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One Year Prior to
Deadline: Submit Intent to Submit a Grant Form,
Meet with Associate Dean of Research, Provide a copy of
the proposal guidelines to the Program Coordinator,
Begin meeting with collaborative team, if applicable, to
determine who will be responsible for various parts of
proposal, and set deadlines for completion.
Six Months
Prior to Deadline: Meet with Program Coordinator
to plan for completion of agency forms and any other
forms that may be needed, Meet with Statistician if
needed for consultation on sample size and data analysis
plan, Meet with Associate Dean of Research to review
progress.
Three
Months Prior to Deadline: Contact Chairperson of
Scientific Review Committee to schedule internal review,
Contact External Reviewers and make arrangements through
Office of Research for external review, Begin securing letters of support and any information
needed from grant personnel, Meet with Center
Administrative Coordinator to begin budget preparation
.
One Month
Prior to Deadline: Begin revisions based on
external review, Meet with Center Administrative Coordinator to
finalize budget, Meet with Program Coordinator to review
proposal application, Meet with Associate Dean of
Research as needed.
One Week
Prior to Deadline: Provide Program Coordinator
completed final budget and budget justification, draft
of narrative, and sample letters of proposal for routing
through the College and to SPAR.
One
Day Prior to Deadline (or earlier)
: Provide Program Coordinator with final,
completed proposal.
C.Budget
The Center Administrative
Coordinator, in conjunction with the College Business
Manager, will assist faculty in preparing grant proposal
budgets.
Budgets to NINR exceeding
$350,000 in direct costs for one year must have written
permission from the agency prior to submission of the
application.
The University of South
Carolina does not recognize a budget item as
“equipment” unless the unit price is $5,000 or
greater. Therefore
computers, laptops, printers, etc. should be listed in
the “supplies” category rather than equipment.
Fringe benefits must be
calculated as a part of the salary cost for any
University of South Carolina employee.
Budget
Preparation
Budget development begins
when the study’s design and methods, timeline, and
investigative personnel have been described. The College of Nursing Business Manager, Research
Center Program Coordinator, and the Associate Dean for
Research will assist you in the preparation of all
aspects of your budget. The process begins with a joint planning meeting
to which you should bring the information specified
above to create a rough draft. The Research Center Program Coordinator will then
create a spreadsheet for the budget that includes all
items that can be specified. The Research Center Program Coordinator also
obtains pricing information (e.g., plane fares, mileage)
and salaries as needed. The spreadsheet along with the notes from which
it was generated will then be forwarded to the PI, the
Business Manager, and the Associate Dean for Research
for review and revision.
As the PI gets further along in the planning
process, the budget will become more detailed. This is an iterative process that usually takes
about 3-4 rounds. If
changes are made in personnel, methods, or timeline,
please remember to share these with everyone who is
assisting with your budget preparation so that the
budget parallels exactly what you will be doing. All directions and guidance to the Research
Center Program Coordinator should be provided in writing
so a record of your requests can be kept with the
budget.
Because of the time lag
between submission and funding and the need to account
for ongoing raises and inflation, inflationary factors
are usually included in all years of the budget.If you will be “employing” personnel from
other departments or schools on campus, the Research
Center Program Coordinator will obtain their current
salaries. For
those outside the school, it is important to remember
that a written approval from the individuals’ chairs
and deans will be needed.
In addition, these other departments often want
to share in the receipt of overhead monies (billed to
the agency as “indirect costs”), so this must be
stated in the letter.
If subcontracts are
planned with another site to pay for personnel or
services, please plan well in advance.
It takes time for two institutions to formalize
such agreements and get the appropriate approvals.
Plan for at least a 2-month period for completing
this process. All
subcontracting must be complete prior to obtaining
University approval to submit the grant.
The final budget will
provide detailed estimates of costs for all years of the
grant. If
the grant program to which you are applying has limits
on the dollars that can be requested, observe them. The Business Manager and Research Center Program
Coordinator will assist you with adjusting the
expenditures to meet the budgetary limits.
The Business Manager will perform the final
review of the budget before it is submitted to SPAR. If the study cannot
viably be done for the amount of money that is
available, do not submit the grant. Once a budget has been approved by SPAR, no
changes can be made without going back through the
entire signature process.
Budget
Justification
Keep notes of how you
arrived at the various budget calculations. The Research Center Program Coordinator will do the same for
those aspects of the budget she estimates.
In addition, make notes as you are working with
your investigative team to decide which individuals will
be responsible for which aspects of the project’s
activities. These
notes then form the basis of the budget justification.
When the budget is
in fairly final form, you are ready to draft the budget
justification. Strive
for accuracy and consistency with the budget – they
must match 100%. The
Associate Dean for Research will review what is written
and provide feedback.
Modular
Budgets
In 1999, the National
Institutes of Health began instituting the modular grant
initiative. The
purpose of this initiative is to streamline the
submission process and to allow reviewers to focus on
the science of the project rather than on budget
details.
In modular grant
applications, total direct costs not exceeding $250,000
per year will be requested in $25,000 increments instead
of detailed and separate budget categories. However, this does not change the budget
preparation process in the College of Nursing.
Unsolicited,
investigator-initiated applications requesting more than
$250,000 in any year will be required to follow the
traditional application instructions and applicable NIH
policies for budget preparation.
The complete announcement
can be found on the NIH website: http://grants.nih.gov/grants/guide/notice-files/not98-178.html
Facilities
& Administrative (F&A or Indirect) Costs
Facilities &
Administrative Costs (formerly known as indirect costs)
are a percentage of the actual costs that are paid to
the University of South Carolina to cover “overhead”
institutional costs of supporting the study, for
example, salaries in the Sponsored Program Office,
utility bills, etc. These costs are not available if the funding is from the
University or another South Carolina state agency. Foundations and private agencies must have written policy
about F&A
Managing
Budgets for Funded Grants
Once a study has been
funded, the Project Coordinator for the grant is
expected to manage the grant budget.
On a project with insufficient funds to hire a
Project Coordinator, the Principal Investigator, with
the assistance of the HPSP Center Administrative
Coordinator, will be responsible for managing the
budget.
Additionally,
either a Project Coordinator specific to the grant or
one of the faculty Administrative Assistants will be
responsible for ordering supplies, preparing printing
requests and travel paperwork, photocopying materials,
completing paperwork to hire personnel, and other
clerical assistance to facilitate the grant.
C.
Agency Forms
The Program Coordinator,
in cooperation with the Principal Investigator, is
responsible for completing any application forms
requested in the grant application by the funding
agency. These
forms typically include a face sheet, an abstract,
budget forms, and biosketches of key personnel.
D.
Research Narrative
The Principal
Investigator, in cooperation with the research team if
applicable, is responsible for the completion of the
research narrative. The Administrative Assistant and the Program
Coordinator in the Office of Research are available to
assist with editing, creating tables and figures, and
final formatting.
Proposal guidelines will
often dictate specific headings and page limitations for
the research narrative. With
NIH, for example, the first four sections of
the narrative – Specific Aims, Background and
Significance, Preliminary Studies/Progress Report, and
Research Design and Methods – cannot exceed 25 pages. The margins should be 1” on all sides of the
narrative text. Although
NIH guidelines state that a font size of 10 is
acceptable, a minimum font size of 11 point is
recommended. A
font size of 12 point is best, if possible.
E.
Appendix
Items included in the
appendix will vary according to the application and the
guideline requirements. Items typically included in the appendix include
letters of support, instruments, and manuscripts. The Principal Investigator or a member of the
research team is responsible for obtaining letters of
support for the project.
G. Information
Required from Key Grant Personnel
The following
information is required from key grant personnel prior
to sending the proposal to the USC Office of Sponsored
Programs and Research (SPAR):
Financial
Disclosure Form – This form must be signed by all
key personnel (not including the consultants unless they
are University employees). This form states that the individual does not
have a financial conflict of interest with the grant
(i.e., they will not make any money from the grant other
than as specifically stated in the grant budget). If someone is in a position to profit from the
grant outside their scope of work with the grant, they
must complete the form with detailed information about
their source of profit. An example of this situation is if someone owned
a lab that will profit from providing analysis of
samples, or if someone owned a public relations firm
that will profit from the production of an informational
videotape or materials to publicize the grant study.
Consultant
Letters – Consultants must write a letter to the
Principal Investigator stating their willingness to
participate in the study, outlining their specific
responsibilities as a consultant, and specifically what
they expect monetarily in return for their services.
If the details have not yet been finalized, the
consultant must state that they agree to the terms as
specified in the grant proposal.
Non-Nursing
USC Employee Consultant/Investigator Letters –
Faculty and staff within the USC system, but outside the
College of Nursing, must provide a letter stating their
willingness to participate in the study, what they will
contribute to the study, and the specific dollar amount
they expect to receive in return for their work. This letter must also address whether or not the
individual’s department expects to recover a portion
of the indirect costs. The letter must be signed by the individual, the department
chair, and the dean.
Information from key
grant personnel may also be needed for biographical
sketches and other support information, if required by
the funding agency.
If you are participating
in a grant submitted through another agency or USC
department, please contact the College of Nursing Office
of Research Program Coordinator to prepare the
appropriate paperwork. A copy of this information will be routed through
the College for appropriate signatures and kept on file
in the Office of Research.
H.
Routing
The Program Coordinator
is responsible for routing proposals through the
University system. This begins with a SPAR processing form that must
be signed by the Principal Investigator.
The proposal must also be signed by the
Department Chair – Dr. Sara Fuller as Chair of the
Faculty or Dr. Carolyn Murdaugh for the Office of
Research, and Dean Parsons before sending to SPAR. At SPAR, the proposal is reviewed for adherence
to the guidelines, accuracy of the budget, and
compliance with University policies.
A SPAR official is the signatory for the
University of South Carolina and proposals cannot be submitted for external funding without approval from
SPAR.
Mandatory
requirements for SPAR review include the Dean’s
signature and a finalized budget. A draft version of the proposal may be routed to
SPAR and changes can continue in the proposal
as long as the budget is not changed. The letters of support must also be reviewed by
SPAR, and all
of the required information for key personnel on the
grant, including letters and financial disclosure forms,
must be provided.
If the SPAR reviewer
questions anything in the proposal, the Program
Coordinator is called, who will work with the Principal
Investigator and the Office of Research to answer the
questions and/or correct any problems. Once the proposal has been approved and signed, the proposal
is returned to the Office of Research.
The Program Coordinator coordinates the continued
progression toward submission with the Principal
Investigator.
I.
Copying
The Office of Research
will photocopy the final proposal for the funding
agency, SPAR, the Office of Research, and up to three
additional copies for the Principal Investigator. Any additional copies will be the responsibility
of the Principal Investigator.
F. Mailing
The Office of Research
will prepare the final package for mailing and deliver
to the carrier service.
Most often, Federal Express will be chosen as the
carrier because of their excellent tracking system.
Grants will be sent for overnight delivery if
necessary, but will be sent for 2-day delivery if time
allows. If
the funding agency is in the Columbia area, the proposal
will be personally delivered.
G.
Filing
The Office of
Research will maintain files of research proposals for
three years past the submission date for unfunded
proposals, and three years past the final closing date
for funded proposals.
At the end of the three-year period, the proposal
file will be returned to the Principal Investigator if
that individual is employed with the College of Nursing.
Otherwise, the file will be destroyed.
H.
USC Procurement Exemption Certification
After submission of the
grant application, the Program Coordinator will prepare
USC Procurement Exemption Certification forms as needed
and forward them to the Principal Investigator for
review and signature.
The certifications will be signed by Dean Parsons
before they are forwarded to SPAR for signature. SPAR will sign and return the forms to the
Program Coordinator, who will send copies to the
Principal Investigator and the budget manager.
The certification forms
can be compared to a request for sole source procurement
– advance permission to hire a particular consultant,
purchase a particular brand of equipment, or use a
particular company for services to be provided. If the signed certification forms are not on file
at the time of award, regular USC policies for
purchasing will apply and some services or products may
have to be purchased from the lowest bidder rather than
from the person or company the Principal Investigator
had originally specified.
III.
Use of Human Subjects
A.
IRB Process
Projects involving human
subjects must have University approval. This policy
applies to all research involving human subjects without
regard to the source of funds supporting the project,
including research required as part of an educational
requirement (such as a class project, thesis or
dissertation).
Investigators are
encouraged to review the IRB Policies and Procedures
found on the SPAR website: http://www.spar.sc.edu/IRBbook.pdf
No
research can be conducted with human subjects unless IRB
approval has been obtained and is currently valid.
If the Principal
Investigator knows the project does not fall under the
exempt category, then the PI may submit application and
required materials directly to the Office of Research
Compliance.
If the
Principal Investigator believes the project falls under
the exempt category, the PI should submit a completed
Application for Approval of Human Research Subjects,
including a Request for Study Exemption Form, a complete
research proposal/protocol, an informed consent form,
survey instruments/research tools, and any other
pertinent materials to the College of Nursing IRB
Liaison.
The
College of Nursing IRB Liaison will review each
application to determine if the research meets the
criteria for exemption according to federal regulations.
The Liaison will make recommendations for any
modifications deemed necessary to best protect the
interests of the human subjects.
If the
project meets the requirements for exemption, the
Liaison will provide a certification of exemption to the
Principal Investigator and send copies to the Office of
Research Compliance.
If the
project does not meet the requirements for exemption,
the Liaison will return the application to the Principal
Investigator for submission to the University’s
Institutional Review Board (IRB).
Student research
proposals submitted for review must include the
signature of the faculty advisor/sponsor of the project.
The Principal
Investigator must report any changes in procedures or
unexpected events that occur in the course of the
research to the College of Nursing IRB Liaison.
Application
Form
The IRB application can
be obtained from the SPAR website: http://www.spar.sc.edu/
Click on “Forms” and
then on “USC/SPAR Forms.”
From there the Institutional Review Board
Application for Approval can be completed using either a
fillable PDF form or by downloading the form in
Microsoft Word. The
Institutional Review Board Application for Continuing
Review is also available in fillable PDF form. A sample IRB application form is located at the
end of this section.
When
to Submit Application Form
The Principal
Investigator is responsible for preparing the form. Policies vary on when approval must be obtained, depending on
the funding agency. Some agencies may require that evidence of IRB
approval accompany the grant proposal submission. The current NIH policy is to submit IRB approval
only for projects that are considered in the “fundable
range” following the peer review stage.
Failure to submit IRB approval to the funding
agency may cause the proposal to be rejected or may
cause a delay in funding.
No
research can be conducted with human subjects unless IRB
approval has been obtained and is currently valid.
Renewal
of IRB Approval
IRB approval is valid for
up to one year. If
the Principal Investigator needs continued IRB approval,
a continuation application must be completed and
submitted to the USC Office of Research Compliance. The Office of Research Compliance will notify
Principal Investigators shortly before the continuation
forms are due.
Required Education in the Protection of Human
Research Participants
NIH requires education on
the protection of human research participants for all
key personnel on NIH applications for grants or
non-competing awards for research involving human
subjects.
At the time of funding,
NIH will request a cover letter identifying key
personnel and the education they have completed
regarding protection of human subjects. A letter stating this information must also be
included in the submission of annual reports. The letter is obtained from the USC Office of Research
Compliance.
Investigators and other
key personnel who have not completed the requirements
for education regarding protection of human subjects,
may complete the training at the following website:
http://tutorial.orc.research.sc.edu/
Once the tutorial has
been completed, you
will automatically be listed in a database at the USC
Office of Research Compliance.
B.
Collaborations
The
Office of Research Compliance will assist in obtaining
appropriate assurances from collaborating institutions.
University
of South Carolina College of Nursing, Office of Research
and Center for Health Promotion and Risk Reduction in Special
Populations
Guidelines for Review of Extramural Proposals
1.
Principal Investigator (PI) notifies the Office
of Research one year prior to the grant submission
deadline for extramural research grants.
(See Intent to Submit
form.) This time line is necessary to plan teaching
assignments to support faculty who are writing
extramural grants.
2.
A complete draft of the proposed research plan
(purpose, background, methods and analysis plan) for
internal review will be submitted to the Office of
Research a minimum of 10 weeks prior to the grant
submission deadline.
Potential external reviewers will be contacted by
the PI to formally ask to review the proposal and
provide anticipated review dates.
3. Draft research plan will be assigned to 2
internal reviewers by the Chairperson of the Center
Scientific Review Committee.
4. Internal reviewers will have a maximum of 2 weeks
to review proposal. An oral presentation/critique will be scheduled
to provide PI with feedback on strengths and weaknesses
of the proposed research plan within 2 weeks after
assigned to internal reviewers (week 8 before grant
deadline).
5. PI will have 2 weeks to respond to the internal
reviewers' comments and revise the proposed research
plan as appropriate (weeks 6 and 7 prior to the
submission deadline).
6. Six weeks before the grant submission deadline,
the revised grant application will be sent out to
external reviewers who have been identified with a 2-3
week review time line.
7. Written critiques from external reviewers will be
returned to the PI approximately 3-4 weeks before the
proposal deadline. During the final 3-4 weeks the PI will revise the
grant application based on the external reviewers'
comments/suggestions as appropriate.
8.
The grant proposal will be mailed prior to the
due date set by the funding agency.
GUIDELINES
FOR OUTSIDE CONSULTANT REVIEWERS
Step
One:
(***Consultant reviewers
are paid from Office of Research E-monies.
The Consultant reviewer will be paid as follows:
One consultant - $250; Two consultants - $150 per
consultant, for a total of $300).
The
Principal Investigator is responsible for:
Selecting the Consultant reviewer to be used, Contacting
the reviewer and providing the potential review date,
two-week time frame to review, and grant deadline,
Informing the reviewer that a written critique of the
grant is expected, Requesting
the reviewer’s social security number, Requesting an
updated curriculum vitae (CV) from the reviewer, Giving
the information to the Office of Research.
Step
Two:
1. The Principal Investigator brings the proposal to
be reviewed and a cover letter to the Office of Research
(A sample cover letter stipulating the expectations of
reviewing the grant is available at the Office of
Research).
2. The Office of Research will mail the cover letter
and proposal to the reviewer by 2-day Fed Ex.
3. An invoice will be included in the packet for the
Consultant reviewer’s signature, address, etc., so
that the reviewer can be paid upon completion of the written
review.
4. A 2-day Fed
Ex form will be included in the packet sent to the
Consultant reviewer. The return postage will be paid by the Office of
Research rather than the Consultant reviewer. This also insures that the grant proposal will be
returned in a timely manner.
Step
Three:
1. Once the Office of Research receives the signed
invoice and the Principal Investigator indicates the
written critique has been received, a DEV (Direct
Expenditure Voucher) is processed for the Consultant
reviewer to be paid.
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