Office of Research Administration

Training and Conflict of Interest

 

 

Working with the IRB & Privacy Board:

Date:

Time:

Location:

Presenter:

October 17th (Wednesday)

12 Noon

 

Classroom 8B

Diann Johnson, MPH

Associate IRB Administrator

 

October 26th (Friday)

12 Noon

 

Perrin Long Library

B6-508

Danielle Lewis, MD

IRB Management Analyst

 

October 26th (Friday)

3 PM

 

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.

 

Important Announcement:

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:

  1. The Common Rule: Impact on Clinical Research (10.16.2018): Power Point or PDF  or Video (Clinical Research Professionals Appreciated and Education Day)
  2. Working with the IRB & Privacy Board (Updated 10.4.2018): Power Point or PDF
  3. Highlights of Changes to Policy IRB-01 (January 2018):  Power Point or PDF
  4. Evolution and Transition of the Downstate IRB:  PDF
  5. IRB -Human Subjects Research: Incoming Staff Orientation (Updated 5.31.2018): Power Point or PDF
  6. IRBNet - Visual Snap Shot of Submission Process (IRBNet Training Energizer-PDF)
  7. IRB Member Orientation: PowerPoint or PDF

 

Biostatistics Presentations:

  1. Biostatistics vs. Lab Research Video (Requires Adobe/YouTube software download)
  2. 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:

  1. Mini-Tutorials
  2. Videos
  3. OHRP Educational Events
  4. 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:

  1. Clinical Investigator Training Course
  2. Clinical Trials Educational Materials
  3. Comparison of FDA and HHS Human Subject Protection Regulations
  4. Expanded Access (Compassionate Use): Information for Physicians
  5. Medical Device Workshops and Conferences
  6. Search for FDA Guidance Documents

 

NIH Educational Materials and Resources:

  1. Human Subjects Protections Training
  2. Research and Training
  3. 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.

  1. Advarra IRB
  2. Association for the Accreditation of Human Research Protection Programs (AAHRPP)
  3. Axiom Research Compliance
  4. BRANY IRB
  5. Chesapeake IRB
  6. Clinical Trials Methodology Course (CTMC)
  7. Clinical Trials Transformation Initiative
  8. Complion Resources
  9. EMORY University IRB
  10. Kinetiq Knowledge Center
  11. National Cancer Institute Central IRB
  12. Neuro Next
  13. PI Program: Professionalism & Integrity in Research
  14. Public Responsibility in Medicine and Research (PRIM&R)
  15. Quorum Knowledge Center
  16. Schulman IRB Webinar Library
  17. SMART IRB
  18. University of Washington - Research Ethics Training for Health in Indigenous Communities
  19. WIRB Copernicus Group Webinars
  20. FORTE Educational Clinical Research Resources

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