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, HIV/AIDS 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. Renewal applications (formerly called competing continuation or competing renewals) are permitted.
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, 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 Project Director/Principal Investigator (PD/PI) who possesses recognized scientific and administrative competence. The PI must show a substantial commitment of time and effort to the program, at least 25%. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. If the multi-PD/PI option is selected, the combined commitment of time and effort for all PD/PIs must be at least 25%, with a minimum effort per PD/PI of 20%. Effort may be divided between administrative and scientific duties. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Individual components (research projects and cores) 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 NIDA's mission, and to complete internal paperwork that assists in the referral of the application to the appropriate study section.
Applications must be submitted using the paper PHS 398 application package and instructions. NIH will make new application packages and instructions available in early December 2009 (http://grants1.nih.gov/grants/forms.htm). Applicants must download and use the new application packages for submissions targeting due dates on or after January 25, 2010 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-002.html) or risk having the applications returned without review. Changes will be substantial and include significantly shorter page limits and restructured application packages.
Standard receipt dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm). The receipt dates for all program projects involving areas of science other than HIV/AIDS are January 25, May 25 and September 25, whether new, renewal (formerly competing continuation or competing renewal), or resubmission (formerly amended or revised). The receipt dates for all program projects involving HIV/AIDS are May 7, September 7 and January 7, whether new, renewal, or resubmission.
Applications must be complete at the time of submission. Applications should be organized 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 limited to 12 pages that explains the overall structure, organization, and rationale of the program project. This should include a description and of the thematic purpose of the program project and the rationale for selecting it as well as the rationale for selecting the individual research projects and cores and the Project Leaders for the research projects and cores. The relationships among components, the way in which multidisciplinary perspectives will be used, the expected "synergy," or productivity to be expected which is greater than would be obtained if each component existed independently of the program project, and the institutional resources supporting the success of the program project should also be described. A leadership plan detailing how responsibility will be allocated and managed, as well as how progress will be monitored and problems resolved is also necessary. If this is a resubmission, an Introduction to the Revised Application limited to one page must be inserted to explain how the application has been revised in response to the previous review.
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.
Page limits: NIH will make new application packages and instructions available in early December 2009 (http://grants1.nih.gov/grants/forms.htm). The new applications will have new formats and new page lengths. These new forms and instructions must be used and the new page limits must be followed or the applications may be returned without review.
The Specific Aims are limited to one page for each research project and core. The Research Strategy (i.e., significance, innovation, approach, preliminary studies for new applications/progress report for renewal applications) is limited to 12 pages for the introduction describing the overall program project, 12 pages for each research project, and 6 pages for each core. The Specific Aims and Research Strategy are separate sections and each has its own page limits as indicated above. Appendix material limits apply to each component separately, and appendices are limited to the contents specified in the PHS 398 instructions. They should be bundled separately, component by component. If the application is a resubmission, each component may also include a one page introductory section to explain changes; this one page does not count towards the 6 or 12 page limit for the Research Strategy.
The signed original and three copies, without appendix material, should be sent via courier delivery or via the US Postal Service (USPS) to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (regular USPS or USPS Express mail)
or
Bethesda, MD 20817 (other courier/express mail delivery)
At the time of submission, two additional copies of the application and all (five) copies of the appendix should be sent to:
Director
Office of Extramural Affairs
NIDA
6101 Executive Blvd., Suite 220, MSC 8401
Bethesda, MD 20892-8401 (for mail)
or
Rockville, MD 20852 (for courier or overnight mail service)
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.
1. Program as an Integrated Effort (Overall)
- 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 administrative 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.
2. 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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research question time sensitive?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the approach justify the need for rapid review and funding?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Additional Review Criteria.
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations.
Applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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/impact 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 revisions to program projects: Applications for revisions 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 revision application. Applications submitted without this agreement will be returned. Applications for revisions 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 are reviewed at CSR, while non-HIV/AIDS P01 applications are reviewed 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, Services and Prevention Research
301 443-6504
e-mail: mglantz@mail.nih.gov
Jag Khalsa, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
301 443-2159
e-mail: jkhalsa@mail.nih.gov
Diane Lawrence, Ph.D.
AIDS Research Program
301 594-3225
email: lawrencedi@mail.nih.gov
Paul Schnur, Ph.D.
Division of Basic Neuroscience and Behavioral Research
301 435-1316
e-mail: pschnur@mail.nih.gov
Laurence Stanford, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
301 443-0107
e- mail: lstanfor@mail.nih.gov
For information on fiscal matters:
Pamela G. Fleming
Chief, Grants Management Branch
301 443-6710
e-mail: pfleming@mail.nih.gov
For information on review:
Teresa Levitin, Ph.D.
Director, Office of Extramural Affairs
301 443-2755
e-mail: tlevitin@mail.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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