Title: PROPOSAL AND AWARD MANAGEMENT
1PROPOSAL AND AWARD MANAGEMENT
- PRESENTERS
- Robert DeNight, Manager, Sponsored Projects
- Andrew Chilkatowsky, Manager, Research Business
Management
2SPONSORED PROJECTS OFFICER (SPO) RESPONSIBILITIES
- Manage the non-financial administrative aspects
of grant applications/awards - Provide proactive guidance to Principal
Investigators (PI) and staff in preparing
proposals - Review application guidelines and ensure proposal
complies with them we do not want an
application returned without review due to
oversight of simple rule (i.e., font size) - Review sponsors terms and conditions and ensure
compliance with them as well as CHOPs
institutional policies mitigate risk
3SPONSORED PROJECTS OFFICER (SPO)
RESPONSIBILITIES (CONTD)
- Manage the negotiation and acceptance of awards
- Request lawson activity numbers for awards
- Manage post-award non-financial administrative
matters (i.e., issuance of subcontracts) - Advise PIs and staff of changing sponsor and
institutional rules - Remind PIs of closeout requirements
- Work closely with Grants Contracts Specialist
(GCS) to negotiate subcontract agreements
4SPONSORED PROJECTS OFFICEFISCAL YEAR 2008
STATISTICS
- CHOP Submitted 1,106 proposals requesting an
annual total amount of 244,520,547 (178,337,201
Direct, 66,183,346 FA) - 5.7 increase over FY07 proposals submitted
- CHOP Received 687 awards totaling 149,462,557
(113,046,915 Direct, 36,415,642 FA) - 2.7 increase over FY07 number of awards
- CHOP receives the third largest annual amount of
NIH funding for pediatric hospitals
5SPO/RBM ASSIGNMENT
- SPOs/RBMs are assigned to Departments and/or
Divisions based on proposal volume award
amounts complexity of proposals/awards (i.e.,
Training Grants, PADoH Tobacco, etc.) - Currently, there are SPO I, SPO II, RBM I, and
RBM II positions - Distribute SPO/RBM Assignment list
- Distribute SPO and RBM organizational chart
6SPONSORED PROJECTS OFFICE PROPOSAL PROCESS
- PI submits Proposal Notification Form (PNF) at
least 30 days prior to deadline. The PNF url is
https//intranet.research.chop.edu/display/deptspb
m/GrantProposalNotificationForm - Budget - developed with RBM. Please note budget
should match scope of work - The application (including draft of science)
should be submitted to the SPO as soon as
possible but no later than 5 business days before
the due date for paper applications and 10
business days for electronic submissions
7PROPOSAL PROCESS (CONTD)
- The application should include our Internal
Routing Form - SPO reviews application to ensure compliance with
sponsor rules and institutional policies - SPO notifies PI, via email, of any required or
suggested changes to the application - Once the required changes have been made, SPO
obtains signature of Authorized Official (AO) - SPO informs PI that application has been signed
and provides Federal Express label, if applicable - Proposal is submitted to the sponsor and follows
the sponsors review/award processes
8RESEARCH BUSINESS MANAGER (RBM) RESPONSIBILITIES
- Manage the financial aspects of grant
applications/awards - Communicate accurate and timely financial data to
PIs, sponsors, and others - Provide proactive financial advice and planning
- Ensure compliance with sponsor rules and
regulations, as well as CHOPs policies
9RESEARCH BUSINESS MANAGER (RBM) RESPONSIBILITIES
cont.
- Act as liaison between PI and HR
- Perform HR administrative functions (CHOPone job
transfers, promotions, merit increases,
terminations and bonuses) - Interact with Research Finance to ensure
submission of Financial Status Reports - Ensure pay for research based employees is
distributed accurately and timely.
10RESEARCH BUSINESS MANAGEMENTFISCAL YEAR 2008
STATISTICS
- Each RBM manages approximately
- 75 activities (grants, contracts etc.)
- 22 Principal Investigators
- 70 employees
- 12 million in expenses annually
- 5 grant submissions/month - 50/year
11RESEARCH FINANCE RESPONSIBILITIES
- Institutions official file of record for awards
- Issue lawson activity numbers
- Oversee CHOPs financial management system
- Interact with RBM to ensure compliance with
sponsor and institutional rules and policies - Submit invoices to sponsors and prime
institutions and deposit payments - Drawdown on NIH letter of credit
- Issue payments to subcontractors and vendors
- Submit Financial Reports to sponsors
- Interact with Internal and External Auditors
- Assist in negotiating FA rate agreement
12REGULATORY REQUIREMENTS
- Projects involving the use of human subjects
require Institutional Review Board (IRB)
approval. General questions can be sent to
orcra_at_email.chop.edu - Projects involving the use of vertebrate animals
require Institutional Animal Care and Use
Committee (IACUC) approval. Melba Martinez can
be reached at x4-9124 or via email
martinez_at_email.chop.edu - Projects involving the use of biohazardous
materials require Institutional Biosafety
Committee (IBC) approval. Ray Colliton can be
reached at x6-2272 or via email
colliton_at_email.chop.edu
13OFFICE OF TECHNOLOGY TRANSFER RESPONSIBILITIES
- Intellectual Property Management
- Corporate and Pharmaceutical Sponsored Research
proposals and awards (i.e., Clinical Trials) - Material Transfer Agreements (MTA)
- Confidential Disclosure Agreements (CDA)
14PROPOSAL INVOLVES A CLINICAL TRIAL
- Please contact the Clinical Trials Office (CTO)
and the Clinical Trials Financial Management
Office (CTFM) - The CTO provides the following services Study
Feasibility Study Placement and Study Personnel - The CTFM provides the following services
Research Registration Patient Care Cost
Management Budget Preparation and Sponsor
Invoicing
15NIH R01 APPLICATION
- The NIH PHS 398 11/07 form url link is
http//grants1.nih.gov/grants/funding/phs398/phs39
8.html - Use English and avoid jargon
- Font size and type Arial, Helvetica, Palatino,
Linotype or Georgia typeface and a font size of
11 points or larger - Type density, including characters and spaces,
must be no more than 15 cpi - Type may be no more than six lines per vertical
inch - Use black ink that can be clearly copied
- Print must be clear and legible
- Use standard (8 ½ x 11) paper
16NIH R01 APPLICATION (CONTD)
- Use at least one-half inch margins for all pages
- Application must be single-sided and
single-spaced and should use only a standard,
single-column format for text - Consecutively number pages throughout the
application - Do not use suffixes (i.e., 5a, 5b) - If a paper submission, submit the original
application and five exact, legible, single-sided
photocopies - Program Announcement (PA) Guidelines supersede
the PHS 398 guidelines - NIH individual Institute rules/regulations
supersede the PA guidelines
17NIH R01 APPLICATION (CONTD)
- NIH requires an eRA Commons username for each PI
submitting an application. PI should contact
Janet Dustman of our office (x4-3744, or via
email at dustman_at_email.chop.edu) to obtain
username - Face Page is developed with assistance from RBM
18NIH R01 APPLICATION (CONTD)
- Project Summary is a succinct and accurate
description of the proposed work including the
broad, long-term objectives and specific aims - Relevance describes the relevance of this
research to public health and should not use more
than two or three sentences
19NIH R01 APPLICATION (CONTD)
- Project/Performance Site(s) indicate where the
work, described in the Research Plan, will be
conducted
20SENIOR/KEY PERSONNEL
- Senior/key Personnel are defined as individuals
who contribute to the scientific development or
execution of the project in a substantive,
measurable way - Typically, these individuals have doctoral or
other professional degrees - These individuals must devote measurable effort
(described in person months) to the project,
whether or not salaries are requested - Effort of zero person months or as needed are not
acceptable levels of involvement for those
designated as Senior/key Personnel - We strongly suggest limiting the list of these
individuals because there are additional
administrative burdens associated with these
personnel
21OTHER SIGNIFICANT CONTRIBUTORS
- This category identifies individuals who have
committed to contribute to the scientific
development or execution of the project, but are
not committing any specified measurable effort
(i.e., person months) to the project - These individuals are typically presented at
effort of zero person months or as needed - Individuals with measurable effort may not be
listed as Other Significant Contributors (OSC)
22TABLE OF CONTENTS
- Provide the page number for each category listed
on the Table of Contents - This form also serves as a useful tool to develop
the application
23DETAILED BUDGET AND ENTIRE PROPOSED BUDGET
- Developed by the RBM based on information
provided by PI - The budget justification, which is part of the
entire proposed budget is developed by the PI and
should describe, the costs that will be incurred
to perform the work
24CONSORTIUM BUDGET MATERIAL
- The following items are needed whenever a
subcontractor will be involved in the project
Face page or Statement of Intent Detailed
budget Entire proposed budget including budget
justification Biographical sketch for key
personnel Resources Statement of work and
Checklist
25CHECKLIST
- Developed by the RBM based on information
provided by PI - It should identify Program Income, if applicable
and FA costs
26Factors Affecting Allowability of Costs
- Reasonableness and allocability
- Conformance to any grant or contract limitations
- Consistent treatment
- Determined in accordance with Generally Accepted
Accounting Procedures (GAAP) - Not included as cost or match in any other
Federally-funded program - Be adequately documented
27Reasonable Costs
- A cost is reasonable if, in its nature or amount,
it does not exceed that which would be incurred
by a prudent person under the circumstances
prevailing at the time the decision was made to
incur the costs.
28Allocable Costs 3 circumstances
- When a cost is incurred directly for the purpose
of a specific grant/contract. - When the cost benefits a grant/contract and
other cost objectives and it can be distributed
among objectives in reasonable proportion to the
benefits received. - When a cost is necessary to the overall operation
of an organization although a direct relationship
to any particular cost objective cannot be shown.
29Composition of Total Costs
- The total cost of any grant program is composed
of the - Allowable Direct and
- Allowable Indirect Costs or FA
30What are direct costs?
- Those costs that can be readily identified with a
particular objective. Examples (program
specific) - Salaries
- Fringe benefits
- Supplies
- Travel
31Whats included in CHOPs Fringe Benefits Rate
- FICA (employer matching to social security)
- Disability insurance
- Life Insurance
- Tuition Remission
- Pension Costs
- Workers Compensation
- Unemployment Insurance
- Health Insurance
32CHOP Fringe Rates for use on grants, contracts
and other agreements.
Applicable to Effective Period Rate Pediatrics
Faculty 7/01/07 to 6/30/09 22.4 Non-Peds.
Fac.(CAA, CSA etc.) 7/01/07 to 6/30/09
16.1 Other staff 7/01/07 to 6/30/09
32.0
33Direct vs. Indirect Costs
- The decision to treat a cost as either a direct
cost or an indriect cost depends upon the
treatment of that cost within the grantees
accounting system. - Cost policy statements provide documentation on
how the grantee treats costs within the
accounting system. - Indirect costs are those costs which are not
readily identifiable with a particular cost
objective.
34Indirect Costs (FA)
- Indirect costs (FA) are classified within two
broad categories - Facilities buildings, equipment and capital
improvement, and operations and maintenance
expenses. - Administration central offices, such as the
director's office, the office of finance,
business services, budget and planning,
personnel, safety and risk management, general
counsel, management information systems, and
library costs.
35Allowable FA Base
- Allowable salaries and wages, fringe benefits,
materials and supplies, services, travel, and
subcontracts up to the first 25,000 (regardless
of the period covered by the subcontract). - Excluded Equipment (gt 5,000), capital
expenditures, charges for patient care, rental
costs and the portion of subcontracts costs in
excess of 25,000.
36CHOPs FA rate
- FA is expressed as a percentage of an indirect
cost pool. Rate calculation Pool/Base -
- CHOPs Indirect Cost Rates
- Applicable to Effective Period Rate
- On-site 7/01/08 to 6/30/09 64.5
- Off-site 7/01/06 to 6/30/09 26.0
37BIOGRAPHICAL SKETCHES
- Required for all individuals listed as Senior/key
Personnel and OSCs - May not exceed 4 pages. (See sample of a
completed Biographical Sketch
http//grants.nih.gov/grants/funding/phs398/phs398
.htmlbiosample.) - Complete sections A, B, and C
- A. Positions and Honors should be listed in
chronological order, concluding with the present
position. Include current CHOP affiliation. - B. Selected peer-reviewed publications or
manuscripts in press (in chronological order).
Do not include manuscripts submitted or in
preparation. - C. Research Support should include both
selected ongoing and completed research projects
for the past three years that are relevant to
the research proposed in the application. Do not
include number of person months or direct costs.
Do not confuse with Other Support. - Essentially, biographical sketches are provided
to indicate that the personnel involved have the
experience to perform the work
38RESOURCES
- This should identify the facilities and equipment
that are available to perform the work outlined
in the proposal - In electronic submissions, there are two separate
sections Facilities and Other Resources and
Equipment
39RESEARCH PLAN
- 1. Introduction to Application applies to
resubmissions only. Responds to reviewers
critiques. It should identify the method (i.e.,
margin-lined) to signal changes from previous
submission. For an R01 the Introduction is
limited to three pages. - 2. Specific Aims - list the broad, long-term
objectives and the goal of the specific research
proposed. One page is recommended. - 3. Background and Significance describe the
background leading to the present application.
Critically evaluate existing knowledge, and
specifically identify the gaps that the project
is intended to fill. If the aims of the
application are achieved, state how scientific
knowledge or clinical practice will be advanced.
Describe the effect of these studies on the
concepts, methods, technologies, treatments,
services or preventative interventions that drive
this field. Two to three pages are recommended.
40RESEARCH PLAN (CONTD)
- 4. Preliminary Studies/Progress Report - for new
applications, use this section to provide an
account of the PD/PI's preliminary studies
pertinent to this application. For Renewal
applications a Progress Report must be provided
and should include the beginning and ending dates
for the period covered since the project was last
reviewed competitively. Summarize the previous
applications specific aims and the importance of
the findings. Discuss any changes in the specific
aims as a result of budget reductions. A list of
publications, manuscripts accepted for
publication, patents, and other printed materials
will be included in Item 7.b do not include that
information here. Six to eight pages are
recommended. - 5. Research Design and Methods - describe the
research design, conceptual or clinical
framework, procedures, and analyses to be used to
accomplish the specific aims of the project.
Describe any new methodology and its advantage
over existing methodologies. Describe any novel
concepts, approaches, tools, or technologies for
the proposed studies. Discuss the potential
difficulties and limitations of the proposed
procedures and alternative approaches to achieve
the aims. As part of this section, provide a
tentative sequence or timetable for the project.
Point out any procedures, situations, or
materials that may be hazardous to personnel and
the precautions to be exercised. - Please note that Items 2-5 may not exceed 25
pages, including all tables and figures
41RESEARCH PLAN (CONTD)
- 6. Inclusion Enrollment Report (Renewal or
Revision Applications only) - if the previous
award involves clinical research, then you must
report on the enrollment of research subjects and
their distribution by ethnicity/race and
sex/gender using the Inclusion Enrollment Report
for each protocol. - 7. Bibliography and References Cited/Progress
Report Publication List - (a) Bibliography and
References Cited - Provide a bibliography of any
references cited. Each reference must include
names of all authors (in the same sequence in
which they appear in the publication), the
article and journal title, book title, volume
number, page numbers, and year of publication.
The references should be limited to relevant and
current literature. (b) Progress Report
Publication List - for Renewal applications list
the title and complete references to all
appropriate publications, manuscripts accepted
for publication, patents, and other printed
materials that have resulted from the project
since it was last reviewed competitively.
42RESEARCH PLAN (CONTD) HUMAN SUBJECTS
- 8. Protection of Human Subjects if the proposed
research involves human subjects, refer to Part
II of the PHS 398 Supplemental Instructions for
Preparing the Human Subjects Section - 9. Inclusion of Women and Minorities if
applicable, describe the inclusion of women and
minorities. - 10. Targeted/Planned Enrollment Table if
applicable, complete this table for each IRB
protocol. - 11. Inclusion of Children if applicable,
describe the inclusion of children.
43RESEARCH PLAN (CONTD) VERTEBRATE ANIMALS
- 12. Vertebrate Animals - if vertebrate animals
are involved in the project, address each of the
following five points 1. Provide a detailed
description of the proposed use of the animals.
Identify the species, strains, ages, sex, and
numbers of animals to be used in the proposed
work. 2. Justify the use of animals, the choice
of species, and the numbers to be used. If
animals are in short supply, costly, or to be
used in large numbers, provide an additional
rationale for their selection and numbers. 3.
Provide information on the veterinary care of the
animals involved.
44RESEARCH PLAN (CONTD) VERTEBRATE ANIMALS
- 4. Describe the procedures for ensuring that
discomfort, distress, pain, and injury will be
limited to that which is unavoidable in the
conduct of scientifically sound research. 5.
Describe any method of euthanasia to be used and
the reason(s) for its selection. State whether
this method is consistent with the
recommendations of the American Veterinary
Medical Association (AVMA) Guidelines on
Euthanasia. If proposed research involving
vertebrate animals will take place at alternate
sites (such as project/performance or
collaborating sites), identify those sites and
describe the activities at those locations. CHOP
is an AAALAC accredited facility.
45RESEARCH PLAN (CONTD)
- 13. Select Agent Research describes hazardous
biological agents and toxins that have been
identified by DHHS or USDA as having the
potential to pose a severe threat to public
health and safety, to animal and plant health, or
to animal and plant products. The CDC maintains a
list of these agents see http//www.cdc.gov/od/sa
p/docs/salist.pdf. If any of the activities
proposed in the application involve the use of
Select Agents, either at the applicant
organization or at any other Project/Performance
Site, address the following three points for each
site at which Select Agent research will take
place. 1. Identify the Select Agent(s) to be used
in the proposed research. 2. Provide the
registration status of all entities where Select
Agent(s) will be used. If the Project/Performance
Site(s) is a foreign institution, provide the
name(s) of the country or countries where Select
Agent research will be performed. 3. Provide a
description of all facilities where the Select
Agent(s) will be used. Describe the procedures
that will be used to monitor possession, use and
transfer of Select Agent(s). Describe plans for
appropriate biosafety, biocontainment, and
security of the Select Agent(s).
46RESEARCH PLAN (CONTD)
- 14. Multiple PD/PI Leadership Plan is required
for applications designating multiple PD/PIs. A
rationale for choosing a multiple PD/PI approach
should be described. The governance and
organizational structure of the leadership team
and the research project should be described,
including communication plans, process for making
decisions on scientific direction, and procedures
for resolving conflicts. The roles and
administrative, technical, and scientific
responsibilities for the project or program
should be delineated for the PD/PIs, including
responsibilities for human or live vertebrate
animal subject studies as appropriate. If budget
allocation is planned, the distribution of
resources to specific components of the project
or the individual PD/PIs should be delineated in
the Leadership Plan.
47RESEARCH PLAN (CONTD)
- 15. Consortium/Contractual Arrangements explain
the programmatic, fiscal, and administrative
arrangements to be made between the applicant
organization and the consortium organization(s). - 16. Letters of Support attach all appropriate
letters of support, including any letters
necessary to demonstrate the support of
consortium participants and collaborators such as
Senior/Key Personnel and Other Significant
Contributors included in the grant application.
Letters are not required for personnel (such as
research assistants) not contributing in a
substantive, measurable way to the scientific
development or execution of the project. For
consultants, letters should include rate/charge
for consulting services.
48RESEARCH PLAN (CONTD)
- 17. Resource Sharing Plan(s) when resources
have been developed with NIH funds and the
associated research findings published or
provided to NIH, it is important that they be
made readily available for research purposes to
qualified individuals within the scientific
community. (a) Data Sharing Plan Investigators
seeking 500,000 or more in direct costs in any
year are expected to include a brief 1-paragraph
description of how final research data will be
shared, or explain why data-sharing is not
possible. (b) Sharing Model Organisms Regardless
of the amount requested, all applications where
the development of model organisms is anticipated
are expected to include a description of a
specific plan for sharing and distributing unique
model organisms or state appropriate reasons why
such sharing is restricted or not possible. (c)
Genome-Wide Association Studies (GWAS)
Regardless of the amount requested, applicants
seeking funding for a GWAS are expected to
provide a plan for submission of GWAS data to the
NIH-designated GWAS data repository, or provide
an appropriate explanation why submission to the
repository is not possible.
49APPENDIX
- Do not use the appendix to circumvent the page
limitations of the Research Plan. Graphs,
diagrams, tables, and charts should be included
in the body of the Research Plan unless a PDF
file is necessary to show detail. When
publications are allowed, a limit of 3
publications, which are not publicly available,
will be considered in the initial peer review. A
summary listing all of the items included in the
appendix is encouraged, but not required. When
including a summary, it should be the first file
on the CD. - Five identical CDs containing all appendix
material must be submitted in the same package
with the application. When preparing CDs - Use PDF format. Where possible, applicants should
avoid creating PDF files from scanned documents.
NIH recommends producing the documents
electronically using text or work-processing
software and then converting to PDF. Scanned
documents are generally of poor quality and
difficult to read.
50APPENDIX (CONTD)
- Label each disk with the PD/PI name and
application title. - If burning CD-ROM disks on a Mac, select the ISO
9660 format. - Do not use compression techniques for the
electronic files. - Do not use password protection, encryption,
digital signature and/or digital certification in
the PDF files. - The following materials may be included in the
appendix to New, Revision, Renewal and
Resubmission applications Up to 3 publications
of the following types. In each case include the
entire document Manuscripts and/or abstracts
accepted for publication but not yet published.
Published manuscripts and/or abstracts where a
free, online, publicly available journal link is
not available. Patents directly relevant to the
project. - Do not include unpublished theses or
abstracts/manuscripts submitted, but not yet
accepted, for publication.
51APPENDIX (CONTD)
- Surveys, questionnaires, and other data
collection instruments, clinical protocols, and
informed consent documents. - Color images of gels, micrographs, etc., provided
that a photocopy (may be reduced in size) is also
included within the 25-page limit of Items 2-5 of
the Research Plan. No images may be included in
the appendix that are not also represented within
the Research Plan. - For materials that cannot be submitted on CD
(e.g., medical devices, prototypes), applicants
should contact the Scientific Review Officer for
instructions following notification of assignment
of the application to a study section. - Publications that are publicly accessible must
not be included in the appendix. For such
publications, the URL or PMC submission
identification numbers along with the full
reference should be included as appropriate in
the Bibliography and References Cited/Progress
Report Publication List section of the Research
Plan, and/or in the Biographical Sketch.
52PEER REVIEWSCIENTIFIC MERIT
- Most applications submitted to the PHS will be
reviewed through a two-tier system. The first
level of review will be performed by a Scientific
Review Group (SRG), often called a study section
or review committee. The SRGs are composed of
scientists from the extramural research
community. The purpose of the SRG is to evaluate
the scientific and technical merit of
applications. The SRG does not make funding
decisions.
53PEER REVIEWADVISORY COUNCIL
- The second level of review is usually performed
by the Advisory Council or Board of the potential
awarding component (Institute, Center, or other
unit). Council or Board recommendations are based
not only on considerations of scientific merit,
as judged by the SRGs, but also on the relevance
of the proposed study to an Institute/Centers
mission, programs and priorities. - A description of what happens to a research
project grant application after it is received
for peer review can be found at the following
location http//cms.csr.nih.gov/ResourcesforAppli
cants/SubmissionAndAssignmentProcess.htm.
54COMPLIANCE
- There are numerous requirements that CHOP must
adhere to including OMB circulars NIH grants
policy statement FAR clauses Civil rights
Drug-free workplace Lobbying Employment of the
handicapped Rehabilitation Act of 1973
Americans with Disabilities Act of 1990 Sex and
Age Discrimination EEO/AA HIPAA Buy and Fly
American Acts Export controls Financial
Conflicts of Interest etc. - The Authorized Officials (AO) signature on an
application is an indication of such assurances,
representations, and certifications
55COMPLIANCE (CONTD)
- Non-compliance can lead to Exceptional status
Expanded authorities revoked Penalties/fines
Imprisonment Debarment/suspension - Who is more at risk? A licensed driver adhering
to posted traffic signs and obeying the law while
driving a registered, insured and well-maintained
vehicle or an unlicensed driver exceeding the
speed limit and ignoring stop signs and red
lights while driving an unregistered vehicle with
broken headlights at night.
56OTHER RESOURCES
- CHOP offers other services including Laboratory
Core and Clinical Core services, as well as
Information Sheets which are available at
https//intranet.research.chop.edu/display/rsp/Hom
e - The NIH website is www.nih.gov and the specific
forms and instructions can be found at - http//grants.nih.gov/grants/funding/phs398/phs39
8.html - The following NIH url provides info on mechanisms
(i.e., R01, R03, R21, P01, etc.)
http//grants.nih.gov/grants/funding/ac.pdf
57FINAL THOUGHTS
- Please contact your SPO or RBM if you have any
questions regarding a research proposal or award
58QUESTIONS