and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov/)
Components
of Participating Organizations
National
Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Exploratory/Developmental Alcohol Research Centers (P20)
Announcement Type
This is a modification of RFA-AA-07-001 which was previously released June 1, 2006
Request For Applications (RFA) Number: RFA-AA-08-003
Catalog of Federal Domestic Assistance Number(s)
93.891
Key Dates
Release Date: July 6, 2007
Letters of Intent Receipt Date(s): November 14, 2007
Application Receipt Date(s): December 14, 2007
Peer Review Date(s): March-June, 2008
Council Review Date(s):October 2008
Earliest Anticipated Start Date(s): December 1, 2008
Additional Information To Be Available Date (Url
Activation Date): N/A
Expiration Date: December 15, 2007
Due Dates
for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible
Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special
Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and
Review and Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application
to the NIH
C. Application
Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional
Review Criteria
B. Additional
Review Considerations
C. Sharing
Research Data
D. Sharing
Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad based Alcohol Research Center program to foster and conduct interdisciplinary, collaborative research on alcoholism, alcohol abuse and the impact of alcohol and health and disease. The NIAAA Centers Program provides leadership in research, research methodology development and information dissemination on a wide variety of topics relevant to the Institute’s mission. These topics include, but are not limited to, investigations into the nature, etiology, genetics, diagnosis, treatment, and prevention of alcohol use disorders and their biomedical, psychosocial, and economic consequences across the lifespan. Centers are also major contributors to the development of new research methods, technologies, and approaches that sustain innovative goal-directed research.
With this RFA the NIAAA invites applications for Exploratory/Developmental Alcohol Research Centers using the NIH planning grant (P20) mechanism. The purpose of Exploratory/Developmental Centers is to permit groups of researchers to initiate and develop a cohesive, interdisciplinary team focused on a significant alcohol research theme and to assist them in establishing the necessary collaborations, core facilities and research capability to justify an application for new Specialized (P50) or Comprehensive (P60) Alcohol Research Center in the future. Grants awarded under this RFA will provide financial support for activities of various kinds including the general development of infrastructure and capacity, team-building and exploratory research projects such as pilot or feasibility studies.
Recent progress across a wide variety of disciplines has markedly advanced our understanding of factors that impact the development of alcohol use disorders and determine vulnerability to alcohol’s effects. Cross disciplinary approaches and translational research are facilitating the integration of basic and clinical research, and improving strategies for prevention and treatment. Alcohol research has progressed to the point that the most pressing issues are inherently complex and cross multiple disciplines. Hence a need for Exploratory/Developmental Centers with the explicit goal of building infrastructures capable of supporting interdisciplinary teams focused on a central theme and a series of interrelated questions.
Thus planning grant applications are expected to identify a relevant and important issue or problem, propose how innovative new research will address the related questions, provide a rationale for the proposed interdisciplinary approach, identify a planning strategy, and propose an appropriate timeline. Planning activities could include, but are not limited to, organizing and conducting workshops and symposia, developing mentoring opportunities for junior investigators, and conducting exploratory or feasibility studies.
The central theme of the proposed Exploratory/Developmental Center should reflect the expertise of the participating investigators, should take advantage of the institution’s strengths and/or unique facilities including, such as access to relevant clinical populations, and should be directed toward a high priority topic of significant importance.
Multiple Principal Investigator leadership structure
In light of the increasing contributions of multidisciplinary team science NIH has instituted the opportunity for applicant institutions to use multiple-PIs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).
The prospect of incorporating Multiple-PI leadership structures into Alcohol Research Centers complements NIAAA s long-standing commitment to a Centers program specifically directed toward multidisciplinary, collaborative research. Examples include support for: clinical and basic research collaborations, translational research, cross-institutional transdisciplinary collaborations, the development of experimental models targeted to significant issues in alcohol research, the rapid adoption and application of new technology, and the addition of an educational or information dissemination component for Comprehensive Alcohol Research Centers (P60). In further support of these goals, the NIAAA for the first time invites Alcohol Research Center applicants to consider using the multiple-PI leadership format.
SPECIAL REQUIREMENTS for Exploratory/Developmental Alcohol Research Centers
The NIAAA Exploratory/Developmental Center grant provides a mechanism for: 1) planning and fostering interdisciplinary cooperation among established investigators conducting high quality alcohol research, 2) supporting investigators engaged in research that has potential for enhancing new discoveries relevant to alcohol and 3) promoting the inclusion of junior investigators likely to bring new ideas and expertise to the field.
All activities will be under the general direction and supervision of the Principal Investigator, who will function as Director of the Exploratory/Developmental Center. The Principal Investigator should be an established, independent scientist in the field of alcohol research and in the chosen scientific theme of the proposed Center. Existence of strong research capability together with viable research potential among faculty and students is fundamental to the establishment of collaborative research that involves participants in coordinated efforts beyond and across departmental structures of an institution. A Center should be an identifiable organizational unit within an institutional structure such as a university, medical center or a consortium of affiliated cooperating institutions. Collaborations that take advantage of unique scientific opportunities and availability of shared resources from other centers and/or investigators in other institutions are encouraged.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity will use the NIH Exploratory/Developmental Alcohol Research Center
(P20) award mechanism.
The applicant is solely
responsible for planning, directing, and executing the proposed project.
A grant supporting an Alcohol Research Center is not transferable to another
institution.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" for the entire Center and for each project and core must be provided in the application.
2. Funds Available
The NIAAA intends to
commit approximately 7-9 million dollars in FY 2009 and expects to fund 4-7 new
and/or competing continuation Center grants in response to this and the three
related RFAs which together employ four different mechanisms (P20, P30, P50 and
P60). The expected annual direct costs for P20 awards will
range from about $250,000 to $700,000. The total cumulative award for a P20 Alcohol Research
Center is limited to $2,500,000 (direct plus indirect) over a three, four or
five-year period, with no more than $1,000,000 and no less than $350,000 in
total costs allowed in any single year. Since Exploratory/ Developmental
grants are not generally intended to support major capital expenditures,
requests for such costs must be justified as necessary for the long-term
viability of the Center.
The earliest anticipated funding date is December 1, 2008. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAAA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Exploratory/Developmental Centers funded under this RFA are not renewable. Awardees of Exploratory/Developmental Centers supported through this RFA are encouraged to direct their future activities toward applying for a Specialized (P50) or Comprehensive (P60) Alcohol Research Center. Future applications for a Specialized or Comprehensive Center may be submitted in response to any future NIAAA Alcohol Research Center funding opportunity and need not wait to coincide with the completion of the total project period for the Exploratory/Developmental Center.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application if your organization has any of the following characteristics:
1.B. Eligible Individuals
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 support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one Center application provided they are scientifically distinct. Applicants are encouraged to contact Program Officials for further guidance.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone 301-710-0267,
Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application
Submission
Applications must
be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
The following paragraphs describe the Special Requirements for an Exploratory/Developmental Center application.
Only applications that focus on alcohol related research will be considered responsive to this RFA.
An Exploratory/Developmental Alcohol Research Center must have a clearly articulated Administrative Core that should serve to integrate the scientific and infrastructure aims. This core should specify the administrative and organizational structures that will be used to support the proposed research and research development activities. It should describe a structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability.
Administrative functions should include: management of fiscal resources; establishment of mechanisms for regular meetings of participating investigators; communication, data management and security operations; and allocation of space, equipment and resources. Where appropriate, applicants should described plans for developing websites for information and data sharing. The Administrative Core is expected to serve as the central operations hub to foster an environment conducive to research excellence, support innovation and creativity, facilitate collaborations, coordinate efforts, and monitor progress of a comprehensive plan. Applicants should also include plans for establishing a Program Advisory Committee to provide independent outside feedback.
It is expected that Center participants will have ongoing active research activities at their institution. The application should explain how alcohol research can be expanded and enhanced by the support requested under this RFA. Particular emphasis should be given to how a Center would facilitate interdisciplinary collaboration that is not otherwise occurring, or is occurring only to a limited extent. The application should describe how the Center will expand and enhance research training and mentoring opportunities for junior investigators and encourage established investigators to focus their efforts on alcohol research. The direct support of training efforts (e.g., stipends), however, must be sought through other mechanisms such as NIH training and career development grants.
An Exploratory/Developmental Center may propose one or more specific research projects which are relevant to the scientific focus and theme the applicant has chosen. It is suggested that at least one project establish the long-term goals of the Center that will carry the momentum of the project through to the next stage of preparing P50 or P60 application. Additional projects can be used to establish strategies for bringing new investigators into alcohol research or to demonstrate the Center s potential for developing novel methodologies or introducing creative new research ideas. Research projects should be described with sufficient detail to allow appropriate peer-review of scientific merit and methodological soundness, but due to the purpose of this RFA and its funding limitations subsequent more rigorous investigations may be necessary for definitive hypothesis testing. In addition small pilot projects may be proposed as a way to establish feasibility or gather preliminary data.
While the management and direction of the pilot projects is left to the discretion of the Center, the application must provide a description of the process to be followed in the solicitation and selection of new projects and/or replacing projects proposed in the application during the award period. All proposed pilot projects need not be ongoing at any one time but may be phased in at different time points during the life of the center grant.
Applications for NIAAA Exploratory/Developmental Alcohol Research Centers are to use the standard format of PHS Form 398 with the exception of page limits. The Administrative Core including the discussion of the Center as a whole will be limited to 25 pages. Other components such as resource cores, each exploratory project, and the pilot projects as a group are limited to 15 pages each. In addition to the overall Center budget, each component requires a separate detailed budget.
The application must also present a detailed plan or timeline for the duration of the proposed Center program.
Multiple Principal Investigators Leadership Plan
Applications using the Multiple-PI option must identify each of the PIs on the Face Page-continuation of the PHS 398 form, and include a new section titled Multiple PI Leadership Plan (PHS 398, Section I, http://grants.nih.gov/grants/funding/phs398/398_forms.doc). The Leadership Plan must provide a rationale for choosing this structure and explain how multiple-PIs will enhance the Center’s strengths and promote its long-term viability. The roles and administrative, technical, and scientific responsibilities should be described for each of the PIs, in relationship to each other and other investigators and staff. If significant changes or contingencies in the PI roles are anticipated, these should be described. A table may be included to illustrate individual as well as shared responsibilities. Section I should be as concise as possible and avoid repeating other parts of the application.
The governance and organizational structure of the leadership team and the research project should be described, including communication plans, a process for making decisions on scientific direction, and procedures for resolving conflicts. If there is to be a distribution of budgetary resources related to the roles of individual PIs these must be included in the Leadership Plan. Clarify whether these distributions are, or are not, associated with budgets for Center components and indicate if this plan would require distributions to different organizational units of the applicant institution. In the event of an award, the requested allocations may be reflected in a footnote on the NOGA (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).
Leadership Plan should summarize the Multiple-PI plan and address the following administrative processes and PI responsibilities:
Additional information about Multiple-PI applications can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html and associated links therein. Additional instructions for Section I are included in the PHS 398 Specific Instructions at http://grants.nih.gov/grants/funding/PHS398/instructions2/phs398instructions.htm#p1_specific_instructions.htm. Applicants considering the multiple-PI option are strongly encouraged to contact the NIAAA program officials at the earliest possible date.
Other Requirements:
Facilities and Environment
Applicants must demonstrate the availability of adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed Alcohol Research Center program. To the extent possible it is desirable for Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Internet access to scientific literature and other information must be readily available. Relevant support services, including for example adequate data processing facilities, must also be readily accessible and documented in the proposal.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A).
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent
Receipt Date(s): November 14,
2007
Application
Receipt Date(s) : December 14,
2007
Peer Review Date(s): March-May 2008
Council Review
Date(s): October 2008
Earliest
Anticipated Start Date(s): December
1, 2008
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NIAAA staff to
estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Abraham Bautista, Ph.D.
Chief, Extramural Project
Review Branch
National Institute on
Alcohol Abuse and Alcoholism
National Institutes of
Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
ATTN:
RFA AA-08-003
6701 Rockledge
Drive, Room 1040, MSC 7710
Bethesda, MD
20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD
20817 (for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Abraham Bautista, Ph.D.
Chief, Extramural Project
Review Branch
National Institute on
Alcohol Abuse and Alcoholism
National Institutes of
Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email [email protected]
Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, the applicant will be notified and the application will not be reviewed.
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIAAA. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
Information on the status of an application can be checked
by the PI in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or competing continuation
award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award costs
incurred. NIH expects the grantee to be fully aware that pre-award costs result
in borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Plan for Sharing Research
Data
The precise content
of the data-sharing plan will vary, depending on the data being collected and
how the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of such
an agreement (including the criteria for deciding who can receive the data and
whether or not any conditions will be placed on their use), and the mode of
data sharing (e.g., under their own auspices by mailing a disk or posting data
on their institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All applicants
must include a plan for sharing research data in their application. The data
sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application
Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NIAAA in accordance with the stated
review criteria.
As part of the initial merit review, all applications
will:
Applications recommended by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, continuity of support, and availability of funds. Awards will be made for up to 5-year project periods with separate fiscal awards made annually.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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. Note that an 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
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators 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? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)? Does the
PD/PI(s) and investigative team bring complementary and integrated expertise to
the project (if applicable)?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit from
unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
Given that the P20 is a planning mechanism, the emphasis should be on team building, multi disciplinary integration, feasibility assessment, creativity and the Center’s long-term impact potential, rather than hypothesis testing. The review criteria for the Exploratory/Developmental Alcohol Research Center application are:
Significance: Does the proposed Center address an important problem in alcohol research? What is the potential for the proposed Exploratory/Developmental Center to lead to a successful application for a Specialized or Comprehensive Alcohol Research Center? If the long-term aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Is there adequate rationale to support the use of a Center, as opposed to other mechanisms (e.g., individual R01 applications)? Does the conceptual and theoretical framework of the Center make optimal use of collaborations to promote a multidisciplinary approach consistent with the Center’s research theme? Specifically:
Innovation: Does the Center propose to develop novel concepts, approaches, measures or methods in alcohol research? Does the theme represent the current state of science and is the Center likely to develop new theoretical or conceptual models to achieve significant advancement? Do the research questions represent a potential for challenging existing paradigms in research or clinical practice; or address critical barriers to progress in the field.
Investigators: Is the Center Director and other senior investigators at the forefront of their respective fields? Will the investigators devote sufficient time to developing a new Center, including research, administrative and mentoring activities? Do they have the experience and authority necessary to organize, administer and direct the Center?
Environment: Does the scientific environment of the Center contribute to the probability of success? Does the Center draw on the strengths of the institution or take advantage of unique features of the scientific environment? Are convincing letters of support and collaboration included? Is there evidence of institutional support? Does the Center have appropriate access to required resources such as existing data sets or clinical populations?
Center as a whole: Does the application demonstrate a potential for developing an organizational structure, a unifying theme and the cohesiveness capable of creating a whole that is greater than the sum of its parts?
The MULTIPLE-PI LEADERSHIP PLAN (optional Section I) will be evaluated with the following criteria:
Aspects of the Multiple-PI plan should be integrated throughout the application and therefore included in the criteria listed above. The criteria listed below refer to the Multiple-PI Leadership Plan as it appears in Section I and an overall assessment of the Multiple Principal Investigator Leadership Plan. Additional guidance for reviewers is available at: http://grants.nih.gov/grants/multi_pi/multi_pi_guidance.doc.
Significance: Does the Multiple-PI Leadership Plan offer a clear and compelling advantage to a traditional single PI model? Will the Leadership Plan contribute to the overall scientific integration and productivity of the Center?
Approach: Is the leadership approach appropriate for the scientific goals and personnel of the Center? Do the identified roles and responsibilities for the PIs match their experience and areas of expertise? Is the proposed governance and organizational structure consistent with and justified by the aims of the project and the roles of the PIs?
Innovation: Does the Multiple-PI Leadership plan contribute to the Center’s originality or innovativeness? Does the Multiple-PI Leadership plan facilitate the development of novel concepts, approaches, or methodologies appropriate for the Center’s intended theme?
Investigators: Are the designated PIs appropriately trained and well suited to carry out their role as described in the application? Is the work proposed appropriate to the experience level of the PIs and other researchers? Do the PIs and the investigative team bring complementary and integrated expertise to the project?
Environment: Does the proposed administrative environment enhance the productivity of the PIs and thereby serve the ultimate goals of the project. Specifically:
2.A.
Additional Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care
and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy. Program staff will be
responsible for the administrative review of the research data sharing plan.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of
the resources sharing plan will be considered by Program staff of the NIAAA
when making recommendations about funding applications. Program staff may
negotiate modifications of the data and resource sharing plans with the awardee
before recommending funding of an application. The final version of the data
and resource sharing plans negotiated by both will become a condition of the
award of the grant. The effectiveness of the resource sharing will be evaluated
as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A
Section VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with NIH policy.
In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information.
We encourage your inquiries concerning this funding
opportunity 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:
1. Scientific/Research Contacts:
R. Thomas
Gentry, Ph.D
Division of Metabolism and
Health Effects
National Institute on
Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2025
Bethesda, MD 20892-9304
Telephone: 301-443-6009
FAX: 301-594-0673
Email: [email protected]
Michael Hilton, Ph.D
Division of Epidemiology
and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2083
Bethesda, MD 20892-9304
Telephone: 301-402-9402
FAX: 301-443-8614
Email: [email protected]
Roger G. Sorensen, Ph.D, M.P.A.
Division of Neuroscience
and Behavior
National Institute on
Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2053
Bethesda, MD 20892-9304
Telephone: 301-443-2678
FAX:
301-443-1650
Email: [email protected]
Peter J. Delany,
D.S.W.
Division of Treatment and Recovery Research
National Institute on
Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039
Bethesda, MD 20892-9304
Telephone: 301-443-0788
FAX: 301-443-8774
Email [email protected]
2. Peer Review Contacts:
Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email [email protected]
3. Financial or Grants Management Contacts:
Judy
Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304 Room 3023
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-4704
FAX: 301-443-3891
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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 Clinical Research:
The NIH maintains
a policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
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 (http://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 applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://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 http://stemcells.nih.gov/index.asp and at http://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 (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, 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.
NIH Public
Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting
that authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more
information about the Policy or the submission process please visit the NIH
Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for
Privacy of Individually Identifiable Health Information:
The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 RFA 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.93.891
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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