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Contents
Purpose
Programmatic Purpose
Information for Applicants
Purpose
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The purpose of this announcement is to inform the research community that the National Institute on Drug Abuse (NIDA) has clarified, amended, and consolidated program and review guidelines for its centers' program. This 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; and those issued in Vol. 25, No. 12, April 19, 1996.
Programmatic Purpose
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NIDA provides support for research center grants to foster a synergistic 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, multi-disciplinary research programs.
NIDA centers must have two sets of essential and defining qualities. The first of these is, of course, the highest caliber of scientific work. The second set relates to the particular characteristics of research centers, as opposed to simply outstanding work supported through other grant mechanisms. This set of center-specific characteristics emerges 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 mere collection of the individual components. Taken as a whole, then, a NIDA center is expected to enable a level of achievement which exceeds that expected on the basis of "the sum of its parts." Center support should be essential to the achievement of work that is proposed.
In addition, NIDA research centers are expected to serve as national research resources. They are expected to attract established and promising investigators into drug abuse research and, for the P50 and P60, to provide opportunities for research training, career development, and mentoring.
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 issues of neuroscience, prevention, treatment, health services, or other drug abuse-related research areas.
Information for Applicants
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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) other information, and (VIII) contacts for additional information.
Eligibility
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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 centers as national resources, foreign applicants are not eligible.
Mechanisms and Period of Support
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NIDA provides support for three types of research centers: core center grants (P30), specialized center grants (P50), and comprehensive center grants (P60). See Figure 1 for information on each.
Core Support Center Grants (P30) are intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources to enhance and extend the effectiveness of research related to drug abuse and addiction. The applicant may propose pooling of existing core resources of currently funded grantees and request additional support for developing a research infrastructure to be shared by them. This research infrastructure support may include, for example, administrative coordination, subject recruitment, equipment, laboratories, statistical analysis and database management. It should be made clear how core center support would enhance the individually funded projects' contributions and result in programmatic coherence, synergy, and integration. Applicants must demonstrate the potential for the continuation of funding of projects included in the core center application, and there must be at least two years of funding left for each project identified at the time of submission. P30 applicants may apply for up to five years of support, whether as new or competing renewal applications.
Specialized Center Grants (P50) provide support for a broadly based, multi-disciplinary 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 thematically integrated, multi-disciplinary, 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. P50 applicants may apply for up to five years of support, whether as new or competing renewal applications.
Comprehensive Center Grants (P60) are intended to include all components of P50s 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 community. Comprehensive research center grants support continuing education for health care professionals, dissemination of information to the public, and 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, epidemiologic, and community prevention), there should be a comprehensive approach to the research theme. P60 applicants may apply for up to five years of support, whether as new or competing renewal applications.
Elements of NIDA Centers
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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.
All NIDA centers must clearly demonstrate the occurrence of consistent, thematically focused, and creative research productivity 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.
There are three necessary characteristics for meeting this set of requirements:
- Thematic Integration -- There must be an over-arching 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 which are relevant to the theme.
- Synergy -- 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 extra productivity, quality, and progress that result from interdependency and linkage, where the levels of productivity, quality, and progress exceed those expected from combining the individual components in an additive fashion. Synergy is further evidenced by creative thinking, a great breadth or depth of expertise focusing on an issue, innovations, and highly significant findings.
- 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 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 interest. Each research endeavor should bear an essential relationship to the integrating theme and efficiently use and contribute to center resources. Centers should enable innovative and important studies, whether they be developmental activities and pilot projects or 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 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 centers' program.
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 particular area(s) of investigation. Applicants must demonstrate that the center is or would serve as a significant national scientific research resource soon after establishment.
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 assures 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.
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 (as documented by publications, patents, honors, and similar indices of stature) researcher. The center director is responsible for overall coordination and for the development of the center. Because of the role and importance of the center director to the success of the center, an individual may not 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 P50 or P60 center director will commit at least 25 percent effort to research and administration of activities directly supported by the center grant.
Center Investigators
A cadre of experienced, productive investigators should be present with active collaborations in place or planned. These investigators should evidence productivity and stature in their respective fields, and 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.
Administrative and Organizational Structure
The center must have appropriate and effective administrative and organizational capabilities to conduct 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, among and between 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(s) 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. P60 centers should also serve a role in informing the public about scientific findings and health issues.
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 rebudgeting or requesting approval to rebudget 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 P30s)
- 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
- P50 and P60 applicants may 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. These pilot studies 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
- 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 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 inpatient, residential, or outpatient facilities which are essential to the conduct of the research (e.g., patient bed costs, research ward costs, outpatient 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
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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 preapplication consultation to all applicants for NIDA center grants. Telephone conversations 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 Section VIII, Contacts for Additional Information) should be contacted to determine what information is needed.
A specific program announcement (PA) or request for applications (RFA) does not need to be cited. The receipt dates for all unsolicited center applications, whether new, competing renewal, or revised, are February 1, June 1, and October 1. Applications should be submitted on the grant application form PHS 398 (rev. 5/95), which is available from most institutional offices of sponsored research. It may also be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, NIH, 6701 Rockledge Drive, Room 3034-MSC 7762, Bethesda, MD 20892-7762; telephone 301 435-0714; e-mail GrantsInfo@nih.gov. It may be downloaded from:
http://grants.nih.gov/grants/funding/funding.htm.
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 form PHS 398. Appendix material limits apply to each component separately; each component's appendix may include up to 10 publications, manuscripts, abstracts, patents, or other printed material directly related to the project. Surveys, questionnaires, data collection instruments, and clinical protocols may also be submitted in the appendix. Original glossy photographs or color images may be included, provided that a photocopy (that may be reduced in size) is included within the 25 pages of the research plan. 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 Section VII for information on 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
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
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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 characterstics outlined above to be considered a research center, along with a preliminary review of scientific and technical merit. To be competitive, NIDA centers applications must clearly display both sets of criteria (i.e., the highest caliber of scientific research and the unique characteristics of a research center) at this step. 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 the requirements for scientific quality, it will not be scored and will not be recommended for further assessment and consideration. In the second stage of review, consisting of a site visit and consideration of the site visit by the SRG, the initial assessments regarding scientific merit and the centers unique added value may or may not be confirmed.
The SRG will perform the initial assessment during the first review cycle after submission. 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 work.
Applications considered at this stage likely to meet all relevant critieria at the highest level will be scheduled for a site visit and second SRG meeting to occur in the following review cycle. Those not meeting these standards will not be scored and there will be no further assessment.
The SRG may determine that some P30 applications are 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 at the next centers' SRG meeting. The quality of the application will be considered, and the application will be scored or not, 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. After Council consideration, applications will be considered for funding decisions by the relevant program staff and the Institute Director.
The review procedures noted above will be used to guide review of revised applications but may vary somewhat according to the issues addressed in the revision. For example, those that have already been site visited may not require another visit.
>Review Criteria
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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. 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 over-arching 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 as components are configured in the applications. To aid in these determinations, 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.
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:
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 may be used as evidence of likely future productivity, especially in competing continuation applications.
- 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, 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 included), 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 25% effort on activities directly supported by the center funding is required for P50 and P60 directors.)
Qualifications of Investigators
- Quality of cadre of investigators and their productivity, 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.
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.
- Outside advisory structures that provide appropriate and objective advice and evaluation, as needed.
- An 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).
Criteria to be used for determination of scientific merit of individual scientific project components
Significance: Does this study address an important problem? If the aims of the application 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 (if any)?
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 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:
- 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.
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, and multi-disciplinary 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.
Other Information
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Revisions
Investigators should contact program staff before revising their applications. In revised applications, the application should include the introductory section of no more than five pages describing the ways the proposed center meets the criteria of thematic integration, synergy, and multi-disciplinary approach that define a NIDA center. Then, an additional three pages may be presented as introduction to describe changes in the application. These two sets of introductory pages should precede the presentations of individual components. 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 after submission is approved by the relevant program staff. A letter of agreement from relevant program staff should 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 will ask center grant directors to participate in meetings on an as-needed basis. Grantees will be contacted about these meetings as the need arises. Funds for one such meeting a year should be requested in the center application budget.
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.
Inclusion of Women and Minorities in Research Involving Human Subjects It is the policy of the NIH that women and members of minority groups and their sub-populations 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, " which were published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources of from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy.
NIH Policy and Guidelines on the 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 and supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Contacts for Additional Information
Top of Page
- Bill Bukoski, Ph.D.
Division of Epidemiology and Prevention Research
Room 9A-53
(301) 443-2974
Internet: BB75H@NIH.GOV
Jack Blaine, M.D.
Division of Clinical and Services Research
Room 10A-10
(301) 443-0107
Internet: JB167N@NIH.GOV
Sander Genser, M.D.
Center on AIDS and Other Medical Consequences of Drug Abuse
Room 10A-08
(301) 443-1801
Internet: SG73F@NIH.GOV
- David Shurtleff, Ph.D.
Division of Basic Research
Room 10A-31
(301) 443-1887
Internet: DS171A@NIH.GOV
Betty Tai, Ph.D.
Medications Development Division
Room 11A-55
(301) 443-3318
Internet: BT26R@NIH.GOV
- For information on fiscal matters, please contact:
- Pamela G. Fleming
Chief Grants Management Officer, NIDA
(301) 443-6710
Internet: PF49E@NIH.GOV
For information on review matters, please contact:
- Teresa Levitin, Ph.D.
Director, Office of Extramural Program Review
Room 10-42
(301) 443-2755
Internet: TL25U@NIH.GOV
All of the named individuals are located at:
- National Institute on Drug Abuse
6001 Executive Blvd
Bethesda, Maryland 20892
Note: NIDA is scheduled to move to a new building in February, 1999. E-mail addresses will not change, but telephone numbers and mailing addresses will. After February 1, mail should be sent using the following format:
Name of recipient
National Institute on Drug Abuse
(insert Office, Center, or Division name)
6001 Executive Blvd., Room ___, MSC___
Bethesda, MD 20892
(Use 20852 for mail delivered by courier. Ascertain the Room and Mail Stop Code before sending if possible.)
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