Title

Title Line

Conflict of Interest and PHS Subrecipients: What you need to know

Page Under Developement

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

  1. Which federal and non-federal sponsors require compliance with the PHS Objectivity in Research (“PHS COI”) regulations?
  2. Are there other sponsors that have a COI requirement for Yale and its subrecipients?
  3. To whom does the PHS COI regulation and the NSF Policy apply?
  4. What should the PI do if s/he wants to include a subrecipient in a proposal and the sponsor has a COI requirement?
  5. What is expected of the Business Office when they are made aware that a subrecipient will be included in a proposal?
  6. Why is the Subrecipient Information and Compliance Form important?
  7. What happens if the subrecipient does not have a PHS COI compliant policy?
  8. What happens if the subrecipient does not have complaint PHS policy and they are unable to quickly adopt a policy?  How can the proposal be submitted and still be in compliance with the regulations?
  9. How do I know at the time of proposal submission whether or not the individuals identified by the PI as responsible for the design, conduct or reporting of the research have completed an appropriate COI disclosure form?   

 
  1. Which federal and non-federal sponsors require compliance with the PHS Objectivity in Research (“PHS COI”) regulations?
    The sponsors that require compliance with PHS COI regulations are listed here.  These sponsors require that Yale flow down the COI requirement to subrecipients.
  2. Are there other sponsors that have a COI requirement for Yale and its subrecipients?

    Yes, the National Science Foundation also requires compliance with its COI policy.

  3. To whom does the PHS COI regulation and the NSF Policy apply?
    Both the PHS COI Regulation and the NSF Policy apply to the PI/PD and any individual they have determined to be responsible for the conduct design, or reporting of the research.  Individuals may include, Senior/key, Non-Key, consultants, and subaward PI/PD and those identified at the subrecipient organization as being responsible for the conduct, design, or reporting of the research.
    Contact GCA with questions.

  4. What should the PI do if s/he wants to include a subrecipient in a proposal and the sponsor has a COI requirement?


    As soon as a PI has decided that s/he will be including a subrecipient in their proposal they should immediately contact their Business Office for assistance.

  5. What is expected of the Business Office when they are made aware that a subrecipient will be included in a proposal?Check the list of known sponsors who have adopted the PHS COI regulations at http://coioffice.yale.edu/frequently-asked-questions
  6. Note: NSF subrecipients have an obligation to comply with the NSF COI requirements.

  7. Why is the Subrecipient Information and Compliance Form important?
    The form is required in order to capture the necessary compliance information about the subrecipient.  For example, Yale is required to know at the time of proposal submission if the subrecipient has a compliant COI policy.  Therefore, 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 in order not to jeopardize the submission of a proposal. 
  8. What happens if the subrecipient does not have a PHS COI compliant policy?
    If the subrecipient does not have a compliant PHS policy, Yale has created a Model Financial Conflict of Interest Policy and Model Financial Interest Disclosure Form for the subrecipient to adopt. 
  9. In order to expedite the submission of the proposal, the department business office is expected to send to the subrecipient the model policy and model financial disclosure form in order for the subrecipient to adopt as quickly as possible.   The business office is not expected to negotiate with the subrecipient regarding the adoption of the model policy but rather is expected to send the documents to their counterpart asking them to forward to the subrecipient’s Authorized Organizational Official. These matters may require the subrecipient to consult with their legal counsel.  Any questions/concerns should be addressed by GCA which is prepared to step in and assist.

  10. What happens if the subrecipient does not have complaint PHS policy and they are unable to quickly adopt a policy?  How can the proposal be submitted and still be in compliance with the regulations?
    First, immediately contact GCA for assistance.  Second, only in unusual and rare situations will Yale permit the subrecipient’s investigators identified as being responsible for the conduct, design, reporting of the research to complete a Yale University Financial Interest Disclosure form.  This form would require the investigator(s) to disclose his/her interests that are directly related to the proposed scope of work to Yale rather than their own institution. 

    In order to expedite the process, the following steps should be taken:

    • The business office contacts GCA and informs them of the situation;
    • GCA would contact the subrecipient’s AOR to discuss the circumstances regarding the inability to adopt the model policy.  GCA will determine if the situation permits the use of a Yale Financial Interest Disclosure form.  If so, GCA will provide the form to the business office to forward to their counterpart for the completion by the identified investigator(s);
    • Completed Financial Interest Disclosure Form is submitted to the Department business office along with the completed Subrecipient Information and Compliance Form; and
    • All of the above documents are sent to GCA.
  11. How do I know at the time of proposal submission whether or not the individuals identified by the PI as responsible for the design, conduct or reporting of the research have completed an appropriate COI disclosure form? 
  12. To ensure that responsible personnel are in compliance with sponsor and Yale COI policy/regulations, the business office must do the following prior to submitting the proposal to GCA:
      • Run the Case Status Report to view the current status and dates of annual disclosures for all responsible Yale personnel.
        Note:  This report will be modified some time in late August 2012 to include all personnel regardless of their department affilciaton.   
    • Since PHS COI Disclosure requirements have changed, responsible personnel must complete and submit a new Yale PHS disclosure form for any PHS (NIH) proposal submitted on or after August 24, the new disclosure form is targeted to be available on August 13, 2012.   
      • Confirm that the responsible investigator completed the appropriate disclosure form for the sponsor in question.  For example, if a proposal is being submitted to the NSF, the PI must have a NSF designation in the Case Status Report AND the disclosure must be current.
      • Immediately contact any responsible personnel who must complete a Financial Interest Disclosure.
      • Disclosures must be submitted for all responsible personnel prior to the submission of the application.
Last update: August 9, 2012 (MG)