PROPOSAL AND AWARD MANAGEMENT

PRESENTERSRobert DeNight, Manager, Sponsored Projects

Andrew Chilkatowsky, Manager, Research Business Management

SPONSORED 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 sponsor’s terms and conditions and ensure compliance with them as well as CHOP’s institutional policies – mitigate risk

SPONSORED PROJECTS OFFICER (SPO) RESPONSIBILITIES (CONT’D)

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 PI’s and staff of changing sponsor and

institutional rules Remind PI’s of closeout requirements Work closely with Grants & Contracts Specialist

(GCS) to negotiate subcontract agreements

SPONSORED 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 F&A)

5.7% increase over FY’07 proposals submitted CHOP Received 687 awards totaling

$149,462,557 ($113,046,915 Direct, $36,415,642 F&A)

2.7% increase over FY’07 number of awards CHOP receives the third largest annual amount

of NIH funding for pediatric hospitals

SPO/RBM ASSIGNMENT

SPO’s/RBM’s 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

SPONSORED 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/deptspbm/Grant+Proposal+Notification+Form

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

PROPOSAL PROCESS (CONT’D)

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

sponsor’s review/award processes

RESEARCH BUSINESS MANAGER (RBM) RESPONSIBILITIES

Manage the financial aspects of grant applications/awards

Communicate accurate and timely financial data to PI’s, sponsors, and others

Provide proactive financial advice and planning Ensure compliance with sponsor rules and

regulations, as well as CHOP’s policies

RESEARCH BUSINESS MANAGER (RBM) RESPONSIBILITIES cont.

Act as liaison between PI and HRPerform 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.

RESEARCH 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

RESEARCH FINANCE RESPONSIBILITIES

Institution’s official file of record for awards Issue lawson activity numbers Oversee CHOP’s 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 F&A rate agreement

REGULATORY REQUIREMENTS

Projects involving the use of human subjects require Institutional Review Board (IRB) approval. General questions can be sent to orcra@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@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@email.chop.edu

OFFICE OF TECHNOLOGY TRANSFER RESPONSIBILITIES

Intellectual Property ManagementCorporate and Pharmaceutical Sponsored

Research proposals and awards (i.e., Clinical Trials)

Material Transfer Agreements (MTA)Confidential Disclosure Agreements (CDA)

PROPOSAL 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

NIH R01 APPLICATION The NIH PHS 398 11/07 form url link is:

http://grants1.nih.gov/grants/funding/phs398/phs398.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

NIH R01 APPLICATION (CONT’D)

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

NIH R01 APPLICATION (CONT’D)

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@email.chop.edu) to obtain username

Face Page is developed with assistance from RBM

NIH R01 APPLICATION (CONT’D)

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

NIH R01 APPLICATION (CONT’D)

Project/Performance Site(s) indicate where the work, described in the Research Plan, will be conducted

SENIOR/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

OTHER 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)

TABLE 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

DETAILED 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

CONSORTIUM 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

CHECKLIST

Developed by the RBM based on information provided by PI

It should identify Program Income, if applicable and F&A costs

Factors 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

Reasonable 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.

Allocable 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.

Composition of Total Costs

The total cost of any grant program is composed of the

Allowable Direct and

Allowable Indirect Costs or F&A

What are direct costs?

Those costs that can be readily identified with a particular objective. Examples: (program specific)

Salaries

Fringe benefits

Supplies

Travel

What’s included in CHOP’s Fringe Benefits Rate

FICA (employer matching to social security)

Disability insurance

Life Insurance

Tuition Remission

Pension Costs

Workers’ Compensation

Unemployment Insurance

Health Insurance

CHOP 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%

Direct 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

grantee’s 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.

Indirect Costs (F&A)

Indirect costs (F&A) are classified within two broad categories:

1. Facilities – buildings, equipment and capital improvement,

and operations and maintenance expenses.

2. 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.

Allowable F&A 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 (> $5,000), capital expenditures, charges for patient care, rental costs and the portion of subcontracts costs in excess of $25,000.

CHOP’s F&A rate

F&A is expressed as a percentage of an indirect cost pool. Rate calculation = Pool/Base

CHOP’s 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%

BIOGRAPHICAL SKETCHES Required for all individuals listed as Senior/key Personnel and OSC’s May not exceed 4 pages. (See sample of a completed Biographical Sketch:

http://grants.nih.gov/grants/funding/phs398/phs398.html#biosample.) 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

RESOURCES

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

RESEARCH 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.

RESEARCH PLAN (CONT’D) 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 application’s 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

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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/sap/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).

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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.

RESEARCH PLAN (CONT’D) 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.

APPENDIX 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.

APPENDIX (CONT’D) 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.

APPENDIX (CONT’D) 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.

PEER 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.

PEER 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/Center’s 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/ResourcesforApplicants/Submission+And+Assignment+Process.htm.

COMPLIANCE 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 Official’s (AO) signature on an application is an indication of such assurances, representations, and certifications

COMPLIANCE (CONT’D)

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.

OTHER 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/Home

The NIH website is www.nih.gov and the specific forms and instructions can be found at

http://grants.nih.gov/grants/funding/phs398/phs398.html

The following NIH url provides info on mechanisms (i.e., R01, R03, R21, P01, etc.) http://grants.nih.gov/grants/funding/ac.pdf

FINAL THOUGHTS

Please contact your SPO or RBM if you have any questions regarding a research proposal or award

QUESTIONS