Helpful Links

• Food and Drug Administration FDA
  
• Office for Human Research Protections OHRP

HRPP Education Program Material

To provide you an opportunity to preview materials for the HRPP Education Program, we have included the following links. We encourage you to print the documents in the "Suggested" and "PowerPoint Handouts" sections and bring them to the Program.

Suggested:

• Program Outline
• Written Attestation (IRB education requirement)

PowerPoint Handouts

• Human Participant Protection in Research
• OUHSC IRB Background and Submission Process
• Information Security
• HIPAA and Human Research
• HIPAA Decision Tree
• Informed Consent and Participant Recruitment
• Clinical Research with Drugs, Biologics, Devices, & Good Clinical Practice
• Issues in Social, Behavioral, and Psychiatric Research

Additional Materials:

Historical Review of Research / Federal Regulations & Governing Agencies

• Provost Memo re: IRB Education Requirements
• The Belmont Report
• Federal Wide Assurance
• Terms of the Federal Wide Assurance
• HHS — Office for Human Research Protections
• FDA Information Sheets — 21CFR Part 50
• FDA Information Sheets — 21CFR Part 56
• Financial Disclosures

Institutional Review Board

• IRB Process
• Exempt Review Criteria
• Expedited Review Criteria
• Consent Form Template
• Relevant Websites

Research Data & Information Security

• Research Data & Information Security Questionnaire

HIPAA & Human Subject Research

• HIPAA Booklet

Clinical Research / Good Clinical Practice

• Good Clinical Practice Guidance

Behavioral & Psychiatric Research

• Certificates of Confidentiality Instructions
• Certificates of Confidentiality Information

Revised: 6/1/2009