RESEARCH FINANCIAL DISCLOSURE

Adopted 10/26/99

See Also:
Research Conflict of Interest  Financial Interest Statement Form
NIH/PHS Policy on Objectivity in Research

CONTENTS
 

PURPOSE :

The Public Health Service (PHS), the National Science Foundation (NSF), and the Office of the Secretary, HHS, have issued regulations (42 CFR Part 50; Subpart F, 45 CFR Part 94 and 60 FR 35820) and established standards and procedures to be followed by institutions that apply for research funding from the PHS and NSF to ensure that the design, conduct, or reporting of research funded under PHS and NSF grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research. 

POLICY :

For each research project conducted under the auspices of Cook County Bureau of Health Services, its component facilities, and/or Hektoen Institute, all investigators are required to disclose the existence of Significant Financial Interests (and those of his/her spouse and dependent children) as defined herein. 

AREAS AFFECTED:       All Research Projects and their staff 

DEFINITIONS:

Investigator: The principal investigator and any other person who is responsible for the design, conduct, or reporting of research. For purposes of determining Significant Financial Interest, includes the Investigator's spouse and dependent children. 

"Significant Financial Interest" : Anything of monetary value, including but limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). 

Significant Financial Interests which are subject to reporting for any given research proposal include those which: 
 

Would reasonably appear to be affected by the specific research proposed; and 
Are interests in entities whose financial interests would reasonably appear to be affected by the research.

a) Salary, royalties, or other remuneration from the applicant institution: 
b) Any ownership interests in the institution, if the institution is an applicant under the SBIR(1⁾ Program; 
c) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; 
d) Income from service on advisory committees or review panels for public or nonprofit entities; 
e) An equity interest that when aggregated for the Investigator and Investigator's spouse and dependent children, meets both the following tests: 

Does not exceed $10,000 in value as determined through reference to public prices and other reasonable measures of fair market value: and

Does not represent more than a five percent ownership interest in any single entity; 
f) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000. 

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PROCEDURE

The Scientific Committees (IRBs) of Cook County, Provident and Oak Forest Hospitals, and, for vertebrate animal research at Cook County Hospital, the Institutional Animal Care and Use Committee are the designated officials who will review those disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research. If so, the responsible Committee will, prior to the start of the research project, act to manage, reduce, or eliminate the conflict of interest. The responsible Committee will also report the existence of such conflicting interests to the PHS Awarding Component or NSF, if applicable. 

1. All investigators applying for approval of research projects conducting research shall submit to the responsible Committee an "Investigators' Acknowledgment Form", attesting to the presence or absence of a Significant Financial Interest in the research. This form will be provided along with instructions to all prospective investigators, and must be completed for every research protocol and submitted with other material required by these committees. 

2. If an investigator reports the existence of a Significant Financial Interest, a Financial Interest Statement describing that interest must also be completed and submitted at the time of application to the Committee for approval of the research. 

3. Investigators planning a research project which does not entail the use of either human or vertebrate animal subjects must complete a "Financial Interest Disclosure Form" and submit it along with the grant application or contract to the Cook County Bureau of Health Services Office of Research Development for consideration. 

4. The existence of any financial interests reported on this form shall be kept confidential to the extent permitted by law. 

5. If a Significant Financial Interest is indicated on the form (if the investigator answers "Yes"), the form, the accompanying description of the financial interest and the research protocol will be considered as part of the review by the responsible Committee. 

6. The responsible Committee will determine if the financial interest described constitutes a Significant Financial Interest that would reasonably appear to be affected by the research and is in entities whose financial interests would reasonably appear to be affected by the research and if the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research. If so, the Committee will determine how to manage, reduce or eliminate the conflict. 

7. If necessary, the responsible Committee may consult with person(s) with expertise in relevant areas, such as law or finance, in making its determination. 

8. If a conflict of interest is determined to exist, steps shall be taken to manage, reduce, or eliminate the conflict. Examples of conditions or restrictions that might be imposed includes, but are not limited to: 

public disclosure of Significant Financial Interests; 
monitoring of research by independent reviewers; 
modification of the research plan; 
disqualification from participation in all or a portion of the research funded; 
divestiture of Significant Financial Interest; or 
severance of relationships that create actual or potential conflicts.

9. Once it has been determined that a conflict of interest exists, and conditions or restrictions have been imposed to manage, reduce, or eliminate the conflict, the findings and actions of the Committee shall be forwarded to the Office of Research Development for review by Bureau Administration. 

10. Investigators must comply with the conditions or restrictions before beginning the research. If an investigator is found by a responsible Committee to have not complied with its recommendations, or to have misrepresented his/her financial interests, the matter will be referred to the appropriate body for administrative and/or peer review. 

11. Investigators are required to report Significant Financial Interests annually as part of regular annual progress reports required by the responsible Committees. If a previously unreported Significant Financial Interest is reported, the applicable Committee shall determine if a conflict of interest exists and if so, shall report to the PHS or NSF and take steps to manage, reduce, or eliminate the conflict, at least on an interim basis, within sixty (60) days of the identification of the conflict. 

12. Records of all financial disclosures and actions taken with respect to each conflicting interest shall be retained in the office of the applicable Committee for at least three years from the date of submission on the final expenditures report, or where applicable, from other dates specified in 45 CFR 7.453(b). Such record shall be made available to HHS or the NSF upon their request. 

1. Small Business Innovation Research (SBIR) Program means the extramural research program for small business that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Publ. L. 97-219, the Small Business Innovation Development Act, as amended. The SBIR Program includes the Small Business Technology Transfer (STTR) Program.
 

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