Funding-CCTS Summer Call For Pilot Applications; August 17, 2015

 


 

Call for Pilot Applications  

 

The Center for Clinical and Translational Science at UK will accept applications for pilot projects according to the following schedule:

 

v Call for Applications: July 21, 2015

v Letter of Intent and Biosketch (new NIH format) due: August 17, 2015

v Invitation to submit Full Application: September 21, 2015

v Full Application due: October 19, 2015

v Funding Decision: January 2016

 

 

 

The categories of awards will be as follows:

 

PILOT AWARDS FOR JUNIOR INVESTIGATORS 

This award is intended to support pilot studies by early stage investigators to obtain preliminary data for an eventual extramural grant submission.  The maximum award will be $25,000 which must be spent over 18 months.  This award is only open to investigators in the early stage of their career, or investigators who are transitioning into a new area. 

 

 

 

PILOT INNOVATION & HIGH IMPACT AWARD FOR ALL INVESTIGATORS

This award is for investigators at all stages of career development, junior, middle level, and senior, and is intended to stimulate innovation and to support pilot studies that will lead to extramural funding.  The total award is limited to $50,000 which must be spent over 18 months. 

 

 

 

Please note that the following emphasis areas will be considered for this round of funding:

·       Risk Related Behaviors with a focus on reducing the risk-related behaviors of obesity, tobacco, or substance abuse.

·        To support collaborations between basic scientists and clinician scientists and to promote clinicians scientists involvement in the proposed project, a supplement of up to $25,000 for up to 10% effort may be requested for the clinician scientist.

 

For questions, please contact Elodie Elayi at elodie.elayi@uky.edu

 

 

 

Elodie Elayi

Research Development Director

Pilot Funding Program Coordinator

University of Kentucky

Center for Clinical and Translational Science

C300 AB Chandler Medical Center

800 Rose Street

Lexington, KY 40536-0293

Phone: 859.323.7939
Fax: 859.257.9560

Email: elodie.elayi@uky.edu

 

CCTS Investigators, please remember to acknowledge the NIH CTSA grant in your publications.

“This publication was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through GrantUL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.”

 

 

*************************************

Proposal Development Office

504 M.I. King Library

859-257-2861

PDO@uky.edu

http://www.research.uky.edu/pdo

 

 

Center for Clinical and Translational Science

Call for Applications

Pilot and Innovation Research Program

 

 

The UK Center for Clinical and Translational Science (CCTS) is now accepting applications for Pilot Projects. The purpose of this funding mechanism is to provide a new opportunity and resources to support innovative, collaborative research relevant to the health challenges and disparities faced by the nation and the citizens of Kentucky.  

 

The categories of awards will be as follows:

 

       I.            JUNIOR INVESTIGATOR AWARD

 

This award is intended to support pilot studies by early stage investigators to obtain preliminary data for an extramural grant submission.  The maximum award will be $25,000 which must be spent over 18 months.  This award is only open to investigators in the early stage of their career, or investigators who are transitioning into a new area.  Applicants must identify a mentor to assist with the investigator’s training.

 

o   Eligibility is limited to full-time faculty (all title series including regular, research, clinical and special) of the University of Kentucky and affiliated institutions.  

o   Investigators who are PIs on other career development awards or R01-type funding are NOT eligible.

o   Investigators in training including residents, post-doctoral fellows, and clinical fellows are NOT eligible to serve as PIs but may be co-investigators.

o   Volunteer faculty and adjunct faculty are NOT eligible to serve as PIs but may be co-investigators.

 

 

    II.            INNOVATION AND HIGH IMPACT AWARD

 

This award is for investigators at all stages of career development; junior, midlevel, and senior investigators, and is intended to stimulate innovation and to support pilot studies that will lead to extramural funding.  The total award is limited to $50,000 which must be spent over 18 months. 

 

o   Eligibility is limited to full-time faculty (all title series including regular, research, clinical and special) at the University of Kentucky and affiliated institutions.

o   Investigators in training including residents, post-doctoral fellows, and clinical fellows are NOT eligible to serve as PIs but may be co-investigators.

o   Volunteer faculty and adjunct faculty are NOT eligible to serve as PIs but may be co-investigators.

 

 

 

 

 

 

 

 

The Center for Clinical and Translational Science at UK will accept applications for pilot projects according to the following schedule:

 

v  Call for Applications: July 20, 2015

v  Letter of Intent due: August 17, 2015

v  Invitation to submit Full Application: September 21, 2015

v  Full Application due: October 19, 2015

v  Funding Decision: January 2016

 

SCOPE:

Within the general guidelines outlined above, the types of projects that will be considered within this mechanism include projects that:

PRIORITIES FOR FUNDING:

The main priorities for funding are: 1) the scientific merit of the project, 2) clear clinical and translational relevance, and 3) the likelihood that funding will result in submission of a competitive application for extramural funding. Where appropriate, priority will be awarded based upon the strength of the research team or, for junior investigators, the mentorship team. Other priorities for funding include:

·         Significance of the clinical and/or translational work in terms of potential health impact.

·         Capacity for overall impact on health of Appalachian Kentucky, Ohio and West Virginia.

·         Scientific rigor and novelty of the proposed approach.

·         Experience and productivity of the investigators.

·         Multidisciplinary research teams representing the basic, clinical and/or applied sciences with an emphasis on bridging the divisions between basic and clinical scientists.

·         Pilot studies which generate critical preliminary data that will lead to subsequent external funding and/or commercial development.

·         Risk Related Behaviors with a focus on reducing the risk-related behaviors of obesity, tobacco, or substance abuse. Special emphasis is accorded to high-impact research, which tests a single risk-related behavior intervention or examines the comparative effectiveness of multiple interventions in Appalachian or other rural settings. The types of projects that might be considered within this mechanism include, but are not limited to:

v  exercise or nutrition/wellness programs,

v  brief motivational interventions

v  treatments grounded in behavioral or pharmacotherapy approaches

 

 

 

 

FUNDING INFORMATION:

Individual project awards (up to $25,000 in total direct costs for junior investigators and 50,000 in total direct costs for high impact awards over an 18-month period) will be made on a competitive basis.  Proposed costs should be commensurate with the work. It is anticipated that funds will be available to support 2 high impact and 2 junior investigator awards.

Sufficient justification and detail should be provided to validate the need and cost of each item. The budget will be comprehensively reviewed to insure that the funds being requested are relevant to the research being proposed.

 

ALLOWABLE COSTS

·         Funds are to be used for the conduct of the project, including supplies, subject payments, assays, etc.

·         Travel funds needed for study conduct are allowed, if essential.

To support collaborations between basic scientists and clinician scientists and to promote clinicians scientists involvement in the proposed project, a research DOE supplement of up to $25,000 for up to 10% effort may be requested for a clinician scientist associated with the Junior Investigator or High Impact Awards.

·         Research DOE for Clinician Scientists – Guidelines

1.      Research DOE provided for clinician scientist collaborating with basic scientist.  The respective roles of the basic and clinical scientist must be well described and both must be essential to performing the project.

2.      Basic scientist and clinicians as Co-PIs on pilot proposal; (i.e. clinician involvement cannot be casual).

3.      Role of clinician scientist must be different from standard of care clinical role. If clinician involvement in the research project does not result in decrease in generation of RVUs, then no additional research DOE should be requested for clinician scientist. For example, if a clinician provides discarded tissue samples from a procedure that does not require any additional time/effort, the clinician’s involvement would not qualify for research DOE.

4.      Research DOE for clinical scientist will be requested as an additional supplement to the pilot proposal.

5.      Clinician scientist may be physician, dentist, pharmacist, etc. but who has no available research time on DOE at the present time.

6.      Clinician scientist effort to be verified in letter of support from division chief and department chair agreeing to the arrangement. 

7.      CCTS to provide up to $25,000 salary plus benefits and department/division must cost share additional funding for minimum 10% effort.

8.      CCTS will fund up to 2 clinician scientist supplements per pilot RFA.

 

NON-ALLOWABLE COSTS.

·         Funding is not available for thesis or dissertation projects.

·         Funding will not be awarded as bridge funding for ongoing projects.

·         Facilities and Administrative costs: also known as indirect costs are not permitted.

 

In the event that additional intra/extramural funds are secured to support the study outlined in your application you must immediately notify Elodie Elayi (859-323-7939, eel222@email.uky.edu).

 

Funds will be held by the CCTS and the budgets invoiced for a period of 18 months maximum, dependent on the nature and scope of the study. Individual principal investigators will not be allowed to hold more than one CCTS pilot research award at any one time.

 

 

LOI AND BIOSKETCH SUBMISSION INSTRUCTIONS

 

Letters of Intent (LOI) and Biosketch (BS) in NIH format will be solicited from faculty on all the campuses. The LOIs will be reviewed and subject to a standard NIH-type study section assessment by the CCTS Pilot Review Committee (PRC). A subset of meritorious LOIs will be selected and applicants will be invited to submit Full applications.

Full proposals will be subject to a standard NIH-type study section assessment. Each proposal will be given a primary and two secondary reviewers.

Email LOI to: Elodie.elayi@uky.edu - DEADLINE DATE for LOI: Friday, August 17, 2015 by 5:00 PM (EST)

The LOI template can be downloaded here.

The BIOSKETCH template can be downloaded here. Note: the new format NIH biosketch is required. 

 

 

PILOT RESEARCH PROTOCOL SUBMISSION PROCESS

 

Investigators are encouraged to contact Elodie Elayi (323-7939, eel222@uky.edu) to schedule a meeting to review the basis of your submission, to learn how the CCTS Pilot Research Program operates, to learn which CCTS services you might utilize for your study, and to devise a budget for your protocol. 

 

We also suggest that you consult with the following:

Ř  For Study Design Consultation: Catherine Starnes, Statistician Assistant (catherine.starnes@uky.edu)

Ř  For help with your Data Safety Monitoring Plan during protocol development:  Lisa Tannock, MD, Research Participant Advocate (lisa.tannock@uky.edu)

Ř  For Biomedical Informatics Consultation: Tammy Harper, MHA, (257-9384, Tamela.Harper@uky.edu).

 

CCTS PILOT RESEARCH PROGRAM APPLICATION INSTRUCTIONS:

Applicants are encouraged to review the instructions provided below carefully and to contact Elodie Elayi (323-7939, eel222@email.uky.edu) with questions. Incomplete or incorrectly prepared applications will be returned without review.

 

Follow the steps below to apply for CCTS pilot research support:

·         For the application, margins must be no smaller than 0.5” at all points.

·         Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies).

·         Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch.

·         EACH page should provide the applicant’s name in the upper right hand corner. The application should be numbered consecutively in the center bottom.

 

*APPLICATIONS SHOULD BE ASSEMBLED IN THE FOLLOWING ORDER*

 

       I.            Cover Page(s): (not included in the 6 page limit)

1.   Title of the Project and Total Amount Requested.

2.   The Category of Grant you are applying for: Junior award, High Impact award.

3.   Applicant’s information for Principal Investigators  and Co-Investigators :

o   Name

o   Degree(s)

o   Rank, Title (s)

o   College

o   Department /Division

o   eRA Commons Username

o   Campus Address

o   Contact Information including e-mail and telephone number

4.   Mentor’s information (Applicable only for junior investigators):

Name, Degree(s) and Rank, Campus Address, and Contact Information

5.   Applicant’s Chair Information for each collaborator:

Name, Campus Address, and Contact Information

    II.            Detailed budget and budget justification in NIH format, direct cost only

Allowable requests include:

·         Animal purchase and housing costs.

·         Specimen collection/analysis or testing

·         Participant reimbursement/recruitment costs

 

 

 

**Budget must be approved by Elodie Elayi BEFORE submission.

 

Applicants must account for fringe benefit costs when considering research assistant salary levels. NO INDIRECT COSTS ARE ASSIGNABLE THROUGH THIS MECHANISM.

 

Budget template can be downloaded here:

·         Initial budget: link

·         Entire Budget Period: link

 

 III.            Body of the proposal: (limited to 6 pages)

The format of the application will follow NIH guidelines as outlined below.

Specific Aims (limited to 1 page)

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

 

Research Strategy

Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography section. Given the length of the application, investigators should strive to provide a relevant, although not exhaustive bibliographic review (described below)

(a) Significance

·         Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.

·         Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

·         Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

 (b) Innovation

·         Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

·         Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).

·         Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

 

(c) Approach

·         Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.

·         Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.

·         If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

·         Clearly describe how each partner will be engaged in the development and/or implementation of the pilot study.  (Applicable for partnership applications)

As applicable, also include the following information as part of the Research Strategy, keeping within the three sections listed above: Significance, Innovation, and Approach.

·         Preliminary Studies. Include information on Preliminary Studies. Discuss the PI’s preliminary studies, data, and/or experience pertinent to this application.  Preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project.

 

  IV.            APPENDIX:

·      Biosketch in NIH format (note: the new biosketch format is required!)

·      Protection of human subjects section and animal assurances (if applicable)

·      References- Authors, year, title and journal information is expected for each citation. Given the length of the application, investigators should strive to provide a relevant, although not exhaustive review.   (Not more than 2-3 pages)

·      The required endorsement letter from the primary mentor for new investigators (see below), as well as letters from key personnel must be included. Relevant assessment materials may be included if they are of reasonable length and significantly enhance the review of the application. DO NOT submit published manuals, materials in the public domain or similar materials. This is NOT a means of extending the length of the proposal itself.

·         MENTORING AND CAREER DEVELOPMENT PLAN (new investigators): Role and qualification of mentor(s). Inclusion of a clinician (physician, dentist, pharmacist, clinical psychologist, physical therapist, etc.) mentor is highly desirable in studies involving direct interaction with human participants. A career development plan must be in place to enhance clinical and translation research capabilities. This may include didactic coursework, the Clinical and Translational Science Seminar Series, and/or the Translational Science Spring/Fall Conference.

 

·         MENTOR ENDORSEMENT (new investigators): To facilitate the effectiveness of the CCTS Pilot Research Program in enhancing the research development of newly appointed faculty investigators, new investigators must provide a letter of endorsement and collaboration from a senior investigator who is willing to serve as a mentor for the applicant over the course of the project. This person must possess a M.D., Ph.D., PharmD or other doctoral degree and must have sufficient clinical research expertise to serve as a mentor to the applicant. The letter should reflect the amount of time the mentor is willing/able to direct to this role as well as the specific types of activities that will be involved. These activities should include reviewing progress on the project, reviewing initial data, helping plan for future project funding after the pilot phase, discussing relevant research articles or related activities. It is NOT required that the mentor have funded effort.  This letter should be included in the appendix material of the application.

 

·         LETTER FROM SUPERVISOR/DEPARTMENT CHAIR: A letter signed by the immediate supervisor (e.g. Division Chief) and/or Department Chair that includes acknowledgement of their support for the project and providing assurance that sufficient protected time to complete the research will be available. No specific amount of protected time is required, but the review committee will consider the distribution of effort and other activities of the applicant.

 

 

REVIEW PROCESS & CRITERIA:

Your submission will initially be administratively reviewed. You will be notified if portions are missing or incomplete. The application will be sent to a minimum of two internal or external reviewers with expertise in fields relevant to the science in the proposal. These reviewers will be asked to disclose any relationships to the grant applicant. Full proposals will be subject to a standard NIH-type study section assessment. The reviewers will then provide written feedback addressing the merits of the protocol. All applications will be scored based upon the written reviews, relevance to the Priorities and Scope outlined above, and the overall relevance to the long term goals of the CCTS. You will be notified of the outcome.

The general criteria for review include:

 

Overall Impact                

 

 

Clinical Significance         Is the study relevant to human health and the health of Kentucky citizens?

Innovation                        Are the aims original and concepts novel? Are novel methodologies proposed?

Approach                          Do the specific aims test the hypotheses? Are statistical considerations provided? Is the risk/benefit ratio acceptable?

Investigators                     Is this a new investigator? If so, a mentorship team must be identified. The qualification and experience of the mentor, and their plan for career development for the new investigator, will be an important aspect of review. Does the investigative team have training, expertise, and experience to conduct the proposed study?

Environment                     Is the environment strong? Do the investigators take advantage of available expertise? Is there a transdisciplinary team involved in the study?

Feasibility                         Is the study feasible from the perspective of recruitment and availability of resources?

Potential                            Will the pilot study generate new knowledge that can be published? Will completion of the study lead to external funding or development of a novel or translational methodology? Is there commercial potential?

 

 

 

 

 

 

AWARDEE RESPONSIBILITIES:

·         Once your protocol is fully approved and funding awarded, you should contact Elodie Elayi, (323-7939, eel222@uky.edu) to schedule a working meeting with the CCTS units involved with your protocol.

 

·         Successful applicants will be required to provide semi-annually progress reports and a final written report describing project accomplishments must be submitted within 60 days of the project end date.

 

·         The UK CCTS is evaluated by the NIH on its effectiveness in stimulating new research findings and publications. The following support acknowledgement should be included on all publications that result from CCTs support :

 

“This publication was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH”

 

 

 

RELEASE OF FUNDS:

·         Funding for successful application will be released upon receipt of applicable IRB/IACUC approval, if applicable.

·         If required IRB/IACUC approval is not provided within a period of 90 days after the announcement of the award, THE FUNDS WILL BE SUBJECT TO CANCELLATION.

 

 

 

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LETTER OF INTENT

CCTS 2015 PILOT GRANT

DEADLINE:  August 17, 2015-5:00 PM

 

1.      PROJECT FULL TITLE:

 

2.      Principal Investigator (s) Information

NAME

 

DEGREES

 

TITLE(s)

 

COLLEGE

 

DEPARTMENT/DIVISION

 

OFFICE ADDRESS

 

EMAIL ADDRESS

 

PHONE

 

eRA COMMONS USERNAME

 

 

 

NAME

 

DEGREES

 

TITLE(s)

 

COLLEGE

 

DEPARTMENT/DIVISION

 

OFFICE ADDRESS

 

PHONE

 

EMAIL ADDRESS

 

eRA COMMONS USERNAME

 

 

3.      Mentor Information (only applicable to Junior Investigators)

NAME

 

DEGREES

 

TITLE(s)

 

COLLEGE

 

DEPARTMENT/DIVISION

 

OFFICE ADDRESS

 

PHONE

 

EMAIL ADDRESS

 

 

Description: C:\Documents and Settings\eel222\Local Settings\Temporary Internet Files\Content.Outlook\SH03WLVW\CCTS B-W.png

PROJECT INFORMATION

1.      CATEGORY OF GRANT YOU ARE APPLYING FOR:

JUNIOR INVESTIGATOR AWARD

INNOVATION AND HIGH IMPACT AWARD

 

                                                                                                                         

 YES           NO

 

2.      HAVE YOU RECEIVED PREVIOUS UK PILOT FUNDS?

           

                                                                                                 

 

A two pages letter of intent is solicited from applicants.  No appendices are allowed. No references required.

Application Guidelines:  The format of the application should follow the NIH guidelines outlined below.

·         Margins must be no smaller than 0.5” at all points.

·         Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies).

·         Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch.

·         EACH page should provide the applicant’s name in the upper right hand corner. The application should be numbered consecutively in the center bottom.

·         Failure to follow these guidelines will result in the return of the LOI without review.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THE TWO PAGES LOI SHOULD BE ASSEMBLED IN THE FOLLOWING ORDER

 

 

 

1.      PROJECT TITLE (Full Project Title required)

 

 

 

2.      RESEARCH OBJECTIVES, SPECIFIC AIMS

Provide concise, clear statements regarding anticipated outcomes of the proposed research and how it will add to existing knowledge or create value

 

 

3.      BRIEF BACKGROUND AND PRELIMINARY DATA (if data are available)

 

 

4.      A SECTION DESCRIBING STUDY DESIGN, METHODOLOGY AND OUTCOMES

 

 

 

5.      PROJECT MILESTONE

 

 

6.      DESCRIBE HOW THE PILOT GRANT WOULD FACILITATE A FUTURE EXTERNAL GRANT

 

 

 

OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person.  DO NOT EXCEED FIVE PAGES.

NAME:

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE:

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

INSTITUTION AND LOCATION

DEGREE

(if applicable)

 

Completion Date

MM/YYYY

 

FIELD OF STUDY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below.

A. Personal Statement

Briefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C).   Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project.   If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service.

B. Positions and Honors

List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.

C. Contribution to Science

Briefly describe up to five of your most significant contributions to science. For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work. For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware) that are relevant to the described contribution. The description of each contribution should be no longer than one half page including figures and citations. Also provide a URL to a full list of your published work as found in a publicly available digital database such as SciENcv or My Bibliography, which are maintained by the US National Library of Medicine.

D. Research Support

List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.