Office of Human Research
Leadership
Positions:
- Director, Office of Human Research
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Email:
Walter.Kraft@jefferson.edu
Contact Number(s):
For Research Activities
Positions:
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology, Anatomy & Cell Biology
Contact Number(s):
For IRB Members
Materials & Instructions
The below materials are provided for use by IRB members. All reviewer questionnaires are provided below as downloadable documents.
Reviewer Forms
IRB Member Continuing Education
IRB member continuing education sessions are presented regularly at IRB meetings. The presentations appear below, starting with the most recent.
2021
| DESCRIPTION | DATE(S) PRESENTED |
| Common IRB Related Audit Findings (PPTX) | Oct 2021 |
| AAHRPP Findings and IRB Education (PPTX) | Sep 2021 |
| Research in the Operating Room (PPTX) | Feb, Mar 2021 |
| The Lessons of History (PPTX) | Feb, Mar 2021 |
2020
| DESCRIPTION | DATE(S) PRESENTED |
| Considerations for IRB Review of Cell Based Therapies (PPTX) |
Dec 2020 |
| Informed Consent Format Update (PPTX) |
Feb 2020 |
2019
| DESCRIPTION | DATE(S) PRESENTED |
| Payment to Participants - A Case Study (PDF) | Oct, Nov 2019 |
| IRB Review (PPTX) | Sep, Oct 2019 |
| Informed Consent/Subject Injury Update (PDF) | Jun, Jul 2019 |
| Sponsor-Initiated Investigational Drug Applications (INDs) (PDF) | May 2019 |
| Cannabis Research Information for Jefferson IRBs (PDF) | Apr 2019 |
| MCARE and Consent - Refresher (PDF) | Mar, Apr 2019 |
| Confidentiality Agreements (PDF) | Feb 2019 |
2018
| DESCRIPTION | DATE(S) PRESENTED |
| New Continuing Review Provisions under Revised Common Rule: Forms & SO (PDF) | Oct, Nov 2018 |
| June 2018 FDA Inspection of IRB (PDF) | Oct, Dec 2018 |
| Drug Development Stages (PPTX) | Sep, Oct 2018 |
| Children as Subjects – Important Ethical and Logistical Considerations (PPTX) | Aug 2018 |
| A Survey Into the Implementation of Commercial IRBs at TJU and Their Impact on the Workload of the Local IRB (PPTX) | Jul 2018 |
| Medicated Assisted Treatment for Opiate Addiction (PPT) | Jun 2018 |
| News from Denver: AHHRPP Conference 2018 (PPT) | May 2018 |
| Adolescents and IRBs (PPTX) | Mar, Apr 2018 |
| PA Court Ruling on Consent (PPTX) | Feb 2018 |
| Common Rule Changes to Consent and Template (PPTX) | Jan 2018 |
2017
| DESCRIPTION | DATE(S) PRESENTED |
| Consolidation of IRB Review (PPT) | Nov 2017 |
| Basic Pharmacokinetics (PPTX) | Oct 2017 |
| Oncology Clinical Trials (PPTX) | Aug, Sep 2017 |
| COI and Human Research (PPT) | Jun, Jul 2017 |
| Consent Coercion Creep (PPTX) | May, Jul 2017 |
| Community Based Participatory Research (PPTX) | Apr, May, Jun 2017 |
| Common Rule Revision (PDF) | Feb 2017 |
| Consent Signatories (PDF) | Jan 2017 |
2016
| DESCRIPTION | DATE(S) PRESENTED |
| Introduction to Export Control (PPT) | Oct, Nov 2016 |
| Sponsor Expectations for Clinical Studies (PPTX) | Sep, Oct 2016 |
| Community Outreach (PDF) | Jul, Aug, Sep 2016 |
| IRB Full Review Voting Guidance (PDF) | Jun 2016 |
| AAHRPP Site Review Feedback (PDF) | May 2016 |
| Data Gathering Activities That Do Not Constitute Human Subjects Research (PDF) | Mar, Apr 2016 |
| Department of Defense (DoD) Funded Human Subjects Research (PDF) | Feb, Mar 2016 |
| The TJU HRPP Part II (PDF) | Jan, Feb 2016 |
| The TJU HRPP Part I (PDF) | Jan 2016 |
2015
| DESCRIPTION | DATE(S) PRESENTED |
| Community Based Participatory Research (PDF) | Oct, Nov 2015 |
| Consent Form Readability (PDF) | Sep 2015 |
| Drug Development and IND Process (PDF) | Aug 2015 |
| Review of New IRB Policies (PDF) | Jun 2015 |
| Pharmacy & the IRB (PDF) | May 2015 |
| Deception in Human Subjects Research (PDF) | Apr 2015 |
| Risks of Standard of Care in Consent Forms (PDF) | Feb 2015 |
| HUD and Emergent Use (PDF) | Jan 2015 |
2014
| DESCRIPTION | DATE(S) PRESENTED |
| Avenues of Consent (PDF) | Feb 2015, Dec 2014 |
| Non-Compliance (PDF) | Nov 2014 |
| HIPAA Breach Notification (PDF) | Sep 2014 |
| Quality Improvement Activities (PDF) | Jul, Aug 2014 |
| Levels of Review (PDF) | Jun, Jul 2014 |
| Exploring 45 CFR 46.111 (PDF) | May 2014 |
| Regulatory Guidance for Genetic Testing (PDF) | Apr 2014 |