Conflict of Interest Indiana Today?s Agenda

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Conflict of Interest Indiana Today?s Agenda

Bentley College, US has reference to this Academic Journal, Peter E. DunnAssociate Vice President in consideration of ResearchOVPR Office of Research Integrity in addition to Regulatory Affairs Spring 2012 UpdateToday?s AgendaOVPR/ORIRA Spring 2012 Update – IPFW2Provide summary/update of Purdue policies in addition to procedures concerning:Conflict of InterestIntellectual PropertyExport ControlsQuestionsMarch 1-2, 2012Individual Financial Conflicts of InterestOVPR/ORIRA Spring 2012 Update – IPFW3Purdue Policy on Individual Financial Conflicts of Interest (Policy III.B.2; July 1, 2011): purdue /policies/ethics/iiib2.html Implements two requirements:Indiana statute: protect state resources.Federal regulations: ensure the objectivity of research.Proposal-Driven Disclosure of Significant Financial Interest in outcome or sponsor of research project (online Financial Interest Statement)Special concerns alongside research involving human and/or vertebrate animal subjects (protocol submission)March 1-2, 2012

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Indiana Conflict of Interest StatuteRequires that all employees of agencies of state government disclose annually so that their employer any financial interest of the employee, their spouse, or their dependent children, in any contract (including employment of a spouse or dependent child), procurement, investment or loan by their employer.Disclosed financial interests are transmitted so that the State Board of Accounts. Employees who fail so that disclose financial interests commit a felony.March 1-2, 20124OVPR/ORIRA Spring 2012 Update – IPFWIndiana Conflict of Interest Statute: Financial Interest Disclosures March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW5Policy administered by Office of the Vice President in consideration of Ethics in addition to Compliance [vpec@purdue ] IPFW local contact: Director of Human Resources [hr@ipfw ]For additional information in addition to resources, see: purdue /ethics/resources.html Provides links to: Interactive form in consideration of Disclosure of Financial InterestFAQsFederal Regulations: Research-Related Financial Conflicts of InterestMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW6Requires institutions that apply in consideration of in addition to receive federal grants in addition to contracts To identify Significant Financial Interests in the outcome of proposed projects or in entities who will be impacted by the outcome of proposed projects held by Investigators (and Dependents of Investigators) prior so that submission of proposals in consideration of projectsTo identify Conflicts of Interest arising from disclosed Significant Financial InterestsTo take appropriate actions so that reduce, manage, or eliminate the Conflicts of Interest prior so that expending federal funds in consideration of the subject project, in addition to To inform certain federal sponsors (NSF, NIH) of identified Conflicts of Interest before expending federal funds in consideration of the subject project

Research-Related Financial Conflicts of InterestMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW7Purdue Policy III.B.2 directs the Vice President in consideration of Research so that appoint a Responsible Official in consideration of Research-Related Financial Conflicts of Interest (P.E. Dunn designated official)Responsible Official will Implement procedures so that identify Investigator Significant Interests in proposed projectsIdentify Conflicts of Interest associated alongside disclosed Significant Financial InterestsDevelop in addition to implement management plans so that reduce, manage, or eliminate Financial Conflicts of Interest before federal funds are expended in consideration of projectNotify federal sponsor of award when required.Who is an ?Investigator?The Principal Investigator (PI) AND any other person who is responsible in consideration of the design, conduct, or reporting of proposed research.Generally includes anyone whose CV is included in the proposal submitted so that the sponsor; but may include others.Can include technicians, postdoctoral researchers, in addition to graduate students, depending on the specific project in addition to the designated roles of staff/students.8March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFWWhat is a Financial Interest??Any interest that will, could or is intended so that lead so that a profit or an ascertainable increase in the income or net worth of an Employee and/or a Dependent. Such a profit or increase in income or net worth could be realized through the receipt of anything of monetary or potential monetary value, including, but not limited to, payments of any kind (e.g., salary, consulting fees, honoraria, gifts, dividends, distributions, rent, paid authorship, etc.), Equity Interests, an increase in the value of real estate or Equity Interests, or Intellectual Property Rights.?9March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW

Energy Energy sources Energy quantities we?ll discuss in Physics 2A Units of energy Can kinetic energy be negative? Can spring potential energy be negative? Fundamental relationships & definitions Is D KE = « m (vf ? vi)2

What is a Significant Financial InterestMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW10A Financial Interest held by an Investigator and/or an Investigator’s Dependent that reasonably appears so that be related so that the Investigator’s Institutional Responsibilities in addition to that consists of one or more of the following:Remuneration (including salary, consulting fees, honoraria, paid authorship in addition to travel reimbursement) received from a publicly traded company during the twelve-month period preceding the date on which an Investigator is making a disclosure, and/or an Equity Interest held in such publicly traded company, if the aggregate value of such remuneration, plus the value of the Equity Interest as of the date of disclosure, exceeds $5,000;Remuneration (including, but not limited to, salary, consulting fees, honoraria in addition to paid authorship) received from a non-publicly traded company during the twelve-month period preceding the date on which an Investigator is making a disclosure, if the remuneration exceeds $5,000;Any Equity Interest in a non-publicly traded company or business, regardless of value; in addition to Any Intellectual Property Rights, regardless of value.Significant Financial Interest ExclusionsSignificant Financial Interest does not include:An Employee’s salary or royalties received from the University and/or the Purdue Research Foundation, Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency or an institution of higher education, orIncome from service on panels in consideration of a federal, state or local government agency or institution of higher education.March 1-2, 201211OVPR/ORIRA Spring 2012 Update – IPFWSignificant Financial Interest vs. Financial Conflict Of InterestA Significant Financial Interest (SFI) is not always a Financial Conflict of Interest (FCOI)An FCOI exists when the designated Responsible Official reasonably determines that an SFI could directly in addition to significantly affect the design, conduct, or reporting of the subject sponsored research/project.12March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW

What is a Financial Conflict of Interest?When applied so that an Investigator, Financial Conflicts of Interest occur in situations in which such Investigator’s Financial Interest (including Significant Financial Interest) compromises, or could appear so that compromise, his or her professional judgment regarding the design, conduct or reporting of research or if such Financial Interest could directly in addition to significantly affect the design, conduct or reporting of research. The bias such conflicts may conceivably impart not only affects collection, analysis in addition to interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, involvement of human participants in addition to the use of statistical methods.Financial Conflicts of Interest also include the use of University facilities, personnel, equipment, and/or IT Resources in consideration of the benefit of an entity other than Purdue University.13March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFWProposal-Driven Disclosure of Significant Financial InterestsOVPR/ORIRA Spring 2012 Update – IPFW14Process initiated when PIs submit proposal so that an SPS Pre-Award Center in consideration of submission so that sponsor.SPS will ask PI so that identify all ?Investigators? in consideration of the proposal.Each ?Investigator? will receive an email from the Pre-Award Center (Amanda Hamaker) directing them so that a website so that complete in addition to submit a Financial Interest Statement (FIS) online (yes/no question).Investigators indicating that they have Significant Financial Interest associated alongside the proposal will be directed so that an online Research-Related Significant Financial Interest Disclosure Form, which will be submitted so that ORIRA.March 1-2, 2012When an award is received from a sponsor ?March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW15The SPS Post-Award administrator verifies that an FIS has been received from each identified Investigator. If not, access so that the award will be delayed.If an FIS has been received from each Investigator, the SPS Post Award administrator will verify that all individuals who submitted a ?yes? FIS have also submitted Research-Related Financial Interest Disclosures andall identified Financial Conflicts of Interest have been reduced, managed, or eliminated.If either of these actions is not complete, access so that the award will be delayed.

New PHS FCOI Rule is Coming!March 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW16In August 2011, the Public Health Service issued a revised regulation so that ensure objectivity in research. New regulation applies so that all proposals/awards from PHS agencies (e.g. NIH).New regulation has several additional requirements, includingRevised definition of Significant Financial Interest which includes reimbursement of investigator travel by an entity other than the grantee institution.Increased reporting so that sponsoring agencyFCOI training in consideration of all investigatorsIncreased requirements in consideration of subrecipientsPublic disclosure of FCOIs in consideration of Key PersonnelInstitutions must implement by August 24, 2012.Intellectual PropertyPurdue Policy I.A.1: Policy on Intellectual Property purdue /policies/academic-research-affairs/ia1.html Executive Memorandum B-53: Use of Copyrighted Materials in consideration of Educational in addition to Research Purposes purdue /policies/academic-research-affairs/b-53.html ResourcesInterpretation of Policy I.A.1 – Office of the Vice President in consideration of Research (Peter Dunn)Guidance on use of copyrighted materials in teaching in addition to research – University Copyright Office (University Libraries: Donna Ferullo)Disclosure, licensing of Purdue intellectual property – PRF Office of Technology CommercializationOVPR/ORIRA Spring 2012 Update – IPFW17March 1-2, 2012Purdue Policy I.A.1: Copyrightable MaterialsPrinciple of University Ownership. The University permits authors so that retain the copyright so that Instructional Copyrightable Works in addition to Scholarly Copyrightable Works. Excepting only Instructional Copyrightable Works in addition to Scholarly Copyrightable Works, the University shall own the copyright so that each Copyrightable Work conceived in whole or in part during the course of any employment, research, or scholarship activity involving or relating so that the use of University Resources.OVPR/ORIRA Spring 2012 Update – IPFW18March 1-2, 2012

Instructional Copyrightable WorkThe term ?Instructional Copyrightable Work? means a Copyrightable Work thata) is authored by an identifiable University faculty member or instructor primarily in consideration of the instruction of students, b) is not specifically commissioned by the University, in addition to c) is not a recording of a teaching performance made so that or in consideration of University students.OVPR/ORIRA Spring 2012 Update – IPFW19March 1-2, 2012Scholarly Copyrightable WorkThe term ?Scholarly Copyrightable Work? means a Copyrightable Work created by any person subject so that this policy primarily so that express in addition to preserve scholarship as evidence of academic advancement or academic accomplishment. Such works may include, but are not limited to, scholarly publications, journal articles, research bulletins, monographs, books, plays, poems, musical compositions in addition to other works of artistic imagination, in addition to works of students created in the course of their education, such as exams, projects, theses or dissertations, papers in addition to articles.OVPR/ORIRA Spring 2012 Update – IPFW20March 1-2, 2012License so that University in consideration of Instructional or Scholarly Copyrightable WorksEach Instructional or Scholarly Copyrightable Work shall, by operation of this policy, be subject so that a perpetual nonexclusive, royalty-free license from the author so that the University so that use, duplicate, in addition to internally distribute the Instructional or Scholarly Copyrightable Work in consideration of any pedagogical, research, or educational purpose of the University, subject so that attribution of original authorship in addition to so that internal academic procedures in addition to requirements of the department in addition to school of origin of the Instructional or Scholarly Copyrightable Work. The foregoing license shall be broadly construed so that enable the University?s efforts so that preserve research integrity in addition to prevent fabrication, falsification, in addition to plagiarism.OVPR/ORIRA Spring 2012 Update – IPFW21March 1-2, 2012

Purdue Policy I.A.1: InventionsPrinciple of University Ownership. The University shall own each Invention conceived in whole or in part during the course of any employment, research, or scholarship activity involving or relating so that the use of University Resources.OVPR/ORIRA Spring 2012 Update – IPFW22March 1-2, 2012Responsibility of Purdue Faculty, Staff, in addition to StudentsMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW23Disclose any/all inventions involving the use of University Resources in addition to all University-owned copyrightable materials so that the PRF Office of Technology Commercialization (OTC). Execute assignments as requested by OTC so that perfect title so that the intellectual property.Assist/cooperate alongside OTC in protecting in addition to licensing intellectual property determined by OTC so that have commercial potential.Responsibility of OTCMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW24Evaluate disclosed Purdue intellectual property so that determine commercial potential.Take appropriate steps so that protect, market, in addition to license Purdue intellectual property so that maximize public/commercial potential.Options include licensing so that the inventor/creator or an entity in which the inventor/creator has an ownership interest.After recovering legal expenses, distribute net proceeds from licensing according so that policy I.A.1.1/3 so that inventors/creators1/3 so that inventors?/creators? academic units1/3 so that Trask Fund

Reconveyance of intellectual propertyMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW25If OTC determines that commercial potential is not sufficient so that justify expenditure so that protect, market in addition to license intellectual property, policy I.A.1 specifies that inventors/creators may request reconveyance of title so that the disclosed intellectual property.Reconveyance requires positive recommendation from Vice President in consideration of Research, Executive Vice President in consideration of Academic Affairs in addition to Provost, Executive Vice President in consideration of Business in addition to Finance in addition to Treasurer, in addition to approval of the President.Export ControlsOVPR/ORIRA Spring 2012 Update – IPFW26U.S. laws that regulate the export of strategically important products, software, services, in addition to technical data so that foreign persons in addition to foreign countries in consideration of reasons of foreign policy in addition to national security. Apply so that ALL activities ? not just sponsored research.March 1-2, 2012What is an Export?OVPR/ORIRA Spring 2012 Update – IPFW27Transfer of equipment, technology, software, technical data, or services outside of the borders of the US, or so that a foreign person in the US (deemed export).Deemed export: Any disclosure of technical data , software, or technology so that a foreign person in the U.S., or anywhere in the world, is deemed so that be an ?export? of that technical data, software, or technology so that the foreign person?s country of citizenship.March 1-2, 2012

Principal Export Control RegimesOVPR/ORIRA Spring 2012 Update – IPFW28International Traffic in Arms Regulations (ITAR; 22 CFR 120 et.seq.)Dept. of State, Div. of Defense Trade ControlsControl access so that military technologiesU.S. Munitions ListExport Administration Regulations (EAR; 15 CFR 730 et.seq.)Dept. of Commerce, Bureau of Industry in addition to Securitycontrol access so that ?Dual-Use? technologies (primary civilian use)Commerce Control ListCountry Specific SanctionsU.S. Dept. of Treasury, Office of Foreign Assets Control (OFAC) March 1-2, 2012Impact of Export ControlsOVPR/ORIRA Spring 2012 Update – IPFW29Export controls may impact your activities ?If your research:Has a specific military purposeInvolves dual use technologyInvolves confidential or proprietary informationInvolves encryption technologyRequires sponsor review in addition to approval before publicationUtilizes technology or equipment on the Commerce Control ListMarch 1-2, 2012Impact of Export ControlsOVPR/ORIRA Spring 2012 Update – IPFW30Export controls may impact your activities ?If you:Travel so that international meetings or study sitesCarry technology when you travel internationallyTravel so that countries subject so that U.S. embargoesPossess control technology in addition to host foreign visitorsPossess control technology in addition to collaborate alongside international scientistsMarch 1-2, 2012

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This Particular Journal got reviewed and rated by Reconveyance of intellectual propertyMarch 1-2, 2012OVPR/ORIRA Spring 2012 Update – IPFW25If OTC determines that commercial potential is not sufficient so that justify expenditure so that protect, market in addition to license intellectual property, policy I.A.1 specifies that inventors/creators may request reconveyance of title so that the disclosed intellectual property.Reconveyance requires positive recommendation from Vice President in consideration of Research, Executive Vice President in consideration of Academic Affairs in addition to Provost, Executive Vice President in consideration of Business in addition to Finance in addition to Treasurer, in addition to approval of the President.Export ControlsOVPR/ORIRA Spring 2012 Update – IPFW26U.S. laws that regulate the export of strategically important products, software, services, in addition to technical data so that foreign persons in addition to foreign countries in consideration of reasons of foreign policy in addition to national security. Apply so that ALL activities ? not just sponsored research.March 1-2, 2012What is an Export?OVPR/ORIRA Spring 2012 Update – IPFW27Transfer of equipment, technology, software, technical data, or services outside of the borders of the US, or so that a foreign person in the US (deemed export).Deemed export: Any disclosure of technical data , software, or technology so that a foreign person in the U.S., or anywhere in the world, is deemed so that be an ?export? of that technical data, software, or technology so that the foreign person?s country of citizenship.March 1-2, 2012 and short form of this particular Institution is US and gave this Journal an Excellent Rating.