Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)  

Components of Participating Organizations
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)

Title: Resource Core Transdisciplinary Prevention Research Centers (P30)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DA-08-012

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: January 14, 2008
Letters of Intent Receipt Date(s):  March 17, 2008
Application Receipt Date(s): April 15, 2008
Peer Review Date(s): June-July, 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September  2008
Additional Information to Be Available Date (Url Activation Date): N/A
Expiration Date: April 16, 2008

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


1. Research Objectives

The purpose of the NIDA Transdisciplinary Prevention Research Center (TPRC) program is to support environments in which scientists from the basic/laboratory and applied/clinical disciplines can come together to develop a coherent program of transdisciplinary research inquiry. The ultimate goal of these centers is to encourage the integration of diverse basic science findings, methodologies, and theories directly into the field of drug abuse prevention research which has traditionally been dominated by behavioral and social science based paradigms. The kinds of basic science disciplines that may be relevant for transdisciplinary integration with preventive intervention approaches are numerous and could include: biochemistry, biology, biomedicine, computational science, computer science, economics, engineering, geography, genetics, informatics/information science, mathematics, neurobiology, neuroscience, physics, or physiology. Note that this list is meant to be illustrative, rather than all-inclusive.

This initiative calls for Transdisciplinary Prevention Research Centers to foster: (a) the translation of research findings from the basic sciences into the development and testing of novel preventive intervention approaches, and (b) the translation of preventive intervention findings back into basic science laboratory studies to explicate intervention mechanisms and/or individual variation in intervention response, or to refine basic theories in ways that may inform future intervention approaches. This type of translational research approach is bidirectional in nature, with findings from the basic sciences informing preventive intervention development and refinement and findings from preventive interventions informing new lines of basic science inquiry. Such research will require collaborative investigative teams comprised of both applied prevention scientists and basic scientists in diverse disciplines. Applicants must form collaborative arrangements with researchers from diverse scientific areas who will serve as principal investigators, co-investigators, collaborators, or outside consultants. Furthermore, the applicants must demonstrate the diverse nature of the particular disciplines being combined and provide a strong and compelling rationale for why this particular integration of disciplines will be fruitful for prevention science. Overall, it is expected that a transdisciplinary approach will be used to explore and catalyze new ways of conceptualizing drug abuse prevention research.

Background

Previous research has identified significant risk and protective factors that influence drug abuse.  Discoveries from the basic biological (e.g. neurobiology, pubertal maturation, or physical development), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications) sciences have elucidated individual and group vulnerabilities to drug use initiation and escalation from occasional use to abuse. Based on these findings and their underlying theoretical frameworks, over two decades of prevention research have produced prevention programs with proven efficacy and effectiveness, from which a general set of science-based prevention principles has emerged.  However, much existing basic science on biological, neurobiological, psychological, and social processes and mechanisms has not been fully utilized for purposes of developing and testing innovative, potentially efficacious, drug abuse prevention interventions.  Moreover, preventive intervention findings generally have not been translated back for further basic science study. In this regard, we believe that preventive intervention trials have unique contributions to make in advancing our understanding of the mechanisms through which risk and protective factors operate, including how environmental and biological factors interact to influence risk or how such mechanisms operate within and across different phases of development.

As an illustrative example, research to date on the development and prevention of behavioral problems has suggested that individual differences in risk for drug use and abuse and other behavioral pathologies are understandable as a function of people’s orientation to and processing of environmental inputs, which are in turn, greatly influenced by genetic and neurobiological mechanisms. These underlying mechanisms, in turn, may interact with the quality of our psychosocial and environmental exposures to alter trajectories either toward or away from drug abuse and other psychopathology. A complementary body of research suggests that, regardless of origin, neural dysfunction may be partially malleable and that compensatory mechanisms can be strengthened with the appropriate psychosocial or biomedical manipulations. This suggests the possibility for innovative, targeted preventive intervention approaches.

NIDA recognizes the need to maximize the use of existing underutilized approaches and basic science findings for the development of innovative preventive interventions targeting the initiation and escalation of drug abuse. The purpose of the NIDA Transdisciplinary Prevention Research Center (TPRC) program is to support environments in which scientists from the basic/laboratory and applied/clinical disciplines can come together to develop a coherent program of transdisciplinary research inquiry. The ultimate goal of these centers is to encourage the integration of diverse basic science findings, methodologies, and theories directly into the field of drug abuse prevention research which has traditionally been dominated by behavioral and social science based paradigms. The kinds of basic science disciplines that may be relevant for transdisciplinary integration with preventive intervention approaches are numerous and could include: biochemistry, biology, biomedicine, computational science, computer science, economics, engineering, geography, genetics, informatics/information science, mathematics, neurobiology, neuroscience, physics, or physiology. Note that this list is meant to be illustrative, rather than all-inclusive.

For the purposes of this RFA transdisciplinary science refers to a process whereby researchers from distinct disciplines work jointly using shared conceptual frameworks drawing together disciplinary-specific theories, concepts, and approaches to address a common problem (Rosenfield, 1992). In this case, the overarching common public health problem to be jointly addressed is the prevention of substance use initiation, escalation to abuse, and related health-risking sexual behaviors.  In transdisciplinary research teams, representatives of different disciplines are encouraged to transcend their separate conceptual, theoretical, and methodological orientations in order to develop a shared approach to the research, building on a common conceptual framework. Such a framework can be used to define and analyze the research problem and develop new approaches for health promotion that more closely represent the historical and present-day reality in which health problems are situated (Rosenfield, 1992).

This initiative calls for Transdisciplinary Prevention Research Core Centers to foster: (a) the translation of research findings from the basic sciences into the development and testing of novel preventive intervention approaches, and (b) the translation of preventive intervention findings back into basic science laboratory studies to explicate intervention mechanisms and/or individual variation in intervention response, or to refine basic theories in ways that may inform future intervention approaches. This type of translational research approach is bidirectional in nature, with findings from the basic sciences informing preventive intervention development and refinement and findings from preventive interventions informing new lines of basic science inquiry. Such research will require collaborative investigative teams comprised of both applied prevention scientists and basic scientists in diverse disciplines to jointly propose plans for integrating their basic/applied inquiries in the service of bidirectional translational research. Applicants must form collaborative arrangements with researchers from diverse scientific areas who will serve as principal investigators, co-investigators, collaborators, or outside consultants. Furthermore, applicants must demonstrate the diverse nature of the particular disciplines being combined, provide a strong and compelling rationale for why this particular integration of disciplines will be fruitful for prevention science, and specify how the transdisciplinary research team will advance a bidirectional translation process.

Overall, it is expected that a transdisciplinary approach will be used to explore and catalyze new ways of conceptualizing drug abuse prevention research. Transdisciplinary collaborations should stimulate the translation of basic science discoveries into the design of innovative preventive intervention components, and capitalize on prior drug abuse prevention research findings to inform basic science hypotheses that have implications for the development of novel intervention paradigms or refinement/improvement of existing paradigms.

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 Transdisciplinary Prevention Research Centers (hereafter called TPRCs) are expected to become regional and national resources in their particular area of expertise. NIDA's TPRC program will support centralized resources and facilities shared by transdisciplinary teams of investigators conducting drug abuse prevention 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 prevention science. 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 transdisciplinary approaches and collaborative research projects will be stimulated. They must have a minimum of three components including an Administrative Core, a Shared Resources Core, and a Pilot Project Component which will provide modest support for new initiatives or feasibility projects to develop new ideas and encourage new investigators.

Centers must focus thematically on areas of research for which: (1) there are significant gaps in the integration of knowledge from several disciplines; (2) there is imminent potential for contributing to the development of new approaches to drug abuse prevention; and (3) there is evidence that the thematic focus can benefit from transdisciplinary collaboration.  Applicants are encouraged to include the study of developmental, gender, racial/ethnic, cultural, sexual orientation, geographic, and socioeconomic differences when possible and appropriate.

The following are examples of scientific themes that might benefit from transdisciplinary collaborations. They are intended to be illustrative, not exhaustive.  Many other topics may be significant and appropriate:

Reference

Rosenfield, P. L. (1992). The potential of transdisciplinary research for sustaining and extending linkages between the health and social sciences. Social Science and Medicine, 35, 1343-1357.

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 Transdisciplinary Prevention Research Centers complements NIDA’s commitment to a Centers program specifically directed toward multidisciplinary, collaborative research. In further support of these goals, NIDA for the first time invites Transdisciplinary Prevention Research Center applicants to consider using the multiple-PI leadership format.

SPECIAL REQUIREMENTS for Resource Core Transdisciplinary Prevention Research Centers

An application for a Resource Core Transdisciplinary Prevention 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. In order to insure that each Center includes ongoing basic science and applied prevention science inquiry, at least one of the qualifying projects must include some ongoing basic science inquiry, and at least one qualifying project should include some ongoing preventive intervention research inquiry. 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 and fluctuate over the duration of the award.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIDA Resource Core Transdisciplinary Prevention 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

NIDA intends to commit approximately 2.5 million dollars in FY 2008 and expects to fund 3-4 new center grants in response to this RFA. The expected annual direct costs for the TPRC P30 awards will range from about $500,000 to $800,000, but may not exceed $800,000. An applicant may request a project period of up to five years under the NIDA TPRC P30 mechanism.

The earliest anticipated funding date is September 15, 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 NIDA 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 Transdisciplinary Prevention 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.

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 301-435-0714, 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 Transdisciplinary Prevention Research Center application.

Only applications that focus on transdisciplinary drug abuse prevention 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. In order to insure that each Center includes ongoing basic science and applied prevention science inquiry, at least one of the qualifying projects must include some ongoing basic science inquiry, and at least one qualifying project should include some ongoing preventive intervention research inquiry. Applications that do not include qualifying projects with ongoing inquiry reflecting both basic science inquiry and prevention science inquiry will be deemed unresponsive.

To be responsive to this RFA, applications must include collaborative investigative teams comprised of both applied prevention scientists and basic scientists from multiple and diverse disciplines, and the applicant must provide a strong and compelling rationale for why this particular transdisciplinary integration will be fruitful for prevention science.

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 Director must have a minimum time commitment of 20 percent to the Center grant (including both administrative and research efforts). In the case of multiple PIs/Co-Center Directors (see the Multiple Principal Investigators Leadership Plan section below) there must be a minimum combined time commitment of 30 percent to the Center grant (including both administrative and research efforts). 

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 Transdisciplinary Prevention 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 Multiple-PI Leadership Plan (4) 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) – 25 pages

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) – 25 pages

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, 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, 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) – 25 pages

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, and they must be conceptually directly related to the overarching scientific theme of the Center. 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. In this regard, the Pilots can be for basic science inquiry or for preventive intervention project development.  Such projects would be appropriate for either new or experienced investigators. A detailed 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. One or more specific initial pilot studies may be proposed in the application; however, this is not a requirement. It is expected that the Pilot Project Component will be an ongoing and developing aspect of the Center that will allow for emerging inquiry over the course of the five year grant period. 

4. 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.

In the case of multiple PIs where the applicants propose Co-Center Directors there must be a minimum combined time commitment of 30 percent to the Center grant (including both administrative and research efforts). 

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): March 17, 2008
Application Receipt Date(s): Arpil 15, 2008
Peer Review Date(s): June-July, 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September  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 NIDA 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:

Director Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@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 DA-08-012
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:

Director - DA-08-012

Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@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 National Institute on Drug Abuse. 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.

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 NIDA in accordance with the stated review criteria.

As part of the initial merit review, all applications will:

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 NIDA 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 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? Do 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: Are the pilot projects conceptually tied to the overarching scientific theme of the Center? Will the pilot projects prepare the way for important basic scientific advances and/or promising new preventive interventions? 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 proposed 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 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? In the case of Co-Center Directors is there a minimum combined time commitment of 30 percent to the Center grant (including both administrative and research efforts)?

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:

·         Are the budgetary and administrative roles and areas of responsibility for each of the PIs sufficiently described to assure effective and collegial leadership?

5. 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 and prevention science be advanced? What will be the effect of these studies on the concepts, methods, technologies, and 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 or integrate existing paradigms or intervention practice to advance the development of novel intervention designs; address an innovative hypothesis or critical barrier to integrating knowledge across disciplines to advance the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for prevention science?

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: This is a critical element of application review scoring. 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 NIDA 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

The TPRCs 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.

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.

Section VII. Agency Contacts


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:

Elizabeth M. Ginexi, Ph.D.
Health Scientist Administrator
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: 301-402-1755
Fax: 301-443-2636
Email: LGinexi@nida.nih.gov

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3. Financial or Grants Management Contacts:

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: mconnell@nida.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.


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