Working with the IRB & Privacy Board:
October 17th (Wednesday)
Diann Johnson, MPH
Associate IRB Administrator
October 26th (Friday)
Perrin Long Library
Danielle Lewis, MD
IRB Management Analyst
October 26th (Friday)
Lecture Hall 1A
Kevin Nellis, MS, CIP
Executive Director, Human Research Protections and Quality Assurance
The IRB will host the above informational sessions to go over working with the IRB and keys to success for submitting IRB applications. Topics include:
- WHY is IRB approval required?
- WHEN do activities require IRB approval?
- WHO can be a Principal Investigator?
- HOW is IRB approval obtained?
- WHAT are some tips for success?
- WHERE is the IRB located?
The presenters will cover key findings of a recent joint internal audit of the IRB and Downstate Investigators by the Research Foundation Office of Internal Audit Services and the Downstate Office of Compliance & Audit Services (OCAS).
You will learn how to submit IRB applications and avoid research non-compliance from this presentation.
Please review the October 2018 IRB Update Memo for key updates on the following topics:
- Working with the IRB & Privacy Board
- Public Responsibility in Medicine & Research Meeting
- Consent template Updates
- IRB Guidance
- Regulatory Changes
- Farewell to Dr. Cukor
- Clinical and Translational Science Center (CTSC)
- European Union General Data Protection Regulation (GDPR)
REQUIRED TRAINING AND CONFLICT OF INTEREST (COI) DISCLOSURES:
Please refer to the "Training and Conflict of Interest Disclosure" guidance (click here).
OPTIONAL EDUCATIONAL OPPORTUNITIES, MATERIALS, AND RESOURCES:
IRB Educational Presentations:
- The Common Rule: Impact on Clinical Research (10.16.2018): Power Point or PDF or Video (Clinical Research Professionals Appreciated and Education Day)
- Working with the IRB & Privacy Board (Updated 10.4.2018): Power Point or PDF
- Highlights of Changes to Policy IRB-01 (January 2018): Power Point or PDF
- Evolution and Transition of the Downstate IRB: PDF
- IRB -Human Subjects Research: Incoming Staff Orientation (Updated 5.31.2018): Power Point or PDF
- IRBNet - Visual Snap Shot of Submission Process (IRBNet Training Energizer-PDF)
- IRB Member Orientation: PowerPoint or PDF
- Biostatistics vs. Lab Research Video (Requires Adobe/YouTube software download)
- Coping with Your Biostatistician
John Conley Division of Medical Ethics and Humanities:
To listen to FREE audio podcast presentations from the John Conley Division of Medical Ethics and Humanities, please download them from iTunesU.
Office for Human Research Protections:
The U.S. Office for Human Research Protections (OHRP) offers various training options to help understand Health and Human Services Regulations. Click on the links below for additional information:
- OHRP Educational Events
- OHRP Guidance
FDA Educational Materials and Resources:
The U.S. Food and Drug Administration (FDA) has several web resources for educational materials, some of which are described below:
- Clinical Investigator Training Course
- Clinical Trials Educational Materials
- Comparison of FDA and HHS Human Subject Protection Regulations
- Expanded Access (Compassionate Use): Information for Physicians
- Medical Device Workshops and Conferences
- Search for FDA Guidance Documents
NIH Educational Materials and Resources:
- Human Subjects Protections Training
- Research and Training
- Office of Behavioral and Sciences Research Training
External Educational Materials and Resources:
The following links are provided for educational materials and resources from external IRBs and other sites.
- Advarra IRB
- Association for the Accreditation of Human Research Protection Programs (AAHRPP)
- Axiom Research Compliance
- BRANY IRB
- Chesapeake IRB
- Clinical Trials Methodology Course (CTMC)
- Clinical Trials Transformation Initiative
- Complion Resources
- EMORY University IRB
- Kinetiq Knowledge Center
- National Cancer Institute Central IRB
- Neuro Next
- PI Program: Professionalism & Integrity in Research
- Public Responsibility in Medicine and Research (PRIM&R)
- Quorum Knowledge Center
- Schulman IRB Webinar Library
- SMART IRB
- University of Washington - Research Ethics Training for Health in Indigenous Communities
- WIRB Copernicus Group Webinars
- FORTE Educational Clinical Research Resources
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