EXPLORATORY/DEVELOPMENTAL RESEARCH: FEASIBILITY PILOT STUDIES
RELEASE DATE: March 21, 2002
PA NUMBER: PAR-02-088
EXPIRATION DATE: July 15, 2002, unless reissued
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
APPLICATION RECEIPT DATE: July 15, 2002
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Sending an Application to the NIH
o Research Plan
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citation
PURPOSE
The NIDCD invites applications for innovative, initial feasibility pilot
studies focused on hearing, balance, smell, taste, voice, speech, and
language, the scientific mission areas of the NIDCD. The proposed research
should involve the testing of novel hypotheses or the application of new
techniques or methodologies at an early stage of development. These novel
ideas may differ substantially from current thinking and practice and may
have an uncertain outcome because sufficient experimental data are
unavailable. Applications submitted under this mechanism should be innovative
with a potential to have a major impact on a field of biomedical research by
breaking new ground or by extending previous discoveries toward new
directions. It is intended that, if promising, the additional pilot data
generated by these exploratory grants may serve as a basis for a more
extensive follow-up investigation (e.g., an investigator-initiated R01 grant
application).
RESEARCH OBJECTIVES
The purpose of this program announcement (PA) is to encourage investigators
working within and outside the communication sciences to submit feasibility
pilot studies within the scientific mission areas of the NIDCD. This PA
supersedes an expired NIDCD PA: Exploratory Research: Feasibility Pilot
Studies, PAR-01-103. The current PA supports the initial feasibility studies
that will test novel ideas or the application of new techniques or methods at
an early stage in their development, and may contribute substantially to our
understanding of the communication sciences. Such areas of investigation
typically lack a historical base of scientific data (e.g., a body of peer-
reviewed publications) and, therefore, would require pilot studies to
generate the amount of pilot data that is needed for the submission of a
regular research grant. The proposed project may be related to an ongoing
research program or may involve a new area of research for the laboratory.
The NIDCD encourages applications from investigators conducting research
outside the communication sciences who possess expertise with methodological
approaches that have not been typically applied to but which would greatly
promote scientific progress within the communication sciences.
The amount of pilot data that typically accompanies an R01 application is not
required as a part of the NIDCD EXPLORATORY/DEVELOPMENTAL RESEARCH grant
mechanism. Nonetheless, the applicant has the responsibility to provide
sufficient pilot data to demonstrate the soundness and feasibility of the
research plan. Past experiences have shown that it is difficult to evaluate
the scientific merit of applications during initial review if insufficient
pilot data are provided. In cases involving a change in research focus or
direction for the laboratory, the appropriate expertise of key personnel and
collaborators to pursue such novel research must be evident.
The NIDCD EXPLORATORY/DEVELOPMENTAL RESEARCH grant mechanism is open to all
investigators, whether newly independent or established. However, the NIDCD
strongly encourages newly independent individuals who are starting their
first independent research program to seek support through the NIDCD Small
Grant (R03) funding mechanism. The NIDCD R03 mechanism is designed to
support a new research program at an early stage of development during the
transition to independence. The newly independent applicant is urged to
contact the appropriate program director during the planning stages of an
application. It is anticipated that applications submitted by established
investigators in response to this PA will seek support to pursue new ideas
that require pilot data and that fall outside the scope of existing research
projects.
MECHANISM OF SUPPORT
This PA will use the NIH Exploratory/Developmental Grants (R21) mechanism.
As an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. The current PA offers nonrenewable awards
for up to two years of support and up to $100,000 per year in direct costs to
support exploratory research where sufficient pilot data to support a regular
research grant application are lacking. Areas of the communication sciences
with sufficient existing preliminary data to support the submission of a
regular research grant application do not qualify under this PA. An
individual may submit only one application as the principal investigator.
This PA uses just-in-time concepts. It also uses the modular budgeting
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
of $250,000 or less, use the modular format.
Submission of an application under this PA precludes submission of any other
application to the NIH containing substantially the same research proposal.
In addition, awards made in response to this initiative 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application if your institution has any of the following
characteristics:
o For-profit and non-profit organizations
o Public and private, such as universities, colleges, hospitals, and
laboratories
o Units of state or local governments
o Eligible agencies of the Federal government.
o Domestic
Foreign organizations or organizations in foreign countries are not eligible,
subcontracts to foreign organizations are allowable, with sufficient
justification.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Hearing:
Dr. Amy Donahue
Telephone: (301) 402-3458
Email: amy_donahue@nih.gov
Dr. Nancy Freeman
Telephone: (301) 402-3458
Email: amy_donahue@nih.gov
Dr. Thomas Johnson
Telephone: (301) 402-3461
Email: thomas_johnson@nih.gov
Dr. Lynn Luethke
Telephone: (301) 402-3458
Email: lynn_luethke@nih.gov
Balance:
Dr. Daniel Sklare
Telephone: (301) 496-1804
Email: daniel_sklare@nih.gov
Taste and Smell:
Dr. Barry Davis
Telephone: (301) 402-3464
Email: barry_davis@nih.gov
Language:
Dr. Judith Cooper
Telephone: (301) 496-5061
Email: judith_cooper@nih.gov
Voice and Speech:
Dr. Lana Shekim
Telephone: (301) 496-5061
Email: Lana_Shekim@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
Rockville, MD 20892-7180
FAX: (301) 402-6251
o Direct your questions about peer review issues to:
Dr. Craig Jordan
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Rockville, MD 20892-7180
Telephone: 301-496-8683
FAX: (301) 402-6250
Email: jordanc@nih.gov
o Direct your questions about financial or grants management 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
Rockville, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: CM249E@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package 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)
The title, EXPLORATORY/DEVELOPMENTAL RESEARCH: FEASIBILITY PILOT STUDIES, and
the number of this announcement, PAR-02-XXX, must be typed on line 2 of the
face page of the application form and the YES box must be marked.
Send two additional copies of the application and five sets of appendices (if
applicable) 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
ROCKVILLE, MD 20852 (for express/courier service)
The submission, review, and award schedule is:
Application Receipt Date: July 15, 2002
NIDCD Committee Review: October/November, 2002
Council Review: January, 2002
Earliest Funding: April, 2003
APPLICATION PROCESSING: Applications must be received by or mailed before the
receipt date listed on the face page of the PA. The Center for Scientific
Review (CSR) will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application
already reviewed, but such an application must include an Introduction
addressing the previous critique.
RESEARCH PLAN:
Do not exceed a total of 10 pages for the Research Plan. This limitation
includes the introductory justification paragraph that is described below, as
well as tables and figures. Enlarged glossy color photographs, electron
micrographs, or photographs of gels may be included in the Appendix.
However, tables or figures included in the Appendix must also appear within
the page limitations of the Research Plan but may be reduced in size.
Justification as Exploratory/Developmental Research
Applications that lack an acceptable introductory justification paragraph
will be returned to the applicant without undergoing initial peer review.
Amply justify the designation of the application as a feasibility pilot study
in an introductory paragraph at the beginning of the research plan. Label
this paragraph, "Justification as Exploratory/Developmental Research." Do not
incorporate the justification within the main text of the research plan.
Explain how this project represents a test of novel ideas that require pilot
studies, justify why the project would not be appropriate for submission as a
regular research grant at this time, and how this project, if fruitful, would
enable you to craft a research program appropriate for submission as a full-
scale research grant application. If you are a newly independent
investigator, justify how this project differs from the main research program
currently in development in the laboratory and why this project is not
suitable for the NIDCD Small Grant (R03) funding mechanism. NIDCD staff will
use the justification paragraph to determine whether the application is
responsive to the goals of this PA. Non-responsive applications will be
returned to the applicant without undergoing initial peer review.
The applications submitted in response to this PA must test specific
hypotheses or develop new technologies or methodologies. Data-driven (e.g.,
database management, mining, or distribution) applications are not eligible.
The current PA provides nonrenewable awards for up to two years of support
and up to $100,000 per year in direct costs. The total cost (Direct plus
Facilities and Administrative (F & A) costs) for any consortium/contractual
arrangement must be included within the overall requested direct cost amount
for the application, which can not exceed $100,000.
PEER REVIEW PROCESS
All applications will be examined for completeness by the CSR and for
responsiveness by NIDCD staff. Incomplete applications or applications
failing to comply with NIH grant format guidelines
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-037.html) will be
returned. Complete and complying applications will be reviewed for
scientific and technical merit in accordance with standard NIH procedures by
a review group convened by the NIDCD Scientific Review Branch.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Deafness 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 your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your 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 your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children, as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
o Does the proposed research represent a test of novel ideas, techniques or
methods that will impact the concepts that drive the field?
o Will the successful outcome of the proposed studies likely generate
sufficient data to pursue follow-up studies and lead to a full-scale
research grant application?
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS:
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are
available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht
m. The amended policy incorporates: the use of an NIH definition of
clinical research, updated racial and ethnic categories in compliance with
the new OMB standards, clarification of language governing NIH-defined Phase
III clinical trials consistent with the new PHS Form 398, and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy 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 is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
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
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.173 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the 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.
https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.