PART C: Consent/assent/HIPAA authorization form information by pr3GG4

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									   Committee on Clinical Investigations     PART D: Disclosure of Financial Interests
   Children’s Hospital Boston H U M A N S U B J E C T S P R O T O C O L A P P L I C A T I O N
Part D: Disclosure of Financial Interests – ALL APPLICANTS MUST COMPLETE
For this form, the following terms/phrases have been defined as:
  “Protocol”                 refers to the protocol listed on the preceding pages, and includes the study to be conducted
                             under the Protocol.
  “You”                      includes yourself and members of your immediate family; i.e. spouse, children, and
                             persons with whom you maintain living arrangements approximating a family relationship.
  “Person affiliated with”   includes all personnel who will work on research under the Protocol and members of their
                             immediate families.
  “Proprietary Interest”     includes inventions, discoveries, patents, copyrights, and licenses.
                             You should include those interests even if they are assigned to someone else; e.g., an
                             academic employer, under a royalty-sharing sharing policy. You should include them
                             whether they are licensed or unlicensed, and whether your ownership is direct or indirect;
                             e.g. through a development partnership or small corporation.
This form also asks about investments, financial relationships, advisory roles, and appointments. While these terms
are not defined, they should be understood broadly, in a "common sense" way. For example, questions about
investments ask for information about stocks, options and any kind of security that you or your family have a direct or
indirect interest in; the specific form is less important than the substance. You can exclude only publicly traded
mutual funds.
Similarly, questions about financial relationships are directed towards any arrangement in which you receive any form of
compensation. As with investment interests, it is more important that you disclose the relationship(s) than that they are
categorized correctly. So if you do not see a clearly applicable category, please simply disclose the interest or
relationship and we will follow up as necessary with you.


  Principal Investigator
  Protocol Title

 1. Do you have or expect to have any investment or financial relationship (examples below) with any entity
    that is providing funds or other support in connection with the Protocol?               Yes       No
     If YES, check the appropriate type investment or financial relationship below. For each type of checked,
     provide details, including value per year and aggregate value over the projected duration of the research.

          Consulting


          Payments for protocol/study design


          Protocol-related payments not included in the research agreement budget


          Stock or Options


          Honoraria


  Children’s Hospital, Committee on Clinical Investigations                                              Page 1 of 4
  333 Longwood Avenue, 4th Floor Boston, Massachusetts 02115 -Phone: (617) 355-7052                      VERSION 6/2007
 Committee on Clinical Investigations      PART D: Disclosure of Financial Interests
 Children’s Hospital Boston H U M A N S U B J E C T S P R O T O C O L A P P L I C A T I O N
        Scientific Advisory Board Membership


        Royalties or License Fees related to the protocol, or to any test article or device which will be
        employed in the conduct of the research under the Protocol (including any royalties or license
        fees received through an academic institution, including Children's Hospital.


        Equipment or other Laboratory Support


        Other support for research unrelated to the Protocol


        Support for educational or other academic or medical efforts


        Other Grants


        Other



2. To your knowledge, does any person affiliated with the Protocol have or expect to have any interest or
   relationship that falls within the scope of Question 1?                                  YES        NO
    If YES, please describe below:



3. Do you have or expect to have any Proprietary Interest related to the Protocol, or related to any test article
   or device that will be employed in the Protocol? (Include Proprietary Interests that you have assigned to any
   entity, including any institution you have been affiliated with.)                            YES        NO
    If YES, please describe the Proprietary Interest as appropriate below:
          Patent-licensed, in whole or part, to an entity providing funds for the research

          Patent-licensed, in whole or part, to another entity


          Other


4. To your knowledge, does any person affiliated with the Protocol have any Proprietary Interest that falls
   within the scope of Question 3?                                                          YES        NO
    If YES, please describe below:




 Children’s Hospital, Committee on Clinical Investigations                                     Page 2 of 4
 333 Longwood Avenue, 4th Floor Boston, Massachusetts 02115 -Phone: (617) 355-7052             VERSION 6/2007
 Committee on Clinical Investigations      PART D: Disclosure of Financial Interests
 Children’s Hospital Boston H U M A N S U B J E C T S P R O T O C O L A P P L I C A T I O N
5. Do you have or expect to have any advisory role, appointment, or employment with any entity that is
   providing funds or other support for the research to be conducted under the Protocol?  YES        NO
    If YES, please provide details as appropriate below:
          Scientific Advisory Board Membership

          Other Advisory Role


          Officer


          Director


          Employment


          Other


6. To your knowledge, does any person affiliated with the Protocol have or expect to have any position or role
   that falls within the scope of Question 5?                                               YES       NO
    If YES, please describe below:



7. Do you have or expect to have any financial interest, financial relationship, or position or advisory role with
   any other entity that may be affected by the research to be conducted under the Protocol (e.g. competitor,
   customer, collaborator or commercial sponsor affiliate)? Include any entity that may be benefited or
   harmed, directly or indirectly.                                                              YES       NO
    If YES, please describe below (reference categories described in preceding questions):



8. To your knowledge, does any person affiliated with Protocol have or expect to have any financial interest,
   financial relationship, position or advisory role that falls within the scope of #7?     YES       NO
    If YES, please describe below (reference categories described in preceding questions):



9. Do you have or know of any arrangement or understanding, tentative or final, relating to any future financial
   interest, financial relationship, future grant, position, or advisory role either related to the Protocol, or
   dependent on the outcome of the research under the Protocol?                                     YES        NO
    If YES, please describe below:




 Children’s Hospital, Committee on Clinical Investigations                                      Page 3 of 4
 333 Longwood Avenue, 4th Floor Boston, Massachusetts 02115 -Phone: (617) 355-7052              VERSION 6/2007
 Committee on Clinical Investigations      PART D: Disclosure of Financial Interests
 Children’s Hospital Boston H U M A N S U B J E C T S P R O T O C O L A P P L I C A T I O N
10. The CCI prohibits special incentives in connection with clinical research, including, finder’s fees, referral
    fees, recruitment bonuses, enrollment bonuses for reaching an accrual goal, or similar types of payments.
    Will you or anyone else in connection with the conduct of any research under the Protocol receive money,
    gifts or anything of monetary value that is above and beyond the actual costs of enrollment, research
    conduct, and reporting of results, from the sponsor or any other entity?                    YES        NO
    If YES, please describe below:



11. Is there anything not disclosed above which you believe might constitute a conflict of interest or an
    appearance of a conflict of interest in connection with the Protocol?                       YES       NO
    If YES, please describe below:




PRINCIPAL INVESTIGATOR SIGNATURE
  I have answered the above questions to the best of my ability and will update my answers in the event of
  changes.



  Signature of Principal Investigator                                                Date



  Print Principal Investigator’s Name



  Position of Principal Investigator




 Children’s Hospital, Committee on Clinical Investigations                                       Page 4 of 4
 333 Longwood Avenue, 4th Floor Boston, Massachusetts 02115 -Phone: (617) 355-7052               VERSION 6/2007

								
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