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3. Proposal Preparation

III. PROPOSAL PREPARATION
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A. APPLICATIONS/FORMS
B. TECHNICAL/SCIENTIFIC SECTION
C. BUDGET/FINANCIAL SECTION


A. APPLICATIONS/FORMS

1. Government Agencies

a. Grants and Cooperative Agreements
b. Contracts
c. Subcontracts

2. Commercial/Industrial Sponsors

3. Biomedically Specific Granting Organizations (e.g., American Cancer Society, Muscular Dystrophy Association, American Lung Association, etc.)

4. Foundations


1. Government Agencies

a. Grants and Cooperative Agreements:
All of the forms listed below can be obtained by accessing the sponsor's website as indicated below:

FEDERAL:
NIH:
Forms can be accessed online.


New/Renewal Applications

Form PHS 398: (Rev. 5/01) -- This form is used for new and renewal applications for basic research grants, Research Career Awards, Institutional Training Grants (T32s) and other applications as directed. This link includes both traditional and modular grant forms.

A modular grant application should be used when total direct costs do not exceed $250,000 per year in any year. The PI will request support in $25,000 increments instead of compiling a budget in detailed and separate budget categories. Modular application, review, and award procedures will apply to all competing individual research project grants (R01), small grants (R03), and exploratory/developmental grants (R21) and Academic Research Enhancement Award (R15). Unsolicited, investigator-initiated applications requesting more than $250,000 in any year will be required to follow the traditional application instructions and applicable NIH policies. Click here for more information on modular grants.

Non-Competing Continuations

Form PHS 2590: (Rev. 5/01) This form is used for Continuation applications. NOTE: As of 11/1/2002, NIH will no longer send out preprinted face pages for ongoing projects. Principal Investigators will need to download the form from the NIH website.

NRSA

Form PHS 416-1 and 9: (Rev. 12/98) These forms are used to apply for Individual National Research Service Awards (NRSA postdoctoral fellowships).

Prior to using an application you have on hand, make sure that the application form is not out of date and that you are using the correct form for the type of award you wish to receive.
National Science Foundation (NSF): The Grant Proposal Guide is located online.

FASTLANE is an interactive, real-time system used to conduct NSF business over the internet, including submission of grant applications. All FASTLANE users must have a PIN number and password, which can be obtained by contacting the Office of Research Administration at extension 2-7349. FASTLANE contains a number of helpful features, including:

  • Proposal preparation
  • Proposal Status
  • Revise Submitted Proposal Budget
  • Notifications & Requests
  • Continuation Funding Status
  • View/Print Award Letters
  • Project Reports System
  • Supplemental Funding Requests
  • Change PI Information

More information regarding FASTLANE features may be obtained online. Additional information regarding NSF proposal preparation may also be found online.

Department of Defense (DoD):

New proposal submissions: The DoD accepts new proposal submissions via the internet. However, if you are a Principal Investigator submitting your first proposal to the DoD, you must REGISTER prior to submission. During the registration process, you will obtain a password that you will use with your e-mail address to access the website in the future. The applicant may designate another individual to assist him/her in the proposal submission process. Proposals may be submitted electronically.

Please note that all proposals must be submitted to this program electronically. Proposal information must be completed online and the PDF (Adobe Acrobat) version of the proposal must be uploaded/submitted through the DoD website no later than 11:59pm (applicant's local time) on the due date specified. The due date may be found on page iii in the guidelines for the specific funding vehicle for which you are applying.

Also note that the DoD does NOT accept printed supplemental materials. Any supporting documentation that the applicant wishes to include must be scanned and incorporated into the PDF formatted application prior to upload/submission.

Click here for additional information regarding DoD grant submission.

OTHER FEDERAL, STATE AND NON-PROFIT AGENCIES

Certain agencies withhold forms distribution until applicants have prepared specific proposals. Therefore, the ORA does not carry a supply of these applications. You are encouraged to obtain the particular agency's forms through the sponsor's website. See section 2.B.2. in this handbook (JHU Research Services Sponsor Sites) for links to other agencies.

b. Contracts:

Contracts are usually solicited by government agencies in the form of RFPs (Requests for Proposals), which describe the work to be performed and the application format. Announcements of federal RFPs are publicized in the Commerce Business Daily, and in the NIH Guide [NIH solicitations only]- cf. preceding section of Handbook.

Investigators who intend to submit federal contract proposals (including continuation and/or renewal proposals) should notify the Office of Research Administration and forward a copy of the RFP as soon as it is available. The ORA will complete the Representations and Certifications section and review the RFP to assist you in negotiating favorable terms and avoiding potential problems. Notifying the ORA of your intent to submit a contract proposal early in the process will save you time.

c. Subcontracts:

Other organizations may request a subcontract proposal for purposes of collaboration on their research grants or contracts. Such proposals must be processed through the ORA. The following is to be included even if the proposal is to be in modular format:

  • An application Face Page pertinent to JHU as the subcontracting institution,
  • A budget specifying both direct and indirect costs (expressed as a dollar amount, not just as a percentage),
  • A description of the workscope,
  • Other Support, Resources and Environment, and a Checklist.

For NIH and other PHS agencies, the Principal Investigator will need to express his willingness to collaborate on the project by including a cover letter (signed by both the other organization's P.I. and Institutional Official, as well as the JHU Institutional Official) with the following required wording:


"The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy."

2. Commercial/Industrial Sponsors

Commercial/industrial organizations continue to be an increasingly important source of research support. Some of this support is given as a result of a relatively informal technical discussion between the sponsor and investigator. This type of technical exchange is encouraged.

However, the appropriate personnel in the Office of Research Administration must negotiate the contractual and administrative functions of such agreements. Therefore, you should avoid discussion of financial or other contractual aspects of the proposal or the agreement (e.g., inventions, patents) until you have consulted with the Office of Research Administration (Ext. 5-3061). All proposals must be approved by your primary department and the Office of Research Administration before they are submitted to the potential sponsor. Failure to do so could result in disapproval of the agreement.


In addition, commercial/industrial sponsors may request that a Confidentiality/Non-Disclosure Agreement be signed before they will allow information to be reviewed by a JHU faculty member. Confidentiality/Non-Disclosure Agreements associated with sponsored research support require review by the Office of Research Administration. (See Sections IV.B2.b.7 and VI.H.).


Most commercial and industrial sponsors do not have specific application formats. However, to reduce the potential for misunderstandings, it is recommended that investigator- initiated proposals to these sponsors be spelled out clearly, including at least the following elements:

  • electronic Information sheet (eIS)
  • Cover page or cover letter with block for institutional endorsement
  • Statement of work to be performed
  • Budget (see Section III.C.). Most industrial sponsors would prefer to negotiate a fee per completed unit of service, such as per completed patient subject, rather than an expense budget. In such cases an internal expenditure budget needs to be developed to document that all costs are included. Note that the budget must include full direct costs and indirect cost recovery at the approved rate.

Provide a copy of any written response to your proposal to your Department Administrator and to the Office of Research Administration. If a formal contract is desired, the ORA will negotiate one with the industrial sponsor. See Section VI for information on patents and inventions.

In cases where the Office of Corporate Liaison (OCL) is assisting you in trying to obtain corporate support, OCL's Director will expect formal proposals to be processed through the faculty member's department and the Office of Research Administration (ORA). (See page 9 regarding the OCL's role.)

Be sure you are familiar with the Johns Hopkins University School of Medicine Intellectual Property Guidelines and related policies before you develop any relationships with commercial organizations (see Sections IV.C., V.F. and VI).

If a commercial or industrial organization initiates contact regarding support of your research, discuss the potential agreement with your Sponsored Research Administrator in the Office of Research Administration or the Associate Dean for Research Administration (see Contact List) before any formal documents or oral understandings have been formulated.

Commercial organizations often ask faculty to consult with them, in addition to providing sponsored projects support. Consulting agreements, scientific advisory board agreements, and Confidentiality/Non-Disclosure Agreements associated with such agreements require review by the School of Medicine's Conflict of Interest Review Coordinator at the proposal stage to ensure that they comply with University and School of Medicine policies, and that they have been approved in writing by your Division and Department Directors from the standpoint of conflict of commitment (see V.F.7.). Work for a commercial sponsor performed using institutional facilities should be negotiated via a contract between the University and the commercial organization, not a consulting agreement between the faculty member and the commercial organization. Thus, design of a protocol to be performed by JHU should be via a contract with the University, not a consulting agreement.

Questions #12a and 12b on the JHU electronic Information Sheet� request disclosure of relationships that may be construed as conflicts of interest. Reviewing such information will allow the Office of Research Administration to advise investigators regarding the applicable sponsor and institutional policies. (See Sections III.C.14.K, IV.A.2, V.F.7. and VI.)


3. Biomedically Specific Granting Organizations (e.g., American Cancer Society, Muscular Dystrophy Association, American Lung Association, etc.)

Many of these organizations have official application forms that are available upon individual request. Most of the forms for these sponsors may be obtained by accessing their websites.

4. Foundations

There are many different kinds of foundations that will fund School of Medicine projects. Some have application forms, some do not, but with rare exceptions those with application forms require that the forms be requested or obtained through their website as needed rather than providing the Office of Research Administration with a supply.

Generally, applications to biomedically specific foundation grant programs do not require institutional clearance through The Fund for Johns Hopkins Medicine to submission. However, many of these advertised foundation programs do limit the number of applications per institution for each grant cycle (e.g., Pfizer Scholars Program, Searle Scholars Program). Discuss such programs with the ORA to determine how much time will be needed for selection of the applications to be submitted.

Uninvited project applications to foundations usually require institution- wide coordination in order to avoid flooding a particular foundation with competing applications. Applications are made to the same foundations for both project support and general fundraising; hence the ORA must coordinate submissions with the University-wide staff. Please discuss your interest in foundations requiring clearance with the officer assigned to your department (accessible through the office of your department director).


B. TECHNICAL/SCIENTIFIC SECTION

1. Factors to Consider in Preparing a Successful Grant Application
2. Factors to be Considered when drafting Abstracts and Program Narratives
3. Research Training Program Plan for Institutional NRSAs (Training Grants):�

a. Training in Responsible Conduct of Research�
b. Recruitment of Minority Individuals Into Research Training Programs

Requirements for the technical/scientific portion of grants and contracts vary considerably according to project, sponsor, and type of funding instrument. The Office of Research Administration provides the following general instructions for preparation of Technical Proposals and can assist you in accessing the most recent set of sponsor guidelines.

1. Factors to Consider in Preparing a Successful Grant Application:

-- Heed sponsor instructions carefully, especially as they relate to page limitations, typeset size, and requirements for human subjects, biohazards, etc. For all NIH grants, format instructions must be followed on all pages, especially the font size. NIH rejects all proposals which do not conform to the specific instructions provided. Helvetica or Arial 12-point is the NIH-suggested font.

-- Workscope statements and abstract summaries should be clear, concise and understandable. While the majority of your applications will be assessed by scientific peer review bodies, reviewers in some organizations may not be totally familiar with your area of specialization. Therefore, it is usually advisable to write for both a general scientific audience and for the technical expert in your field. Regardless of sponsor, always have a draft proposal reviewed by at least one expert in your project area and one senior faculty member in the same general field who is less conversant with the specific area of your project. Their comments can help you adjust your text to the needs of both types of reviewers.

-- Editorial assistance is available through some departments to help faculty members with scientific and grant writing. The Welch Medical Library also offers a Scientific Editing Service for The Johns Hopkins Medical Institutions' faculty, staff, and students. Authors can receive assistance in writing for a specific audience, organizing ideas logically, writing persuasively, and grammar usage.

-- The School of Medicine, in conjunction with the Welch Medical Library, sponsors lectures and workshops to give students, faculty and staff of the Johns Hopkins Medical Institutions practice in improving scientific writing skills.

In addition to the general factors presented above, specific items to consider when preparing NIH applications include the following:

-- Applicants may provide information to facilitate the assignment and review of their proposals. This can be done by including a cover letter with the application at the time of submission suggesting an initial review group and/or a PHS component to which it could be appropriately assigned. Word choice in the title and abstract often controls to which group your application is assigned. Although the referral staff will consider cover letter requests for specific assignments, the final decisions will be based on a number of factors. Membership of the review groups is available in publications such as NIH Advisory Committees. Review of the members' publications will often alert you to relevant portions of their prior work, which should be considered in light of the methods presented in your proposal.

-- Applications to NIH for clinical research grants, cooperative agreements, and Proposals for Contracts are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. This information should be included in the Research Plan of PHS form 398 .

-- The human subject and vertebrate animal sections of the Research Plan must be identical with the protocols reviewed by the IRB and specified on the JHU Information Sheet and the approval dates stated in the application must be the most current.

-- If a portion of the grant activity is being performed at a collaborating organization outside of JHU, the applicant organization's Research Plan must include a description of the portion(s) of the workscope being conducted at the subcontractor organization so that the Research Plan conforms with the summary project budget. Additionally, reviews for Human Subjects and/or Animals must be performed and certified by the subcontract organization.

2. Factors to be considered when drafting Abstracts and Program Narratives:

Abstract
While an abstract is not required by all sponsors, it is a highly effective means of presenting a project to a reviewer or review committee. The abstract should be approximately 250-300 words and should outline the proposed project, including its objectives and the methods of meeting them.

Special care and attention should be given to the construction of the abstract, for it can be a very important element in an application. Many agencies appreciate a project abstract since it facilitates the initial review of the proposal. Also, abstracts often help a sponsor in developing statistical profiles of their programs.

Program Narrative
The program narrative, the body of the proposal, should have the following information, written in layman's language:

Project Objectives: Start with a discussion of the need for the project; state the questions which the proposed project is designed to answer. Provide information that convinces reviewers that the questions are important and worth answering, and that your approach is sound. Prepare a statement of the problem, purposes (goals), objectives, specific activities, and present status of work related to your project.

Literature Review: This should not be an annotated bibliography, but rather a concise and scholarly critique. This demonstrates that the proposer is aware of the overall significant and current research in the field. It also shows how the proposed project will extend the state of knowledge about the field.

Project Activities: Indicate what activities will be undertaken, who will do them, when they will be done, how these activities will assist in meeting program objectives, and how you will know that program objectives have been met. Give precise information on project arrangements and materials which are to be developed. It is very important that you include a timeline and discuss evaluation procedures.

Project Methodology: The precise methods you will use to carry out the study should be detailed. This section is probably the one the reviewers will study most carefully. Your writing should assure reviewers that you are conversant with the methodology in your field and that you have the expertise and skill necessary to successfully complete the project.

Findings/Conclusions: Here you should discuss the contributions the successful project will make to knowledge in the discipline. If applicable, you should note how the results can be replicated and disseminated.

3. Research Training Program Plan for Institutional NRSAs (Training Grants):


a. Training in Responsible Conduct of Research

Applications for competitive new and/or renewal NRSA Institutional Research Training Grants submitted to NIH require as an integral part of the proposed training program, the principles of scientific integrity and responsible conduct of research. Accordingly, it is requested that all applications from the School of Medicine include the following statement as well as additional description of how these issues and policies will be further covered within the specific proposed training program.

"The Johns Hopkins University School of Medicine has established policies on Conflict of Commitment and Conflict of Interest, Procedures for Dealing with Professional Misconduct, Grievance Procedures and Rules and Guidelines for Responsible Conduct of Research (enclosed). All faculty, students and fellows, as required by the Rules and Guidelines for Responsible Conduct of Research, receive a copy of these policies as well as a copy of the booklet, "Honor in Science," published by Sigma Xi. These Policies have been developed by the Medical School community through case study discussions in open school-wide faculty meetings. Prior to adoption, the final policies were reviewed and approved by both the Advisory Board of the Medical Faculty and the Medical School Council (representing faculty and students). Discussions of these policies by senior faculty and deans of the school are held at the following annual seminars for students and faculty: Data Recording and Management, Animal Research, Authorship and Publication Practices, and Human Research."

For further information on the seminars, contact the Office of the Vice Dean for Research (Ext. 5-2411).

b. Recruitment of Minority Individuals Into Research Training Programs:

In order to recruit individuals from minority groups that are underrepresented nationally in the biomedical and behavioral sciences, NIH has expanded their instructions for Institutional NSRAs (Training Grants) to include a description of a grant program's plan to recruit individuals from underrepresented racial/ethnic groups. The narrative for the Research Training Program Plan requires that a statement concerning minority recruitment plans must be made in the Research Training Program Plan, Section B.3., "Recruitment of Individuals from Underrepresented Racial/Ethnic Groups."

In consultation with the University's Affirmative Action Officer, the following are examples of minority recruitment strategies, some of which must be included in the proposal and implemented with specific references to named contacts and activities:

-- Contact dean of medical school with a large number of minority students (Howard, Meharry, Morehouse, Charles Drew University, University of Puerto Rico).

-- Contact departments of historically black universities with graduate programs in related biological sciences

-- Inform deans of minority affairs in medical schools with formal minority programs (Harvard, Columbia, Stanford, Duke, Case Western, Universities of Oklahoma, Pennsylvania, Texas and Virginia).

-- Inform the Minority Affairs Officer of the Meyerhoff Scholars Program at the University of Maryland, Baltimore County.

--Contact program directors of Minority Access to Research Careers programs (MARC) and Minority Biomedical Research Supplement programs (MBRS).

-- Contact Association of Minority Health Professionals Schools and National Association of Medical Minority Educators.

-- Contact professional organizations in the field(s) and directors of related training programs with high percentage of minority students.

-- Work with office of student affairs of your institution (see below) and minority schools to identify, contact, and recruit minority students.

-- Meet with representatives of minority health organizations.

-- Interview all minority applicants who meet the minimum qualifications of the program(s).

-- Review the Minority Graduate Student Directory as a source for a mailing list.

-- Place ads in the Journal of the National Medical Association.

-- Submit positions to FASEB placement service.

-- Plan a symposium on career areas and opportunities for minorities in biomedical sciences.

For additional guidance in minority recruitment strategies, contact the Associate Dean for Graduate Student Programs, School of Medicine, at Ext. 4-3385.


C. BUDGET/FINANCIAL SECTION

  1. Personnel: General
  2. Personnel: Salaries
  3. Personnel: Fringe Benefits
  4. Consultants
  5. Equipment
  6. Supplies
  7. Travel
  8. Patient Care Costs and Physician Fees
  9. Alterations and Renovations/Construction
  10. Other Expenses
  11. Subcontracts (Consortium Agreements)
  12. Trainee Costs
  13. Indirect Costs
  14. Assurances/Certifications

Peer reviewers on Study Sections or other committees are asked to determine whether all items of the budget are realistic and justified in terms of the aims and methods of the project and currently available resources. Presuming that the reviewers are enthusiastic about the workscope, the ideal budget justification should relate the costs to the work so closely and thoroughly that no decrease in the budget could be recommended without a corresponding change in the workscope. The ORA can show you samples of effective budget justifications and can refer you to faculty who have served on Study Sections and are willing to provide advice concerning these issues.

The outline of budget line items below follows the format of a standard NIH research application, but is generalizable for use in preparation of applications to many other sponsor agencies as well. We urge you to read the directions provided by the sponsor and the additional guidelines provided by the ORA which accompany NIH applications. Then carefully read the information below and consult with your Departmental Administrators and/or the Office of Research Administration for additional clarification as needed.

1. Personnel: General
The "gold book"� (http://www.insidehopkinsmedicine.org/goldbook/index.html) for full-time faculty or the "blue book" for part-time faculty, Policies and Guidelines Governing Appointments, Promotions and Professional Activities, is distributed to School of Medicine faculty at the time of appointment. Full-time faculty are expected to generate an appropriate share of their income from grants and contracts for which they have academic responsibility. Generally, part-time faculty are only paid if salary is provided by a grant or contract.

Project personnel are customarily listed in the following order: Principal Investigator, Co- Investigator, other professional personnel, and non- professional staff. Be sure that all project positions are enumerated even though the specific individuals who will fill the positions may not yet have been identified. Note that Federal agencies do not use the position "Co-Principal Investigator." All participating faculty must have consented to be included as project participants. (See Section IV.A.1.) Except for fellowships, the Principal Investigator must be a faculty member.

Please also note that proposals which involve immediate family members or financial interests of any participant, family member or supervisor require prior written disclosure to the Department Chairman and the School of Medicine's Conflict of Interest Review Coordinator for their review and approval in accordance with the "Faculty Policies of the Johns Hopkins University School of Medicine."� (http://www.hopkinsmedicine.org/research/policies_conflict.html)�
Titles: Use titles appropriate to the project (e.g., P.I., Co- Investigator, Technicians, etc.). Avoid using faculty titles (e.g., "Research Associate") for personnel who do not or will not hold faculty appointments at the time of the award.

Inter- divisional/Departmental Personnel: Personnel of Johns Hopkins Hospital or departments other than the applicant's are not to be listed as project personnel without the full knowledge and consent of the department or division in which he/she holds a primary appointment.

Effort/Cost Sharing: The time which each individual will devote to the project should be expressed in terms of a percentage. The reporting of professional effort in terms of hours is unacceptable because it is difficult to reflect and measure scientific contribution by hour, and because of the burdensome recordkeeping mechanism which would have to be established for this kind of system.

-- Do not promise more effort than you can deliver.

-- Be sure that reimbursement is requested for full percent of effort indicated (see Salaries, below). Failure to request full salary recovery constitutes voluntary cost sharing which results in the University's paying for salary and benefits as well as indirect costs for the contributed effort. Consult the ORA if you would like a more detailed explanation of cost- sharing policies.

-- Nevertheless, faculty should generally not have more than 95% effort on sponsored projects. Exceptions to this rule are Research Associates and junior faculty on career development awards who otherwise do/will not have teaching, patient care, and/or institutional/departmental committee responsibilities. Deviations from this rule should be discussed with your Departmental Administrator/Director, who must certify such exceptions in writing to the Associate Dean for Research Administration.

-- Investigators should not propose more than the minimum effort stated in the PHS K award guidelines (e.g., K08, K12 and R29, See Section II.3). Effort that exceeds the minimum will not improve priority scores and further limits the applicant's potential effort and salary support from other grants and contracts.

2. Personnel: Salaries
Project and prorate salaries according to each budget period within the project period. Remember salary information is sensitive and should remain confidential.

Obtain current salary figures. If your budget includes faculty from other departments, check with appropriate Departmental Administrative personnel to make sure that your projections for that faculty member are adequate. Especially if new positions are contemplated, check with Departmental Administrators to determine whether salary matrix shifts are planned which will cause increased minimal salaries.

For future years, project salary increases based on the latest guidelines available from your Department Administration.

If a budget period does not correspond to the University fiscal year or salary period, prorate the salary. For instance, if the grant period is April 1 through March 31, calculate three months at the old salary rate and nine months at the new rate (assuming a salary increase on or around July 1).

When calculating future year salary projections on your budget for the entire project period, consider that professional staff involved on the project may not be requesting salary support until Year 2 or 3 of the grant because they are the current recipient of a research career award which restricts salary supplementation from other Federal sources. In addition, there may be circumstances where personnel begin participating on the research project after the initial 12 month budget period.

Certain NIH research career awards (K series grants, e.g., Mentored Research Scientist Development Award [K01], Mentored Clinical Scientist Development Awards [K08], etc.,) specify in their program guidelines that salary supplementation is not permitted from Federal funds, unless explicitly authorized under the terms and guidelines of the program. Faculty and staff should carefully review the specific program guidelines and consult with your Department Administrator and/or the Office of Research Administration for additional clarification.
Review the section above on Effort/Cost Sharing. Reimbursement of salaries should usually be requested for the full percent of effort indicated.

a. Salary Cap:
Information regarding salary limitation for the National Institutes of Health grant and cooperative agreement awards and extramural research and development contract awards is posted at http://grants.nih.gov/grants/policy/salcap_summary.htm.

b. Administrative and Secretarial Salaries
For federal grants and contracts, Section F.6.b. of the July 1993 revision of Circular A-21 says that the salaries of administrative and clerical staff should normally be treated as Facilities and Administrative Costs. This section goes on to say that direct charging of these costs may be appropriate where a major project or activity explicitly budgets for administrative or clerical services and the individuals involved can be specifically identified with the project or activity.

This provision is intended to establish the principle that the salaries of administrative and clerical staff should usually be treated as Facilities and Administrative Costs, but that direct charging of these costs may be appropriate where the nature of the work performed under a particular project requires an extensive amount of administrative or clerical support which is significantly greater than the routine level of such services provided by academic departments. The special circumstances requiring direct charging of the services would need to be justified to the satisfaction of the awarding agency in the grant application or contract proposal.

The following examples are illustrative of circumstances where direct charging the salaries of administrative or clerical staff may be appropriate.

- Large, complex programs, such as General Clinical Research Centers, Primate Centers, Program Projects, environmental research centers, engineering research centers, and other grants and contracts that entail assembling and managing teams of investigators from a number of institutions.

- Projects which involve extensive data accumulation, analysis and entry, surveying, tabulation, cataloging, searching literature, and reporting, such as epidemiological studies, clinical trials, and retrospective clinical records studies.

- Projects that require making travel and meeting arrangements for large numbers of participants, such as conferences and seminars.

- Projects whose principal focus is the preparation and production of manuals and large reports, books and monographs (excluding routine progress and technical reports).

- Projects that are geographically inaccessible to normal departmental administrative services, such as seagoing research vessels, radio astronomy projects, and other research field sites that are remote from the campus.

- Individual projects requiring project-specific database management; individualized graphics or manuscript preparation; human or animal protocol, IRB preparations and/or other project-specific regulatory protocols; and multiple project-related investigator coordination and communications.

c. Graduate Students/Postdoctoral Fellows:
(Note: Wages/Salaries are payments for services rendered. Stipends/fellowships are living allowances to further the education and training of the recipient for which no services are rendered, i.e., the University receives no benefit from the activities. Refer to Section III.C.Trainee Costs, for stipend support.)

-- Graduate Students (degree candidates).
The Office of the Associate Dean for Academic Affairs publishes guidelines for graduate education stipends. In order to equate net salary to stipend and/or fellowship levels, salaries may need to be higher than stipend levels to adjust for income tax and/or tuition responsibility.

-- Postdoctoral Fellows.
Approved maximum salary levels for postdoctoral fellows are published by the Office of the Assistant Dean for Postdoctoral Programs. Combined stipend and salary support for any postdoctoral fellow may not exceed these levels. Do not confuse these levels with the rates set by various sponsors- including NIH- for training grants and fellowships (see Section III.C.Trainee Costs).

3. Personnel: Fringe Benefits

Fringe benefits are the University's contribution to Social Security, group insurance plans and retirement programs. These contributions are expressed in terms of a percentage of salary. They are re- stated at the beginning of each fiscal year and publicized widely, along with the announcement of indirect cost rates (see Appendix H for current and future fringe benefit rates).
In calculating fringe benefits, please recall that:
-- Fringe benefits for most personnel change at the beginning of the new fiscal year (July 1) and should be prorated in the same manner as salaries.

-- Student wages (OE, OW, OH, OG) are exempt from FICA taxes only while the student is enrolled full- time and attending classes. (See the Student Tax Guide issued by the Office of Accounting Services.) Overseas salaries (OS) are also exempt from any personnel benefit changes.

-- No benefits are assessed to object code OV, wages paid to nonresident postdoctoral fellows, the costs for applicable health, life and disability insurance should be budgeted under "Other Expenses."

-- Salaries paid to personnel who are not U.S. citizens and who are employed at foreign sites (object code OS) are also exempt from fringe benefit charges.

-- Some types of awards do not allow fringe benefits. However, it is important to recover fringe benefits (as well as full salaries) whenever possible.

The ORA will assist you in calculating fringe benefits if you still have difficulties after reading Appendix H. Please also consult us for information on recovery of fringe benefits for I.P.A.s (Intergovernmental Personnel Act Agreements) and for other information on salaries/fringes which you might need to complete your applications.

4. Consultants
Refer to the policy guidelines of the sponsoring agency to determine when project funds may be used for consultant fees. Note that the NIH will approve consultant fees only if: (1) the services to be provided are essential and cannot be provided by persons receiving salary support under the grant; (2) a selection process has been documented in writing regarding the selection of the most qualified person available; and (3) the charge is appropriate to the services rendered and the consultant's qualifications.

If a School of Medicine salaried faculty member is to serve in the capacity of a paid consultant on your project, list him/her among the project personnel rather than requesting compensation by consultant fee. Consulting fees do not carry income tax and FICA deductions. The IRS does not allow the University to pay an individual consulting fees for the same professional services for which he is employed. Note that federal employees are usually not allowed to be paid consultants on federal grants and contracts. Federal employees are also required to obtain written permission from their federal agency for any paid consulting. All consultants will be required to complete the University's Contract for Personal Services Rendered By a Consultant/Independent Contractor (Form B-33) as well.

Note that there is a difference between consultants (advice and one- time assistance) and collaborative research (proposed as a subcontract and budgeted under "Consortium/Contractual Costs") in which part of the workscope is actually being performed by another investigator at another institution. Service agreements do not involve workscope design and modification and should be budgeted under the categories of "Other Expenses" or "Patient Care" if appropriate.


5. Equipment
Equipment, as defined by federal guidelines and by the University's object code system, is an article of nonexpendable personal property having a useful life of more than one year and an acquisition cost of $5,000 or more per unit. However, please use the "old" definition of equipment (...two years of useful life and $500) for sponsored research proposals until the "new" definition is incorporated into the University's Indirect Cost Proposal to DHHS. Items which do not meet these criteria should be classified as "Supplies." Nonfederal sponsors may use other criteria for classifying equipment.

Accessories, component parts and installation costs of an item of equipment should be classified as part of the basic unit cost of the equipment. Do not list such charges separately! However, replacement parts are classified as Supplies.

For most applications, justification must be provided for requests to purchase items of equipment that appear to duplicate or to be equivalent to items already available in the research environment.


6. Supplies
Supplies such as chemicals, glassware and other small laboratory equipment (under $500) should be itemized by category.

Costs for purchase and care of animals are usually listed under Supplies. A written estimate of animal purchases and care cost can be obtained from the Division of Comparative Medicine (refer to Section IV.A.3 of this handbook). NOTE: Animal care costs now include the cost of Animal Facilities starting in July of 1994. It is expected that by July 1997, these facility costs will be fully added to daily care rates. The amount estimated by Comparative Medicine is the minimal amount which would be needed currently in this category from the sponsor agency. We recommend that you escalate the per diem estimate for periods beginning with July 1, 1996-1997 by 10-15% per year for each of the two years remaining before facility costs are fully loaded in the daily care rates. Thereafter, assume 4-5% annual increases. (Animal Services also reviews application information regarding proposed animal use to ensure compliance with federal law and NIH regulations; see Section IV.A.5.)

In future year projections for research supplies, increase the amount budgeted per supply item by at least the rate of the current Biomedical Research and Development Price Index (BRDPI) (assuming similar volumes/types of supplies will be needed). Provide separate justification for cost items which may exceed this estimate.


7. Travel
Funding agencies are insistent on full justification for travel requests. Describe the purpose of the travel, destination(s), names or titles of individuals for whom funds are requested, and frequency of repetitive trips.


8. Patient Care Costs and Physician Fees
Research funding should cover only those patient care expenses resulting from the research procedures; routine costs of patient care for treatment purposes are unallowable. Likewise patients and/or third party insurers should not be responsible for the costs of supplies, procedures and/or diagnostic tests which are required for research purposes only and not for routine treatment. New, experimental drugs, devices and procedures will probably not be reimbursed by third-party payors (see Section IV.A.3.e). Obtain approval from your department administrator for such patient care costs.

Before planning research involving large numbers of patients, be sure that you have obtained the proper clearances from Hospital or clinic authorities. Cost data for patient care services must be obtained from the appropriate Practice Plan or Hospital administrative unit(s). Contact your Hospital functional unit administrators for assistance. Federal grant and contract proposals must use the Hospital's current federal Patient Care Costs agreement rates.

Refer to Core Research Facilities, Clinical Research Centers, to determine if the patient care costs could be supported by one of these resources.

Lab tests in licensed labs may be classified as patient care costs. However, lab tests in unlicensed University research labs should be broken down into their cost elements (salary, supplies, etc.) as appropriate and not included as patient care costs.

Remember that research involving human subjects must be reviewed by the� Johns Hopkins Medicine Institutional Review Board (see Section IV.A.3).

Carefully review the sponsor's guidelines concerning when patient care costs and physician fees are allowable.

Usually a research project involving direct patient contact will have two components of professional effort (research and physician services). Both can be budgeted under "salaries" or research can be budgeted under "patient care" if the Practice Plan will invoice the research project. Such billing from a Practice Plan can only be for procedures which are already offered for patient care purposes and occur in clinical, not research, space.

Note that patient care costs are excluded from indirect cost when using the federally approved indirect cost rate. Patient care costs are not excluded from indirect costs when using the Total Direct Cost base for clinical trials.


9. Alterations and Renovations/Construction
"Alterations and renovations" are modifications of the interior of University or Hospital buildings.

The Facilities Management Committee of the School of Medicine must approve all alterations and renovations. Before requesting funds for construction, renovation or alteration of any University or Hospital facility, consult with your Department Director/Administrator, who must obtain approval from the Associate Dean, Finance and Administration, prior to submission of the proposal to a potential sponsor. Cost estimates for approved alterations must be provided by Facilities Management.

Carefully review the sponsor agency's guidelines to determine their policy in regard to funding for this item. In NIH research applications, construction costs per se are not permissible direct cost charges except in the case of specific construction grant programs. Many foundations will allow alteration/construction as direct costs even though they do not fully fund indirect costs.


10. Other Expenses
NIH applications include under "Other" such expenses as publication costs, telephone, rental and leases, computer costs, and patient subject costs such as travel expenses incurred by human subjects participating in the project. Also, when employing students on research grants, include costs of applicable health, disability and life insurance, under "Other Expenses," as these costs are not a part of the University fringe benefit rates for students. Calculate these costs proportionately to the level of support that the salary represents.


11. Subcontracts (Consortium Agreements)
The following is an explanation of the use of the word "subcontracts" as a budget item in your grant or contract. For an explanation of procedures to follow when another organization is subcontracting to you, see Section III.A.1.c.

If a portion of the workscope other than the services of a consultant is to be provided by an organization outside of J.H.U., the costs should be budgeted under this category and a formal subcontract will be required if the grant or contract is awarded. The collaboration is ordinarily such that the subcontract P.I. will assist in designing the project, participate in the project on an ongoing basis, and expect to be named as a co-author on publications.

The following items are needed from the subcontractor at the time of proposal submission:

-- a letter of intent from the subcontractor indicating their willingness to collaborate on the project (signed by both the other organization's P.I. and Institutional Official, as well as the JHU Institutional Official), including the following required wording if the proposal is to an NIH/PHS agency:

"The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy."
-- a budget specifying both direct and indirect costs.
-- an Abstract or description of the workscope.
-- Other Support.
-- Biographical Sketch.
-- Resources and Environment.
-- Relevant Human Subject IRB approval and Vertebrate Animal IACUC protocol approval.
-- Checklist.

The total costs (direct and indirect) should be entered in your direct cost budget under the category "Consortium/Contractual Costs," e.g., "Subcontract, University of XYZ: $25,000." The first $25,000 of each subcontract, per project period, is included in the indirect cost base.


12. Trainee Costs
Stipends are non- salary support for pre- or postdoctoral fellows; no services are rendered to the University to earn this support. The Office of the Associate Dean for Academic Affairs publishes guidelines for graduate education support. Postdoctoral stipends and salary support may not exceed the approved salary levels for postdoctoral fellows issued by the Office of the Assistant Dean for Postdoctoral Programs - see Section III.C.2.c. Do not confuse these parameters with the stipend rates set by various sponsors - including NIH - for training grants and fellowships. Sponsors frequently define the stipend level according to year of study. Supplementation from other sources may be restricted by the sponsor's policies.

Tuition and Fees:
Predoctoral: full tuition charged for full- time graduate study.
Postdoctoral: tuition charges only for special courses outside of the Department.

Health Insurance costs should be recovered whenever possible. NIH allows individual (not family) coverage for each trainee under an institutional training grant. For individual NRSAs, the trainee should plan on using a portion of the institutional allowance for medical insurance. For School of Medicine fellows, include additional charges for life and disability insurance.

Trainee Travel - budget as you would for any staff travel, but include under "trainee costs."
Institutional Allowances - Unlike training grants, NIH Individual Fellowships (NRSAs) provide stipend and institutional allowance only. The institutional allowance may be spent in any way desired, hence detailed budgeting on the application is not required.


13. Indirect Costs

a. What are indirect costs?

Many of the actual services used by a sponsored project are not charged directly (per unit of use) because to do so would be too cumbersome and expensive. Instead, the actual costs of operating and maintaining space, utilities, department administration, library, general administrative services (accounting, payroll, purchasing, etc.), school administration and required institutional oversight (human subjects, biohazards, radiation safety, etc.) are usually charged by use of indirect cost rates.

b. How are the indirect cost rates established?

Federal accounting regulations require the following procedure for establishing federally negotiated university wide indirect cost rates:

(1) Total anticipated costs for all indirect services and facilities are computed.

(2) Modified total direct costs (direct costs less equipment, patient care, major alterations, etc.) are estimated for three basic functions of university activity (organized research, departmental research/instruction, and other sponsored activities).

(3) Total indirect costs, with and without space costs, are distributed among the three basic functions (organized research, instruction/departmental research, other sponsored activities) based on applicability to function, percent of direct costs in each function and functional purpose of space (see Appendix J for actual distribution of these costs).

(4) The ratios of indirect costs to modified total direct costs result in two indirect cost rates for each of the three functions:
"On- Campus" (includes space cost)
"Off- Campus" (excludes space cost)

(5) The indirect cost rates may be further adjusted to account for previous years' over- or underrecovery of indirect costs.

Thus the ratio of indirect costs to modified total direct costs is the indirect cost rate:

(Indirect Costs)/(Modified Total Direct Cost) x 100 = Indirect Cost Rate

c. What happens when the indirect cost rate used in a project is less than the approved rate?

Use of a lesser rate results in an underrecovery of the actual indirect costs. Such underrecovery must be paid from sources of general funds other than indirect cost, such as tuition and endowment earnings. Tuition must be used to support instructional programs. Endowment income (which amounted to only 2.0% of the total funds expended by the School of Medicine for 1994-95) is for the most part restricted by the donors to purposes other than sponsored project support. Accordingly, the School of Medicine can accept only a limited number of sponsored projects which do not provide full recovery of indirect costs.


d. When must the federally negotiated indirect cost rate be used?

-- All federal research and service grants and contracts
-- All on-campus for- profit corporate grants and contracts which provide service or data for the benefit of the company
-- All subcontracts from other institutions which are funded by federal or commercial grants or contracts
-- All other sponsors who will pay the federally negotiated indirect cost rate


e. When should a Total Direct Cost rate basis be used?

All fixed-fee on-campus and off-campus commercially funded research agreements, that do not require return of unspent funds, should use a rate based on total costs (TDC) instead of modified total direct costs. This TDC rate avoids confusion regarding the basis of the federal rates and what categories qualify for inclusion, thereby avoiding negotiation delays with commercial sponsors of clinical trials. The School of Medicine sets this TDC-based rate for commercially funded clinical trials based on the federally negotiated on- and off-campus indirect cost rates.


f. When may a rate other than the approved indirect cost rate be used?

Less than the approved rate may be used in cases such as the following:

-- non- profit foundations and disease specific societies which have a written policy specifying a smaller maximum indirect cost rate

-- federal training grants, fellowships, conference and construction grants which specify other rates

-- State of Maryland grants which limit indirect cost reimbursement

-- affiliated Hospital service agreements - separately negotiated; consult the School of Medicine Business Office.


g. What approved rate should be used?

(1) Appendix H summarizes the current approved rates by the federally defined functions of sponsored projects:

Organized Research (all research and development activities that are separately budgeted and accounted for)

Instruction/Departmental Research (training grants, fellowships, career development awards, course development, and academic activity not separately budgeted and accounted for as "Organized Research" or "Other")

Other Sponsored Projects (service projects such as clinical lab tests or demonstration of new health care delivery methods)

(2) Each function has two rates defined as follows:

ON CAMPUS: Project will take place in space owned or leased by the University without recovery of space rental as a direct cost item in the project budget.

OFF CAMPUS: Project will take place in space provided at no cost by another organization or space costs are included as a direct cost item in the project budget.

(3) Rate Basis:

TOTAL DIRECT COST: "The total allowable direct costs incurred by the grantee institution to carry out an approved grant supported project."

MODIFIED TOTAL DIRECT COST (MTDC): Total direct costs less individual items of equipment in excess of $500, the total costs of each subcontract in excess of $25,000, patient care costs, stipends, tuition payments, alterations and renovations in excess of $5,000, direct charges for University scientific computer usage and space rental charges. The new federal standard redefines equipment as those items having a useful life of more than one year and an acquisition cost of $5,000 or more per unit. However, please use the "old" definition of equipment for sponsored research projects until the "new" definition is incorporated into the University's Indirect Cost Proposal to DHHS.


h. How are indirect costs calculated for a project budget?

(1) Determine whether your project is organized research, instruction, or other.

(2) Determine whether your project is "on" or "off" campus.

If significant parts of the project are at both "on- campus" and "off- campus" locations, the project costs should be apportioned accordingly. For example, supplies used and personnel effort expended at the "off- campus" location should be presented as a separate budget from those costs at the "on- campus" location.

(3) Determine if the project should use a TDC or MTDC indirect cost base (TDC for off-campus commercially funded clinical trials).

(4) If MTDC based, calculate Modified Total Direct Cost (MTDC):

Indirect costs are NOT charged on the following direct cost items if the approved indirect cost rate is applied:

-- equipment (over $500)
(Note: The new federal standard defines equipment as those items having a useful life of more than one year and an acquisition cost of $5,000 or more per unit. However, please use the "old" definition of equipment (... two years of useful life and $500) for sponsored research proposals until the "new" definition is incorporated into the University's Indirect Cost Proposal to DHHS.)
-- alterations/renovations (over $5,000)
-- patient care costs
-- subcontracts of a portion of the workscope (amount in excess of $25,000 for each subcontract)
-- University scientific computer charges
-- stipends and tuition payments
-- space rental

Total direct costs less these listed items = Modified Total Direct Cost (MTDC). MTDC should be multiplied by the appropriate indirect cost rate to calculate the correct indirect cost to include in your budget.

If less than the approved indirect cost rate is allowed (see Section III.C.13.e.), exclude only those items specifically prohibited from indirect costs by sponsor policy.
In the matter of budgeting for indirect costs, as in other areas concerning proposal preparation, we urge you to contact the Office of Research Administration if further explanation would be helpful.

If a JHU application requests funds for a subcontract, the collaborating institution will include their indirect costs in accordance with their DHHS negotiated indirect costs rate agreement. The first $25,000, per project period, of all subcontracts is included in the JHU direct cost base. Amounts over $25,000 of each subcontract are excluded from the base.


14. Assurances/Certifications

On grants and cooperative agreements to the federal government, the University is required to certify, by the signature of the official signing for the applicant organization on the face page of the application, that assurances have been filed pertaining to compliance with governmental administrative, scientific, and fiscal regulations.

The list of assurances summarized below is intended to provide an understanding of the policies and procedures pertinent to the grants administration process and is not a comprehensive outline of all PHS, federal or private sponsor requirements or policies.

The following assurances/certifications are included in PHS applications:

a. Human Subjects:

Refer to Section IV.A.3., Human Subjects, for a discussion on hugman subjects in research activities and Johns Hopkins Medicine Institutional Review Board (JHM IRB).

b. Vertebrate Animals:

Refer to Section IV.A.5., Animals, for information on JHU policies and procedures relating to the care and use of vertebrate animals in research activities.

c. Inventions and Patents:

For additional information on inventions, patents and licenses, Investigators visit the Office of Licensing and Technology Development website.

d. Debarment and Suspension:

The applicant organization is required to certify that neither it nor its principals, officers, or investigators are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any federal agency.

e. Drug-Free Workplace:

The Drug-Free Workplace Act of 1988 requires that the applicant institution certify that it will maintain a drug-free workplace. PHS grant application forms have been revised to include a specific assurance from all applicants that a drug-free workplace will be provided.

f.�Certification Regarding Lobbying:

Recipients of federal grants are prohibited from using appropriated funds for lobbying in connection with any federal support.

g. Non-Delinquency on Federal Debt:

The applicant institution must certify that it is not delinquent in repayment of any federal debt. On PHS applications for individual fellowships (PHS 416-1), the named fellow applicant is certifying that he/she is not delinquent on repayment of any federal debt.

For individuals appointed under institutional training grants, the trainee appointed under the institutional NRSA is required to submit a Statement of Non-Delinquency on Federal Debt (PHS-T-600) along with the required forms for appointment of the trainee and payback agreement.

h. Misconduct in Science:

Each institution which receives or applies for research, research-training, or research-related grants or cooperative agreements under PHS must submit an annual assurance certifying that the institution has established administrative procedures regarding dealing with and reporting possible misconduct in science. The rules and guidelines for responsible conduct of research at The Johns Hopkins University, School of Medicine are addressed�in the booklet entitled: "Faculty Policies of The Johns Hopkins University School of Medicine." For further information on investigator responsibilities, please refer to Section V.F.6. outlining responsible conduct of research.

i. Civil Rights, Handicapped Individuals, Sex Discrimination, and Age Discrimination:

The University is required to file assurance of compliance forms with the Department of Health and Human Services, Office for Civil Rights, pertaining to civil rights, handicapped individuals, sex discrimination, and age discrimination. For additional information, contact the University's Office of Equal Opportunity and Affirmative Action Programs. Copies of these assurances are on file in the Office of Research Administration.

j. Program Income:

Program income is defined as "gross income earned by a recipient from activities part or all of the cost of which is either borne as a direct cost by a grant." Examples of program income include:
-- Fees earned from services performed under the grant, such as those resulting from laboratory drug testing.
-- Rental or usage fees, such as those earned from fees charged for use of computer equipment purchased from grant funds.
-- Third-party patient reimbursement for hospital or other medical services, such as insurance payments for patients where such reimbursement occurs because of the grant-support activity.
-- Funds generated by the sale of commodities, such as tissue cultures, cell lines, or research animals.
Question #13 on the JHU electronic Information Sheet requests that the Principal Investigator report if he/she anticipates that program income will be generated under the subject project.

k. Financial Conflict of Interest:

PHS/NSF has established standards and procedures to be followed by institutions that apply for research funding from the PHS/NSF to ensure that the design, conduct or reporting of research funded under PHS/NSF grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research. Significant conflicts (5% or $10,000 worth of equity and/or $10,000 in aggregate payments from royalty, consulting fees, etc.) must be disclosed to the Department Director and School of Medicine prior to submission of the proposal and reported to PHS/NSF as managed, reduced or eliminated prior to the expenditure of any funds. (See IV.A.2, V.F.7, and VI).

 

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