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Principal Investigator Certification Form

Addendum - ADD Investigators to PI Certification Form

 

Disclosure of Significant Financial Interests

Investigators engaged in research must report details of any significant financial interest held by the Investigator and family members (defined as spouse and dependent children) related to the Investigator's Institutional Responsibilities. Investigators are defined as individuals with responsibility for the design, conduct or reporting of research. Effective 3/1/13, Mount Sinai Beth Israel Investigators use the web-base COI-SMART system to submit these reports. A disclosure form must be submitted via COI-SMART before engaging in research initiated after that date, at least annually thereafter, and updated within 30 days if and when relevant circumstances change.

Investigators initially access the system when they receive an e-mail from the COI-SMART system. That e-mail includes a link that brings them to a login screen. The first time they access the system they will be asked for a user name, which is the same as their Mount Sinai Health System Outlook e-mail address, and they will be asked to set a unique password. They will then be brought to an announcement screen, which will introduce them to the COI-SMART system. To complete the questionnaire, respondents proceed through a series of screens to answer questions. Investigators should be prepared to give other identifying information for their current research such as IRB number(s), as well as to specify significant financial interests, as appropriate. Investigators who need assistance with this system should contact OGARA@chpnet.org.

 

Principal Investigator Certification Form

Principal Investigators must include a fully completed and signed Principal Investigator Certification form with an initial or renewing Institutional Review Board application or other grant or contract submission.   By the PI’s electronic signature/submission of the Principal Investigator Certification form, the PI attests to the following:

  1. All Investigators for the project being submitted have been identified and listed;
  1. All Investigators have submitted annual and/or updated Disclosure of Significant Financial Interests at the Investigator's primary site. Mount Sinai Beth Israel Investigators complete their disclosures via the web-based COI-SMART system. If an Investigator has not previously submitted an annual Disclosure of Significant Financial Interests, or has a new significant financial interest, an updated disclosure is required prior to submission of the Principal Investigator Certification form;
  1. All named Investigators have completed conflict of interest training via the on-line CITI system. No document attachment is required for Investigators who complete training via the CITI system;
  1.  The PI has reviewed with each Investigator whether any significant financial interest represents a real or potential conflict of interest for a submitted project, and has indicated this status on the Principal Investigator Certification form.

For assistance with inquiries regarding the conflict of interest disclosure status and training status of Investigators, please contact the Grants Manager or other individuals named on the “Contacts” page for Mount Sinai Beth Israel or email OGARA@chpnet.org.


Addendum - ADD Investigators to PI Certification Form

Principal Investigators use the Addendum – Add Investigators to PI Certification form to declare the names of Investigators added to their project’s roster subsequent to submission of a complete PI Certification form, to affirm that the required training has been accomplished and to affirm that a conflict of interest disclosure has been submitted for each added Investigator. The Addendum-Add Investigators to PI Certification form should show only newly added Investigators as described above.  There is no need to repeat Investigator data already submitted. 

For projects submitted to the Institutional Review Board prior to 8/24/12, Principal Investigators must submit a complete PI Certification form to add Investigators to the project roster.  See PI Certification guidance for specific instructions.

For assistance with inquiries regarding the conflict of interest disclosure status and training status of Investigators, please contact the Grants Manager or other individuals named on the “Contacts” page for Mount Sinai Beth Israel or email OGARA@chpnet.org.



Submit completed forms to OGARA@chpnet.org.

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