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P01 and P50 - Program Project and Center Grant Guidelines


Guidelines for Preparing Program Project and Specialized Center Grant Applications

General Instructions Using Forms in the PHS-398 (Revised 06/2009)

Instructions for the Research Plan

Initial Review of Program Project and Specialized Center Applications


Review by the National Advisory Neurological Disorders and Stroke Council


Staff Consultation


Illustrations (1-4)



Guidelines for Preparing Program Project and Specialized Center Grant Applications (Revised 1/20/2010)


Background

The National Institute of Neurological Disorders and Stroke (NINDS) uses the program project (P01) and specialized center (P50) grant mechanisms to encourage multidisciplinary research approaches to a diverse array of nervous system disorders. These grant mechanisms are designed to support broadly based multidisciplinary research programs that have a well-defined central research focus or theme. The P01 and P50 grant mechanisms support a minimum of three interrelated projects that contribute to the program objective. The grants may also include support for common or shared resources (Cores) required for the conduct of two or more of the component research projects. Interrelationships among component projects are expected to result in a greater contribution to the program goals than if each project were pursued separately.

For the purposes of preparation of an application or the subsequent review, Program Projects (P01s) and Specialized Centers (P50s) are indistinguishable and will hereafter be collectively referred to as Program Project Grants (PPGs). The chief distinction between NINDS P01 and P50 grants is that new P50 applications are accepted only in response to a Request for Applications (RFA) or Program Announcement (PA) soliciting applications in a particular area of research.

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Policy


NIH policy requires that applicants for ALL unsolicited grants that request $500,000 or more in direct costs (exclusive of consortium F&A costs) for ANY year of the application must obtain agreement from NINDS program staff that NINDS will accept the application for consideration for an award. (see Staff Consultation, page 10). This policy applies to new, amended, and competing continuation applications.

To ensure compliance with this policy, the applicant must: 1) contact the NINDS program staff at least 6 weeks before submitting the application; 2) obtain agreement from the NINDS staff that NINDS will accept the application for consideration for award; and 3) include a cover letter with the application identifying the NINDS staff member who agreed to accept assignment of the application. Additional information on this policy is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Any application subject to the policy that does not contain the required information in the cover letter may be returned to the applicant without review.

It is also NIH policy that foreign institutions and international organizations are not eligible to receive program project and center grants.

In addition to the NIH policies stated above, it is the policy of NINDS that unsolicited Program Project and Research Center grants may not exceed $1,000,000 direct costs (exclusive of consortium F&A costs) in ANY year.

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Distinguishing Features of the Program Project and Research Center Grant

Program project and research center grants support investigator-initiated research programs in which a team of investigators works in a clearly defined area of mutual scientific interest. In a program project, achievement of the objective of the research effort is facilitated by the sharing of ideas, data, and specialized core resources such as equipment, laboratories, clinical facilities, and administrative services. An essential requirement is a central theme toward which the total scientific effort is directed and to which each research project relates. In keeping with the tradition of investigator-initiated research, the NINDS expects the program director to define the integrating theme and to develop the approaches that would be used to accomplish the objective of the proposed research program. The theme of a program project may be, for example, basic research on regeneration and plasticity in the nervous system or basic and clinical research on a specific disease process; the unifying concept may be an hypothesis concerning the fundamental mechanisms that result in the clinical manifestations of the specific disease process.

The projects to be included in a PPG should be carefully considered. All projects that are included will affect the overall outcome of the review and should be of the highest technical merit.

The program director must be an established leader in scientific research with demonstrated capabilities in program direction. Regular meetings of participating investigators, who share and evaluate results and new ideas, are essential to the consolidation of the research projects into a cohesive program. In addition, an internal advisory committee can be effective in assisting the program director in making scientific and administrative decisions. An annual review of the program by external consultants who meet as an external advisory committee is strongly recommended.

In summary, the following distinguishing features must be well documented in the program project and research center application.

  • There must be a unifying well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the creative strengths of the others. There is the expectation that support of interrelated projects and collaborating investigators would yield results beyond those achievable were each project pursued separately and without formal interaction among the participating investigators;
  • The program director must possess recognized scientific and administrative competence and must show a substantial commitment of time and effort to the program and exercise leadership in the maintenance of its quality. The anticipated duties and responsibilities of the Program Director should be clearly defined and an appropriate level of effort proposed;
  • A program project must contain a minimum of three component research projects that are judged to have significant and substantial scientific merit on their own as well as being complementary or contributory to the central theme of the PPG;
  • Program projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to, and share in, the responsibilities of fulfilling the program objective.

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Receipt Dates for Program Project Applications

Receipt dates are the same for all Program Project and Research Center grant applications, including renewal and resubmission applications. The receipt dates can be found on this website: http://grants.nih.gov/grants/funding/submissionschedule.htm. Investigator-initiated AIDS applications have the following receipt dates: January 7, May 7, and September 7.

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Submission of Materials

The original and five copies of the completed application must be mailed to the NIH Center for Scientific Review (CSR), the address label for which is included in the application kit (Form PHS 398). The CSR is responsible for assigning all program project applications to the appropriate Institute of the National Institutes of Health. The assignment to an Institute is based on the central theme and goals of the proposed program. PPG applications assigned to the NINDS are given a study section assignment by the Chief of the NINDS Scientific Review Branch.

If it does not place an undue burden upon the institution, applicants are asked to send at the time of submission an additional copy to the Chief, Scientific Review Branch, NINDS, NSC Building, Room 3208, 6001 Executive Blvd., MSC-9175, Rockville, Maryland 20852 (for courier delivery). Submission of this copy will allow more time for the scientific review administrator to study the application and plan for its review.

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General Instructions Using Forms in the PHS 398 (revised 06/2009)

The following guidelines are offered to supplement the instructions for grant application form PHS 398 (revised 06/2009). Instructions for obtaining application materials and directions may be found at http://grants.nih.gov/grants/forms.htm.

Since the Form PHS 398 is designed primarily for the traditional research project grant (R01) application, several sections have to be modified so that the form can be used to provide the information needed for a program project grant application.

Applications must adhere to the page limitations outlined in the PHS 398 form instructions, or they will be returned to the applicant without review. The 12-page limitation for the Research Strategy applies to each individual project of a program project or center application. The page limit for the Research Strategy for each individual Core is 6 pages. Graphs, charts, figures and tables that are essential to the research strategy must be included within the 12 or 6 pages. An application that does not observe these limitations may be returned. The appendix will not be duplicated with the application; the five sets that you provide will be sent only to certain members of the SRG who will serve as the assigned reviewers of the application. Appendix material should be sent separately (See Appendix ).

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Cover Letter

Any application requesting $500,000 or more direct costs for any year must include a cover letter that identifies the NINDS program staff member who agreed to accept the application. Any application that does not contain the required information will be returned.

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Labeling the Application (Form Page 1 of PHS 398)

Applicants should prepare only a single face page for the entire application, not one for each component. For P50 applications responding to an RFA or PA, the applicant should check "Yes" in Item 2 of the face page, and insert the relevant RFA or PA number and title. The title of the Program listed in Item 1 should be followed by "(P50)". For P01 applications responding to an RFA or PA the applicant should check "Yes" in Item 2, followed by the RFA or PA number and title. The title of the Program listed in Item 1 should be followed by "(P01)". For unsolicited applications, the applicant should check "No" in Item 2. Complete all items on the face page of the application. This is page 1 of the application; number all succeeding pages consecutively. Do not use letters or Roman numerals for pagination.


Senior/Key Personnel (Part of Form Page 2)

Multiple PI's are not currently allowed for NINDS P01and P50 applications, so the program director for the overall program project should be listed as the PD/PI. The principal investigator of each component project or core should be listed as Senior/Key Personnel, following the instructions. Under "Role on Project" state the investigator's role on the PPG (e.g., "Principal Investigator, Project 1", "Director, Core B").

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Table of Contents (Form Page 3)

Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the core units last. Refer to Illustration 1 for a typical format and as a guide to the organization of the components of the application. Identify each project by title, and assign each project a number and each core unit a capital letter that reflects the order in which the projects and core units are presented in the application, and provide the name of the investigator responsible for each component. Number the pages consecutively. Indicate the beginning page numbers for each project and core unit.

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Budget (form pages 4-5)

For the entire PPG, as well as for each project and core, prepare the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." (Illustrations 2 and 3). Identify each budget page (e.g., "Composite", "Project 1", etc.). Place the composite budget pages first, followed by the projects and cores. All budgets (composite, projects, and cores) will be in this one section. Individual project budgets should not be included with the project research plans.

NOTE: The NINDS does not accept applications for program project and research center grants that request more than $1,000,000 (direct costs) in any year. Facilities and administration costs incurred by subcontract/consortium arrangements, while reflected in the total direct cost for the entire application, do not count for purposes of the NINDS $1,000,000 cap. Facilities and administration costs associated with subcontract/consortium arrangements should be explicitly identified in the appropriate sections of the form pages.

Person Months Distribution among Projects

If appropriate, insert a Person Months Distribution table following the Budget section (See Illustration 4.)

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Biographical Sketches

Prepare biographical sketches as described in the Instructions for Form PHS 398. Put the biographical sketch for the Program Director of the PPG first, followed by the other biographical sketches in alphabetical order. Put all of the biographical sketches together in one section immediately after the budget section. Biographical sketches are required for all key personnel and consultants who participate in the research projects and core units.

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Resources

If necessary, use continuation pages to describe multiple facilities and to explain geographic relationships. Present all Resources pages in one section.

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Instructions for Research Plan on Program Project and Research Center Grant


Resubmission Application

Resubmission applications (also known as "amended" or "A1" applications must include an Introduction that summarizes any substantial additions, deletions, and changes that have been made. Include responses to criticisms in the previous summary statement and highlight these changes in the text by appropriate bracketing, indenting, or changing of typeface. Incorporate in the progress report any work that has been completed subsequent to the prior version. A resubmission application will be returned without review if substantial changes are not clearly apparent. The Introduction to Resubmission Application section for the overall program project should not exceed three pages. (In addition to the Overall Introduction, a one page Introduction is allowed for each individual project and core.)

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Overview

Prepare an introductory overview section that describes the rationale, scientific goals, and significance to the field of the program project. Indicate all prior and current collaborative arrangements, describing briefly other projects not included in the application that would contribute to the intellectual environment. Explain the strategy for achieving the objectives of the overall program and how each project and core unit relates to that strategy. The general introduction is the appropriate place to:

  • Emphasize the events that led to the current application;
  • Explain how the proposed projects would collectively further the stated objective(s) of the proposed research;
  • Describe how these projects are mutually reinforcing.

There are no page limits for this section. However, a limit of 3-5 pages is recommended.

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Organizational and Administrative Structure

Describe the lines of authority and responsibility for decision-making and administration, beginning with the program director and including the principal investigators responsible for the research projects and core units. Indicate where, in the chain of responsibility, internal or external advisory committees would be used, and describe their function. In new applications describe the expertise to be represented in the external advisory committee, but do not name potential members of the committee and do not include letters from such individuals. Members of the internal advisory committee should be named and their letters of agreement included.

  • Indicate who would be responsible for assisting the program director with the day-by-day administrative detail, research patient care, program coordination, and the planning and evaluation of the program;
  • Describe the relation between the proposed program project and other existing research, academic, and administrative units of the applicant institution, such as centers, institutes, departments, and central administration;
If the proposed program includes requests for funds for research activities that involve institutions other than the applicant organization, the program will include a consortium arrangement. The need for the consortium activity must be justified. Such cooperative activities may be included in a program project grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations (including necessary assurances) are explained fully. Include a letter from each of the cooperating organizations that signifies their intent to participate and to provide the necessary resources proposed in the application. The NIH policy on consortium agreements is found in the NIH Grants Policy Statement at http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm.

There are no page limits for this section. However, every effort should be made to be succinct.

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Summary Report of Progress

Competing continuation (renewal) applications must include a progress report that highlights achievements of the overall program project since the last competitive review. (A specific progress report is required for each project in its respective section of the application.) The progress report must include the following information:

  • A brief summary of major accomplishments that can be attributed to the program project grant and a brief explanation of how these accomplishments have contributed to the furtherance of the stated objective(s) of the program;
  • A list of all publications and manuscripts accepted for publication that have resulted from the program project grant since the last competitive review;
  • A list of all changes in the professional staffing since the last competitive review;
  • A paragraph about each project that was not initiated or that has been discontinued, completed, or modified since the last competitive review, identified by number and title, with a brief report of accomplishments and an explanation of the reasons for the change;
  • How the current project will build upon previous work.

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Format for Preparation of Research Plans for Projects and Cores

The Research Plan of each research project or core should consist of a title page, Description (use form page 2 of PHS 398 for this), and Research Plan, using the sections described in the PHS 398, as appropriate: Please note that the Research Strategy sections are limited to 12 pages for Projects and 6 pages for cores.

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Appendix

Applicants should wait to submit the Appendix until they have been notified of the assignment (including Institute, study section, and application number). This information will appear in the Principal Investigator's NIH Commons account. Once the application has been assigned to NINDS and has received a study section assignment, five collated sets of Appendix material should be mailed separately to:

Chief,
Scientific Review Branch, NINDS,
NSC Building, Room 3208,
6001 Executive Blvd., MSC-9529,
Rockville, Maryland 20852).

Details on the latest rules about what may be included in an appendix can be found in the following NIH Guide notice: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html .

Please pay close attention to the rather stringent limits on a) what may be included as an appendix item and b) the total number of appendix items that are allowed.

It is very helpful if the appendix materials are separated by projects and cores. Also, reviewers find it very helpful if there is a one or two sentence explanation of how each item in the appendix is intended to help them evaluate the application.

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Additional Supplementary Materials

Applicants should consult the Scientific Review Officer assigned to the application regarding the format and deadline for submission of any additional supplementary material. Current NIH Policy on Submission of Additional Grant Application Materials is described at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-082.html.

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Initial Review of Program Project and Research Center Applications

The first phase of the review involves evaluating the individual research projects and cores. Projects are evaluated using the standard NIH review criteria for research projects (Significance, Investigators, Innovation, Approach, and Environment). Cores are evaluated, and approved or disapproved, using the following review criteria:

  • Quality of the facilities or services provided by this core (including procedures, techniques, and quality control) and criteria for prioritization of usage;
  • Qualifications, experience, and commitment of the personnel involved in the core.
  • Does the core provide essential facilities or service for two or more projects judged to have substantial scientific merit?

The second phase of the review by the SRG assesses the overall program using the following review criteria:

  • The overall scientific objectives and hypotheses;
  • The scientific gain of combining the component parts into a program project (beyond that achievable if each project were to be pursued separately); the thematic cohesion of the program; the interrelationship of individual projects and cores;
  • The principal investigator/program director's scientific and administrative qualifications and his/her commitment to the program.
  • The administrative structure of the program, including any internal and external advisory committees.

All of the strengths and weaknesses identified during both phases of the SRG's review enter into the overall score assigned to the application.

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Review by the National Advisory Neurological Disorders and Stroke Council

The second level of the peer review system is the review by the National Advisory Neurological Disorders and Stroke Council. Items considered in this review include the:

  • Issues raised by the initial review for scientific and technical merit, including any special concerns about human subjects and animal welfare;
  • Significance of the research program to the neurological sciences;
  • National needs and program balance;
  • Policy and budgetary considerations.

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Staff Consultation

Inquiries about whom to contact regarding acceptance of applications over $500,000 direct costs/year, application format, and review procedures may be addressed to:

Chief, Scientific Review Branch,
Division of Extramural Research, NINDS, NIH
NSC Building, Room 3208, MSC 9529
6001 Executive Blvd.
Bethesda, Maryland 20852
(301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

Inquiries regarding budget and/or grant policy may be addressed to:

Chief, Grants Management Branch
Division of Extramural Research, NINDS, NIH
NSC Building, Room 3290, MSC 9537
6001 Executive Blvd.
Bethesda, Maryland 20852
(301) 496-9231
FAX: (301) 402-0219

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Illustrations


Illustration 1

TABLE OF CONTENTS

SECTION 1                                                                                                    PAGE

Form Page 1 (Face Page)                                                                                     1

Description, Project/Performance Sites, Senior/key Personnel,
Other Significant Contributors, and Human Embryonic Stem Cells (Form Page 2)       2

Table of Contents                                                                                                  3

Composite Budget for First 12 Month Budget Period                                                 4

Composite Budget for All Years of Support Requested                                              5

Effort Distribution Among Projects                                                                           6

Individual First and Future Years Budget Estimates:

Project 1                                                                                                                7

Project 2                                                                                                                9

Project 3                                                                                                               11

Project 4                                                                                                               13

Project 5                                                                                                               15

Core A                                                                                                                  17

Core B                                                                                                                  19

Biographical Sketches                                                                                            21

Resources                                                                                                             91

SECTION 2

Introduction                                                                                                            100

Project 1                                                                                                                105

Project 2                                                                                                                125

Project 3                                                                                                                150

Project 4                                                                                                                175

Project 5                                                                                                                200

Core A                                                                                                                   215

Core B                                                                                                                   230

Return to "Illustrations"

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Illustration 2. Sample Composite Budget

DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY

FROM

THROUGH

PERSONNEL (Application organization only)

Months Devoted to
Project

INST.
BASE
SALARY

DOLLAR AMOUNT REQUESTED (omit cents)

NAME

ROLE ON
PROJECT

Cal.
Mnths

Acad.
Mnths

Sum.
Mnths

SALARY
REQUESTED

FRINGE
BENEFITS

TOTAL

Project 1

 

       

80,771

13,920

94,691

Project 2

         

79,954

14,586

94,540

Project 3

         

50,679

5,204

55,883

Project 4

         

93,331

27,999

121,330

Core A

         

133,932

44,912

178,844

Core B

         

57,699

17,310

75,009

                 

SUBTOTALS =================================================>

496,366

123,931

620,297

CONSULTANT COSTS

Core A $3333

3,333

EQUIPMENT (Itemize)

Project 3 $15333
Project 4 $12666
Project 4 $28950

 

56,949

SUPPLIES (Itemize by category)

Project 1 $31999
Project 2 $38132
Project 3 $34666
Core A $ 1867
Core B $84893

 

220,822

TRAVEL

Project 1 $ 1333
Project 3 $ 1333
Project 2 $ 1333
Core A $ 2667

6,667

PATIENT CARE COSTS

INPATIENT  
OUTPATIENT  

ALTERATIONS AND RENOVATIONS (Itemize by category)

 

OTHER EXPENSES (Itemize by category)


Project 1 $ 6733
Project 2 $ 7800
Project 3 $11066
Project 4 $2667
Core A       $333
Core B   $10000

38599

CONSORTIUM/CONTRACTUAL COSTS

DIRECT COSTS

$53,332

SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (item 7a, Face Page)

$811,936
CONSORTIUM/CONTRACTUAL COSTS

DIRECT COSTS

$17,333
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (item 7a, Face Page) $1,017,332

PHS 398 (Rev. 04/06)   Page _____   (Form Page 4)

Illustration 3

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT
DIRECT COSTS ONLY

BUDGET
CATEGORY
TOTALS

INITIAL
BUDGET
PERIOD
(form From
Page 4)

ADDITIONAL YEARS OF SUPPORT REQUESTED

2nd

3rd

4th

5th

PERSONNEL:
Salary and fringe
benefits.
Applicant organization only.

620,297

620,297

620,297

620,297

620,297

CONSULTANT
COSTS

3,333

3,333

3,333

3,333

3,333

EQUIPMENT

56,949

56,949

56,949

56,949

56,949

SUPPLIES

220,822

220,822

220,822

220,822

220,822

TRAVEL

6,667

6,667

6,667

6,667

6,667

PATIENT CARE
COST
INPATIENT          
OUTPATIENT          
ALTERATIONS
AND
RENOVATIONS
         
OTHER
EXPENSES

38,599

38,599

38,599

38,599

38,599

CONSORTIUM
CONTRACTUAL
COSTS

DIRECT

53,332

53,332

53,332

53,332

53,332

SUBTOTAL DIRECT COSTS
(SUM = Item 8a, Face Page)

999,999

999,999

999,999

999,999

999,999

CONSORTIUM
CONTRACTUAL
COSTS

F&A

17,333

17,333

17,333

17,333

17,333

TOTAL DIRECT COSTS

1,017,332

1,017,332

1,017,332

1,017,332

1,017,332

TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT
PERIOD
$5,086,660

JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.

PHS 398 (Rev. 04/06)   Page _____   (Form Page 4)

From Budget for Initial Period:
Describe the specific functions of the personnel, collaborators, and consultants and identify individuals with appointments that are less than full time for a specific period of the year, including VA appointments.

For all Years:
Explain and justify purchase of major equipment, unusual supplies requests, patient care costs, alterations and renovations, tuition remission, and donor/volunteer costs.

From Budget for Entire Period:
Identify with an asterisk (*) on this page and justify any significant increase or decrease in any category over the initial budget period. Describe any change in effort of personnel.

For Competing Continuation Applications:
Justify any significant increases or decreases in any category over the current level of support.

Return to "Illustrations"

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Illustration 4

Person Months Distribution Among Projects and Core Units

Personnel - Position

Project or Core Designation

Totals

 

1

2

3

4

5

A

B

 
Doe, J. - Principal Investigator

1.5

 

3.0

     

1.5

6.0
Walsh, P. - Co-Investigator

1.2

 

1.8

        3.0
Smith, M. - Technician  

1.5

 

1.5

      3.0
To Be Named:                
Cell-culture technician

4.0

2.0

6.0

        12.0
Programmer  

1.5

1.5

   

6.0

  9.0
Senior Neurologist  

3.0

       

2.0

5.0
Patient Coordinator      

1.0

      1.0

Last updated January 26, 2010