Presentations and Slideshows

Brown Bag Series

  • Resources, Recruitment, Qualifications, Complaints….Oh My! (PPT) ~ May 2014
  • Minimizing Risk in Research & Identifying Conflict of Interest (PPT) ~ April 2014
  • UCD Human Research Protection Program Accreditation (PPT) ~ March 2014

AAHRPP Accreditation Training

  • Part I: Human Research Protection Program Plan (PDF)
  • Part II: Human Research Protection Program Plan continuation (PDF)
  • Part III: Investigator Manual (PDF)
  • Part IV: Criteria for Approval (PDF)
  • Part V: Informed Consent Process and Documentation for Research (PDF)
  • Part VI: Elements of Informed Consent (PDF)
  • Part VII: Vulnerable Populations (part 1) (PDF)
  • Part VIII: Vulnerable Populations (part 2) (PDF)
  • Part IX: Reportable New Information (PDF)

Ethics and Principles

  • Nuremberg Code: History of informed consent (PDF)
  • Declaration of Helsinki: History and establishment of guidelines to conduct human subject research (PDF)
  • Belmont Report: Presentation on the ethical principles of human subject research (PDF)

FDA

  • Drugs, Dietary Supplements, and Medical Foods: Presentation on understanding the difference between drugs, dietary supplements, and medical foods. (PDF)
  • Additional Safeguards for Children in Clinical Investigations: Presentation of the FDA’s final rule published in 2013 (PDF)
  • IRB Responsibilities for Reviewing Qualifications: Review of the FDA draft guidance on IRB responsibilities for reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an IND/IDE is needed. (PDF)
  • Humanitarian Use Device (HUD): Presentation on the FDA application and IRB processes (PDF)
  • Medical Mobile Applications: Review of the FDA draft guidance for industry (PDF)
    • Medical Mobile Applications decision flow chart (PDF)

Policies and Procedures

  • Overview of the Criteria for Approval of Research: IRB training for new committee members and staff (PDF)
  • Reportable New Information: Review of HRP-214, “Reportable New Information” (PDF)