Tufts Medical Center and Tufts Health Sciences Campus

RESEARCH DISCLOSURE OF FINANCIAL INTERESTS

The Principal Investigator (PI) and each research team member are to complete this form. Responses should include financial interests of spouse/domestic partner and dependent children of the person completing the form. The PI is to retain in his/her study files the completed forms for research team members. The form completed by the PI and any forms from research team members with “YES” responses are to be submitted to the IRB office(Box 817). Forms will be forwarded to the Office of the Vice President for Research at Tufts MC or the Office of the Vice Provost for Research at Tufts University Health Sciences (TUHS), as appropriate, for review and determination in accordance with institutional COI policy.

Research Team Member:
(whose COI information is below)
Protocol Title:
IRB #:
Principal Investigator:
Study funding source:
Summary of study:
Will the study have an
Informed Consent Form: / Yes No
  1. Do you, your spouse/domestic partner, or dependent child(ren) have or expect to have any financial relationship with any entity that is providing funds or other support in connection with the above-referenced protocol in any of the following capacities?:
  • Please note that if this research is funded by institution or departmental funding, being an employee of the institution or department does not constitute a conflict.
  • If a financial interest exists, please include the dollar value in order to streamline the review process.
  • Missing information may delay IRB review and approval of your study.
  • Please check here if you do not have a spouse / domestic partner, or dependent child:

I do not have a spouse / domestic partner, or dependent child

If yes to any, please explain,
including relationship, if any,
to this research project: / If yes, provide the dollar value
of compensation from the last
12 months and/or the total
value of equity.
  1. Scientific advisory board membership:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Other advisory role:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Officer of the entity:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Director of the entity:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Employment at the entity:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Payments for protocol or study design (i.e., Payments for protocol or study design paid directly to you. Please note: It is permissible to include a study start-up fee for document preparation in the study budget; when included as part of the study budget this is not considered a conflict and does not need to be reported as such.):
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Any other payments, related to the protocol, that
are not included in the research agreement budget:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Stock or options :
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Honoraria:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Consulting:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. 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 Tufts MC or Tufts University):
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Support for educational or other academic or medical efforts:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. Other:
You:
Yes No
Your spouse/domestic partner or dependent child:
Yes No
  1. To your knowledge does Tufts MC/TUHS have any intellectual property interests or equity in the company sponsoring this research or connected to the above-referenced research?

Yes No

If yes, please describe:

  1. Do you, your spouse/domestic partner, or dependent child 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 with which you have been affiliated.)

Yes No

If yes, please describe the proprietary interest 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.Do you,your spouse/domestic partner, or dependent child 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., a competitor, customer, collaborator or affiliate of a commercial sponsor)? Include any entity that may be benefited or harmed, directly or indirectly.

Yes No

If yes, please describe, using the categories described in the preceding questions:

5.Do you, your spouse/domestic partner, or dependent child have any arrangement or understanding, tentative or final, relating to any future financial interest, financial relationship, 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:

6.The IRB prohibits special incentives in connection with clinical research, including, but not limited to, finders’ fees, referral fees, and recruitment bonuses. In connection with the conduct of any research under the protocol, including enrollment, will you receive from the sponsor or any other entity any money, gift or anything of monetary value above and beyond the costs of enrollment, conduct of research, and reporting on the results? This includes, for example, finders’ fees, referral fees, recruitment bonuses, and an enrollment bonus for reaching an accrual goal or similar types of payments. Please note, even if these items were to be part of the study budget, Tufts MC and Tufts University prohibit these types of incentives.

Yes No

If yes, please describe:

7.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:

I have answered the above questions to the best of my ability and will update any answers in the event of a change.

Person whose COI information appears above: / Principal Investigator:
Signature of Research Team Member Whose Information is Above / Signature of Principal Investigator
Date / Date
Typed name of Research Team Member / Typed name of Principal Investigator
Position / Role on Research Team / Principal Investigator

Version 05/14/2015Page 1 of 4