HIGH IMPACT RESEARCH: FEASIBILITY STUDIES
Release Date: March 6, 2000
PA NUMBER: PAR-00-075
National Institute on Deafness and Other Communication Disorders
Application Receipt Date: July 21, 2000
THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
The National Institute on Deafness and Other Communication Disorders (NIDCD)
invites applications for feasibility studies of high impact (HI) research
focused on hearing, balance, smell, taste, voice, speech, and language, the
scientific mission areas of the NIDCD. This Program Announcement (PA)
supersedes a previous NIDCD PA: High Impact Research: Feasibility Studies,
PAR-99-092 (NIH Guide, April 29, 1999). HI research involves
pilot/feasibility studies in which the technological, methodological, or
theoretical approach to a problem lacks a historical precedent or sufficient
preliminary/baseline data, but whose successful outcome would have a major
impact on a scientific area or field. HI research has been described as
"groundbreaking" and "paradigm shifting" (High Risk/Innovative Research
Identification in NIH Peer Review Notes, Division of Research Grants, June
1993).
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 focus areas. This PA is related to one or
more of the focus areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of state or local governments, and eligible agencies of
the Federal government. Applications from minority individuals, women, and
individuals with disabilities are encouraged. Foreign organizations or
organizations in foreign countries are not eligible; subcontracts to foreign
organizations are allowable, with sufficient justification.
Submission of an application under this PA precludes concurrent submission of
any other application containing substantially the same research proposal.
In addition, these R21 awards may not be used to supplement research projects
currently supported by Federal or non-Federal funds, or to provide interim
support of projects under review by the Department of Health and Human
Services.
MECHANISM OF SUPPORT
Support for this program will be provided through the National Institutes of
Health (NIH) Exploratory/Developmental Grants (R21) mechanism. This
mechanism offers support for HI research that lacks a historical precedent or
sufficient preliminary data. Areas of science in which there is a sufficient
historical basis or sufficient preliminary data to support the submission of
a regular research project grant application do not qualify under this
Program Announcement. However, the applicant does have the responsibility
for developing a demonstrably sound research plan designed to assess the
feasibility of the proposed pilot project. It is expected that the
preliminary data generated by these grants, if promising, will serve as a
basis for a more extensive follow-up investigation, typically pursued through
the submission of an R01 grant application. This initiative provides
nonrenewable awards for up to two years of support and up to $50,000 in
direct costs per year. However, an application whose direct cost budget
includes Facilities and Administration (F&A) costs associated with
subcontract/consortium activity may exceed the $50,000 ceiling by the amount
of one module ($25,000). The grants may be extended in time, but not amount,
at the discretion of the applicant organization.
Investigators are encouraged to consider carefully whether their research can
best be accomplished through this or other grant mechanisms, such as the R01
or the small grant (R03) program of the NIDCD. The R03 program is for
scientists who are in the early stages of pursuing an independent research
career, but are not yet ready to submit a new-investigator R01 application.
Specific application instructions have been modified to reflect "MODULAR
GRANT" streamlining efforts being examined by the NIH. The modular grant
concept establishes specific modules in which direct costs may be requested
as well as a maximum level for requested budgets. Only limited budgetary
information is required under this approach. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff. Complete and detailed instructions and information on
Modular Grants can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
RESEARCH OBJECTIVES
The purpose of this PA is to encourage the submission of feasibility studies
for HI research that have the potential for leading to a technological,
methodological, or conceptual breakthrough or major contribution in the basic
and clinical biomedical and behavioral sciences of human communication. This
research may involve: 1) pilot testing of novel scientific experimental
hypotheses, 2) the development of new or novel techniques or technologies,
and/or 3) the acquisition of a body of data that is potentially high-impact
for the scientific enterprise. The research must be focused on one or more
areas within the scientific mission of the NIDCD: hearing, balance, smell,
taste, voice, speech, and language.
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," which have been published in the Federal Register of March 28,
1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994.
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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may obtain copies from these sources or from the program staff
person listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
APPLICATION PROCEDURES
The PHS 398 (rev 4/98) is the form to be used to apply for this program. The
form may be downloaded from the NIH Home Page at
http://grants.nih.gov/grants/forms.htm. It is also available at most
institutional offices of sponsored research, or it may be obtained from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7910,
telephone: 301/435-0714, email: GrantsInfo@nih.gov. The instructions in the
PHS 398 application kit must be adhered to, except where they have been
modified by the following Supplemental Instructions.
RESEARCH PLAN:
Do not exceed a total of 10 pages for the research plan, Sections a-d. This
limitation includes the introductory paragraph described below, tables and
figures, but not Sections e-i. Do not use the appendix to circumvent the 10-
page limit by including tables or figures in the appendix that should appear
in the research plan.
Amply justify the designation of the application as a feasibility study for
HI research in an introductory paragraph at the beginning of the research
plan. Justify why the project would not be appropriate for submission as a
traditional research grant and how this project, if fruitful, would enable
the applicant to craft a research program appropriate for submission as a
full-scale research grant application. Label this paragraph, Justification
as High Impact Research. Applications that lack the introductory
justification or exceed the page limitation will not be reviewed and will be
returned to the applicant.
Some applications submitted in response to this PA may be design-driven
(e.g., development of novel or new technologies) or data-driven rather than
problem-driven (e.g., testing of scientific hypotheses). In the first two
cases, the Specific Aims should state the technique/technology development
needs or the data acquisition needs driving the research rather than the
experimental hypotheses to be tested.
BUDGET INSTRUCTIONS
The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $50,000 or $75,000, the latter in
the case of consortia for contractual activity) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period. Items 8a and 8b should be completed, indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year.
o Under Personnel, List key project personnel, including their names,
percent of effort, and roles on the project. No individual salary information
should be provided.
o For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded to
the nearest $1,000. List the individuals/organizations with whom consortium
or contractual arrangements have been made, the percent effort of key
personnel, and the role on the project. Indicate whether the collaborating
institution is foreign or domestic. The total cost for a
consortium/contractual arrangement is included in the overall requested
direct cost amount for the application. Under these circumstances, the latter
may exceed $50,000 by one module ($25,000). Provide an additional narrative
budget justification for any variation in the number of modules or direct
cost amount requested across a two-year grant period.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations; and
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues, if additional
information is necessary following the initial review.
Submission Instructions
The title and number of this PA must be typed on line 2 of the face page of
the application form and the YES box must be marked.
The completed original application and three copies (less appendices) must be
submitted to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
Send two additional copies of the application and five sets of appendices to:
Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD 20892-7180
The application receipt date is July 21, 2000; applications received after
this date will be returned to the applicant. The earliest date of award is
May 1, 2001. This PA may be reissued in the future.
REVIEW CONSIDERATIONS
All applications will be examined for completeness by the Center for
Scientific Review and responsiveness to this PA by NIDCD staff. Complete and
responsive applications will then be reviewed for scientific and technical
merit in accordance with the standard NIH procedures by a review group
convened by the NIDCD. As part of the initial review, all applications will
receive a written critique. Those applications deemed to have the highest
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level of review by
the NIDCD Advisory Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. The application
does not need to be strong in all categories to be judged likely to have
major scientific impact and thus deserve a high priority score.
(1) Significance: Does this feasibility study have the potential to
significantly impact the scientific enterprise, and if so, to what degree?
If the aims of the application are achieved, how will scientific knowledge be
advanced? Will a successful outcome from this feasibility study lead directly
to more extensive follow-up studies that would likely achieve the long-term
goals of this application?
(2) 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? Does the application contain a demonstrably sound plan
designed to assess the feasibility of the pilot project?
(3) Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies? Does the
project generate a body of data that provides a foundation for important new
research directions?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
conducted contribute to the probability of success? Is there evidence of
institutional support for the research? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include children, both genders, and minorities
and their subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be evaluated.
o The reasonableness of the proposed budget and the project’s duration in
relation to the proposed research.
o The adequacy of the measures proposed for protection of humans, animals
and/or the environment, to the extent they may be adversely affected by the
research proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other favorably
recommended applications. Funding decisions will be based on the quality of
the proposed project as determined by peer review, program priorities, and
availability of funds.
INQUIRIES
NIDCD staff welcome the opportunity to clarify any issues or questions about
this initiative from potential applicants. Direct inquiries regarding
programmatic issues, including eligibility and responsiveness, to:
Hearing:
Dr. Amy Donahue
Telephone: (301) 402-3458
Email: amy_donahue@nih.gov
Dr. Nancy Freeman
Telephone: (301) 402-3458
Email: nancy_freeman@nih.gov
Dr. Thomas Johnson
Telephone: (301) 402-3461
Email: thomas_johnson@nih.gov
Dr. Lynn Luethke
Telephone: (301) 402-3461
Email: lynn_luethke@nih.gov
Balance:
Dr. Daniel Sklare
Telephone: (301) 496-1804
Email: daniel_sklare@nih.gov
Smell:
Dr. Rochelle Small
Telephone: (301) 402-3464
Email: rochelle_small@nih.gov
Taste:
Dr. Barry Davis
Telephone: (301) 402-3464
Email: barry_davis@nih.gov
Voice/Speech:
Dr. Beth Ansel
Telephone: (301) 402-3461
Email: beth_ansel@nih.gov
Language:
Dr. Judith Cooper
Telephone: (301) 496-5061
Email: judith_cooper@nih.gov
The address and FAX number for all of the above named persons are:
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Bethesda, MD 20892-7180
FAX: (301) 402-6251
Direct inquiries regarding fiscal matters to:
Castilla McNamara, M.S.
Grants Management Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: CM249E@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.173. Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant and recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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