and Human Services (HHS)
EXPIRED
BIOENGINEERING RESEARCH GRANTS
Release Date: October 11, 2001
PA NUMBER: PA-02-011
Updates:
- This PA has been reissued, see PA-06-419
- Expiration date extended until reissue later in 2006, see NOT-EB-06-006
- Expiration date extended, see NOT-EB-05-005
- See NOT-EB-04-003 and NOT-EB-04-003
Expiration Date: May 17, 2006, unless reissued.
National Institute of Biomedical Imaging and Bioengineering
National Cancer Institute
National Center for Research Resources
National Eye Institute
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
National Institute on Aging
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute on Deafness and Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Library of Medicine
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS
MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR
BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001)
AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
Participating Institutes and Centers (ICs) of the National Institutes of Health
(NIH) invite applications for R01 awards to support Bioengineering Research
Grants (BRGs) for basic and applied multi-disciplinary research that addresses
important biological or medical research problems. The BRGs support multi-
disciplinary research performed in a single laboratory or by a small number of
investigators that applies an integrative, systems approach to develop knowledge
and/or methods to prevent, detect, diagnose, or treat disease or to understand
health and behavior. A BRG application may propose hypothesis-driven,
discovery-driven, developmental, or design-directed research at universities,
national laboratories, medical schools, large or small businesses, or other
public and private entities.
On October 1, 200l, NIH issued a related program announcement (PA) PAR-02-010
for Bioengineering Research Partnerships (BRPs). The BRPs differ from the BRGs
in that the BRP research will be performed by multi-disciplinary research teams
from several laboratories or organizations and by several investigators.
BACKGROUND
Many of today"s biomedical problems are best addressed using a multi-
disciplinary approach that extends beyond the traditional biological and
clinical sciences. Principles and techniques in allied quantitative sciences
such as physics, mathematics, chemistry, computer sciences, and engineering can
be applied to effectively address biomedical problems. Bioengineering
integrates principles from a diversity of technical and biomedical fields, and
the resulting multi-disciplinary research is providing new basic understandings,
novel products, and innovative technologies that improve basic knowledge, human
health, and quality of life. Bioengineering also crosses the boundaries of
scientific disciplines that are represented throughout academia, Federal
laboratories, and industry.
Recognizing the importance of bioengineering in public health, the
Bioengineering Consortium (BECON) was established in 1997 as a focus for
bioengineering activities at the NIH. To facilitate communication between the
allied and biomedical disciplines and to provide input from the scientific
community on research needs and directions, the BECON has held annual two-day
symposia on emerging topics of interest related to bioengineering including
bioengineering (1998), bioimaging, (1999), nanotechnology (2000), and reparative
medicine (2001). Summaries of the proceedings and recommendations of these
symposia are available on the Internet at
http://www.becon.nih.gov/becon_symposia.htm.
Discussions and recommendations of symposia participants aided the formulation
of the BRP and BRG program announcements. Both the BRP and BRG PAs recognize
that applications for bioengineering projects often focus on technology
development rather than on proving or disproving scientific hypotheses.
Therefore, the NIH review criteria for bioengineering applications submitted in
response to these PAs have been modified to ensure that these proposals are
evaluated appropriately and fairly.
In December 2000, the National Institute of Biomedical Imaging and
Bioengineering (NIBIB) was established at the NIH with a mission to improve
health by promoting fundamental discoveries, design and development, and
translation and assessment of technological capabilities. In support of this
mission, the NIBIB funds research aimed at developing fundamental or cross-
cutting technologies that can be translated into several biomedical
applications. Studies involving technological application to a specific
disease, organ system, or social issue will be considered by the appropriate NIH
institute or center.
RESEARCH OBJECTIVES
Applications for a BRG award should focus on an area of basic, applied,
behavioral, or clinical research in bioengineering that supports the missions of
the NIH institutes and centers and where progress is likely to make a
significant contribution to improving human health.
MECHANISM OF SUPPORT
The mechanism of support will be the NIH R01 research grant. Responsibility for
the planning, direction, and execution of the proposed project will be solely
that of the applicant. The total requested project period for a competitively-
reviewed application may not exceed five years.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit, non-profit, public, and
private organizations. Examples of eligible organizations include universities,
colleges, hospitals, national laboratories, industrial research organizations,
large or small businesses, units of state and local governments, eligible
agencies of the Federal government, and faith-based organizations. Foreign
institutions are not eligible to apply. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
APPLICATION PROCEDURES
Applicants are strongly advised to personally contact the appropriate IC
scientific program staff listed under INQUIRIES to discuss the relevance of
their proposed work to the institute’s mission before preparing a BRG
application. Detailed information on research missions and programs for each
NIH institute and center is available on the individual IC’s Web sites which can
be accessed through the NIH Homepage at http://www.nih.gov.
The PHS 398 research grant application instructions and forms (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying
for these grants and will be accepted at the standard application deadlines
(http://grants.nih.gov/grants/dates.htm) as indicated in the application kit.
This version of the PHS 398 is available in an interactive, searchable format.
Although applicants are encouraged to begin using the 5/2001 revision of the PHS
398 as soon as possible, the NIH will continue to accept applications prepared
using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002,
however, the NIH will return applications that are not submitted on the 5/2001
version. For further assistance contact GrantsInfo, Telephone 301/710-0267,
Email: [email protected].
Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct
costs for any year are advised that he or she must contact the Institute or
Center (IC) program staff before submitting the application, i.e., as plans for
the study are being developed. Furthermore, the application must obtain
agreement from the IC staff that the IC will accept the application for
consideration for award. Finally, the applicant must identify, in a cover
letter sent with the application, the staff member and Institute or Center who
agreed to accept assignment of the application.
Follow the PHS 398 instructions for "Preparing Your Application" with the
following modifications and additions to the section titled Research Plan :
A. Specific Aims Applications submitted in response to this program
announcement may be design-, problem, need-, or hypothesis-driven. Thus, the
application should state the hypotheses, designs, problems, and/or needs that
will drive the proposed research. Describe the specific aims in the appropriate
area of bioengineering research and the goals for the first year and for the
long term. Describe the expected applications of the bioengineering research
that will improve human health. One page is recommended.
B. Background and Significance - Briefly describe the area of
bioengineering research that is the focus of the BRG. Critically evaluate
existing knowledge and approaches that have been or are being applied in the
area and specifically describe how the proposed BRG approach will advance the
field. State concisely the importance and health relevance of the research
proposed to achieve the Specific Aims.
C. Preliminary Studies and Rationale - Preliminary studies that support
the proposed research should be submitted with the application.
D. Research Design and Methods - A BRG should focus on a significant area
of bioengineering research where advances are likely to affect human health or
health-related research. If the proposed BRG research is closely related to
ongoing research, explain how the research activities of the BRG will complement
but not overlap the existing research. Provide a tentative sequence or
timetable for the project. Include how the data will be collected, analyzed, or
interpreted. Applications should also include a plan for making available to
the research community the technologies developed or enhanced by work supported
by this program announcement. Investigators are required to make unique
research resources readily available for research purposes to qualified
individuals within the scientific community when they have been published. The
intent of this policy is not to discourage, impede, or prohibit the organization
that develops the unique research resources or intellectual property from
commercializing the products.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
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. The just-in-time concept
allows applicants to submit certain information only when there is a possibility
for an award. It is anticipated that these changes will reduce the
administrative burden for the applicants, reviewers and NIH staff. The research
grant application form PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in
applying for these grants, with modular budget instructions provided in Section
C of the application instructions. Applicants are permitted, however, to use
the 4/1998 revision of the PHS 398 for scheduled application receipt dates until
January 9, 2002. If you are preparing an application using the 4/1998 version,
please refer to the step-by-step instructions for Modular Grants available at
http://grants.nih.gov/grants/funding/modular/modular.htm. Additional
information about Modular Grants is also available on this site.
The title and number of this program announcement must be typed on line 2 of the
face page of the application form, and the YES box must be marked.
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
for the review because reviewers are under no obligation to view the Internet
sites. Reviewers are cautioned that their anonymity may be compromised when
they directly access an Internet site.
APPLICATIONS EXCEEDING $500,000 PER YEAR DIRECT COSTS
In accordance with NIH policy
(http://grants.nih.gov/grants/guide/notice-files/not98-030.html),
an applicant planning to submit a proposal that requests
$500,000 or more in direct costs for any year must obtain approval to submit the
application from scientific program staff at a research institute or center.
This approval must be obtained at least six weeks before the application receipt
deadline. The applicant must identify the institute or center and the
scientific program staff member who agreed to accept assignment of the
application in the cover letter that transmits the proposal. A list of
scientific program contacts for each of the NIH IC’s is available on the
Internet at http://www.nibib.nih.gov/Funding/Bioengineering/Contacts.
Applications exceeding $500,000 per year direct costs in any year that are
submitted without this approval will be returned.
APPLICATION SUBMISSION INSTRUCTIONS
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)
REVISED APPLICATIONS
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 substantive revision of an
application already reviewed, but such an application must include an
introduction addressing the previous critique.
REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR staff.
Applications that are complete will be evaluated for scientific and technical
merit by Scientific Review Groups of the CSR. As part of the initial merit
review, all applications will receive a written critique and undergo a process
in which only those applications deemed to have the highest scientific merit
(generally the top half of applications under review) may be discussed, assigned
a priority score, and receive a second-level review by the appropriate national
advisory council or board.
REVIEW CRITERIA
The NIH review criteria have been adapted to ensure that the BRG application is
evaluated appropriately. The score should reflect the overall impact that the
BRG award could have on the selected area of bioengineering research based on
consideration of the five criteria given below. The emphasis on each criterion
can vary from one application to another 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 major technical or scientific impact
and thus deserve a high priority score. For example, an investigative
partnership may propose to perform important work that by its nature is not
innovative but is essential to advance a field.
A BRG may propose discovery-driven, developmental, non-hypothesis-driven,
design-directed, or hypothesis-driven research at universities, national
laboratories, medical schools, large or small businesses, or other public and
private entities. The review criteria include:
1. Significance. If the specific aims of the project are achieved, will they
provide significant advances in the selected area of bioengineering research? Is
the research likely to have a significant impact on other areas of research?
Will the technological advances have a significant impact on human health?
2. Approach. Are the engineering, scientific and clinical approaches and methods
adequately developed, well integrated, and appropriate to the aims of the
project? Does the application address potential problem areas and consider
alternative strategies? Is a timetable with adequate research milestones
proposed? Are appropriate specifications and evaluation procedures provided for
assessing technological progress? Is the plan for sharing or disseminating
(through commercialization or other ways) technologies developed or enhanced
under this program announcement adequate?
3. Innovation. Does the BRG propose new approaches, explore new research
paradigms, or represent new concepts that combine bioengineering, physical, and
clinical sciences? Will the proposed approaches or concepts solve current
scientific or technical problems in novel ways?
4. Investigators. Is the PI capable of coordinating and managing the proposed
project? Are the investigators (partners) appropriately trained in their
disciplines and capable of conducting the proposed interdisciplinary work?
5. Environment. Does the scientific and technological environment in which the
work will be done contribute to the probability of success? Does the proposed
research take advantage of unique features of the scientific environment or
employ useful collaborative arrangements within the partnership? Is there
evidence of institutional support?
AWARD CRITERIA
BRG applications will compete for available funds with all other recommended
applications. Funding decisions will be based on the quality of the proposed
research as determined by peer review, availability of funds, and the
institute’s programmatic priority for the focus of the proposed research.
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 is 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" published in the NIH Guide for Grants and Contracts on August 2,
2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).
Recent revisions relate to NIH-defined Phase III clinical trials and require: a)
all applications or proposals and/or protocols to 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) all
investigators to report accrual and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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 on the Internet at
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is available in the NIH Guide for Grants an
Contracts, June 5, 2000 (Revised August 25, 2000), available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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:
http://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.
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 program announcement is related to one
or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" on the Internet at http://www.health.gov/healthypeople/.
INQUIRIES
Inquiries concerning this PA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Inquiries or contacts concerning institute-specific scientific or financial
issues should be directed to the NIH BECON scientific or financial contacts
listed at the following Web site:
http://www.becon.nih.gov/becon_contacts.htm.
These scientific contacts can also be used to obtain permission to submit
applications that request more the $500,000 of direct costs in any year.
Inquiries regarding general programmatic issues should be directed to:
Dr. Richard E. Swaja
National Institute of Biomedical Imaging and Bioengineering
31 Center Drive Room 1B37
Bethesda, MD 20892-2077
TEL: 301-451-6771
FAX: 301-480-4515
E-mail: [email protected]
Inquiries concerning review issues should be directed to:
Dr. Eileen Bradley
Center for Scientific Review
6701 Rockledge Drive
Bethesda, MD 20892
TEL: 301-435-1179
FAX: 301-480-2241
E-mail: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.394, 93.395, 93.396, 93.306, 93.867, 93.172, 93.837, 93.838, 93.839, 93.866,
93.273, 93.855, 93.856, 93.846, 93.864, 93.865, 93.929, 93.279, 93.173, 93.121,
93.847, 93.848, 93.849, 93.113, 93.821, 93.859, 93.862, 93.242, 93.853, 93.361,
and 93.879. Awards are made under authorization of Sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered under
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92.
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes general
information about the grant application and review process, information on the
terms and conditions that apply to NIH grants and cooperative agreements, and a
listing of pertinent offices and officials at the NIH.
The PHS strongly encourages all grant and contract 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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