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Human Research Protection Program Policies

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
 

DOHP 400-1.1 Institutional Oversight of Assurance

DOHP 400-1.1 Institutional Oversight of Assurance web-DOHP 400-1.1-10 Institutional Oversight of Assurance.pdf 198.93 kB