CONFLICT OF INTEREST IN RESEARCH

FINANCIAL DISCLOSURE FORM

Complete EITHER Part A or Part B of this formand return a signed original to the Institutional Review Board (IRB).

NAME:DEPARTMENT:PHONE:

PROJECT TITLE:

PART A.FINANCIAL CERTIFICATION

I certify that:

1.I, or any member of my family (spouse, domestic partner,children, and any other person living in the same household), have not entered into any financial arrangement with the study sponsor(s) (e.g., bonus, royalty, or other financial incentive) whereby my compensation could be affected by the outcome of the research;

2.I, or any member of my family, do not have a proprietary interest (e.g., patent, trademark, copyright, licensing agreement, etc.) in the product tested in the clinical study;

3.I, or any member of my family, do not have anyequity interest (i.e., ownership interest, stock option, or other financial interest whose value cannot be calculated with reference to publicly traded prices or other measure of fair market value) in the study sponsor(s).

4.I, or any member of my family, have not received any payment from the study sponsor(s), or manufacturer of the product or service being tested, having a total value in excess of $0 when aggregated for the immediate familyother than payments for conducting the research study. (Examples of such significant payments include, but are not limited to, grants or funding for ongoing research, compensation in the form of equipment, retainers for ongoing consultation and honoraria that are (a) paid directly to investigators or to the institution with which the investigators are affiliated, and (b) paid in support of investigator activities.);

5.I, or any member of my family, do not have a Board or executive relationship related to the research, regardless of compensation.

I have answered fully and to the best of my ability and will update this form promptly if my circumstances change.

______

Signature

Date

PART B.FINANCIAL DISCLOSURE

I disclose the following (check all that apply and attach detailed information):

___I, or a member of my family, have entered into financial arrangement(s) with the study sponsor(s) (e.g., bonus, royalty, or other financial incentive) whereby my compensation could be affected by the outcome of the research;

___I, or a member of my family,have a proprietary interest (e.g., patent, trademark, copyright, licensing agreement, etc.) in the product tested in the clinical study;

___I, or a member of my family,have an equity interest (i.e., ownership interest, stock option, or other financial interest whose value cannot be calculated with reference to publicly traded prices or other measure of fair market value) in the study sponsor(s);

___I, or a member of my family,are receiving payments from the study sponsor or research entities other than the sponsorhaving a total value in excess of $0when aggregated for the immediate family, other than payments for conducting the research study. (Examples of such payments include, but are not limited to, grants or funding for ongoing research, compensation in the form of equipment, retainers for ongoing consultation and honoraria that are (a) paid directly to investigators or to the institution with which the investigators are affiliated, and (b) paid in support of investigator activities.);

___I, or a member of my family, have a Board or executive relationship related to the research, regardless of compensation;

___I am aware of the Trinity Health – New England policy on financial disclosure regarding amounts between $5,000 and $50,000 indicating I need a management plan and cannot serve as the PI. I am also aware that any amount over the threshold of $50,000 will not allow me to be involved on the study at all. More information on this policy can be found on the infonet (Investigator Conflicts of Interest in Funded Research Policy)

I have answered fully and to the best of my ability and will update this form promptly if my circumstances change.

______

SignatureDate

Financial Interest Related to Research is defined as a financial interest in the sponsor, product or service being tested, or competitor of the sponsor. This covers anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interest); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). For the purposes of this policy, Disclosable Financial Arrangements are:

  • Compensation made to the investigator in which the value of compensation could be affected by study outcome.
  • A proprietary interest in the tested product, including but not limited to: a patent, trademark, copyright or licensing agreement.
  • Any equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.
  • Any equity interest in a publicly held company that exceeds $0 in value.
  • Payments of other sorts, which are payments that have a cumulative monetary value of $0 or more made by the sponsor of a covered study to the investigator or the investigator’s institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.

The term does not include:

  • Salary, royalties, or other remuneration from SFHMC;
  • Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
  • Income from service on advisory committees or review panels for public or non-profit entities;
  • An equity interest that when aggregated for the Investigator and the Investigator’s family members, meets both of the following tests: Does not exceed $0 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than 0% ownership interest in any single entity;
  • Salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s family members over the next twelve months, are not reasonably expected to exceed $0.

Non-Financial InterestRelated to Research is defined as an interest in the sponsor, product or service being tested, or competitor of the sponsor which excludes financial interest. For the purposes of this policy, Disclosable Non-Financial Arrangements are:

  • Having a Board or executive relationship related to the research, regardless of compensation.
  • Have been involved, or plan to become involved in the design, conduct, or reporting of the research.

January 2017