NSMC INSTITUTIONAL REVIEW BOARD (IRB)

RESEARCH FINANCIAL DISCLOSURE FORM

This Research Financial Disclosure Form is intended to collect information on your financial relationships, if any, that may be relevant to the IRB’s review of your research protocol (the “Research”). Investigators and all study staff listed on IRB application materials as participating in the research must complete this form and submit to the IRB in conjunction with the Human Subjects Research Application form when the research involves ANY of the following:

(1) for-profit sponsor or funding source;

(2) a marketed drug, device, or other technology, or a drug, device, or other technology in development; or

(3) a new technology, software or therapeutic approach.

This form does not take the place of your obligation to fill out other periodic conflict of interest disclosure forms that you may receive from NSMC or Partners HealthCare System, Inc. (PHS). You must report to the IRB any changes to the information provided, as soon as possible, but in no event later than thirty (30) days after the change.

Name:

Protocol Title:

Please identify the business, if any, sponsoring (or providing funding for) the Research (the “Sponsor”):
Please identify any business that owns, manufactures, or licenses the technology on which the Research is focused (the “Trial Company”): Note: The Trial Company may or may not be the same as the Sponsor.
Principal Investigator Name:
Please identify your direct-report supervisor(s) (may be more than one):
  1. Do you or, to your current knowledge, does a Family Member of yours, have (a) a Financial Interest either in the Sponsor or the Trial Company,or (b) any other Financial Interest that might be affected by, or be perceived as being affected by, the Research? Note: You must disclose all such Financial Interests regardless of amount.
/ no / yes
If yes, please describe (please include the nature of the Financial Interest; the amount; who holds it; and whether it was obtained prior to the start of the Research, will be obtained during the course of the research, or is expected to be obtained after conclusion of the research; in addition, if your “yes” is in response to part (b) above, please describe how the Research could affect, or be perceived as affecting, your Financial Interest):
  1. Do you or, to your current knowledge, does a Family Member of yours:

  • Serve (or have ever served) on the Board of Directors of the Sponsor or the Trial Company?
/ no / yes
  • Hold (or have ever held) an Executive Position in the Sponsor or the Trial Company?
/ no / yes
3(a) Are you or, to your current knowledge, is a Family Member a named inventor on, or owner of, a patent or patent application that has been or which you anticipate will be filed, claiming technology that is involved in the Research? / no / yes
3(b) Do you or, to your current knowledge, does a Family Member have a right to receive royalties or any other payments for any other intellectual property, including copyrightable materials such as software, involved in, or the value of which would reasonably be perceived as being affected by the Research? / no / yes
If yesto 3(a) or (b), explain:
“Family member” is defined as your spouse, minor/dependent children, and other persons living in the same household with you. Note that you are asked to provide information on your Family Members only on the basis of what you currently know – you are not asked to or obligated to ask Family Members for more information about their finances.
“Financial Interest” is defined as an interest in a company consisting of: (1) any stock, stock option or similar ownership interest in the business, but excluding any interest arising solely by reason of investment in a company by a mutual, pension, or other institutional investment fund over which you do not exercise control; or (2) receipt of, or the right or expectation to receive, any income from such business (or from an agent or other representative of such business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof.
NOTE THAT for purposes of this document, the term financial interest includes:
• Any royalties presently being received;
• Any rights to receive any royalties in the future; and
• Licensing fees or milestone payments from the business, whether negotiated directly by you or NSMC.
An “Executive Position” is defined as any position, which includes responsibility for a material segment of the operation or management of a business; it specifically includes the titles of “Scientific Director” and “Medical Director”.

I certify that the statements herein are true, complete, and accurate to the best of my knowledge, and accept the obligation to comply with all applicable federal regulations and state laws, institutional policies and procedures, and the requirements and determinations of the NSMC IRB with respect to this research.

Signature

/

Date

If you have questions or concerns about potential conflicts of interest, contact the NSMC IRB at 781-477-3678.

NSMC Research Financial Disclosure FormPage 1 of 2

Version Date: June 2008