It is the intent of Husson University (i) to foster a research environment that does not allow any financial interests to directly and significantly affect the design, conduct or reporting of any Husson University Research ; and (ii) prior to any expenditure of funds awarded by the U.S. Public Health Service (PHS) to report the existence of such conflicting interests to the appropriate agency and to act to protect PHS-funded research from bias due to conflict of interest. This Policy applies to all Investigators participating in Husson College Research regardless of the source of funding.
A. "Investigator" means the principal investigator and any other person who is responsible for the design, conduct or reporting of Husson University Research and includes such person's spouse and dependent children.
B. " Husson University Research" means any and all Research which is:
1. Sponsored by Husson University, or
2. Conducted by or under the direction of any employee or agent of Husson University in connection with his or her institutional responsibilities, or
3. Conducted by or under the direction of any employee or agent of Husson University using any property or facility of this institution, or
4. Involving the use of Husson University non-public information to identify or contact prospective subjects.
B. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge related broadly to public health, including behavioral and social-sciences research, whether basic or applied.
C. "Significant Financial Interest" means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights ( e.g., patents, copyrights and royalties from such rights). The term does not include:
1. Salary, royalties, or other remuneration from Husson University;
2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
3. Income from service on advisory committees or review panels for public or nonprofit entities;
4. An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or
5. 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.
The IRB Coordinator shall administer this policy. He/she shall:
A. Cause each Investigator to receive a copy of this policy,
B. Solicit and review financial disclosure statements from each Investigator,
C. Forward completed statements to the Chair of the Husson University IRB and
D. Maintain records of all financial disclosures made by Investigators and all actions taken by Husson pursuant to this Policy for at least three years after submission of final research expenditure reports.
Prior to submitting an application to any entity proposed to fund Husson University Research, including PHS, each Investigator must submit to the IRB Coordinator a listing of his/her known Significant Financial Interests and those of his/her spouse and dependent children:
A. That would reasonably appear to be affected by the Research, and
B. In entities whose financial interests would reasonably appear to be affected by the Research.
All such disclosures must be updated during the period of the award on an annual review basis or sooner if a new reportable Significant Financial Interest is obtained.
The Report of Significant Financial Interests form is attached and must be submitted in every case even if there are no such interests. If such a report has been filed, however, with another institution as part of a multi-institution Research project, then a copy of that report may be provided instead. If Husson University is the primary site, then Investigators at sub-contracting sites must file the Husson University report unless their institution provides Husson University with written assurance that it has complied with this policy.
III. Certification to PHS
The Chair shall certify, in each application for PHS funding that:
A. There is in effect at Husson University a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the PHS,
B. Prior to Husson University expenditure of any funds under the award, Husson University will report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interests or other details) found by Husson University and assure that the interest has been managed, reduced or eliminated in accordance with this Policy; and, for any interest that Husson University identifies as conflicting subsequent to Husson University's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification.
C. Husson University agrees to make information available, upon request, to the HHS regarding all conflicting interests identified by Husson University and how those interests have been managed, reduced, or eliminated to protect the research from bias; and
D. Husson University will otherwise comply with applicable law and regulation.
II. Management of Conflicting Interests
A. Husson University endorses the attached opinion 8.03 and 8.031 of the 1992 Code of Medical Ethics, Current Opinions of the Council on Ethical and Judicial Affairs.
B. The Chair must review all financial disclosures; and determine whether a conflict of interest exists and, if so, determine what actions should be taken by Husson University to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the Chair reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct or reporting of Husson University Research.
Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to:
1. Public disclosure of Significant Financial Interests;
2. Monitoring of Research by independent reviewers;
3. Modification of the Research plan;
4. Disqualification from participation in all or a portion of the Research;
5. Divestiture of Significant Financial Interests, or
6. Severance of relationships that create actual or potential conflicts.
If the failure of an Investigator to comply with this Policy has biased the design, conduct or reporting of any Husson University Research, Husson University must promptly notify the PHS Awarding Component or other entity funding the Research of the corrective action taken or to be taken.
Husson University will comply with any directions from PHS or other entity funding the Research on how to maintain appropriate objectivity in the funded project, including:
A. Submission or review on-site of all pertinent records to PHS or other entity funding the Research, and
B. Disclosure by the Investigator of the conflicting interest in each public presentation of the results of the Research.
Eastern Maine Medical Center
Investigator Financial disclosure Policy
AMA Opeinions on Practice Matters
8.03 CONFLICTS OF INTEREST: GUIDELINES. Under no circumstances may physicians place their own financial interests above the welfare of their patients. The primary objective of the medical profession is to render service to humanity; reward or financial gain is a subordinate consideration. For a physician unnecessarily to hospitalize a patient, prescribe a drug, or conduct diagnostic tests for the physician's financial benefit would be unethical. If a conflict develops between the physician's financial interest and the physician's responsibilities to the patient, the conflict must be resolved to the patient's benefit.
8.031 CONFLICTS OF INTEREST: BIOMEDICAL RESEARCH. Avoidance of real or perceived conflicts of interest in clinical research is imperative if the medical community is to ensure objectivity and maintain individual and institutional integrity. All medical centers should develop specific guidelines for their clinical staff on conflicts of interest. These guidelines should include the following rules: (1) once a clinical investigator becomes involved in a research project for a company or knows that he or she might become involved, she or he, as an individual cannot ethically buy or sell the company's stock until the involvement ends and the results of the research are published or otherwise disseminated to the public; (2) any remuneration received by the researcher from the company whose product is being studied must be commensurate with the efforts of the researcher on behalf of the company; (3) clinical investigators should disclose any material ties to companies whose products they are investigating. They should disclose their financial ties, participation in educational activities supported by the companies, participation in other research projects funded by the companies, consulting arrangements, and any other ties. The disclosures should be made in writing to the medical center where the research is conducted, organizations that are funding the research, and journals that publish the results of the research.