EMORY UNIVERSITY INVESTIGATOR REPORT OF FINANCIAL INTERESTS IN RESEARCH This form must be completed by every “Investigator” at the time of proposal submission. “Investigator” is defined as any members of the research team engaged in the design, conduct, or reporting of the research, not just the PI. This may include staff, fellows, residents, and students as well as faculty. At a minimum Investigator Report of Financial Interests in Research must be provided for: Any person whose biographical sketch is included in the proposal; and/or Any person whose name appears in the budget1 No proposals may be submitted, nor awards issued to Emory University until all Emory University Investigator Certification of Financial Interests in Sponsored Research associated with each proposal are on file. Investigators seeking external research support must disclose all Significant Financial Interests in any way associated with the research project that could appear to be affected by research for which funding is sought. These interests could include payments (fees, honoraria, royalties) from or ownership interest in: Sponsors of the project; Businesses that make or distribute products/services used in the research as well as competitors; Businesses developing a product that the research is intended to evaluate or further develop; and/or Any party whose financial interests would seem to be directly and significantly affected by the research; Additionally, proprietary interests (patent or copyright) related to the research must be disclosed. Federal regulations and University Policy require that investigators disclose the existence and nature of financial interests or the potential of a financial conflict prior to the submission of a grant or contract application. 2 The original of this certification must be submitted with the proposal to the Office of Sponsored Programs. One copy should be retained with the Principal Investigator's records relating to the project. 1. Name:_______________________________________________________________________ 2. Department/Unit:______________________________________________________________ 3. Phone Number:_________________________E-mail:___________________________ 4. Lead Principal Investigator/Program Director/Responsible faculty member: Name:_______________________________________________________________________ 5. Sponsor: NSF PHS other sponsor (specify)_________________________________ 6. Title of proposal: ______________________________________________________________ Check all financial interests related to the research that apply to you (including immediate family individually or in aggregate): Payments of $10,000 or more including salary, consulting fees, royalty or licensing payments from intellectual property, honoraria and/or gifts received within the past 12 months or anticipated over the next 12 months (excluding salary, grant support, and other payments for services from Emory University); Equity or ownership interest (includes stock options) of more than 1% of the entity or worth $10,000 or more as determined by reference to its publicly listed price (excluding mutual funds); Any equity or ownership interest if the value cannot be determined by reference to publicly listed prices (privately held companies, for example, start-up companies); A position as director, officer, partner, trustee, employee, or any other position of management; 1 For NIH proposals and awards this this includes any person referenced in the modular budget narrative or in the detailed budget. It also included consultants and any “to be appointed” positions 2 Frequently Asked Questions: Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart D, Grants and 45 CFR Part 94, contracts: See: http://grants.nih.gov/grants/policy/coifaq.htm#c1: http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm See also Reminder of Financial Conflict of Interest for All NiH Supported Institutions: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html Patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving the University; or Any combination of remuneration, fees, royalties, or honoraria, which exceeds $10,000 per year received in the past 12 months or anticipated for the next 12 months] when aggregated, from an entity whose products or services are used or studied in the research or who are developing products or services that the research is intended to study or evaluate Any compensation whose value could be affected by the outcome of the research. None of the above. Certification I certify that: 1. All financial interests meeting the criteria above have been disclosed. 2. If I am the Principal Investigator, I have obtained and submitted disclosures for all Emory members of the research team meeting the definition of “Investigator” as defined above. 3. I am aware and understand that I have an ongoing responsibility to update my disclosure immediately upon any change in outside financial activities that are related to this research project Additionally, if I am Principal Investigator for this research project I understand that it is my responsibility to ensure that the other members of the research team update their disclosures on an ongoing basis as their circumstances change. 4. I have read and understand Emory University policies regarding conflict of interest disclosure including the Emory Statement of Guiding Ethical Principals available at: http://www.emory.edu/SECRETARY/Statement/ . 5. To the best of my knowledge I and members of my immediate family and dependents are in compliance with federal regulations concerning disclosure of outside activities and financial interests. 6. I have taken the NIH Office of Extramural Research Financial Conflict of interest tutorial available at: http://grants2.nih.gov/grants/policy/coi/tutorial/fcoi.htm ______________________ ______________________ Investigator Signature* Date * No “per” signatures or stamps will be accepted DEFINITIONS Conflict of Interest: may arise when a Faculty member, his or her Family Member, or an entity with which the faculty member is associated: has an existing or potential financial or other external interest that impairs or might reasonably appear to impair the Faculty Members independence of judgment in the discharge of his or her responsibilities to the University; or may receive personally a material financial or other benefit from the use or disclosure of information confidential to the University. See also NIH definition3 Copyright4 fee: A copyright is a legal protection for an original piece of work, such as art, film, software, or writing; the fee is the per use return to the owner for the use of the copyrighted work. For example an author may receive a fee each time a copy of their book is sold. At Emory, the University holds any patents that come about as a result of sponsored research, but the individual faculty member often hold the copyright(s). Sponsored research agreements may specify other, or additional, provisions. Questions about copyright may be addressed to either the Office for Technology Transfer or the Office for Sponsored Research. Consulting Fee(s): the definition of a consulting engagement is a contractual arrangement where in a faculty member provides: advice/assistance to an external entity (company, foundation, government agency) for a fee. A person who is engaged to give professional advice or services for a fee, but is not acting as an employee 5. The NIH defines a consultant as an individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services6. Corporation7: an organization formed with state governmental approval to act as an artificial person to carry on business (or other activities), which can sue or be sued, and (unless it is non-profit) can issue shares of stock to raise funds with which to start a business or increase its capital. There are also non-profit (or not for profit) corporations organized for religious, educational, charitable or public service purposes. Dividends8: A distribution of a portion of a company's earnings, decided by the board of directors, to a class of its shareholders. The dividend is most often quoted in terms of the dollar amount each share receives (dividends per share). It can also be quoted in terms of a percent of the current market price, referred to as dividend yield. Equity interest9: An equity interest is a proportion of ownership, typically via investment in a business. Stocks are also known as equities. Also, there is an accounting concept called owner's equity. One person might own 90% of a business, and the other 10%. Entity: A non-Emory, non-governmental, for-profit, or non-profit institution, company, corporation, partnership, LLC or other organization with whom a faculty member has a relationship outside of or in association with their work for University. Fiduciary Role: A special relationship of trust, confidence, and responsibility to others, such as that created by serving as an officer, trustee or member of the governing board of an entity. Financial Interest: Any financial interest in or relationship with an entity, including, but not limited to, ownership of stocks, bonds, stock options, partnership or other equity interests, rights to patent or royalty payments, receipt of consulting fees, speaking fees, 3 NIH Glossary of Terms: http://grants.nih.gov/grants/glossary.htm Federal conflict of interest regulations were developed to ensure that Government employees, scientific review group members, Council members, or others in situations where there was the ability to influence funding decisions have no personal interest in the outcome. The purpose of all conflict of interest requirements are to protect patients and human subjects as was to preserve research objectivity and scientific integrity from being corrupted by personal gain. 4 See also the US Copyright Office at: http://www.copyright.gov/ 5 For a broad definition of consulting see: www.foundation.csulb.edu/fndgrant/sections/GLFEB97.HTM 6 For the NIH definition of consulting see: PHS 398 Instructions available at: grants.nih.gov/grants/funding/phs398/instructions/p3_definitions.htm 7 See Law.Com Dictionary at: http://dictionary.law.com/default2.asp?selected=358&bold 8 See Forbes Investopedia™ at: http://www.investopedia.com/terms/d/dividend.asp 9 See Wikipedia at: http://wiki.answers.com/Q/What_is_an_Equity_interest salary, loans, gifts, lectureship fees, compensation for serving on boards of directors, scientific and other advisory boards, or other remuneration. For the purposes of this disclosure, financial interests Note: this does not include stock owned through mutual funds or reimbursement for travel expenses. Gift: is any transfer of an item of value (including a trip, personal belongings, or special concessions in connection with personal business) for less than fair market value, including a personal discount. Business dinners or other business outings are not considered “gifts,” unless the business component is not significant or the social component does not comport with the overall professional standard of avoiding actual and apparent conflicts of interest. Honoraria: is a one time payment from another University or non-for-profit entity made to a faculty member for a volunteer non- employment service such as a presentation or speech on an area of expertise. The intent of an honorarium is to show appreciation for a service rather that to provide compensation. Federal regulations do not require disclosure of income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities (42 CFR Part 50, Subpart F). Immediate family and dependents include: (i) a spouse; (ii) children; and (iii) any other person residing in the same household as the investigator who is a dependent of the investigator or of whom the investigator is a dependent. Intellectual Property: Legally protected works of the mind (such as technology, software, or scholarly or artistic works) including inventions, plants, mask works, copyrightable works, trademarks, and trade secrets. Intellectual property includes commercializable biomaterials, such as transgenic animals or cells and viruses. Investigator10: An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH or NSF, or proposed for such funding. The definition includes the Investigator’s spouse and dependent children. License fees: The legal mechanism by which one party can obtain the right to use someone else’s patent or copyright, usually by paying licensing fees. LLC11: A Limited Liability Company (LLC) is a relatively new business structure allowed by state statute. LLCs are popular because, similar to a corporation, owners have limited personal liability for the debts and actions of the LLC. Other features of LLCs are more like a partnership, providing management flexibility and the benefit of pass-through taxation. Owners of an LLC are called members. Since most states do not restrict ownership, members may include individuals, corporations, other LLCs and foreign entities. There is no maximum number of members. Most states also permit “single member” LLCs, those having only one owner. Officer: A key appointed position of authority in any entity, including, but not limited to, president, vice president, medical or research director, secretary or treasurer. Other “Tangible” property: An item that has physical presence such as real estate or equipment. Outside Activity: include leadership participation in professional, community, or charitable activities, any self-employment, any participation in business partnerships, or any employment or consulting arrangements with entities other than Emory. Outside Activities may be either compensated or uncompensated. In general, any service on any board: for-profit, non-profit, advisory, honorary, or otherwise, will constitute an Outside Activity Ownership interest: Federal conflict of interests disclosure requirements stipulate that any ownership interests in excess of 1% be reported annually; The University has mandated responsibility to ensure that it is aware of faculty outside interests. It also has a mandated obligation to monitor faculty ownership interests and where necessary to put management place to manage ownership interest to prevent or compromising the achievement of the University’s educational, research, service and patient care missions. Partnership12: A partnership is the relationship existing between two or more persons who join to carry on a trade or business. Each person contributes money, property, labor or skill, and expects to share in the profits and losses of the business. A partnership must file an annual information return to report the income, deductions, gains, losses, etc., from its operations, but it does not pay income tax. Instead, it "passes through" any profits or losses to its partners. Each partner includes his or her share of the partnership's income or loss on his or her tax return. Personal Property: All property, tangible (e.g., equipment) or intangible (e.g., patents, intellectual property), except real property. 10 See the NIH Conflict of Interest Frequently Asked Questions (FAQ) at: http://grants.nih.gov/grants/policy/coifaq.htm#b1 11 See IRS: http://www.irs.gov/businesses/small/article/0,,id=98277,00.html 12 See IRS: http://www.irs.gov/businesses/small/article/0,,id=98214,00.html Principal Investigator: PI/Principal Investigator/Project Director the individual officially responsible for the conduct of a sponsored project. On research projects, the PI is usually a faculty member; on other types of awards, such as financial aid, the PI may have an administrative appointment. [See NIH Definition at: http://grants.nih.gov/grants/multi_pi/faq.htm#a1]13 PHS Award: The PHS (Public Health Service) is division of the Department of Health and Human Services (DHHS). PHS encompasses nine agencies, which include: AHRQ (Agency for Healthcare Research and Quality, the CDC (Centers for Disease Control and Prevention), the FDA (Food and Drug Administration), HRSA (Health Resources and Quality Policy and Research), the NIH (National Institutes of Health) and SAMSA (Substance Abuse and Mental Health Services). The Public Health Service issues awards in the form of grants, cooperative agreements and contracts to research entities, profit and non-profit corporations and individuals who apply for funds through one of the PHS entities in furtherance of the mission supported by that entity. An obligation of the individuals and/or entities accepting these awards is to have a system in place whereby Applicants for PHS funding have a current Annual Disclosure Form on file, indicating all significant financial interests that relate to research for which funding is sought. A useful overview is available at: http://www.hhs.gov/pharmacy/overview.html. Remuneration: Any form of compensation from an outside entity including, but not limited to, ownership of stocks, bonds, stock options, warrants, partnership interests, rights to patent or royalty payments, receipt of consulting fees, honoraria, speaking fees, salary, loans, gifts, lectureship fees, or payment for serving on boards of directors, scientific and other advisory boards. For the purposes of this disclosure, remuneration does not include reimbursement for travel expenses. Royalty: any and all consideration received for the grant of a license, including but not limited to "running royalties" (those royalties paid based on the sale of Licensed Products) and any fixed fees paid under the license (such as up-front fees, milestone payments, minimum annual royalties, etc.). Research: is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development. The term includes, but is not limited to, any such activity for which research funding is available from an outside entity (federal or non-federal). Research includes conducting clinical trials. Significant financial interest: is defined as anything of monetary value of more than $10,000 14 or more than 1% ownership interest, in value as determined through references to public prices or other reasonable measures of fair market value. This includes, but is 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); intellectual property rights (e.g., patents, copyrights and royalties) from such rights. Equity that is not under the faculty member’s direct control and is managed by a third party, such as a mutual fund, is not considered a significant financial interest. Sponsor: An individual or entity (such as a family trust, charitable organization, federal funding agency) which typically provides financial support for mission related University activities including but not limited to support for research, service, patient care or educational activities. Typically such support is of a charitable nature, although deliverables may also be called for as part of the sponsors agreement to provide support. Stocks/stock options: the shares of a particular company or corporation, the certification of ownership of such stock. 13 http://grants.nih.gov/grants/multi_pi/faq.htm#a1 The Principal Investigator or Project Director/Principal Investigator (PD/PI) is defined as: A PD/PI is/are the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the submission of all required reports.” The presence of more than one identified PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI . 14 Note a $10,000 interest is defined as that amount derived from one arrangement or the total of smaller amounts resulting from arrangements with the entity.
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