and Human Services (HHS)
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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: Resource Core Alcohol Research Centers (P30)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-AA-08-004
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(s) 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. Address to 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.
This RFA uses the NIH Resource Core Center mechanism (P30) to support the development and provision of shared, core resources that are otherwise not available to individual projects. These shared resources are expected to promote greater efficiency, productivity and creativity than would be possible from separate projects. Resource Core Alcohol Research Centers (hereafter called Resource Core Centers) are expected to become regional and national resources in their particular area of expertise. NIAAA's Resource Core Center program will support centralized resources and facilities shared by investigators conducting alcohol research. Each Resource Core Center will be composed of administrative, resource and developmental components, which together will enrich the effectiveness of ongoing research and stimulate new research directions to advance the field. Resource Core Centers will enhance individual research projects by providing necessary resources or performing required services that would be difficult, costly, or impractical to provide by individual labs or projects. The Resource Core Centers will foster a cooperative and interactive research environment through which multi-disciplinary approaches and collaborative research projects will be stimulated. The Resource Core Centers should provide a means to develop new ideas and encourage new investigators via pilot projects.
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 Resource Core Alcohol Research Centers
An application for a Resource Core Alcohol Research Center award must identify at least three currently funded research projects (hereafter called qualifying projects) that will collaborate with the Center and use the proposed Shared Resources. These qualifying projects may be funded by NIH, other government agencies, or private organizations but must have been awarded through a peer-review process. The Resource Core Center is expected to maintain three or more active qualifying project collaborations at all times, although it is expected that they may change over the duration of the award.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This
funding opportunity will use the NIAAA Resource
Core Alcohol Research Center (P30) award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
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" is to be submitted with 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 P30 awards will range from about $750,000
to one million dollars. An applicant may request a project period of
up to five years and a budget for total costs up to 1.25 million dollars per year under the NIAAA P30 mechanism.
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.
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
Applications for a Resource Core Alcohol Research Center must identify three or more currently funded "qualifying research projects" at the time of submission (see Section IV. Application and Submission Information, 2. Content and Form of Application Submission.) Special attention must be paid to avoiding scientific overlap between Shared Resources funded by the proposed Resource Center and those funded by the qualifying research projects. Applicants must clearly explain which research costs would be funded by the Resource Center grant, which are funded by the grants for the qualifying research project, and which costs, if any, will transition between appearing in the budgets of the qualifying research projects and the budget of the Resource Center.
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: GrantsInfo@nih.gov.
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 a Resource Core Alcohol Research Center application.
Only applications that focus on alcohol related research will be considered responsive to this RFA.
To be responsive to this RFA the application must identify three or more currently funded research projects (i.e., at the time of submission) that will become users of the Shared Resources.
A Resource Core Center must be an identifiable organizational unit with an administrative structure and clear lines of authority, which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations.
The Center Director will have responsibility for planning and coordination of the Resource Core Center program, preparation of the budget, and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center.
The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the center program. The Scientific Director will be responsible for assuring the coordination of activities within the Center and the scientists collaborating with the Center.
The Scientific Director also will be responsible for the direct monitoring of ongoing research and identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described.
A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Resource Core Center, should be composed of at least five members. These members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects.
Resource Core Alcohol Research Center Components
Resource Core Centers must have a minimum of three components including an Administrative Core (1), a Shared Resources Core (2), and a Pilot Project Component (3). They may also contain an optional Research Translation Component (4) and/or a Multiple-PI Leadership Plan (5) as described below. The research plan for each component is limited to twenty five (25) pages. Pages not used for one component may not be used to extend the page limit of other components. In addition to the overall Center budget, each component requires a separate detailed budget.
1. ADMINISTRATIVE CORE (required)
There are two major responsibilities within the Administrative Core. The first is the management and administration of the resources, facilities, staff, and activities conducted by the Resource Core Center and funded by its budget. The second is the management of relationships, joint projects, and collaborations with other research studies which participate in the use of the Shared Resources. The former is described in the "Internal Administration" subsection below; the latter in the "External Collaborations" section.
Administrative Core: Internal Administration
The Administrative Core provides the organizational framework for the management, direction, and coordination of the Resource Core Center. It must be managed by the Center Director or Scientific Director. This Core should ensure that all of the related activities will function in an optimal and synergistic manner. An important function of this Administrative Component is also the administration of the budget. It may include funds for scientific enrichment activities such as lectures, symposia, seminars, and workshops for research faculty and staff. This Administrative Core should be described in sufficient detail to assure that all proposed activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this Administrative Component.
Administrative Core: External Collaboration
An important purpose of Resource Core Centers is to serve as a nexus of scientific contact between multiple projects investigating related research areas or sharing similar resources. Thus a portion of the application should describe both the initial collaboration among the qualifying projects and describe the plans for the evolution of future collaborations in the use of the Shared Resources.
Proposed Resource Core Centers should contain a minimum of three independently funded projects (i.e., qualifying projects) that share resources provided by the Center. These qualifying projects may be funded by NIH, other government agencies, or private organizations but must have been awarded through a peer-review process; moreover, they may be located at the same institution or at other institutions. Typically, the three qualifying projects will be comparable to R01 projects in scope and complexity. Each of the identified qualifying projects must be a significant user of the Center resources, with no more than 50% of the total Center usage allocated to a single qualifying project. While qualifying projects are required, other projects may also use the Shared Resources of the Center.
During its lifetime, a Center should seize opportunities to attract, promote, and initiate additional collaborations among investigators whose work could benefit by access to the Shared Resources provided by the Center. At least three collaborating projects must be active at all times. Collaborating projects should be encouraged among independent investigators either residing in the same institution as the Resource Core Center or at other institutions. Applications should contain a description of steps that will be taken to seek and establish collaborative projects with investigators not currently collaborating with the Center and identify potential areas of research where the Shared Resources available to the Center could be brought to bear to stimulate new and promising research directions. Principal Investigators of all collaborating projects, existing and future, should be provided with an appropriate voice and role in the governance of the Center, and this should be described as a part of the Administrative Component of the application.
In addition, the application should specifically address the need for this particular Resource Core Center. Need could be in terms of efficiency of scale, but would also be expected to provide greater flexibility, innovation or responsiveness to the changing requirements of the collaborating research projects.
Readers should note that throughout this document "collaboration" is used in a wide sense to describe a range of participating activities that can take place between a Resource Core Center and the projects that use its Shared Resources. In some cases, there may be extensive cooperation and partnership in all phases of study design, data collection, analysis, and publication of results. In other cases, joint participation might be more limited, such as the use of Shared Resources to analyze data only, secondary analysis of data previously collected, access to data, equipment, services, or facilities through subcontracts or other commercial arrangements, or the use of Shared Resources by junior investigators to conduct small pilot projects. All such forms of joint activity are considered collaborations for the purposes of this funding opportunity.
2. Shared Resources Core (required)
Shared Resources Core include datasets, tissue repositories, genetic information repositories, equipment, and laboratory facilities that are shared among several projects in order to enhance or make more effective the data, services, techniques, or instrumentation used by investigators of the Resource Core Center. The main function of the Resource Core Center program is to support the existence of Shared Resources which are designed to furnish groups of Resource Core Center investigators with data, tissue samples, services, or instrumentation that will enhance the research in progress, consolidate effort, and contribute to cost effectiveness. These resources should be sufficiently large, expensive, or complex so as to be more efficiently supported by a Resource Core Center than by individual research project grants alone. The utilization of Shared Resources by pilot projects is also required. Shared Resources provided by Resource Core Centers should be unique and not duplicate services or facilities that already exist at the parent or at a collaborating institution. Proposed Shared Resources that appear to replicate data, tissue samples, services, or instrumentation already available to the applicant institution will not be allowed without extensive justification.
The applicant organization should prepare a plan that explains how Resource Core Center capacity will be allocated to Principal Investigators of collaborating projects. The plan should permit appropriate access to Shared Resources for investigators who do not direct collaborating projects, so that the Center will serve as a shared resource for all participants. Plans should establish guidelines to determine the most appropriate methods for providing access to the shared resources, facilities, and services, and for prioritizing work within the Center.
3. Pilot Project Component (required)
Applications should include a Pilot Projects component, which would provide modest support for new initiatives or feasibility projects. Pilot Projects should be based on the opportunities uncovered by ongoing projects or made possible by the existence of Shared Resources Component. Such projects would be appropriate for either new or experienced investigators. Pilots should be short-term projects to explore the feasibility of new areas of study which lead to the collection of sufficient data to pursue support through other funding mechanisms. A plan to support pilot studies should be included in the application. The description of a plan to solicit, review, and administer pilot projects should be included. Criteria and procedures for the review of proposed Pilot Projects, making awards, and evaluation of progress should be described in the application.
4. Research Translation Component (optional)
An important goal of all NIH Institutes is that scientific advances achieved through NIH-sponsored research should supply a basis for improving health. This research translation goal has two meanings. For basic research, the goal is to encourage the incorporation of new scientific discoveries into clinical trials of promising treatment or prevention protocols. For clinical trials and prevention studies, the goal is to facilitate the adoption of recent research discoveries into routine clinical and public health practice. Resource Core Centers may optionally elect to include a component that encourages and stimulates the use of scientific findings generated by ongoing research into the next step along a continuum that moves research advances from bench to bedside. Example studies proposed under this component might include, but would not be limited to: incorporation of new basic science discoveries into animal models for further laboratory experimentation; incorporation of results from animal studies into protocols for clinical trials; and improving current understanding of the processes whereby recent findings from human trials are incorporated into in routine clinical or public health practice.
5. Multiple Principal Investigators Leadership Plan (optional)
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.
Competing Renewal Applications
A comprehensive progress report is required for competing continuation (renewal) applications. A statement describing the progress made by the Resource Core Center as a regional or national research resource should be included. Collaborative activities, if any, with other NIAAA Alcohol Research Centers should be described along with a list of joint accomplishments. In addition, for each qualifying project of the existing Resource Core Center grant, a succinct account of the published and unpublished results based on use of the shared resources must be provided, indicating progress toward achieving aims regardless of whether the project has been submitted for renewal. Ongoing or completed activity that has enhanced or facilitated alcohol research should be described. Past performance and accomplishments based on Center related collaborations should be described, as should the effect of services provided by Shared Resources on investigators' scientific progress and contributions. For competing renewal applications, information should be provided on past experience in utilizing pilot funds to further Resource Core Center goals. This should include an assessment of overall benefits derived from the availability of pilot resources.
Progress Report for Components being extended into the next funding period are to be included in the 25-page limit for each Component. Progess Reports for Components that have been terminated are limited to 5 pages
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-June, 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 bautista@mail.nih.gov
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-08-004
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 bautista@mail.nih.gov
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 should be
checked by the Principal Investigator 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.
Although
the Resource Core Center mechanism has special features for sharing data and
resources among participating collaborators as described in the Shared
Resources Component section above, applicants also need to develop a plan for
sharing data and resources with the research community more broadly. This
section describes these additional responsibilities, which are common across
all NIAAA Center mechanisms (P20, P30, P50, and P60).
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
The
criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
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?
For the NIAAA Alcohol Research Centers the initial review for scientific and technical merit of applications will emphasize two major aspects: First, review of each component: the Administrative Component, the Shared Resources Component, the Pilot Project Component, and the Research Translation Component and the Multiple-PI Leadership Plan (as applicable); and Second, review of the Center as an integrated whole. Review will also include an assessment of the academic and physical environment and special considerations, e.g. compliance with human subjects and animal welfare requirements, and compliance with policies concerning inclusion of women, minorities and children in clinical research study populations.
1. The ADMINISTRATIVE CORE will be evaluated with the following criteria:
Administrative Core: Internal Administration
Approach: Are the arrangements and organizational structure, adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the application describe how day-to-day management will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate?
Investigators: Are the investigators appropriately trained and well suited to carry out the proposed organizational interactions?
Environment: Does the environment contribute to the successful management of scientific projects? Does the proposed arrangements take advantage of unique features of the environment such as mutually-beneficial collaborative arrangements or access to community resources? Is there evidence of institutional support?
Administrative Core: External Collaboration
Note that since each collaborating project is expected to be independently funded, the scientific merits of each project will have already been reviewed. Here, the quality of these projects as a package, the extent to which they make use of and further develop the Shared Resources, and the promise of plans to attract new collaborating projects should be the basis of the review.
Significance: Do the proposed collaborations have the potential to advance research on important problems? Do they make full use of the Shared Resources? Does the plan for attracting new collaborating projects improve the effective use of the Shared Resources and create additional opportunities to advance knowledge?
Approach: Do the scientific approaches employed by the collaborating projects make appropriate and optimal use of the Shared Resources? Does this collaboration lead to further improvement of the Shared Resources? Will the enhanced interactions among the participating projects contribute to the Center’s overall success and research advancement?
Innovation: Does the plan to use the Shared Resources create new and promising uses of these scientific tools, methods, or facilities?
Investigators: Are the collaborating investigators scientific leaders in the field? Does the collaboration plan also attract promising more junior investigators and make the Shared Resources available to them?
Environment: Does the proposed environment have the features and resources necessary to promote effective collaboration among multiple projects? Is there a plan for sharing the resources effectively among the participating investigators?
2. The SHARED RESOURCES CORE will be evaluated with the following criteria:
Significance: Do the Shared Resources have the potential to contribute to research on important problems and will scientific knowledge be advanced? Are the Shared Resources appropriately ones that are too large, expensive, or complex to be feasibly and efficiently supported by individual project grants?
Approach: Are the procedures used to obtain and create the Shared Resources of the highest scientific quality in design, methods, instrumentation, and analysis techniques? Does the application acknowledge potential problems, consider alternative approaches, and propose improvements in existing methods?
Innovation: Is the use of Shared Resources original and innovative? Does the use of the Shared Resources make it possible to challenge existing paradigms, address an innovative hypothesis, or overcome a critical barrier to progress in the field?
Investigators: Are the investigators appropriately trained and experienced to carry out the proposed work? Does the investigative team bring complementary and integrated expertise to the use and development of the proposed Shared Resources?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed Shared Resources benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
3. The PILOT PROJECT COMPONENT will be evaluated with the following criteria:
Significance: Will the pilot projects prepare the way for important scientific advances and promising new methods? Do they have the potential to develop into full-scale independent projects of fundamental importance?
Approach: Do the pilot projects contribute to the full and appropriate use of the Shared Resources? Is there an adequate selection process for new and replacement pilot projects?
Innovation: Do the pilot projects explore and develop new and complementary uses of the Shared Resources? Do they use the Shared Resources in ways that reflect the cutting edge of scientific inquiry? Do they propose ways that the existing Shared Resources can be improved?
Investigators: Do the propose investigators have the necessary training, expertise, and experience to use the Shared Resources to their best potential? Are newer investigators with creative pilot projects encouraged and attracted?
Environment: Does the research environment contain a variety of facilities, equipment, data sources, etc. that can be used to support pilot projects in new areas? Are the Shared Resources managed in such a way that they are appropriately available to use by the pilot projects?
4. The RESEARCH TRANSLATION COMPONENT (optional) will be evaluated with the following criteria:
Significance: Do the proposed translational activities overcome significant barriers in moving research findings from bench to bedside? Do they effectively bridge the gap between basic research findings and their application in proposed clinical trials or between clinical findings and their adoption in routine care and public health practice?
Approach: Are appropriate and effective methods of using existing knowledge to stimulate the next phase of research translation proposed?
Investigators: Does the investigative team have the multidisciplinary mix of skills and expertise that will facilitate the translation of new findings into the next phase of research or practice adoption?
5. 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:
6. CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:
Significance: Do the Center’s research goals 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?
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?
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?
Coordination and Cohesiveness: Is the coordination among the Components adequately explained? Is the usefulness of the Shared Resources maximized? Is there synergistic potential among Center s Components?
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: Beyond the internal data
sharing activities described in the Shared Resources section above, the
external data sharing activities with the broader research community are
subject to the following considerations.
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
Beyond the internal
resource sharing activities described in the Shared Resources section above,
the external resource \sharing activities with the broader research community
are subject to the following considerations.
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.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
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
NA
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 Notice
of Award will be generated via email notification from the awarding
component to the grantee business official (designated in item 14 on the
Application Face Page). If a grantee is not email enabled, a hard copy of the
Notice of Award 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 Notice of Award. 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
Resource
Core 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 Resource Core 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.
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.
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: tgentry@niaaa.nih.gov
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: mhilton@mail.nih.gov
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: rsorense@mail.nih.gov
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 delanyp@mail.nih.gov
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 bautista@mail.nih.gov
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: jfox@mail.nih.gov
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 at http://www.cfda.gov/ 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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