EXPLORATORY RESEARCH: FEASIBILITY PILOT STUDIES

Release Date:  May 31, 2001

PA NUMBER:  PAR-01-103

National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov)

Application Receipt Date:  August 10,  2001

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.

(http://grants.nih.gov/grants/funding/modular/modular.htm)

PURPOSE

The National Institute on Deafness and Other Communication Disorders (NIDCD) 
invites applications for exploratory, initial feasibility pilot studies 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-00-075 (NIH 
Guide, March 6, 2000).  The current PA places more emphasis on exploratory, 
initial feasibility pilot studies into new areas of research within the 
communication sciences and less emphasis on the potential for high impact.  
Exploratory research involves initial feasibility pilot studies in which the 
technological, methodological, or theoretical approach to a problem lacks 
sufficient preliminary/baseline data and a body of peer-reviewed publications, 
but whose successful outcome would make a significant contribution to a 
scientific area or field.  It is anticipated that most applications will be 
submitted by investigators with ongoing research programs who wish to change the 
focus of their current research effort or move into a new area of research 
within the communication sciences but need additional funds to complete initial 
pilot studies. The NIDCD encourages applications from investigators conducting 
research outside the communication sciences who possess expertise with 
methodological or technological approaches which have not been typically applied 
to but which would greatly promote scientific progress within the communication 
sciences.  The NIDCD R21 funding mechanism is not intended for the advanced 
postdoctoral fellow starting to plan an independent research career or for the 
new investigator at the early stages of independence.

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 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.

MECHANISM OF SUPPORT

Support for this program will be provided through the National Institutes of 
Health (NIH) Exploratory/Developmental Grants (R21) mechanism.  This mechanism 
provides nonrenewable awards for up to two years of support and up to $50,000 in 
direct costs per year to support exploratory research where sufficient pilot 
data to support a regular research grant application is lacking. Areas of 
science with sufficient existing preliminary data to support the submission of a 
regular research grant application do not qualify under this PA.   

Specific application instructions have been modified to reflect "MODULAR GRANT" 
streamlining efforts established 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 established investigators working within 
and outside the communication sciences to submit exploratory, initial 
feasibility pilot studies within the scientific mission areas of the NIDCD:  
hearing, balance, smell, taste, voice, speech, and language.  The proposed 
research should have the potential for leading to a technological, 
methodological, or conceptual contribution in the basic or clinical biomedical 
or behavioral sciences investigating one or more of the aforementioned areas.   
This research should involve preliminary exploration of novel scientific 
experimental hypotheses and/or the development of new methodologies or 
technologies that represent a different research focus or new research direction 
for the laboratory.  The NIDCD R21 grant mechanism provides an opportunity to 
propose research that has an uncertain outcome because sufficient experimental 
data are unavailable.  It is intended that the additional pilot data generated 
by these exploratory grants, if promising, will serve as a basis for a more 
extensive follow-up investigation, commonly pursued through the submission of an 
investigator-initiated R01 grant application.  This mechanism does not support 
research that is essentially the logical progression of an ongoing 
research program.

The NIDCD R21 grant mechanism is designed primarily for investigators with 
ongoing research programs who wish to introduce a change in research focus or a 
new research direction into the laboratory but need additional research funds to 
complete initial feasibility pilot studies.  A change in research focus or new 
research direction may involve a different methodological approach, the adoption 
of a newer technology, the use of another animal model, the exploration of a gap 
area of research, or entry into an area of the communication sciences that is 
not typically associated with the research of the laboratory.  Investigators 
without an ongoing research program and who have had a history of research 
support and productivity are not precluded from applying.  In these special 
cases, the application must demonstrate a need for research funds to conduct 
pilot studies that represent a change in research focus or a new 
research direction.

Although the amount of pilot data that typically accompanies an R01 application 
is not required as a part of this NIDCD R21 funding mechanism, the applicant has 
the responsibility to provide sufficient pilot data to demonstrate the soundness 
of the research plan.  Moreover, since the goal of the NIDCD R21 grant mechanism 
is to encourage a change in research from that of an ongoing research program, 
the appropriate expertise of key personnel and collaborators to pursue such 
novel research must be evident. 

A new investigator at the beginning of an independent research career is not 
eligible to submit a NIDCD R21 grant application in response to this PA.  A new 
investigator is defined as an individual (including an advanced postdoctoral 
fellow) who is in the planning- or early-stages of pursuing an independent 
research career and has not received Federally-funded research support, with the 
exception of National Research Service Award (NRSA) fellowships and 
trainee-ships or mentored career development awards.   It is recommended that 
such individuals use the NIDCD Small Grant (R03) mechanism to pursue new 
research ideas.  The NIDCD R03 grant mechanism is designed specifically to 
support the transition of scientists who are in the early stages of pursuing an 
independent research career (including advanced postdoctoral fellows) but who 
are not yet ready to submit a R01 application.

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 
sub-populations 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 
(http://grants.nih.gov/grants/guide/notice-files/not94-100.html).
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.  
There are also new requirements for education in the protection of human 
research participants 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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:  
301/710-0267, 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 justification 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.  Avoid the use of color photographs in the research 
plan to demonstrate critical pilot data, experimental approaches, and unique 
equipment because the applications are reproduced using black-and-white 
photocopying.  A larger color version of any black-and-white photograph in the 
research plan may be included in the appendix.

Justification as Exploratory Research

Amply justify the designation of the application as an initial feasibility pilot 
study in an introductory paragraph at the beginning of the research plan.  
Explain how this project represents a change in research focus or a new research 
direction for your laboratory, 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.  Label this paragraph, 
 Justification as Exploratory Research.  Applications that lack the introductory 
justification 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 new technologies) or data-driven (e.g., database management, 
mining or distribution) rather than problem-driven (e.g., testing of scientific 
hypotheses).  In the cases of design-driven or data-driven applications, 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: Item 7a should indicate Direct Costs (in $25,000 increments up to 
a maximum of $50,000). Item 7b should indicate 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 all 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 
costs plus Facilities and Administrative costs) for each year, each rounded to 
the nearest $1,000.  List the individuals/organizations with whom the 
contractual arrangements have been made, the per cent effort of all personnel 
and their role on the project. Indicate whether the contracting organization is 
foreign or domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested direct cost amount for the application.  
Provide an additional budget justification narrative 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 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

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, EXPLORATORY RESEARCH:  FEASIBILITY PILOT STUDIES, and the number of 
this PA, PAR-01-103, 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 (without 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
ROCKVILLE, MD  20852 (for express/courier service)

The submission, review, and award schedule is:

Application Receipt Dates:  August 10, 2001
NIDCD Committee Review:     October/November, 2001
Council Review:             January, 2002
Earliest Funding:           April, 2002

REVIEW CONSIDERATIONS

All applications will be examined for completeness by NIDCD staff.  Incomplete 
applications or applications failing to comply with NIH grant format guidelines 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-012.html) will be returned.  
Complete and complying applications will be reviewed for scientific and 
technical merit in accordance with the standard NIH procedures by a review group 
convened by the NIDCD Scientific Review Branch. 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 NDCD 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 pilot study address an important problem and have 
the potential to impact the scientific enterprise significantly.  If the aims of 
the application are achieved, how will scientific knowledge be advanced? 

(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 sound research plan that is 
designed to adequately 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?  

(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, key personnel and other collaborators (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 
sufficient institutional support for the research? Do the proposed experiments 
take advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?

(6)  Evaluate 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.

(7)  Evaluate the reasonableness of the proposed budget and the project’s 
duration in relation to the proposed research.

(8)  Evaluate 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.

SPECIAL REVIEW CRITERIA

In addition to the above criteria, all applications will also be reviewed with 
respect to the following:

1. Does the proposed research represent a change in research focus or a new 
research direction for the laboratory that requires feasibility pilot studies, 
or is the proposed research the logical continuation of ongoing 
research efforts?

2. In the case of research that is hypothesis-driven, 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? 

3. In the case of proposed research that is either technology-driven or 
design-driven, will the project generate a body of data, a technological advance 
or product that will be useful to the communication sciences community? 

4. How will the successful completion of the proposed studies impact the 
concepts, methods, or technologies that drive the field?

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 and strongly encourage potential applicants to contact the 
appropriate program officer prior to the start of formulating a grant proposal.  
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) 402-3458
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

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
Rockville, 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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