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6.2 Research Involving Investigational and Marketed Devices

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

6.4 Emergency Use of a Test Article

1.0 Purpose The purpose of this policy and procedure is to describe the requirements for utiliza...

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.33 Posting of Clinical Trial Consent Forms

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.32 Confidentiality of the Review Process

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.31 Observers at IRB Meetings

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.30 Use of the Rapid Response IRB

1.0 Purpose The purpose of this policy and procedure is to describe the criteria for use of, and...

1.29 ClinicalTrials.gov Reporting

1.0 Purpose The purpose of this policy and procedure is to describe the requirements and procedu...

1.28 External Investigator Assurance

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.27 Research Personnel Qualifications and Responsibilities

1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respo...

1.25 Financial Conflicts of Interest

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s procedure...

1.24 HRPP Training Requirements for IRB Members

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.21 Post-Approval Monitoring of Research

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.20 Community Involvement in Research & Outreach Activities

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s involveme...

1.19 IRB Signature Authority

1.0 Purpose The purpose of this policy and procedure is to describe Organization’s requirements ...

1.17 Retention of Research Records

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.16 ORA Record Keeping Requirements

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.15 Research Subject to Department of Justice Regulatory Requirements

1.0 Purpose The purpose of this policy and procedure is to specify the Organizations requirement...

1.14 Research Subject to Department of Defense Regulatory Requirements

1.0 Purpose The purpose of this policy and procedure is to specify the Organization’s requiremen...