糖心原创

Below is a link to our official Policies and Procedures, compliance with which is mandatory for both the IRB and the research community. The Policies and Procedures define important terms and define the roles, structure, and responsibilities of听the 糖心原创听University Human Research Protection Program (HRPP).听

More guidance and recommendations听can be found in the Guidance Documents听辞谤听Templates, Checklists & Decision Trees听sections of our website.

听

Human Research Protection Program

• HRPP Purpose and Authority
• Maintenance of IRB Policies
• Requests for Participation of 糖心原创 Faculty, Staff, or Students in Research

Institutional Review Board Operations

• Membership of the IRB
• Collaborative Research & External Review
• Clinical Trials Registration

IRB Submission and Review

• Investigator Credentialing
• Determination that Project is Not Research, or Does Not Involve Human Subjects
• Exempt Determinations
• Expedited Reviews
• Convened IRB Meetings
• IRB Study Closure

Study Procedures

• Vulnerable Populations
• Informed Consent Process
• HSR Use and Disclosure of PHI (HIPAA)

FDA Regulated Research

• Investigational Drugs and Biologics
• Investigational Medical Devices
• Emergency Use
• Expanded Access
• Humanitarian Use Devices

Reportable Problems & Noncompliance

• Mandatory Reporting
• Reportable Problems
• Non-Compliance