Presentations and Slideshows
In This Section
- Self-guided eLearning Resources
- IRB Review at UC Davis
- Informed Consent
- Brown Bag Series
- AAHRPP Accreditation Training
- Ethics and Principles
- FDA
- Policies and Procedures
Self-guided eLearning Resources
- UC Davis Human Research Protection Program Overview
- Is IRB Review Required?
- New Project Applications
- Initial Review Application Guide
- Post Approval Submissions
- Informed Consent Form Requirements
- Remote Consent for Research
- Outside Financial Interest Reporting in Human Research
IRB Review at UC Davis
- IRBNet Training Resources (PDF)
- Guidelines for Successful Submission to the IRB: New Project (video, 18 mins)
- How to apply for initial review of a new project (video, 17 minutes)
- 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)
Informed Consent
- Presenting Information for Effective Communication (Presented by Steven Woloshin, MD, MS and Lisa M. Schwartz, MD, MS) (Video, PDF)
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
- 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)