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These guidelines are effective after the October 2, 2003 receipt date and expire with October 2, 2006, unless reissued.
Contents
Purpose
Programmatic Objectives
Information for Applicants
Other Information
Contacts For Additional Information
Figure: A Brief Summary of the Essential Elements of Centers
Purpose
The purpose of this announcement is to inform the research community that the National Institute on Drug Abuse (NIDA) has clarified and amended the consolidated program and review guidelines for its Centers program. This reissued announcement of Consolidated Program and Review Guidelines will replace guidelines issued in the NIH Guide, Vol. 24, No. 33, September 22, 1995; those issued in Vol. 25, No. 4, February 16, 1996; those issued in Vol. 25, No. 12, April 19, 1996, and those issued in October 9, 1998, http://grants1.nih.gov/grants/guide/notice-files/not98-137.html.
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Programmatic Objectives
NIDA provides support for research center grants to foster an innovative, synergistic and thematically coherent approach to drug abuse and addiction research and to enable studies that would not occur without the climate, facilities and research resources that a research center can uniquely provide. NIDA encourages the application of multiple scientific perspectives and approaches to the problem of addiction. NIDA's research centers program is intended to support the highest quality, multidisciplinary programs of innovative research.
NIDA centers must have three essential and defining qualities. First, they must demonstrate the highest caliber of multidisciplinary scientific work. The second quality relates to the particular characteristics of research centers. Center-specific characteristics emerge from the confluence of thematic integration, synergy, and multidisciplinary involvement. Research supported at a NIDA research center must be thematically focused and must reflect in clear ways interdependence of components of the research program that would not occur simply from the collection of the individual components. Taken as a whole, a NIDA center is expected to enable a level of achievement that exceeds that expected on the basis of "the sum of its parts." Center support should be essential to the achievement of the proposed work. The third quality is innovation. Centers are expected to provide the next generation of ideas and approaches. Incremental work, though valuable, should not be the focus of Center activities. Rather, new and creative directions are expected, and it is expected that a Center will transform knowledge in the sciences it is studying.
In addition, NIDA research centers are expected to serve as national research resources in the drug abuse research field. They are expected to attract established and promising investigators into drug abuse research. The P50 and P60 applications are expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.
Through the Centers program, NIDA seeks to encourage outstanding scientists to bring a full range of expertise, approaches, technologies, and creativity to the study of problems related to drug abuse and addiction. Investigative efforts are expected to be broadly based and to encompass a variety of areas, including biological, biomedical, social, behavioral, and/or clinical sciences and to address critical research issues.
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Information for Applicants
These guidelines summarize the purpose and intent of the NIDA research center grant program including: (I) eligibility, (II) mechanisms and period of support, (III) elements of NIDA centers, (IV) application procedures and submission dates, (V) procedures for review of new and competing continuation applications, (VI) review criteria, (VII) required Federal citations. Applicants are urged to contact NIDA staff before submitting a center application.
- Eligibility
Applications may be submitted by domestic, for-profit and non-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal Government. A single individual may not concurrently be the center director on more than one NIDA center grant. Because of the role of the centers as national resources, foreign applicants are not eligible as center directors but can participate in center programs.
- Mechanisms and Period of Support
NIDA provides support for three types of research centers: core center grants (P30), specialized center grants (P50), and comprehensive center grants (P60). The P30 mechanism supports an administrative core and one or more scientific cores; the P50 and P60 support an administrative core, scientific cores and research projects. Applicants may apply for up to five years of support, whether as new or competing renewal applications.
Core Support Center Grants (P30) are intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources to enhance the effectiveness of existing research and also extend the focus of research related to drug abuse and addiction. The applicant may propose pooling of existing core resources and request additional support for developing a shared research infrastructure. The research infrastructure support may include, for example, administrative coordination, subject recruitment, equipment, laboratories, statistical analysis, quality control, training in methodology, and database management. It should be made clear how this center support would enhance the funded constituent projects and result in programmatic coherence, synergy and integration. Applicants must demonstrate the potential for the continuation of funding of participating projects, and there must be at least two years of funding left for each project identified at the time of submission. For competing renewals, the applicants must also describe the process of recruitment of new participating projects. Since the P30 supports infrastructure for existing funded projects, funds may not be requested for research pilot projects.
Specialized Center Grants (P50) provide support for a broadly based, multidisciplinary, innovative research program consisting of related research endeavors and associated core infrastructure to ensure their effective and synergistic functioning. The activities included in the supported research must be innovative, thematically integrated, multidisciplinary, and synergistic. It is important that the research supported not be simply a collection of independent research projects that are only loosely related. Each individual research component must be systematically related both to some other components and to the core infrastructure. Training and mentoring to enhance junior researchers' or other researchers' skills should be conducted in the context of the research, but funds may not be used for training stipends or training not required to conduct the research.
Comprehensive Center Grants (P60) are intended to include all components of the P50, plus the additional elements described below. They are designed to bring together into common focus divergent but related research and resources / facilities within a given research community. A Comprehensive Center provides opportunities for bi-directional transdisciplinary work and supports translational drug abuse treatment research. In addition, Comprehensive Centers support continuing education for health care professionals and dissemination of information to the public. They should include components of basic, clinical, prevention, epidemiologic, health services, or other applied areas. While not all of these areas must be represented (e.g., a center could propose basic science and community prevention), there should be a comprehensive approach to the research theme.
- Elements of NIDA Centers
- Essential Organizational and Administrative Characteristics of a NIDA Center
The application needs to justify the configuration and numbers of components proposed and to demonstrate that the proposed center infrastructure would facilitate effectively the achievement of the desired level of integration and synergy. The center mechanism is not appropriate to support a set of complex unitary investigations that would be best supported as a single R01.
All NIDA centers must clearly demonstrate the occurrence of innovative, rigorous, thematically focused, and productive research that emerges from interdependent components of the research program and that would not emerge from the mere collection of those individual components. Applicants should explicitly discuss the integration of work in the center in the introductory section of the application. Further, it must be shown how having this research center is essential to accomplishing the scientific aims set forth in the application. In addition to narrative, evidence of components' interdependency should be summarized in a table. Organization structure should be summarized in a diagram.
There are three necessary characteristics for meeting this set of requirements:
Thematic Integration -- There must be an overarching theme that integrates and focuses the center. Further, there must be an essential relationship of each component part to the overall theme of the center and to the other components. Interdependency and integration of the projects should be clearly evident, so that the center does not appear to be a collection of independent research projects. These linkages may be conceptual, spatial, and/or temporal. The type of integration proposed may be different for different genres of science. Some types may emphasize conceptual integration and focus, while others may emphasize sharing of data, instruments, and other resources. Linkages should encourage cross-fertilization of ideas and interactions among investigators that are relevant to the theme.
Synergy -- Synergy is evidenced by creative thinking, a novel approach, innovations, and highly significant findings. The degree of coordination, interaction, and collaboration should foster original and creative contributions to scientific understanding over and above that which would be obtained if each component existed independently. Synergy refers to the intense interaction among participating components that results in greater depth, breadth, quality of research and productivity. The intellectual interdependency and linkage among the components and core(s) must result in levels of productivity, quality, and progress that will exceed those expected from combining the individual components in an additive fashion. The center must demonstrate that the whole is greater than the sum of its parts.
Multidisciplinary Involvement -- There must be research activity across a variety of disciplines or subdisciplines such that multiple scientific perspectives and approaches are brought to bear on an area or question. There must be evidence that significant transdisciplinary collaborations will occur and contribute to thematic integration as described above.
The following components should also be present in the application, unless exceptions are noted for specific mechanisms.
Research Activities
NIDA's centers should support research activities of the highest and most innovative caliber. Research may occur in any area of NIDA's mission. Each separate project should bear an essential relationship to the integrating theme and efficiently use and contribute to center resources. Centers should enable highly innovative and important studies, whether they are developmental activities and pilot projects or more mature, complex investigations. Further, there should be evidence that the presence of a center structure is essential for the accomplishment of the research activities. Although center support is not intended to support direct research activities in P30s, there should be evidence that the support of the core activities enables the more efficient implementation of associated research and that this research is innovative and of the highest caliber, as well as consistent with the overall purposes of the NIDA Centers program.
The NIH policies regarding human subjects protection, data safety and monitoring and inclusion of women, minorities and children must be followed for research proposed involving human subjects. Data safety and monitoring plans or boards must be included for phase I, II and III pharmaceutical trials and stage 1, 2 and 3 behavioral studies, multi-site clinical trials, and to prevention health services and other interventions, when appropriate. (See Section VII Required Federal Citations for more information.)
Data Sharing
NIDA's centers are expected to share their findings in a timely manner. This sharing can be accomplished in many ways, including posting findings in the center's website or using archival services. In most instances, the data sharing will extend beyond that of one's own center to the research community. Data sharing plans must be provided (See Section VII Required Federal Citations for more information.)
Research Environment and Facilities
Each center must provide an environment that promotes the conduct of the highest quality, state-of-the-art research, innovation, and leadership in its areas of investigation. Applicants must demonstrate that the center is, or would serve, as a significant national scientific research resource soon after establishment. For competing continuations, the application must demonstrate how the Center continues to serve as a national resource.
There must be appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. While all members of the center need not be located physically in facilities controlled exclusively by the center, there must be a clearly identifiable physical location for the center which insures adequate administrative oversight for the center and the associated core units providing shared resources.
For competing continuations, applicants should demonstrate the research environment's conduciveness to productivity by identifying the originally approved specific aims, the progress made on each specific aim, and relevant publications produced in the previous funding period. It is especially important that competing continuations (1) identify innovative work accomplished by the center during the current funding period and (2) propose innovative work for the new funding period.
Much of the shared research environment and many facilities will be located in or funded through the core components. Each core component should contribute toward cost-effectiveness and quality control in resource utilization. Data analytic capacities, data base facilities, and data resources should be specified as needed. Provisions for shared laboratory resources and the quality of laboratory space should be indicated. Similar information should be provided for clinical facilities.
Center Director
Each center must have a scientifically and administratively qualified center director with responsibility for the scientific, administrative, budgetary, and operational aspects of the center. The center director should be a productive, senior (as documented by publications, patents, honors, and similar indices of stature) and outstanding researcher. The center director is responsible for overall coordination and for the development of the center. An individual cannot serve as director of more than one NIDA research center grant. In addition, it is expected that the center director will make a substantial commitment of time and effort to the center. Although the average center director will commit more time to the center and associated activities than the minimum, it is expected that the center director will commit at least 15 percent effort to administration and 20 percent effort to research activities directly supported by the center grant.
Center Investigators
A cadre of experienced, independent and productive investigators should be present with active collaborations in place or planned. These investigators should evidence productivity, stature and leadership, or potential strong leadership role, in their respective fields. A broad range of expertise relevant to the center's goals should be present. Investigative efforts may encompass researchers with primary appointments to the applicant institution as well as to other collaborating sites. Investigators must commit to the data sharing and communication with other investigators in the center.
Administrative and Organizational Structure
The center must have appropriate and effective administrative and organizational capabilities to conduct multidisciplinary research, to foster synergy, and to plan and evaluate center activities. There should be clear and convincing evidence of the applicant institution's commitment to the center. Administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the center. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research, publications, and generation of future grant applications, and also takes maximum advantage of the center's drug abuse research capability (this is particularly important to explain when there are multiple participating institutions in the center); (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources; (c) the use of a standing outside advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the center director; (d) internal advisory, decision-making, and priority setting processes appropriately charged to conduct the activities of the center; and (e) appropriate criteria and processes for determining and sustaining individual participation in the center based on productivity, research direction, and overall contribution. Administrative support might also include plans for recruitment, training, and supervision of staff.
Provisions for Mentoring, Career Development, and Dissemination (P50 and P60 only)
The P50 and P60 centers should serve as a magnet for attracting and mentoring investigators in the field, and the application should present plans for training, career development and mentoring of investigators. The applicant institution must therefore demonstrate that it has plans and facilities that provide the capacity to train predoctoral and / or postdoctoral students for careers in drug abuse research, the capacity to provide career development and mentoring opportunities for potential drug abuse researchers, and career development for current drug abuse researchers. A philosophy of mentoring and continued career development for researchers at various phases of their careers should be presented. The unique opportunities for mentoring that are (or will be) provided by the center should be identified.
If the center does not have formal training programs of its own, there must be specific provision for coordination between the center and the training programs of the applicant institution and / or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, center staff should participate in the development of training programs, and center resources should be made available for use of trainees. In addition, as national resources, P50 and P60 centers should also facilitate the sharing of data and methodologies as well as training in such methodologies with the scientific community.
It is also expected that the comprehensive P60 centers will serve a role in informing the public about scientific findings and health issues. Community outreach and K-12 school education must be incorporated into the center's overall program.
- Allowable Budgetary Items and Supportable Activities
Allowable costs in NIH grants are governed by rules set forth in the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Grant Award. Under these rules, the center director may exercise flexibility to meet unexpected center requirements by re-budgeting or requesting approval to re-budget among budget categories within the total direct cost budget of the center (as shown on the Notice of Grant Award). In developing the budget for core center activities, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The center is intended to provide reasonable support for activities clearly related to the specialized research needs of the center, as noted below:
Research Projects and Core Units
- Direct support of research relevant to NIDA's mission (not applicable to P30).
- Direct support of core units used by research projects
Center Administration
- Salaries and support for a limited number of administrative and clerical personnel. However, salary and support for central administrative personnel, usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel, are not allowable.
- Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment, when not covered by institutional overhead charges.
- Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowable.
Shared Resources and Services
- Shared resources and services intended to provide access to technology that enhances the research productivity of the center and provides foci for scientific interaction and consultation, as well as access to services that facilitate the research and strengthen the administrative and organizational cohesion of the center.
- Costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies.
Planning and Assessment of Progress
- Costs for the use of ad hoc scientific and technical consultants when appropriate and for the conduct of seminar series designed to promote interdisciplinary interaction, education, and center cohesiveness.
- Costs of center planning and evaluation, including the costs of an external advisory committee.
Pilot Projects
- P30 applications may not propose pilot projects.
- P50 and P60 applicants are encouraged to propose and request funding for specific, already conceptualized pilot projects, which may be "research and development" pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. Sufficient details should be provided for these pilot studies that will be reviewed by the scientific review group as part of the assessment of scientific and technical merit.
- In addition, P50 and P60 applicants may request funds for pilot projects that are yet to be conceptualized. These projects should have the potential for developing into, or providing the foundation for, larger projects that could compete for funds on their own. The support of pilot projects studies should be of relatively short duration (e.g., 1-2 years), depending upon the nature of the research. Because these projects cannot be reviewed by the scientific review group, applicants must describe and provide a process for a within-center scientific review of pilot projects. In general, the total amount of money allocated to yet-to-be-conceptualized pilot projects for P50 or P60 applications should not exceed 10% of the center grant's total annual direct costs, and exceptions must be strongly justified.
- Whether specifically proposed in the application or developed later under center auspices, pilot projects must comply with applicable NIH policies, and the necessary human subject and animal welfare assurances must be submitted.
- For projects not specifically proposed in the application, center grantees are to provide the NIDA program officer with written notification of the initiation of new pilot projects. The notification should contain a brief description of (and rationale for) the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, and a statement that the project will comply with applicable NIH policies and that the necessary assurances have been submitted and obtained. The program officer must also be provided with assurance that the projects have received an appropriate within-center scientific review.
Mentoring and Career Development (applicable to P50 and P60 only)
- Costs associated with providing mentoring and career development opportunities. As noted above (see "Provisions for Mentoring, Career Development, and Dissemination"), center grant funds may not be used to pay stipends or other trainee costs. However, center staff may participate in the development of training programs.
- Support of research for participation of promising investigators in center grant projects.
Research-Related Treatment and Prevention Costs
- P50 and P60 applicants from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources, NIH, or a comparably supported clinical research facility are encouraged to explore the possibility of using the facilities or arranging for other means to conduct some of the center's proposed research. If a center applicant wishes to identify a GCRC or comparably supported clinical research facility as a source for conducting proposed research, a letter of agreement from the program director or principal investigator of the GCRC or comparably supported clinical research facility should be included in the application material.
- Centers may request funds for use of in-patient, residential, or out-patient facilities that are essential to the conduct of the research (e.g., patient bed costs, research ward costs, out-patient facility and other health services costs). Similarly, centers may request funds for prevention program services or community interventions needed to conduct the research. In such cases of paying for beds, facilities, services, etc., funds will be provided only when it is clear that no other funds are available and the services are essential to the conduct of the research.
Travel
- Travel of center director and other investigators to scientific meetings justified as essential to the conduct of research under the center may be supported.
- Travel of technical staff for training justified as essential to enhancing the quality of the research projects may be supported.
- Application Procedures and Submission Dates
Applications are to be submitted on the grant application form 398 (rev. 6/02). Application kits are downloadable at NIH website, http://grants1.nih.gov/grants/funding/phs398/phs398.html#forms. The title of this program announcement (PA) needs to be cited on line 2 of the face page. The receipt dates for all unsolicited center applications, whether new, competing renewal, or revised, are February 1, June 1, and October 1.
Applications must have a Dun and Bradstreet (D&B;) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form.
Potential applicants are strongly encouraged to contact NIDA program staff early in the planning process. An applicant requesting $500,000 or more in direct costs for any year of a center is required to obtain agreement from the Institute program staff that the Institute is willing to accept the application for review and possible funding. The name of the program contact should be indicated in a cover letter submitted with the application. Applications that do not identify a program contact will be returned to the applicant without review.
NIDA staff will provide pre-application consultation to all applicants for NIDA center grants. Telephone conversations, email exchanges and meetings with NIDA staff can provide information that will be useful to ensure that applications are complete and responsive. It is often of value to the potential applicant to send a preliminary plan to program staff at least 90 days prior to initial submission of an intended center grant application in order to receive feedback on responsiveness and compliance with NIH requirements. However, program staff will not provide a critique of the scientific aspects of the application. Program staff (see Contacts for Additional Information) should be contacted to determine what information is needed.
Applications must be complete in order to be accepted. Applicants are encouraged to organize their application by initially presenting the face page, the abstract page with key personnel, a table of contents, summary budget pages for the entire center, and other documentation pertaining to the entire center. This should be followed by an introductory section of no more than five pages that addresses the ways in which the application meets the criteria that define a NIDA center. After that introduction, each core and research project should be presented with its accompanying individual budget, budget justification, biographical sketches, other support information, and research plan. For each core and research project component, there is a 25-page limit for the sections of the research plan (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) as indicated in the PHS 398. Appendix material limits apply to each component separately; each component's appendix must follow PHS 398 guidelines. Applications exceeding page limits, font limits, or appendix limits will be returned to the applicant without review. Appendices should not be placed within the body of the application but should be bundled separately, component by component. (See Other Information) for submitting revisions.)
In order to expedite review planning, two copies of the application and five copies of the appendix should be sent to:
- Director
Office of Extramural Program Review, NIDA
6001 Executive Blvd, Room 3158, MSC 9547
Bethesda, Maryland 20892
The signed original and three copies, without appendix material, should be sent to:
- Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC-7710
Bethesda, MD 20892-7710
or
Bethesda, MD 20817 (for courier or overnight mail services)
- Procedures for Review
Upon receipt of the application, staff at the Center for Scientific Review will review the application for completeness and conformance with NIH policy. NIDA staff will review the application for responsiveness to the NIDA guidelines. If the application is incomplete or fails to comply with NIH policy or NIDA guidelines, it will be returned to the applicant. New and competing applications will be assigned to a NIDA scientific review group (SRG) for first-level scientific review. The National Advisory Council on Drug Abuse performs a second-level review.
Because of the important role that NIDA centers are expected to play in advancing the nation's public health and because of the substantial investment of resources in them, the peer review process is thorough and lengthy, usually requiring two review cycles for completing the evaluation of competitive applications. (Cycles are given in the PHS 398 kit under instructions for submitting applications.)
In the first step of this two-cycle process, the SRG will conduct an initial assessment of whether the proposed center meets the overall essential characteristics to be considered a research center, along with a preliminary review of scientific and technical merit. To be competitive, NIDA center applications must clearly display exceptional quality for both sets of criteria (i.e., the highest caliber of innovative scientific research and the unique characteristics of a research center) at this step.
The preliminary review of scientific and technical merit will be based, in most cases, on written assessments submitted by scientists selected for their expertise. The written assessments will present information and opinions on the significance, approach, and innovativeness of the proposed research, and the conclusions will be treated as recommendations on the merit of the proposed work.
Applications considered at this stage likely to meet all relevant critieria at the highest level will typically be scheduled for a site visit.
If the initial assessment and preliminary scientific review show that an application does not meet the essential characteristics of a center or does not meet sufficiently the requirements for scientific quality in terms of innovation and other criteria, it will not be scored and will not be recommended for further assessment and consideration.
The SRG may determine that a P30 applications is sufficiently well developed to allow scoring in a single review cycle (i.e., after the initial SRG) without a site visit.
The site visit's purposes are to allow further investigation of the extent to which the characteristics of a NIDA center are met and to further determine the level of scientific merit. A site visit may be either "on site" or a "reverse site visit."
After the site visit, the application will be given a second review by the SRG at its meeting of the following council cycle. The site visit information will be used in determining the quality of the "centerness" and scientific merit of the application (in particular its innovation). The application will be scored, or not scored, based on all the review criteria.
Applications scored by the SRG will receive a second-level review by the National Advisory Council on Drug Abuse. The Council concurs or not with the recommendations of the review committee as described in the summary statement. In the event of non-concurrence, the application may be returned for re-review. The Council does not evaluate the scientific and technical merit of applications but focuses on matters pertaining to program relevance, policy considerations, adequacy of the initial review, and budget. Funding decisions are made by the Institute Director.
The review procedures noted above will be used to guide the review of revised applications but may vary somewhat according to the issues addressed in the revision. Those that have already been site visited usually will not be site visited.
Applications that are competing renewals (competing continuation) follow the same procedures noted above for new applications but usually will not be site visited.
- Review Criteria
Applications will be reviewed by the review criteria below. Applicants should ensure that their applications are responsive to the research goals of NIDA and to the "Essential Organizational and Administrative Characteristics of a NIDA Center" as described in these guidelines. Applications will also be reviewed for appropriateness of budget and protections for human subjects, animal subjects, and the environment, as needed. Gender and minority representation will be assessed as needed, as will the inclusion of children. The adequacy of the data and safety monitoring procedures, where relevant, will be considered, as will data sharing plans. Not every criterion will apply to every mechanism, but reviewers will attempt to apply them as broadly as possible within the constraints of specific mechanisms.
- Special Criteria for NIDA Research Centers
Quality of integration of center components (including components not directly supported under a P30 but which utilize core functions) to an overarching theme that integrates and focuses the center, as well as the presence of an essential relationship of each component to the theme. Interdependency and linkages of components to each other need to be demonstrated for at least a significant nucleus of components.
Evidence of synergy among components. To aid in this determination, reviewers may look at the quality of provisions for the sharing of resources, procedures for formal and informal planning, and plans for developmental or pilot work in order to determine if the application reflects a depth and breadth of expertise and experience not normally present in an individual research project grant.
The involvement of different scientific disciplines or subdisciplines in the center's activities and the demonstration of substantial interaction among scientists from different disciplines or subdisciplines and different perspectives. It is expected that multidisciplinary or cross disciplinary research will be emphasized.
Evidence of innovation and creativity in the center projects. The research projects should have a high probability of moving drug abuse field to a new and higher level of accomplishment. Innovation in approach, techniques, problem solving, conceptualization or other areas is expected in each component and in the center as a whole. Competing continuation applications must document how work during the current funding period has been innovative and creative.
The degree to which the necessary components of a center (Research Environment and Facilities, Director, Investigators, Administrative and Organizational Structure, Provisions for Mentoring and Career Development, and Research Activities) are consistent with, and contribute to, a comprehensive research center. For a P30, this includes evidence that there are at least two years of funding left for each project at the time of submission and that there is the potential for continued funding of projects in the center.
- Other Important Criteria:
Progress
Applicable to all competing renewals: Evidence must be provided of substantial progress in reaching stated goals: These include records of publications Ð quality and quantity of publications, dissemination, patents, awards, training activities, placement record of trainees. For P50 and P60 with funded pilot studies, details of progress should be included in the progress report and whether the research led to NIH or other funding.
Research Environment and Facilities
Plans for development and maintenance of an environment that promotes the conduct of the highest quality of research, innovation, and leadership. Demonstrations of past productivity are evidence of likely future productivity, especially in competing renewal applications, where innovation needs to be demonstrated.
Appropriateness and adequacy of facilities for administrative, research, and shared resources, including a clearly identifiable physical location for the center which assures necessary functions can occur.
Facilities that indicate the center is, or would soon be, a national scientific research resource.
Evidence that core components contribute toward cost-effectiveness and quality control in resource utilization.
Quality and extent of data analytic capacities, data base facilities, coordination, and data resources.
As needed, the quality of provisions for shared laboratory resources, the quality of laboratory space, and the quality of clinical facilities.
Qualifications of the Center Director
Ability to lead a scientific program (including a program with training components, if applicable), as noted by scientific achievements, productivity, stature in a relevant field, and planned activities.
Ability to lead administrative and operational aspects of the center, as noted by administrative skills, achievements, and planned activities.
Evidence of ability to develop or maintain a role for the center as a national resource.
Adequacy of commitment of time and effort for the research and administration of the center. (A minimum of 35% effort on activities directly supported by the center funding is required for all center directors.)
Qualifications of Investigators
Quality of cadre of investigators, their productivity and leadership ability, as noted by their scientific achievements, honors, and recognition.
Quality of interactions among investigators and investigative teams.
Breadth of expertise represented among investigators.
Quality of investigators at collaborating sites and the nature of collaborations.
Evidence of multidisciplinary/transdisciplinary backgrounds and interests.
Administrative and Organizational Structure
Organizational and administrative structure and support conducive to research, synergy, and joint planning.
Structure for long range planning and evaluation of center activities.
Programmatic structure that effectively promotes productive scientific interactions and takes maximum advantage of the applicant institution's drug abuse research capacity.
Arrangements for internal quality control of research, publications, and grant applications.
An organizational structure with clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leverage of resources to enable additional or future work. Evidence of how the center has attracted additional sources of funding or leveraged resources is especially relevant for competing continuation applications.
An outside advisory structure that provides appropriate and objective advice and evaluation.
An appropriate, fully described internal process that allows for priority setting and decision making to sustain the center.
Appropriate specification of criteria and processes for determining and sustaining individual participation in the center based on productivity, research direction, and overall contribution.
Clear and convincing evidence of the applicant institution's substantial commitment to the center and appreciation of its goals and role in public health.
Adequacy of provisions, especially in core components, for sharing of data base development and analytic capacities. Innovative, state-of-the-art analytic capability.
As needed, plans for recruitment, training, and supervision of staff.
Mentoring, Career Development, and Dissemination (P50 and P60 only
The capacity to train predoctoral and / or postdoctoral students for careers in drug abuse research, as demonstrated by plans and facilities for workshops, seminars, and other educational activities.
The capacity (including plans and facilities) to provide career development and mentoring for potential drug abuse researchers.
Career development plans for current drug abuse researchers.
Demonstrated success in mentoring and career development activities and a cogent philosophy of mentoring and career development that takes advantage of the unique qualities of a center.
Quality of plans to disseminate research findings and to educate other scientists (P50 and P60) and the public (P60 only).
For competing renewals, evidence that trainees have successfully embarked on drug abuse research careers.
Data sharing plan
Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. 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 priority score.
- Criteria to be used for determination of scientific merit of individual scientific project components
The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the component in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:
- Significance
- Approach
- Innovation
- Investigator
- Environment
Each of these criteria will be considered in assessing merit. Of particular importance will be the innovation of the project and the likelihood that the results would have a major impact. Furthermore, successful centers are expected to show outstanding merit on all criteria.
Significance: Does this study address an important problem? If the aims of the component are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
Investigators: Is each investigator 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? Is the principal investigator considered a leader in the field or has the principal investigator demonstrated potential leadership quality? How does the principal investigator interact with, and contribute to, other members of the research team for this project and for the center as a whole? Is there evidence of cross-disciplinary teamwork?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?
For pilot studies, what is the likelihood that the research will contribute to the development of multidisciplinary programs or more mature research endeavors?
If applicable, what is the adequacy of plans for data safety and monitoring? Are provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures adequately described?
If applicable, what is the adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research?
If applicable, what is the adequacy of plans to include children as appropriate for the scientific goals of the research?
In addition, the SRG will assess:
Justification for this research being conducted within a center structure. The connectedness: people interact with other research projects or cores within the center and relationship to the overall theme of the center.
The appropriateness of the proposed budget and duration in relation to the proposed research.
The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application.
The plans for sharing data with the scientific community.
- Criteria for determination of overall scientific and technical merit of the center
SRG members will be asked to exercise their considerable professional judgment in determining an overall score for the center application. This will be based on an assessment of the extent to which thematic integration, synergy, innovation, and multidisciplinary involvement -- the key characteristics of a NIDA center-- are present. The scientific and technical merit of the center as a whole, the scientific and technical merit of each project, the likelihood of scientific productivity, and an overall assessment of the work's potential scientific and public health impact will also be the basis of the scores. Innovation is an especially important component of the scientific and technical merit assessment of each component and of the center as a whole. As noted elsewhere, a NIDA Center is expected to propose and to accomplish innovative, not incremental, work. It is expected to lead to the transformation of knowledge in the areas of science it is studying. Innovation may be evident in theoretical, analytic or other aspects of the components. Applicants must clearly demonstrate the creativity and novelty of each scientific project.
Renewal applications must demonstrate the innovation and impact of work completed during the current funding period.
- Required Federal Citations
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:
Research components involving clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring: NIH Guide for Grants and Contracts, June 12, 1998: http://grants1.nih.gov/grants/guide/notice-files/not98-084.html
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: UPDATED AUGUST 2, 2000:
It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html; a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.
The revisions related to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all Type 1 and 2) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies.
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Other Information
- Revisions
Investigators should contact program staff before revising their applications. In revised applications, the application should include an introductory section of no more than five pages describing the ways the proposed center meets the criteria of thematic integration, synergy, innovation, and multidisciplinary approach that define a NIDA center. Then, an additional three pages per component should be presented to describe changes in the application. Also, within the research plan but not counting toward the 25-page limit, each component is allowed three pages to address revisions.
- Supplements
Applications for supplements to center grants will be supported only under the most exceptional circumstances and they will be accepted for review only if there is pre-approved submission by relevant NIDA staff. Specifically, a letter of agreement from relevant program staff must be submitted with the supplement application. Applications for supplements to center grants are expected to meet all criteria for a NIDA center listed above. The review procedures outlined above will be used and modified as needed to achieve an expeditious but thorough review. The supplement must contribute to the overall theme of the center and be clearly linked to other ongoing center projects in a synergistic fashion. A supplemental application that presents outstanding science but does not demonstrate how it will contribute to the synergy, multidisciplinary nature, and theme of the ongoing center will not be scored.
- Meetings of Center Grant Directors
To promote information sharing, to facilitate collaboration, and to address issues of common concern among NIDA research centers, NIDA may ask center grant directors to participate in meetings on an as-needed basis.
- Changes in Personnel
Any major change in the level of participation of key personnel named on the Notice of Grant Award must be submitted to NIDA for approval by the program officer as soon as this information is known but no later than 30 days before the expected date of departure or change in participation level. A letter of justification for the change in appointment, co-signed by the responsible university official, and a biographical sketch for the replacement key personnel must be submitted to NIDA. The request will be reviewed by program and grants management staff and, if the arrangements proposed by the grantee and the qualifications of any proposed replacement are acceptable to NIDA, the change will be authorized.
- Changes in Projects
Any change in the scope of the center or its component projects must be submitted for approval by NIDA.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects
The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations before submitting an application for research involving administration of compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under "Funding" or may be obtained by calling (301) 443-2755.
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Contacts for Additional Information
For information on review matters, please contact:
Teresa Levitin, Ph.D.
Director, Office of Extramural Affairs
Room 3158
(301) 443-2755
E-mail: TL25U@NIH.GOV
For information on fiscal matters, please contact:
Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
Room 3119
(301) 443-6710
E-mail: GF6S@NIH.GOV
All of the named individuals are located at:
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Bethesda, Maryland 20892
(Use 20852 for mail delivered by courier. Ascertain the Room and Mail Stop Code before sending if possible.)
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