NOTE: Downstate employees are no longer required to take CITI training module. County may provide copies of the HIPAA Compliance training module completed through People Soft. training required by the employee’s institution. Conflict of Interest (COI) Training At a minimum, only those who are designated by the PI as an “Investigator for COI purposes” Note: External employees may have additional requirements by their institution. Take the COI training required at Downstate: “Conflict of Interest (COI) and Research Misconduct Training.” To enroll investigators the PI must complete the OCAS “Research Compliance Training Registration - COI Intake Form” (located on IRBNet) and forward to The IRB will check the Downstate COI training online, therefore it is not necessary to upload the training certificate in the IRB application This training is valid for 4 years. NOTE: Downstate employees are no longer required to take CITI COI training module. Complete the optional CITI Conflict of Interest training module offered through affiliation with SUNY Downstate. Complete the optional CITI Conflict of Interest training module offered through affiliation with SUNY Downstate. -OR- Provide copies of the COI training required by the institution where the individual is employed. Dangerous Goods Shipping Certification Individuals who are involved with shipping specimens, infectious substances, biological or hazardous substances Enroll in free online training online provided by the Mayo Clinic: Complete the Section 1 on Investigator Education and Training. Individuals must pass this quiz with a score of 80% or greater in order to obtain a dangerous goods shipping certificate. Please attach a copy of the certificate to the submission. The expiration date of the training is on the certificate. GCP Training Effective January 1, 2017, all NIH-funded investigators and clinical site staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials must be trained in Good Clinical Practice (GCP). A clinical trial is defined by NIH as a research study in which one or
adjudication letter) designated by the PI as an “Investigator for COI purposes” available in IRBNet and e-mail a copy of the form to Dr. Imah Jones at . 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+HH 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+ HH 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 H+H 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 (e.g. adjudication letter) from their employer, which 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 are any SFI’s, please provide a COI management plan approved by their employer. -OR- For independent investigators or external investigators who are from a site that does not grant COI adjudication or have a COI policy, complete and submit the . Follow the instructions for Downstate employees (see above) once access is granted to COI Smart by OCAS.
SBE Refresher 1 – History and Ethical Principles (ID: 936) SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029) SBE Refresher 1 – Assessing Risk (ID: 15034) SBE Refresher 1 – Privacy and Confidentiality (ID: 15035) SBE Refresher 1 – Research with Prisoners (ID: 939) SBE Refresher 1 – Research with Children (ID: 15036) SBE Refresher 1 – Research in Educational Settings (ID: 940) SBE Refresher 1 – International Research (ID: 15028) Refresher Stage 2 (3rd time) REQUIRED MODULES: SBE Refresher 2 – Federal Regulations for Protecting Research Subjects (ID: 15040) SBE Refresher 2 – Informed Consent (ID: 12620) OPTIONAL MODULES: SBE Refresher 2 – History and Ethical Principles (ID: 12702) SBE Refresher 2 – Defining Research with Human Subjects (ID: 15038) SBE Refresher 2 – Assessing Risk (ID: 12624) SBE Refresher 2 – Privacy and Confidentiality (ID: 12622) SBE Refresher 2 – Research with Prisoners (ID: 12627) SBE Refresher 2 – Research with Children (ID: 15043) SBE Refresher 2 – Research in the Public Schools (ID: 15042) SBE Refresher 2 – International Research (ID: 15045)