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Research Compliance NEW MEXICO THE UNIVERSITY of.

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Presentation on theme: "Research Compliance NEW MEXICO THE UNIVERSITY of."— Presentation transcript:

1 Research Compliance NEW MEXICO THE UNIVERSITY of

2 Research Compliance What is a Conflict of Interest? A situation associated with an investigators participation in UNM research where it reasonably appears, on an actual or potential basis: 1. that the investigators significant financial interest could directly and significantly affect the design, conduct or reporting of UNM research activities; or 2. the investigators situation could directly and significantly compromise his or her professional commitments or allegiance to UNM. Conflict of Interest

3 Research Compliance Goals of the COI Policy While it is not possible in modern research universities to eliminate all conflict, the goal is to manage actual or potential conflicts of interest and the key is: DISCLOSURE Conflict of Interest

4 Research Compliance Keep in mind that… Conflicts of Interest are inevitable in modern research universities and do not imply any impropriety on the part of the investigator. A conflict of interest may exist despite the highest standards of conduct and candor. Conflicts of interest frequently involve perceptions, and are judged by others not by those directly involved. UNM favors more rather than less disclosure. Disclosure does not automatically mean a conflict- this is what the Committee will decide. Conflict of Interest

5 Research Compliance Disclosure requirements apply to the following types of research: Sponsored Research Human Subject Research Animal Subject Research Research funded by a formal award from UNM sources based on submission of a proposal (such as RAC awards) Conflict of Interest

6 Research Compliance Who must disclose? Any person who is responsible for the design, conduct or reporting of UNM research. Principal investigator Co-principal investigator Faculty, staff and students Non-UNM Consultants Conflict of Interest

7 Research Compliance What must be disclosed? Generally, the following financial interest must be disclosed: More than $10,000 in consulting income, salaries, royalties, payments such as honoraria or equity. Interests and ownership. More than 5% equity in a company Intellectual Property rights and royalties other than through than UNM/STC Outside employment that could appear as a potential conflict Position as a director, officer, partner, trustee, manager, or employee of an outside entity that conducts business in an area related to the research Other : A married couple or domestic partners working on the same research grant. Significant financial interests include those of the investigator, his or her spouse or domestic partner and dependent children. Conflict of Interest

8 Research Compliance What must be disclosed? NIH Thresholds Will be implemented in August 2012 Aggregated salary, royalties or other payments, such as consulting fees and honoraria, other than through UNM or STC, that are expected to total more than $5,000 over the next 12 months? Equity interests in a single entity, such as stocks, stock options and other ownership interests that are more than $5,000? Sponsored travel related to your institutional responsibilities from an entity that is NOT a federal, state, or local government agency associated with an institution of higher education? Required NIH FCOI Training Conflict of Interest

9 Research Compliance Disclosable Interest Related to the Research Interests are "related to the research" if an investigator has a relationship with an entity outside of UNM that has either an interest in the subject matter of an investigator's research or whose activities overlap with an investigator's area of expertise. Conflict of Interest

10 Research Compliance Examples of Potential Conflicts of Interest » An investigators consulting relationship with the Sponsor of his/her research; » A management role or equity holdings in an entity that is sponsoring his/her research, or selling goods or services to the university; » Ownership in patents or technology that is the subject of his/her research; » Supervising the same student(s) both in a University activity and as employees of his/her company. Conflict of Interest

11 Research Compliance Examples of what is NOT a Conflict of Interest » An investigators consulting relationship with an organization that conducts business in an area not related to the research. » Stock or equity in a company that does not constitute a significant portion of the companies holdings. » Volunteer work that is not directly related to the research Conflict of Interest

12 Research Compliance Annual Disclosure Process Conflict of Interest In August of 2012 UNM Main and Branch Campuses be implemented an annual FCOI disclosure process. The annual FCOI disclosure focuses more broadly on how an investigators outside financial interest relate to their institutional responsibilities rather than focusing on how the disclosed interest relates to a specific project.

13 Research Compliance Annual Disclosure Process Conflict of Interest We are defining institutional responsibilities using the NIH definition: An investigators professional responsibilities on behalf of the Institution, and as defined by the Institution, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and serves on panels such as IRBs or Data Safety Monitoring Boards

14 Research Compliance Annual Disclosure Process Conflict of Interest Using this definition we hope to capture a broader picture of the investigators role at UNM and how it relates to their disclosable outside interests. The COI Committee will then create a management plan that will cover the investigator for the year of disclosure rather than for a specific project.

15 Research Compliance How do I disclose? Disclosures are submitted via the electronic FCOI disclosure system. You can access the site by going to:

16 Research Compliance Examples of managing potential conflict(s) of interest Modification of the research protocol to mitigate or eliminate the conflict Involve an independent investigator to collect, analyze and interpret the data Appoint a monitor to oversee the research Disclosure of the financial interest in publications and presentations Severance of the investigator's relationships that create the conflict Exclusion of the investigator from participation in some part of the research Conflict of Interest

17 Research Compliance Main Campus COI Website http://researchcompliance.u Conflict of Interest

18 Research Compliance Contact Information Adelicia Gunn Office Phone: 277-2968 MSC02 1665 1805 Sigma Chi NE Albuquerque, NM Conflict of Interest

19 Research Compliance Questions? or Comments? Conflict of Interest

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