EMORY UNIVERSITY.rtf by shenreng9qgrg132


									                                                        EMORY UNIVERSITY

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

        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:


    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;

  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
  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:
       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.

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:

______________________            ______________________
Investigator Signature*                 Date

                                    * No “per” signatures or stamps will be accepted

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,

 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.
    See also the US Copyright Office at: http://www.copyright.gov/
    For a broad definition of consulting see: www.foundation.csulb.edu/fndgrant/sections/GLFEB97.HTM
 For the NIH definition of consulting see: PHS 398 Instructions available at:
  See Law.Com Dictionary at: http://dictionary.law.com/default2.asp?selected=358&bold
  See Forbes Investopedia™ at: http://www.investopedia.com/terms/d/dividend.asp
  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.

   See the NIH Conflict of Interest Frequently Asked Questions (FAQ) at: http://grants.nih.gov/grants/policy/coifaq.htm#b1
   See IRS: http://www.irs.gov/businesses/small/article/0,,id=98277,00.html
   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

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.

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 .
   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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