

COMMITTEE ROLES AND RESPONSIBILITIES

3.1 Composition of the IRB [pdf ]

3.2 IRB Committee Member, Consultant, and Staff Conflicting Interests [pdf ]

IRB REVIEW PROCEDURES

4.1 IRB Review Responsibilities [pdf

4.2 IRB Determinations/motions [pdf ]

4.3 Research Exempt from IRB Review [pdf ]

4.4 IRB Review of Human Subjects: Expedited [pdf ]

4.5 IRB Review of Human Subjects: Full Committee [pdf ]

4. 6 Human Subject Research/Non-Research Determination [pdf ]

4.7 Amendments to Claims for Exemption [pdf ]

4.8 Continuing Review] [pdf ]

4.9 Reporting of Unanticipated Problems and Adverse Events [pdf ]

INFORMED CONSENT PROCESS

5.1 Legally Effective And Prospectively Obtained Informed Consent [pdf ]

5.2 Documentation of Informed Consent [pdf ]

5.3 Waiver of Informed Consent [pdf ]

5.4 Asset/Dissent by Children or Cognitively Impaired Adults [pdf ]

5.5 Approval And Expiration Dates on Informed Consent Documents [pdf ]

VULNERABLE POPULATIONS

6.1 Special Categories of Research: Pregnant Women [pdf ]

6.3 Special Categories of Research: Children [pdf ]

6.4 Special Categories of Research: Cognitively Impaired Persons [pdf ]

INVESTIGATIONAL DRUGS, BIOLOGICS AND DEVICES

7.4 IRB Review of Humanitarian Use Devices [pdf ]

7.5 Emergency Use of FDA Regulated Products [pdf ]

EDUCATION AND TRAINING

9.1 Investigator and Key Study Personnel Training [pdf ]