HomeGrantsGrant Policies and Guidelines Guide to Genome Research Resource Grants

Print Version

Guide for Applicants: Genome Research Resource Grants (P41)

Created in 2002, this basic guide to applying for an NHGRI P41 grant includes valuable information and background on clarifying and defining your Biotechnology Research Resources application.

Introduction

The National Human Genome Research Institute (NHGRI) led the contribution of the National Institutes of Health (NIH) to the International Human Genome Project (HGP), which had as its primary goal the sequencing of the human genome. After this project was successfully completed, the NHGRI's mission expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease.

To that end NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training of investigators and the dissemination of genome information to the public and to health professionals.

The ultimate product of the HGP was a set of information, material, analytical, and methodological/technological resources available to the entire research community to facilitate further research and the application of the knowledge gained to the prevention, diagnosis and treatment of disease.

Economical attainment of the goals of the HGP requires the development and provision of shared research resources to the genome research community. Many of the important individual and collaborative research projects undertaken within the HGP have been facilitated by the ready availability of shared data, technology or material resources.

These guidelines are intended to provide potential applicants with information regarding the use of the P41 (Biotechnology Research Resource) grant and specific instructions for applying for research resource grants.

General Description

The NHGRI awards P41 resource grants to develop the complex technical, material and data resources needed in genome research, and to provide the genome and biomedical research communities with access to these capabilities.

The grants provide funds for service; dissemination of information; resource maintenance; collaborative research; technological research and development; and training. Each resource must include service and dissemination activities. However, the nature of the resource will determine the appropriateness of the other, listed activities. The inclusion of, and emphasis placed on, each activity will depend on the goals of the resource and the stage of development of the resource technology.

Service

Providing genome researchers and other biomedical investigators access to the resource's technology and/or data resources constitutes the service activity. This includes making available specialized data collections, reagents, instrumentation, equipment, and techniques, as well as offering consultation and technical assistance in their use. Data collections should be distributed by multiple means. The most appropriate distribution methods should be chosen based on the size and complexity of the data collection and on the technology available to the end users of the collection.

Dissemination

This activity involves informing the scientific community about the resource's technology or accomplishments by publishing articles or books, conducting conferences, distributing software products, or transferring technologies to end users or to industry where they will be distributed widely. In resources that are developing software, emphasis should be placed on producing portable, well-documented software, and making it readily available to the user community.

Resource Maintenance

Depending on the type of resource, this activity may involve collecting and maintaining data or biological reagents or maintaining specialized instrumentation or laboratory facilities.

Collaborative Research

New applications of a resource technology to genome research should be continuously developed. This is often best accomplished through collaborative research projects. These projects involve resource personnel working jointly with investigators outside the resource who have expertise in a particular aspect of genome science. Such efforts should lead to joint publications and eventually to enhanced or expanded use of the resources.

Technological Research and Development

A resource should incorporate dynamically evolving technology, which may be an important subject for research and development in its own right. The technological research and development component consists of investigations in the technology that is designed to increase its usefulness in genome research. Such research and development may involve modification of existing systems, instruments, or equipment, or development of new systems, instruments, or equipment. For example, it may involve development of computer software or new methods to prepare or manipulate reagents or perform analyses. Technological research and development is most effective when it responds to unfulfilled technological needs of the genome research projects served by the resource. Activities essential to the resource, which combine research, design and engineering (database design and implementation, for example), should be included in this category.

Training

The training aspect of a resource includes educational programs designed to explain to members of the national research community the use of the resource's technology and/or data in genome research. Short courses, workshops, and individual training of visiting scientists and students are examples of appropriate activities. Particular emphasis should be placed on training research scientists who are members of underrepresented minority communities in the use and application of the resource to genomic research. Funds are also provided for required resource administration, to organize a resource advisory committee and to conduct regular meetings of this committee. The advisory committee can provide valuable input both on long-range planning, and in setting priorities for allocation of resource facilities. Membership of this committee should be balanced among scientists knowledgeable about the resource's technology and those who are expert in its application to genome research problems. Committee members should, with few exceptions, be from outside the host institution and should serve for a specified term. The chair of the committee should be knowledgeable about both the resource's technology and the science it serves. The committee advises the principal investigator on future directions for the resource (particularly in responding to new challenges and opportunities presented by advances in the available technology and the genome and biomedical science being served); eligibility criteria for use of the resource; and guidelines for the resource's use. The advisory committee should meet at least annually.

Criteria for Consideration as a Resource Grant

• The resource must provide service and dissemination. The other activities -- maintenance, collaborative research, technological research and development, and training -- should be included if appropriate, and if so, at levels appropriate for the proposed resource.
• The resource capabilities must be state-of-the-art and not broadly available by other means.
• The projects served by the resource must involve a variety of genome and other biomedical researchers. If a single investigator or a local collaborating group of investigators require the resource's use, support should be sought through an individual research project grant or a research center grant.
• The resource is expected to serve investigators in the surrounding region, and preferably across the nation or around the world.

Funding Plan of a Resource

The NHGRI provides support for the establishment and initial user operations of a resource, in addition to the funding of the technological research. Continued support depends primarily upon the successful application of the resource's data or technology to important genome research problems. Resources are not intended to serve selected users or laboratories on a permanent basis; long-term collaborative and service users are encouraged to acquire separate funding for their research resource needs directly. After the initial establishment period, costs of routine service activities should also be shared, for example through joint grant support, institutional funding, or a charge back system. The exception to the above is public databases, which are not expected to become self-supporting.

Types of Resources Appropriate for Genome Research Resource Grants

The following is a non-exclusive list of examples of areas considered appropriate for NHGRI research resource support:

Genome-related Databases

Genome data resources implement robust databases for genome mapping data or other data useful to genome researchers; collect and curate those data; and distribute them to the genome research community in a variety of forms.

Genome Analysis Computing

Computational resources provide research and facilities for advanced computing for genome data management and analysis. Examples of appropriate areas of emphasis include linkage analysis; mathematical modeling and simulation; sequence analysis; quantitative imaging and display; microelectronic and digital technology; and information technology, especially laboratory data management.

Instrumentation Engineering

Instrumentation engineering resources provide comprehensive biophysical and analytical engineering skills and facilities to investigators to aid them in solving genome research problems (e.g., specialized instruments, detectors, or apparatus). An instrumentation engineering resource should have the facilities to produce finished engineering products for use by the genome research community.

Comprehensive Reagent Collections

These resources provide access to specialized collections of reagents for genome analysis. These may include large-insert clone libraries representing a single chromosome or an entire genome, hybrid cell panels, or family collections useful for linkage mapping.

Instructions for Applicants

Eligibility

Eligibility for NHGRI genome research resource grants is limited to institutions located in the United States. Both profit and nonprofit organizations are eligible for support.

Coordination Required to Develop Applications

It is strongly recommended that a proposed resource project grant application be discussed with the NHGRI staff before a formal application is submitted. These discussions provide applicants with a clearer understanding of the program policies and guidelines. An applicant should also discuss a competing continuation application with NHGRI staff to determine if future plans for the project conform with current policies of the program.

Studies using vertebrate animals or human subjects require assurances and review by the Institutional Animal Care and Use Committee or Institutional Review Board, respectively, and must conform with current NIH policies. Review of the grant application may be delayed if protocols have not been approved by the appropriate institutional committee. This includes studies involving volunteers.

Application Form

The current version of Form PHS 398, Application for Research Grant, should be used for resource grant applications. Application kits are available at most institutional offices of sponsored research and on the web at grants.nih.gov/grants/funding/phs398/phs398.html

Application kits may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910. Phone (301) 435-0714, e-mail: GrantsInfo@nih.gov.

In order to assure proper identification of the application, line 2 of the application form should state "Human Genome Research Resource."

Submit a signed original of the application, including the checklist and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC 7768
Bethesda, MD 20892-7768

At the time of submission, two additional copies of the application, including all appendices, must be sent to:

Scientific Review Branch
National Human Genome Research Institute, NIH
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Phone: (301) 402-0838
Fax: (301) 435-1580

Budget Section of Form PHS 398

The Budget for the application form should be completed as described in the instruction sheet for Form PHS 398. Funds may be requested for service, dissemination of information, resource maintenance, technological research and development, training, administration (including advisory committee meetings), and the resource's expenses associated with collaborative research projects. The outside investigators of collaborative and service projects must derive support for their projects from sources outside the genome research resource grant. The budget justification on page 5 should include a detailed justification for the equipment requested for the resource. An evaluation of alternative systems or manufacturers should be included along with a discussion of the proposed procurement plan. Similar justifications should be provided for any subcontractual or consortium arrangements. Continuation pages should be used as needed.

Research Plan Section of Form PHS 398

The 20-page limit for Research Plan Sections A-D does not apply to research resource applications. The length of the application should be consistent with the scope of the proposed resource and the number of collaborative and research projects. It is important to be concise, but there should be sufficient information about each aspect of the project to permit its evaluation.

Section C, Progress Report/Preliminary Studies, should include a plan that states long-term goals and overall objectives for the resource. Information on factors and events contributing to the decision to create the resource and on comparable resource activities elsewhere should be presented. Preliminary or initial requirements analyses and designs (e.g., database, instrumentation) should be presented. For competing continuation or supplemental applications, a brief summary of the resource's progress should be included in this section, and a copy of the resource's most recent annual progress report should be included as an appendix.

Section D, Methods, should include a discussion of the proposed work related to each of the major resource activities proposed: service and dissemination (required), resource maintenance, collaborative research, technological research and development, and training. Indicate the relative emphasis to be given to these activities and explain the proposed division of effort.

• Service: The categories of research projects to be served by the resource should be described, as well as the specific resource activities undertaken to serve them. If service of specific projects is planned or anticipated, representative examples of those projects should be presented. In either case, the categories or individual projects should be described in sufficient detail to allow the reviewers to evaluate the need for the resource technology in the proposed project. Evidence should be given that there are no comparable resources available to the target scientific community.
  
  It is the applicant's responsibility to demonstrate the existence of a research community that needs and will make use of the resource. The service component will provide an important justification for the long-term need for the resource and this justification should be described. The service provided to users should reflect the impact of the resource on achieving the goals of the Human Genome Project.
  
  
• Dissemination: Plans for dissemination of the resource's technology, expertise or accomplishments must be presented.
  
  
• Resource Maintenance: Plans for establishing and maintaining the resource should be described. In this section, describe, for example, plans for data collection and curation, routine activities to maintain reagent or culture collections, etc.
  
  
• Collaborative Research: Of collaborative projects between the resource staff and outside genome research investigators are proposed, each should be presented. For each project, the specific objectives, the rationale for the proposed approach to the problem, methods and procedures to be used, the significance of the proposed work, and the impact the resource technology will have on the project should be described. Literature citations should be included. The collaborator's name, institution and funding status of the project (including grant number and term) should accompany the description of the project.
  
  
• Technological Research and Development: Any technological research and development projects to be conducted should be presented. For each project, the background, objectives, rationale, methods and procedures, significance, and facilities available to conduct the project should be described. If research activities involve support at more than one location through a consortium arrangement or a subcontract, the application should provide a separate description, including a detailed budget and budget justification for each location.
  
  Maintaining state-of-the-art resource technology, whether through development or adoption, is an important consideration in reviewing competing continuation proposals. Long-term support depends strongly on the resource's commitment to the introduction and application of new technology.
  
  
• Training: If resource user training will be required, plans for appropriate training activities should be presented. Funds to support courses given for credit may not be requested. Individuals involved in the training experiences may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree. Information on NHGRI programs to increase the cadre of underrepresented minorities participating in genomics research is available online.

Resource Organizational Structure

A separate section on resource organizational structure should be provided, which should include:

• Management Plan and Structure: The management structure and plans for administering the resource should be described, including how the resource will relate to the administrative structure of the grantee institution. An organizational chart for the resource, showing all resource staff positions, should be included.
• Resource Staff Responsibilities: The proposed resource staff responsibilities with respect to the resource activities (provision of service, dissemination, resource maintenance, collaborative research, technological research and development, training, and general resource administration) should be clearly described. The scientific and technical expertise of the staff should be indicated.
• Resource Operating Procedure: Operating procedures and policies planned for the resource should be described as well as the mechanisms for user access and scheduling and methods for selecting collaborative research and service projects.
• Resource Advisory Committee: The role of the resource advisory committee should be described. For example, the committee's role in advising on equipment purchases, reviewing collaborative and service projects for merit and appropriateness, allocating resource time and reagents, should be explained. The scientific disciplines to be represented by the advisory committee should be given. For new applications, it is advisable not to organize the advisory committee or contact potential advisors prior to review of the application. However, if an advisory committee has been appointed, names of committee members should be included, accompanied by a brief description of their qualifications.

Review Procedures

Applications for NHGRI research resource grants will be reviewed in accordance with the usual NIH peer review procedures. Applications will first be screened by NIH staff to determine their appropriateness for support by the P41 mechanism. Those deemed appropriate will be evaluated for scientific merit by the Genome Research Review Committee (GRRC). Subsequent to evaluation by this initial review committee, applications will receive a second-level review by the National Advisory Council for Human Genome Research. Applications will be accepted according to the receipt dates for regular research grants specified by the Center for Scientific Review, namely February 1, June 1 and October 1.

Review Criteria

The NIH review criteria have been adapted to ensure that NHGRI P41 applications are evaluated appropriately. The emphasis on each criterion can vary depending on the nature of the application and its relative strengths. An application need not be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, a research resource may propose to carry out important work that by its nature is not innovative, but is essential to move the field forward.

Significance:

• Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced?
• Responsiveness to the regional, national, or international user community of genome-related research programs: It is the applicant's responsibility to identify user communities that both need and will use the research capabilities to be provided by the resource.
• Balance of the component activities proposed as consistent with the needs and opportunities presented by the resource's potential user community.

Approach:

• Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
• Service (Required Activity): Adequacy of plans to provide genome researchers and other biomedical investigators access to the resource's technology and/or data resources, including plans to make available specialized data collections, reagents, instrumentation, equipment, software, and techniques and offering consultation and technical assistance in their use.
• Dissemination (Required Activity): Adequacy and appropriateness of the proposed plans for informing the scientific community about the resource.
• Resource Maintenance: Adequacy of plans to collect and maintain data or biological reagents or maintain specialized instrumentation or laboratories.
• If the proposal includes training: Adequacy of plans for providing educational programs designed to explain to members of the national research community the use of the resource's technology and/or data in genome research.
• If the proposal includes collaborative research projects involving resource personnel working jointly with research investigators outside the resource designed to increase its usefulness for genome research, address the following:
• Scientific merit of the research proposed, and how well the research fits into the focus of the overall research resource; adequacy of the experimental design and feasibility of the proposed methods; novelty or originality of the proposal, as appropriate; training, experience, and research competence of the investigator(s);  potential of the effort to lead to enhanced or expanded use of the resource, and to respond to unfulfilled technological needs of genome research projects served by the resource; suitability of the facilities for the proposed research, including the availability of required special resources.

Innovation:

• Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator:

• Does the principal investigator and the other professional staff have the appropriate scientific and managerial experience to carry out this work?

Environment/Resource Organizational Structure:

• Quality, adequacy and appropriateness of the administrative management, including the fiscal aspects of the resource.
• Does the scientific environment in which the work will be done contribute to the probability of success?
• Does the proposed resource development take advantage of unique features of the scientific environment or employ useful collaborative arrangements?
• Institutional commitment to the resource (for example, costs associated with alterations and renovations, purchase of routine instrumentation and computers and salaries of some resource staff may be borne by the grantee institution).
• Role of the advisory committee, or (in proposed resources) plans for the committee, and whether the members have or will have sufficient breadth and ability to take an effective role in the review and guidance of the resource operations.
• Reasonableness and duration of the proposed budget and the adequacy of resources for the work proposed.

Letter of Intent

A letter of intent to submit an application is most helpful to staff for purposes of guiding the applicant on the acceptability of the proposed grant structure and to assist staff in planning review workload. Applicants are strongly encouraged to send such a letter three months before the receipt date on which the application is to be submitted. The letter should include the name of the principal investigator and key co-investigators, the title and a brief description of the proposed research.

Additional information is available from:

Genome-related Databases

Peter Good, Ph.D.
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, Maryland 20892-9305
Phone: (301) 496-7531
E-mail: goodp@mail.nih.gov

Genome Analysis Computing

Lisa Brooks, Ph.D.
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, Maryland 20892-9305
Phone: (301) 435-5544
E-mail: brooksl@mail.nih.gov

Instrumentation Engineering

Jeffery Schloss, Ph.D.
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, Maryland 20892-9305
Phone: (301) 496-7531
E-mail: schlossj@mail.nih.gov

Inclusion of Women and Minorities in Research Involving Human Subjects

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research" that were published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and are available on the web at the following URL: grants.nih.gov/grants/guide/notice-files/not94-100.html

Inclusion of Children as Participants in Research Involving Human Subjects

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that were published in the NIH Guide for Grants and Contracts, March 6, 1998, and are available at the following URL: grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA, Centers of Excellence in Genomic Science, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at: www.health.gov/healthypeople.

URLS In NIH Grant Applications or Appendices

All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. However, for databases and computer resources, reviewers may need to look at Web pages to properly evaluate software applications. URLs should be provided as needed. Reviewers are cautioned that their anonymity may be compromised when they directly connect to an Internet site.

Top of page

Last Reviewed: April 1, 2008