Conflict
of Interest
Contractual
Agreements
Drug-Free
Workplace
Facilities
& Administrative
Costs
Faculty
Overloads
Agencies Without Specific
Guidelines or Budget
Instructions
Intellectual
Property
Scholarly
Misconduct
|
Conflict
of Interest
The following
outlines Kennesaw State University’s (KSU's) policy and procedures
regarding conflicts of interest in relation to research, educational, or
service projects funded by federal agencies, either directly or through
another institution or organization.
Policy
It is the policy
of KSU to comply with federal regulations (Title 42, Chapter 1, Part 50), ensuring that sponsored activities
will not be compromised by investigators’ financial interests that
reasonably could be expected to bias the design, conduct, or reporting of
the research. In accordance with these regulations, the University has the
responsibility to disclose, manage, reduce, or eliminate any actual or potential
conflicts of interest that may be presented by a financial interest of an
investigator.
Definitions
Conflict of
Interest - A conflict of interest exists when the university reviewer(s)
reasonably determines that a significant financial interest could directly
and significantly bias the design, conduct, or reporting of the federally-funded
research, educational, or service activities.
Investigator - Investigator means the principal investigator/project director, co-principal
investigators, co-project directors, and any other person(s) responsible
for the design, conduct, or reporting of research, educational, or service
activities funded, or proposed for funding. Interests of the investigator
that would constitute a conflict of interest include interests of the investigator’s
spouse and dependent children.
Institution - Any domestic or foreign, public or private, entity or organization (excluding a Federal agency).
Research - A systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development.
Significant
Financial Interest - 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), or
income generated by the manufacture or sale of products;
• equity
interests (e.g., stocks, stock options or other ownership interests);
• intellectual
property rights (e.g., patents, copyrights and royalties from such rights).
The term does
not include:
• salary,
royalties, or other remuneration from the applicant institution;
• any
ownership interests in the institution, if the institution is an applicant
under the Small Business Innovation in Research program;
• income
from seminars, lectures, or teaching engagements sponsored by public or
nonprofit entities;
• income
from service on advisory committees or review panels for public or nonprofit
entities;
• an
equity interest that when aggregated for the investigator and the investigator’s
spouse and dependent children, (1) does not exceed $10,000 in value as
determined through reference to public prices or other reasonable measures
of fair market value, and (2) does not represent more than a five percent
ownership interest in any single entity. (Both conditions must be met);
• salary,
royalties or other payments that, when aggregated for the investor and
the investigator’s spouse and dependent children over the next twelve
months, are not expected to exceed $10,000.
Procedures
Compliance
with the federal regulations requires that investigators disclose a listing
of significant financial interests (and those of their spouse and dependent
children):
(1) that
would reasonably appear to affect the research or educational activity
funded, or proposed for funding; or
(2) in entities
whose financial interests would reasonably appear to affect such activities.
Such disclosure
must be made to the designated university official(s) prior to the submission of a proposal for funding. This official(s) will review the disclosures
and determine which, if any, financial interests could directly and significantly
affect the design, conduct, or reporting of the research. The institution
must, prior to any expenditure of awarded funds, comply with the conflict
of interests reporting requirements of the funding agency.
Financial disclosures
must be updated annually during the award period and as new reportable significant
financial interests are obtained.
The procedural
steps for this policy are as follows:
(1) Each
investigator shall complete the Disclosure Questionnaire (Form
A). If the investigator does have activities to report that may constitute
a conflict of interest the Statement of Significant Financial Interest
(Form B) must also be submitted in a
sealed envelope marked CONFIDENTIAL. One or both forms (if applicable)
should be forwarded to the Office of Grants and Contracts at the same time
the proposal is submitted for the administrative review process.
(2) The
Associate Dean for Grants and Contracts will review the proposal and disclosure
questionnaire only and forward the Disclosure Questionnaire (Form
A) and the sealed envelope containing the Statement of Financial Interest
(Form B) to the Vice President (VP) for Research, the designated university official. When no conflict of interest
exists, disclosure questionnaires will be retained in the Office of Grants and Contracts.
(3) After
a grant application has been submitted and prior to the acceptance of
an award, the VP for Research will review all financial disclosures,
determine whether a conflict of interest exists, and if so, determine
what conditions or restrictions, if any, should be imposed by the institution
to manage, reduce, or eliminate such conflict of interest.
Concurrent
with the foregoing process, the investigator, in cooperation with the investigator’s
department chair and dean, shall develop and present to the VP for Research a resolution plan that details proposed steps that could
be taken to manage, reduce, or eliminate any actual potential conflict of
interest or presented by a significant financial interest. This plan will
be seriously considered in the determination of appropriate action.
Examples of
conditions or restrictions that might be imposed include, but are not limited
to:
• public
disclosure of significant financial interests;
• monitoring of the research or project by independent reviewers;
• modification of the research or educational plan;
• disqualification from participation in all or a portion of the
research or educational activity;
• divestiture of significant financial interests;
• severance of relationships that create actual or potential conflicts.
(4) Should
the investigator disagree with the proposed conditions or restrictions,
he/she may appeal the decision. The VP for Research will convene
a randomly selected review committee comprised of three to four senior faculty
(not above department chair level) representing a cross section of disciplines
and a research administrator to hear the appeal. The committee will review
the disclosed potential conflicts and either concur with the previous resolution
plan or suggest amendments based upon supporting documentation and agency
regulations. Final resolution of conflict of interest questions will rest
with the President of KSU.
(5) The approved
Resolution Plan shall be incorporated into a Memorandum of Understanding
(MOU) between KSU and the investigator that details the conditions or restrictions
imposed upon the investigator in the conduct of the project or in the relationship
with the Business Enterprise or Entity. This MOU shall be signed by the
investigator, the department chair/unit head, the dean, and the VP for Research.
(6) If the
VP for Research determines that imposing the conditions or
restrictions would be either ineffective or inequitable and that the potential
negative impacts that might arise from a significant financial interest
are outweighed by interests of scientific progress, technology transfer,
or the public health and welfare, then he/she may recommend that, to the
extent permitted by federal regulations, the research go forward without
imposing such conditions or restrictions.
(7) Prior to expenditure of any funds under an award, the University will
comply with reporting requirements of the sponsoring agency concerning the
existence of a conflict of interest. The investigator will update any financial
disclosures at least annually throughout the period of the award or as new
reportable significant financial interest is obtained.
(8) For any
interest that the institution identifies as conflicting subsequent to the
institution’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 60 days of that identification.
(9) Records
of investigator financial disclosures and of actions taken to manage actual
or potential conflicts of interest shall be retained by the VP for Research for at least three years beyond the completion of the grant
or longer if required by the agency.
(10) The university
agrees to make information available, upon request, to the sponsoring agency
regarding all conflicts of interest for the specified PI identified by the
institution and outlining how those interests have been managed, reduced,
or eliminated to protect the project from bias.
(11) If an
investigator violates this policy or the terms of the MOU, the VP for Research will recommend appropriate sanctions to the President of
the university. If failure to comply has biased the design, conduct, or
reporting of the funded research or educational activity, the institution
will promptly notify the awarding agency of the corrective action taken
or to be taken. The awarding agency may take action or refer the matter
to the institution for further action.
(12) Collaborators/sub-recipients/subcontractors
from other academic/not-for-profit institutions must either comply with
this policy or provide a certification from their institutions that they
are in compliance with federal policies regarding investigator Significant
Financial Interest disclosure and that their portion of the project is in
compliance with their institutional policies.
Financial Conflict of Interest Training
Beginning October 1, 2009, PIs and undergrad, graduate students, and postdocs involved in research must complete training in FCOI prior to submitting a proposal to a federal agency. Please complete the online tutorial at the URL below. When you complete the quiz, please print the certificate of completion and submit it with your proposal.
http://www.ori.dhhs.gov/education/products/rcradmin/topics/coi/open.shtml
Scholarly
Misconduct
Policy - KSU Faculty
Handbook (Section 7, Part XXXII, Page 7.55)
Program - required for federal proposals
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Drug-Free
Work Place
Policy - KSU Faculty
Handbook (Section 7, Part XL, Page 7.67)
Program - required for federal proposals
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Facilities
and Administrative Costs
Proposals shall include F&A costs (indirects). F&A costs are institutional costs which are not readily identifiable with a particular project or activity but which are, nevertheless, necessary to the general operation of the University and to the conduct of each of the activities performed. They include an allotted share of such items as operation and maintenance of the physical plant; departmental, college, and institutional administration; library operations; charges for use of equipment and facilities; and certain general expenses attributable to sponsored programs. Unless institutions are reimbursed for the facilities and administrative costs incurred on behalf of sponsored activities, resources provided for other educational objectives must be used for this purpose. The rate of F&A costs for KSU is negotiated with the US Department of Health and Human Services and is based upon the expenses cited above in accordance with cost principles promulgated by the federal government. Federal agencies recognize these rates and expect the University to recover these expenses with limited exceptions; e.g., training grants. KSU cannot make poorly-documented exceptions to the federally-negotiated rate for F&A costs without jeopardizing its F&A rate.
KSU expects to receive the full recovery of F&A costs in all proposals submitted to prospective sponsors. Exceptions and the process for waiver or partial waiver of F&A are as follows.
(1) Federal and state grants and contracts as well as some foundations and nonprofit agencies occasionally limit the rate of F&A costs and specify the limitation in the program guidelines, in written policy, or on their web sites. When such documentation is included with the proposal and routing form, no F&A waiver is required.
(2) Granting organizations that do not address F&A costs in their program guidelines or written policy are expected to provide full recovery of F&A costs. In order to receive a waiver for such organizations; e.g., a non-profit that can only pay limited, if any, F&A due to limited resources, many of which may not have a written policy, KSU project directors must complete the F&A waiver form (http://www.kennesaw.edu/osp/F_and_A_Waiver.doc).
(3) If a project director encounters an exception not covered in those above, the project director should contact OGC.
Grants and contracts from for-profit companies or organizations will seldom, if at all, receive waivers of F&A costs. Granting waivers to for-profit entities means that the taxpayers of Georgia are subsidizing for-profits; hence, a strong case must be made for a waiver to be granted.
When preparing proposal budgets for grants or contracts from nonfederal agencies that pay either no F&A or a reduced rate, project directors are encouraged to budget directly for costs that are normally considered to be part of the federally negotiated F&A rate, such as clerical salaries and basic phone charges. See the list of typical direct and indirect costs below. If such costs are included in the direct costs, this information should be included in the Request for F&A Waiver.
Waivers of F&A costs must be submitted on the Request for F&A Waiver form located at http://www.kennesaw.edu/osp/F_and_A_Waiver.doc. These requests must be submitted to OGC at least three days prior to submission of a proposal or contract. Following review by OGC, the Request for F&A Waiver form and comments of OGC staff will be submitted to the Vice President for Operations or his designee for review.
TYPICAL DIRECT AND F&A COSTS
| Direct Costs |
F&A Costs |
| Salaries, Wages, and Fringe Benefits of Faculty, Technicians, Scientists, Research Assistants, Postdocs, or other Technical and Programmatic Personnel who are necessary to meet the goals of the project |
Salaries, Wages, and Fringe Benefits of Clerical and Administrative positions such as Fiscal Officers, Accountants, Secretaries, Directors, Vice Presidents, President, Office Personnel, and Executive Assistants |
| Scientific and Technical Equipment |
Memberships |
| Computer Costs (Software, Supplies, and Services) |
Subscriptions, Library Books, and Periodicals |
| Long-distance Telephone Charges |
Office Supplies |
| Maintenance Projects related to Scientific and Technical Equipment |
Equipment (Office and General) |
| Materials including Non-capitalized Equipment |
Janitorial Services |
| Participant Expenses |
Photocopy for Office and General Use |
| Supplies (Items solely consumed by the Project) |
Postage |
| Services including Outside Consultants |
Repairs and Maintenance |
| Subgrants and Subcontracts |
Sanitation Services including Hazardous Waste |
| Subject Costs |
Telephone (Basic Monthly Fee, Installation, and Maintenance) |
| Travel |
Departmental Administration |
| Tools and Uniforms |
Student Services |
| Conference Fees |
General Administration |
| Chemical and Glassware |
Photographic Supplies |
| Publication and Page Charges |
|
Negotiated
Indirect Cost Rates
KSU's indirect cost rate is 34% of direct costs excluding capital expenditures (buildings, individual items of equipment, alterations and renovations) and that portion of each subaward in excess of $25,000.
The F&A policy is available in the Office of Sponsored Operations
Policies and Procedures Manual (http://www.kennesaw.edu/budgets/grants/PPM.HTM).
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Contractual
Agreements
Policy
Any Contractual
Agreement (whether a contract, subcontract, or consulting agreement) under
which KSU faculty or staff will provide services or perform research for
an external sponsor is subject to the same internal review process as standard
grant and contract proposal submissions. These agreements must be processed
through OGC, which is the only office authorized to negotiate contractual
agreements for compliance with agency, Regents, and KSU policies. All agreements
processed through OGC are signed by Dr. Randy C. Hinds, CIO and Interim
Vice President of Business and Finance, or his designee. Faculty are not
authorized to sign grants, contracts, or other agreements on behalf of KSU.
NOTE: Information on the process for using active grant or contract funds
to hire a consultant or subcontractor is located at the Office of Grants and Contracts post award web site (http://www.kennesaw.edu/budgets/grants.htm).
Procedures
Faculty are
encouraged to seek collaborative projects with external sponsors such as
industry. This typically involves technical discussions and providing informal
quotes. Once the project has been developed between faculty and a sponsor,
the faculty member must formalize the quote and a contractual agreement
through OGC. The following information is provided to assist faculty in
this process:
General
Instructions for Agencies without Specific Guidelines or Budget Instructions
Any
agreement for services with an external funder (other than direct payment
for individual consulting) is subject to the same internal review process
required for standard grant submissions.
(1)
Obtain a proposal routing sheet from the OGC, x6046, Room 3426, Kennesaw
Hall, or download from the OGC web site.
(2) Obtain
department chair, dean, and other signatures as appropriate.
(3) Prepare
a statement of work.
(4) Complete
a budget and provide supporting documentation. The OGC can provide guidance
and assistance with development of the budget.
(5) Submit
signed proposal routing sheet and budget to the OGC. (Allow five working
days for the internal administrative review process.)
(6) When
project is approved by the Administration, a contractual agreement will
be finalized, signed, and sent to the funding agency for signature.
(7) Once
the Agreement has been signed by both parties, the project director will
meet with the Grants Officer in the Office of Grants and Contracts (x3377),
to set up an account. Fiscal responsibilities of KSU and the project personnel
will be outlined at that time.
(8) Please
read carefully the KSU policy on overloads. Overloads MUST be approved
PRIOR to application submission and are not approved retroactively. Note
that federal grants do NOT allow overloads during the academic year.
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Intellectual
Property -
KSU Faculty
Handbook (Section 7, Part XXXI, Page 7.48)
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Faculty
Overload Policy -
KSU Faculty
Handbook (Section 7, Part XXI, Page 7.26)
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