| I. IRB Authority and Institutional Commitment
|
| DOHP 400-1.1 Institutional Oversight of Assurance
|
|
| DOHP 400-1.2-10 Activities Subject to IRB Jurisdiction
|
| DOHP 400-1.3 Review of Human Subject Protections in Funding Agreements
|
|
| DOHP 400-1.4-10 Differentiating Research from Public Health Practice and Quality Improvement
|
| DOHP 400-1.5 Research Exempt from IRB Review
|
|
|
| II. Investigator Responsibilities
|
|
| DOHP 400-2.1-10 Investigator Qualifications
|
| DOHP 400-2.2 General Responsibilities of Investigators
|
| DOHP 400-2.3 Identifying, Evaluating and Managing Researcher and Research Staff Conflicts of Interests
|
| DOHP 400-2.4 Data and Safety Monitoring Plans
|
| DOHP 400-2.5 Certificates of Confidentiality
|
|
|
| III. Committee Roles and Responsibilities
|
| DOHP 400-3.1 Composition of the IRB
|
| DOHP 400-3.2 Identifying, Evaluating and Managing Committee Member, Consultant, and Staff Conflicts of Interests
|
|
|
| IV. Research Review Procedures
|
| DOHP 400-4.1 IRB Review Responsibilities
|
| DOHP 400-4.2 Review of Human Subjects Research: Conduct of Meetings by the Convened IRB
|
| DOHP 400-4.3 Review of Human Subjects Research: Initial Review
|
| DOHP 400-4.4 Review of Human Subjects Research: Continuing Review
|
| DOHP 400-4.5 Review of Human Subjects Research: Amendments and Modifications of Approved Research
|
| DOHP 400-4.6 Problems Requiring Prompt Reporting to the IRB
|
| DOHP 400-4.7-10 Recruitment and Advertising
|
| DOHP 400-4.8 Monitoring of the Informed Consent Process
|
|
|
| V. Informed Consent Process
|
| DOHP 400-5.1 Legally Effective and Prospectively Obtained Informed Consent
|
| DOHP 400-5.2 Documentation of Informed Consent
|
| DOHP-400-5.3 Waiver and Alteration of Informed Consent
|
| DOHP-400-5.4 Assent and Dissent in Research Involving Cognitively Impaired Adults
|
|
|
| VI Research Involving Vulnerable Populations
|
| DOHP-400-6.1 Research Involving Pregnant Women
|
| DOHP-400-6.2 Research Involving Prisoners
|
| DOHP-400-6.3 Research Involving Children
|
| DOHP 400-6.4 Research Involving Cognitively Impaired Participants
|
|
|
| VII Use of Investigational Drugs, Biologics, and Devices
|
| DOHP 400-7.1 Ensuring Regulatory Approval for Research Use of Investigational Articles
|
| DOHP 400-7.2 Investigational Devices
|
| DOHP 400-7.2 Storage, Handling, and Control of Investigational Drugs and Devices
|
| DOHP 400-7.3 Investigational Devices
|
| DOHP 400-7.4 Investigational Drugs, Agents and Biologics
|
| DOHP 400-7.5 Humanitarian Use Devices
|
| DOHP 400-7.6 Emergency Use of FDA Regulated Products and Emergency Use Authorizations
|
|
|
| VIII Documentation of Research Review Activities
|
| DOHP 400-8.1 Human Research Protection Program Records
|
|
|
| IX Education and Outreach
|
| DOHP 400-9.1 Research Ethics Education and Training
|
| DOHP 400-9.2-10 Community Involvement
|
|
|
| X Addressing Allegations and Findings of Non-Compliance
|
| DOHP 400-10.1 Investigating any Noncompliance, Serious or Continuing Noncompliance
|
| DOHP 400-10.2 Suspensions and Terminations of IRB Approval
|
| DOHP 400-10.3 Reporting to Institutional Officials, Department, or Agency Heads
|
| DOHP 400-10.4 Responding to Inquiries and Complaints Regarding Human Subjects Research
|
|
|
| XI Definitions
|
| DOHP 400-11.1 Development and Approval and Maintenance of Policies
|
|
|
web-DOHP 400-1.1-10 Institutional Oversight of Assurance.pdf