Human Research Protection Program Policies
Policies that do not have links are being revised.
| I. IRB Authority and Institutional Commitment |
| DOHP 400-1.1 Institutional Oversight of Assurance |
| DOHP 400-1.2 Activities Subject to IRB Jurisdiction |
| DOHP 400-1.3 Review of Human Subject Protections in Funding Agreements |
| DOHP 400-1.4 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 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 Review of Recruitment / 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 |
| 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 |