INFORMATION ON REQUIRED TRAINING AND CONFLICT OF INTEREST (COI) DISCLOSURES:
For required training and COI disclosure requirements, please refer to "IRB Training Requirements of Investigators and Key Personnel; and Conflict of Interest (COI) Requirements for 'Investigators for the Purposes of COI'"
For more information, contact the SUNY DMC IRB at 718-613-8480. For verification of training or COI submissions of Downstate employees, please contact Nakih Gonzales at 718-270-4372 or email@example.com
Instructions for COI Disclosures NYC Health +Hospitals,. Kings County investigators:
Employees of NYC Health +Hospitals, Kings County must e-mail a copy of their completed COI Disclosure Form to Dr. Imah Jones at Imah.Jones@nychhc.org. Be sure to include the name of the study and indicate the research is being reviewed by the SUNY Downstate IRB. Dr. Jones will return the determination to the investigator making the request. Once the (COI) determination document (e.g. adjudication letter) is issued by NYC H+H COI Committee, please add the document in the IRB submission package in IRBNet. If a management plan is needed for a Significant Financial Interest, the NYC H+H COI Committee will develop a Management Plan to be shared with the SUNY Downstate IRB and the SUNY Downstate Conflict of Interest Committee.
The conflict of interest (COI) determination document (e.g. adjudication letter) from NYC Health +Hospitals, Kings County should include:
- Name of the investigator
- Name of the study
- A statement that the institution is in compliance with federal regulations, effective August 24, 2012, for researchers who are applying for or have received research funding from the Public Health Service (PHS).
- A statement about whether or not there are any Significant Financial Interests (SFI).
If there are any SFI’s, please provide a COI management plan approved by their employer.
For any additional information on the NYC Health +Hospitals/Kings County process please contact one of the following NYC Health +Hospitals/Kings County Facility Research Coordinators:
OPTIONAL TRAINING OPPORTUNITIES:
IRB Educational Presentations:
- Highlights of New Policy IRB-01: Power Point or PDF
- Working with the IRB: Why, when, Who, How, What, & Where: PowerPoint or PDF
- Evolution and Transition of the Downstate IRB: PDF
- IRB -Human Subjects Research: Incoming Staff Orientation: PowerPoint or PDF
- IRBNet - Visual Snap Shot of Submission Process (IRBNet Training Energizer-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
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 Transformation Initiative
- Complion Resources
- EMORY University IRB
- Kinetiq Knowledge Center
- National Cancer Institute Central IRB
- Neuro Next
- Public Responsibility in Medicine and Research (PRIM&R)
- Quorum Knowledge Center
- Schulman IRB Webinar Library
- SMART IRB
- WIRB Copernicus Group Webinars
- FORTE Educational Clinical Research Resources
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