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PURPOSE: The purpose of this announcement is to inform the research community that the National Institute on Drug Abuse has clarified its program and review guidelines for Program Project grants (P01 mechanism).
PROGRAMMATIC PURPOSE: NIDA awards Program Project grants for research projects closely related to a central theme that can be conducted effectively and efficiently through a coordinated collaborative or multidisciplinary approach using common resources, facilities, and instruments. NIDA supports Program Projects of only the highest quality, and each research project within the P01 award must be supportable on its own merit. The scientific merit of each research project is assessed independently as well as within the context of the whole program.
Program projects are expected to be broadly based investigative efforts with a well defined central focus or objective. The efforts should address critical issues of neuroscience, behavior, prevention, treatment, epidemiology, etiology, health services, or other drug abuse-related research areas.
ELIGIBILITY: Applications may be submitted by domestic, for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions may not be awarded grants for program projects. Applications addressing any of NIDA's programmatic areas are acceptable for consideration.
PERIOD OF SUPPORT: Program Projects, whether new or competing renewals, may request up to five years of support. After the initially approved period of funding, a competing application will be required to continue the support.
ESSENTIAL CHARACTERISTICS OF PROGRAM PROJECTS: There must be a unifying and well defined goal or problem area of research which clearly establishes the direction, objectives, and aims of the program project. In addition, there must be specific research projects that relate to and contribute toward those objectives and aims. The program project must utilize coordinated collaborative efforts in addressing the research areas, and multidisciplinary perspectives are encouraged. The combination of specific projects should produce a context that allows each research effort to share the creative strengths of the others. A P01 must support a minimum of three interrelated research projects that contribute to the program objectives. The grant may also include support for common or shared resources ("cores" or "core units") required for the conduct of the research projects. If cores are included, each must provide essential facilities or services for two or more individual research projects.
Interrelationships between component projects are expected to result in a greater contribution to the program goals than if each project were pursued separately. This enhanced productivity, or "synergy," should be facilitated by the administrative and physical organization of the program, the composition of the team, the selection of topics for study, coordinated scheduling of staff and support services, economies achieved through consolidated management, and in other ways as appropriate to the particular program project. While projects should cooperate and share resources to enhance productivity, they should not depend on each other for essential elements (e.g., subjects, reagents, data). That is, individual projects should be able to exist independently.
There must be appropriate and adequate facilities dedicated to the conduct of administrative, shared resource and research activities. A mechanism for effective administrative oversight of all program project activities must be assured and should contribute to enhanced creativity and productivity. Equipment and facilities are shared whenever possible to promote efficiency and scientific progress.
The P01 must be led by a Principal Investigator (PI) who possesses recognized scientific and administrative competence. The PI must show a substantial commitment of time and effort to the program, at least 35%. In addition, individual projects require the participation of an established Project Leader with a multi-disciplinary team of investigators or a team with expertise in several specialized areas within a specific discipline. All investigators must contribute to and share the responsibilities of fulfilling the program objective.
The application needs to justify that a program project mechanism is required for the desired level of integration and productivity.
APPLICATION PROCEDURES AND SUBMISSION DATES: Potential applicants are strongly encouraged to contact NIDA program staff early in the planning process. Applications requesting $500,000 or more in direct costs for any year of support must indicate a prior agreement from NIDA program staff to consider the application for possible funding. The name of the NIDA program contact should be indicated in a cover letter submitted with the application. Applications that do not identify a program contact will be returned without review. Applicants benefit from contacting program staff even if submitting a budget less than $500,000. In addition to agreement to consider for funding, program staff are able to provide guidance in developing a complete application, to explain NIH policies and procedures, to ensure relevance of the application to NIDAÕs mission, and to complete internal paperwork that assists in the referral of the application to the appropriate study section.
A specific program announcement does not need to be cited. The receipt dates for all program projects, 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. 4/98), 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://www.nih.gov/grants/funding/funding.htm
Applications must be complete at the time of submission. Applicants are encouraged to organize the application by initially presenting the face page, the abstract page with key personnel, a table of contents, summary budget pages for the entire program project, and other documentation pertaining to the entire project. This should be followed by an introductory section of no more than three pages that explains the thematic purpose of the program project, the relationships among components, the way in which multidisciplinary perspectives will be used, and the expected "synergy," or productivity to be expected which is greater than would be obtained if each component existed independently of the program project. This introduction should make clear why support as a program project is appropriate and essential for achieving the expected results. If this is a revised submission, an additional section ("Introduction to the Revision") of three pages may be inserted to explain how the application has been revised.
Following the introduction(s), each component (the research projects and cores, if any), should be presented individually with its accompanying individual budget and justification, biographical sketches, other support pages, 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, and appendices are limited to the contents specified in the form PHS 398. They should be bundled separately, component by component. If the application is a revision, each component may also include a three page introductory section to explain changes; these three pages do not count towards the 25 page limit.
In order to expedite the review planning, at the time of submission two copies of the application and five copies of the appendix should be sent to:
Director
Office of Extramural Program Review
NIDA
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547 (for mail)
Or
Bethesda, MD 20852 (for courier or overnight mail service)
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 (for mail)
Or
Bethesda, MD 20817 (for courier or overnight mail services)
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 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 new 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. 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 or 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: http://www.nih.gov/grants/guide/notice-files/not98-024.html
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 that involves the administration of compounds to human subjects. The guidelines are available on the NIDA Home Page at http://www.nida.nih.gov/funding/hsguide.html or may be obtained by calling (301) 443-2755.
NIDA HIV/AIDS COUNSELING AND TESTING POLICY: As noted in the NIH Guide of June 9, 1995, researchers funded by NIDA whose research brings them into ongoing contact with persons at risk for HIV infection are strongly encouraged to provide HIV risk reduction and counseling.
REVIEW CRITERIA: The review of the scientific and technical merit of Program Project grant applications will emphasize two major aspects: (1) review of the program as an integrated research effort focused on a central theme, and (2) the review of each component project and core unit(s). The review will also include an assessment of the academic climate and physical environment and special considerations, e.g., compliance with the human subjects and animal welfare regulations.
Criteria
- Program as an Integrated Effort
- The significance of the overall program goals and the development of a well-defined central research focus of importance and relevance to the goals and mission of the Institute.
- The degree to which the program reflects multidisciplinary involvement, perspectives, and resources.
- The degree of coordination, cohesiveness, interrelationship of components, and synergistic potential of the program project.
- The quality, justification for and usefulness of the core facilities, or other provisions for shared resources, to the research projects.
- The scientific leadership, ability, stature, experience, and adminis-trative competence of the PI and his or her commitment and ability to devote substantial time and effort to the program.
- The scientific stature and qualifications of Project Leaders and other investigators, and the extent to which each contributes to the overall program goals as well as their commitment to the program.
- Accomplishments and progress of the program to date (particularly for renewal and supplemental applications).
- Administrative arrangements and organizational structure for facilitating and monitoring the attainment of objectives and ensuring quality control. For example, plans to enhance communication and cooperation among the investigators, mechanisms for the allocation of funds, arrangements for long-term planning and periodic evaluation, plans for oversight and advisory activities, contractual agreements, and procedures for the replacement of key personnel could be assessed. Institutional strength, stability, commitment to research, and support for the proposed program (e.g., available fiscal systems and management capabilities) will be assessed.
- Evidence that a coordinated program project is necessary for the attainment of stated goals and objectives.
- Individual Components
The following criteria will be used to assess the individual research projects. They (along with the criteria above) will also be used to guide consideration of core components, applying them insofar as possible, as aspects of these may apply well to some core components (e.g., a biostatistical core) but not to others (e.g., a technical service core). Progress under a previous project will be used to inform reviewers' considerations of the criteria.
- 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 methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
- Investigator
Is the 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? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?
As part of the initial merit review, applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. In addition, applications will be evaluated for compliance with NIH policies on the inclusion of women, minority groups, and children, as well as for protections for human subjects, animal welfare, and biohazards, as applicable. The appropriateness of the budget for each component and for the overall program project will be assessed.
OTHER INFORMATION:
Submission of requests for supplements to program projects: Applications for competitive supplements to program projects will be supported only under exceptional circumstances and will be accepted for review only after the submission is approved by program staff. A letter of agreement from the relevant program staff (i.e., the project officer of the program project) should be submitted with the supplement application. Applications submitted without this agreement will be returned. Applications for supplements are expected to meet the requirements for a program project and contribute to the essential characteristics of program projects as defined above.
Submission of R01 applications: NIH policy allows the submission of P01 components as separate R01 applications. This may occur simultaneously with or subsequent to the P01 submission. In cases of simultaneous submission, the R01 and P01 may be assessed by the same reviewers, using the appropriate criteria for each mechanism. However, this may not always be possible since the R01 applications may be reviewed at CSR or NIDA, while the P01 will be normally be reviewed by a Special Emphasis Panel at NIDA. Applicants should discuss with program staff the advisability of simultaneous submission if this is being considered. Applicants are requested to include a statement noting dual submissions in a cover letter with each P01 and R01 application where there are dual submissions.
CONTACTS FOR FURTHER INFORMATION:
For information on programmatic concerns:
Meyer Glantz, Ph.D.
Division of Epidemiology and Prevention Research
301 443-6504
e-mail: MG115G@NIH.GOV
Jack, Blaine, M.D.
Division of Clinical and Services Research
301 443-0107
e-mail: JB167N@NIH.GOV
Sander Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
301 443-1801
e-mail: SG73F@NIH.GOV
David Shurtleff, Ph.D.
Division of Basic Research
301 443-1887
e-mail: DS171A@NIH.GOV
Betty Tai, Ph.D.
Medications Development Division
301 443-1428
e-mail: BT26R@NIH.GOV
For information on fiscal matters:
Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
301 443-6710
e-mail: GF6S@NIH.GOV
For information on review:
Teresa Levitin, Ph.D.
Director, Office of Extramural Program Review
301 443-2755
e-mail: TL25U@NIH.GOV
All of the above individuals are located at:
National Institute on Drug Abuse
(insert Division, Office, or Branch name)
MSC 9585
6001 Executive Boulevard
Bethesda, MD 20892-9585
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