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COI CHECKLIST & TOOLS FOR SUBMITTING A PROPOSAL OR PROGRESS REPORT TO PHS or A SPONSOR REQURING ADHERENCE WITH PHS COI REGULATIONS

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Reminder: proposals are due to GCA, 5 business days before the submission deadline. 

    1. Is the proposal to a PHS Sponsor or Sponsor requiring adherence with PHS COI regulations? 
      • Department business office checks list of known sponsors who have adopted the PHS COI regulations at http://coioffice.yale.edu/frequently-asked-questions

      • If sponsor is PHS or a sponsor who has adopted PHS COI regulations, continue to question 2 below.   If not, these regulations do not apply.

    2. Does the proposal or progress report include a subrecipient?  If no, skip to question 3 below; if yes, continue.
      • Department business office sends the Subrecipient Information and Compliance form to the subrecipient.

      Subrecipient Information and Compliance Form
      • Use this form to collect required information and certifications from a subrecipient
      • Subrecipient’s Authorized Official must complete and sign
      • Submit completed, signed form, and any attachments with the TranSum and proposal to GCA
      • Form is required before a proposal or progress report is submitted to the sponsor
      • When completing the subrecipient Information and Compliance Form the subrecipient will disclose whether it has a compliant COI policy.  Department business offices should ask subrecipients to review the COI section of the form as soon as possible to determine if they have a compliant policy. 

      • If the subrecipient does not have a compliant PHS policy, the department business office must send the subrecipient the model policy and financial disclosure form and ask that the subrecipient establish a compliant policy.  These two documents have been developed to assist subrecipients in implementing a PHS compliant COI policy. 

        1. Model Financial Conflict of Interest Policy
        2. Model Financial Interest Disclosure Form

        Ultimately it is the subrecipients responsibility to implement a compliant policy and while Yale has created these two documents to facilitate the establishment of a compliant policy by the subrecipient, Yale will not provide advice on their implementation.  These matters may require the subrecipient to consult with their legal counsel.  Inquiries along these lines from subrecipients should be directed to the GCA. 

        • If the subrecipient does not have a compliant PHS policy at the time of proposal or progress report submission, as a last resort the subrecipient may disclose to Yale to allow the proposal to be submitted.  In such cases, the subrecipient must have a compliant PHS policy by the time of award.  The Subrecipient Information and Compliance form addresses this as an option.  At the time of proposal, all subrecipient personnel who are responsible for the design, conduct or reporting of the research must complete and submit a Financial Interest Disclosure form to Yale disclosing significant financial interests that are directly related to the research.

        Financial Interest Disclosure Form (contact GCA for form)

      Use this form when a subrecipient does not have a compliant policy.  Responsible personnel must make a disclosure to Yale before the proposal or progress report may be submitted.

      • Department business office sends the Financial Interest Disclosure form to the subrecipient for completion by responsible personnel.

      • Department business offices collects the completed Finanancial Interest Disclosure form(s) from subrecipient.

      • The completed form(s) are attached to the Subrecipient Information and Compliance form and submitted with the TranSum and proposal or progress report to GCA.
    3. Have All Senior/ Key Personnel and others identified by the PI as being responsible for the design, conduct or reporting of the research been entered in Section V of the TranSum? 

        • Because of a system limitation which is being addressed, all key personnel are considered to be responsible, unless otherwise specified by the PI.  In such cases, the PI may document by email or letter attached to the TranSum those who are responsible.  Note: A new TranSum will be released in the coming days that will more clearly identify responsible personnel and it will not be necessary to attach a letter documenting those who are responsible.

        • Non-Yale personnel that the PI identifies as being responsible for the design, conduct or reporting of the research must also comply with PHS regulations.  Contact GCA for consultation about how to handle these situations.

    4. Have all Yale personnel identified as responsible for the design, conduct or reporting of the research completed the appropriate disclosure?  To ensure the responsible personnel are compliant the business office must do the following prior to submitting the proposal to GCA:
      • Runs the Case Status Report to view the current status and dates of annual disclosures for all responsible Yale personnel.  Note:  This report is being revised to allow departments to view all personnel on a proposal and will not be limited to just the submitting department’s personnel.  This revision is planned to be implemented in late August. 
      • PHS Disclosure requirements have changed.  Responsible personnel must complete and submit a new Yale PHS disclosure form for any proposal submitted on or after August 24.  The new disclosure form/system will be available soon.  A link will be provided here as soon as it is available.
      • Confirms that appropriate disclosure statements have been made and are current.
      • Immediately contacts any responsible personnel who must make a disclosure.
      • Disclosures must be filed for all responsible personnel before the proposal or progress report may be submitted.
    Last update: August 7, 2012 (MG)