Presentations and Slideshows

In This Section

Self-Guided eLearning Resources

IRB Review at UC Davis

  • Initial Review Application Update (video, 32 min)
  • UC Davis Guidelines for Successful Submission to the IRB: New Project (video, 18 mins)
  • UC Davis Post Approval Submissions (video, 90 mins)
  • IRB Reporting Requirements (video, 51 mins)
  • Presenting Information for Effective Communication (Presented by Steven Woloshin, MD, MS and Lisa M. Schwartz, MD, MS) (Video, PDF)
  • The Reliance Process when UCD IRB Cedes Review (video, 54mins)
  • IRBNet Training Resources (PDF)
  • Transitioning to the Post Approval Submission Form (PDF)
  • Serious Adverse Event Reporting Flow Chart (PDF)
  • Thinking Outside the Box: Overcoming Challenges of IRB Review for Ethnographic Research (PDF)
  • 2018 Common Rule – If, When, and How it Impacts Your Research (PDF)
  • General Data Protection Regulation (PPT)

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

Note: The UC Davis IRB is no maintains AAHRPP Accreditation

  • 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  • IRB Responsibilities for Reviewing Qualifications: Review of the FDA draft guidance on IRB responsibilities for reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an IND/IDE is needed.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

  • International Research: Overview of the requirements to conduct international research (PDF)
  • Community Engagement: Overview of resources available to researchers involved in community based qualitative research (PDF)
  • 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)
  • NIH Revisions to Human Subjects Research (PDF)