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Work Group on Single and Multiple Project Grants
Report

I.   Background

The Work Group on Single and Multiple Project Grants (WGSMPG) was formed to provide advice to the National Deafness and Other Communication Disorders Advisory Council and to the NIDCD Director. Their charge was to consider the benefits and drawbacks of single project (R01) grants in contrast to multiple project (P01, P50, P60) grants, and to explore the possible value of adding Core Grants (P30) to the extramural research activities supported by the NIDCD. Additionally, the Work Group was asked to provide an in-depth examination of the rationale for the nurture, development and continuing support of multiple project grants. Questions suggested for discussion included the following:

1. Should there be a recognizable need for collaboration which underlies the development of a multiple project application? Under which circumstances are multiple project awards most useful?
   1. to stimulate new research areas/paradigms
   2. to foster clinical research or a mixture of translational and clinical research
   3. to attract new disciplinary approaches
   4. to nurture/enhance collaboration
   5. to provide other research benefits
   6. to enhance research training and career development

2. Assuming that a demonstrated need for collaboration among individuals, not presently interacting, is a fundamental component of multiple project grants, does it follow that certain research areas of the NIDCD will need more, or fewer, multiple project awards?

3. Is it reasonable to suggest that publications arising from multiple project grants will reflect broader, more comprehensive research activities?

4. When collaborations arising from a multiple project grant prove fruitful, is it possible (desirable?) to subsequently continue such research on one or more R01s?

5. If many, or most collaborations arising from a multiple project grant are continued on as separate single project awards, is it reasonable to expect that some, or many multiple project grants on a particular theme would have a finite life span, for example, 5-10 years? 10/27/98

6. In cases where the transition from a single multiple project to multiple single projects occurs, is it likely that critical resources will be lost? Would there be a benefit to offering core grant (P30) support to further enhance these collaborative efforts? Might this approach also be of value to groups of activities which have arisen apart from multiple project awards?

7. With regard to the critical problem of assuring a continuous infusion of new investigators into science, is there relevance to the single/multiple project discussion? For example:
   1. Do multiple project awards provide "shelter" for people beyond postdoctoral training that is different (better) than that which might be obtained as a key (not principal) investigator on a traditional individual research project (R01)?

   2. Conversely, in the current multiple project grant, are there disincentives or delays to encouraging independence among younger investigators?

Suggestions and guidance from the scientific community were requested. The NIDCD placed the charge to the Work Group and the questions listed above on its Home Page. The American Academy of Otolaryngology ñ Head and Neck Surgery (AAO-HNS), Association of Chemoreception Sciences (AChemS), Association for Research in Otolaryngology (ARO), and the American Speech-Language-Hearing Association (ASHA), communicated electronically with their members.

In addition, the principal investigators of all multiple project grants (P01, P50, P60) active in 1997 were solicited individually for their evaluation of those 39 grants. They were asked to respond to the following questions:

1. Has your "P" grant been greater than the sum of the subprojects? That is, has there been a positive synergistic effect on collaboration directly linked to this administrative framework? Please provide specific examples.
2. What are the main goals of the "P" grant, and to what extent are they being accomplished?
3. Describe the purpose of each core and its importance to the research activity.
4. Why do you believe the research is better served by the "P" activity? If part of your response rests on drawing together persons of varied research backgrounds, please list the disciplines represented on your grant.
5. Please provide two lists of bibliographic references arising from your "P" grant subgrouped as:
   1. Examples of the most significant papers
   2. Papers co-authored by two or more subproject leaders

The WGSMPG met three times. The first two meetings were by teleconference call on May 22, 1998 and June 30, 1998. The third meeting took place in Bethesda on August 13-14, 1998.

II.    Summary of Input from the Scientific Community

Almost all Principal Investigators of multiple project grants ("Ps") active in 1997 responded to the letter requesting an evaluation of their grant. They were uniformly positive about the "P" mechanism. They cited advantages of synergy and collaboration, particularly between basic and clinical scientists; availability and efficiency of shared infrastructure resources; flexibility in supporting junior investigators; and visibility in the university and the community. The key concrete element that supported these advantages involved the shared core facilities. In clinical research, shared patient populations often played a key role. A second component that fostered interactions on some, but not all "P" awards, was the process of working together in preparing an application and the resulting critical scientific input from all those involved.

Input from the general community had a different emphasis, with certain uniform elements. They considered the R01 to be the gold standard for research. Many felt that multiple project grants have some merits, but questioned whether its stronger parts carry along weaker projects. There was also concern that multiple project grants disproportionately favor a subset of scientists. The different review processes for "R" and "P" grant applications was a major concern. Two of the respondents had extensive experience with both, and they were emphatic about the disparity between the two review processes. One of them strongly recommended changes to review and funding guidelines, the other recommended abolition of most multiple project grants and implementation of a Core Grant (P30) program within NIDCD.

From the testimony given to them, plus their own experiences as scientists, grantees (R01, R29, P01, P50 and P60), and reviewers [within the NIDCD as well as the Center for Scientific Review (CSR) or its predecessor, the Division of Research Grants (DRG)], the members of the WGSMPG identified several important principles as the foundation for their recommendations:

1. Collaboration among scientists is increasingly important and should be fostered on individual research grants (traditional R01s), between or among R01 grantees, as well as on multiple project grants.

2. Whenever possible, the extramural research activities of the Institute should be based on R01 grants.

3. The resources provided to centers to enhance collaboration should be made available to a broader segment of the extramural scientific community.

4. Issues of fairness in review between that which is NIDCD-based and that which is CSR-based should be identified and resolved.

III.    Multiple Project Center Grants (P50)

The WGSMPG recommends that NIDCD adopt a more limited type of multiple project research activity based on the following:

1. Essential Criteria for Multiple Project Center Grant Applications
   1. Projects must be interdependent, interrelated, and multidisciplinary; there must be a unifying theme; and

   2. The feasibility of the research proposed on any project would be significantly diminished if that project were submitted as a traditional individual research grant (R01) application.

2. Description and Definitions

   Each multiple project grant must have a well-defined central unifying theme with three or more subprojects and supporting cores as appropriate. The program will be led by a principal investigator who has the authority and responsibility to manage the overall scientific effort and the budget. The program must be multidisciplinary, consisting of interdependent, interrelated subprojects that are inappropriate for funding by other mechanisms. Multidisciplinary is defined as subproject leaders and/or projects representing different scientific backgrounds, training and expertise. This feature alone does not constitute a rationale for the use of a multiple project grant, since many individual investigator-initiated research grants (R01s) are multidisciplinary in nature. Frequent, extensive and committed interactions between the disciplines must be evident. Interdependent means that materials, results, data or methodologies, are shared among the projects. Results of one project may depend on results from the other projects for interpretation and understanding. This interdependence would preclude successful submission as an individual project (R01) application. Interrelated means that each project must have goals and objectives that focus on the common theme.

3. Examples: One example for such a multiple project grant would be a group of projects focused around a clinical study. Each project would require clinical data, clinical specimens and/or other related materials derived from a cohort of patients with a disorder of hearing, balance, voice, speech, language, smell or taste. Another example would be studies focused on a common experimental model or animal cohort that meet the same interdependence requirements. Core support must be justified as providing essential resources to the subprojects.

4. Letter of Intent

   Prospective multiple project grant applicants must write a letter of intent to the appropriate program health scientist administrator (HSA) within NIDCD prior to submitting a formal application. The HSA, in consultation with others, will evaluate the appropriateness of the proposed application based on answers to the following questions:

   1. Is the theme of the application appropriate to the programmatic mission of the NIDCD?
      
      
   2. Explain specifically why the intended activity could not be accomplished as a series of R01 grants with core support?
      
      
   3. Characterize the disciplines to be represented in this multidisciplinary application. Describe the types of scientific interactions that are envisioned and indicate how they meet the criteria (listed above) for multiple project grants.
      
      
   4. What are the qualifications and leadership experience of the principal investigator?
      
      

   Following an evaluation by NIDCD staff, the prospective applicant will be advised whether or not to proceed with the multiple project application, and if not, which other research grant mechanisms may be more appropriate.

IV.    Core Grants (P30)

In addition to the Multiple Project Center Grant, the WGSMPG recommends that the NIDCD initiate a Core Grant Program similar to that utilized by other NIH institutes. Most WGSMPG members felt there would be value in designating P30s as centers. [These two activities together would then constitute the centers program of the NIDCD and should, if possible, be separated from the Research Project Grant (RPG) budget category.]

The overall goal of the Core Grant Program is envisioned to support and facilitate research and collaborative interactions between or among independently-funded investigators who are working on a common theme relevant to the mission of the NIDCD. The sharing of core resources and services with other NIH-funded investigators is encouraged so as to bring advanced technology, cutting-edge instrumentation facilities and unusual animal and family pedigrees to bear on communications research.

Core Grants are subdivided into discrete units or modules, with each devoted to a specific activity that would be impractical or less efficient to support on an individual research project grant. Modules are based on function:

Resources Modules

Examples: Electron microscopy, Image analysis, Biostatistics, Tissue culture, Laboratory animal resources

Service Modules

Examples: Mechanical, Electronics, Photography, Continuing education, Information dissemination

The WGSMPG requests that NIDCD staff formulate specific policy and review criteria for the Core Grant Program. Their considerations should include a determination of the minimum number of NIDCD funded (individual) research projects required to be eligible for a P30 grant. Further, the WGSMPG strongly emphasized the desirability of attracting non-NIDCD grantees to these cores as a means to promote new and broader research directions.

The WGSMPG examined the language in the legislation establishing the NIDCD which mandated the creation of multipurpose centers, a function which is presently funded as a P60 activity. These centers (presently five in number) must support research, training, continuing education and information dissemination. The legislation allows for renewal of support at regular intervals if recommended to the NIDCD Director after appropriate peer review.

With regard to current P60 (as well as current P50 and current P01 grants), the Work Group indicated that, if the research components are to be considered as part of a competing multiple project application, they should be required to meet the same review criteria and review processes outlined in III (1) above. Further, the WGSMPG recognizes the importance of continuing education and information dissemination, but most members questioned the need to carry out such activities as part of a comprehensive multipurpose center. It was recommended that an alternative funding mechanism for the continuing education and information dissemination of P60 activities be explored. For example, if a grantee institution with strong interests and experience or potential for continuing education and/or information dissemination, could demonstrate need beyond that obtainable at the local level, such activities might be proposed as a module in a Core Grant application.

V.    Investigator-Initiated Interactive Research Project Grants (R01)

The WGSMPG examined the NIH Interactive Research Project Grant (IRPG) program and recommends that NIDCD be included as a participant. This program provides support for formal investigator-initiated collaborative relationships.

An IRPG group consists of the coordinated submission of two or more applications for related traditional research project grants (R01) on related topics, with a formalized agreement to collaborate in specific ways to enhance the achievement of the goals on all projects. The IRPG, therefore, offers a means of promoting limited collaborative efforts between or among projects that are scientifically related, while providing a record of independently obtained awards and retaining the research autonomy of each principal investigator (PI). Other benefits of the IRPG program include the establishment of collaborations on an equal footing at separate sites (including foreign locations) and the possibility of transferring an award with the PI to another institution without disrupting the IRPG group.

The WGSMPG is aware that the IRPG program has not been widely used by the institutes currently participating in this program. The chief difficulty has centered around the likelihood that certain R01 applications from an IRPG group may be reviewed in different study sections in the CSR. While preserving the desirable feature of having the R01 application reviewed by the most appropriate study section, the assessment of resource needs may be hampered by the limited information available regarding the scientific merit of the other R01 applications in the IRPG group. Nevertheless, because of this program's potential to enhance collaboration while maintaining a fair review process, the WGSMPG believes that support for this activity is warranted at this time. [The WGSMPG has also recommended an enhanced review procedure (See VI. (3) below) that should improve the assessment of resource needs for IRPGs.]

VI.    Initial (Peer) Review

A major focus for the WGSMPG involved the examination of additional means by which to better ensure that more research grant applications would be subjected to the same initial review (scientific merit) process. Achieving this goal would create a single and fairer playing field for investigators, with the vast majority of reviews being handled by study sections in the CSR. At the same time the WGSMPG realized that exceptions for which an Institute based review is essential exists for a limited number of research activities. With this in mind the Work Group recommended the following:

1.  Multiple Project Center Grants (P50)

   The following steps are recommended as a requirement prior to the review of a multiple project grant application:

   1. Pre-application discussion with staff;
   2. Letter of intent and,
   3. Response by relevant staff regarding suitability of the mechanism and responsiveness to minimum requirements for inclusion in the program.

   Multiple project grant applications should continue to be reviewed within the NIDCD. The Communication Disorders Review Committee (CDRC) membership should be adjusted to reflect the expertise most needed for what is anticipated to be a more focussed set of review activities. In addition, this standing committee should be augmented appropriately with experienced ad hoc members. It may be desirable to review as many applications as possible at the same meeting. When that is not feasible, there should be substantial overlap of reviewers between or among the initial review meetings.

   Each subproject will be reviewed using the five initial review criteria of significance, approach, innovation, investigator and environment. It is important that each subproject be assigned a score on the basis of these review criteria. The entire program should then be assigned an overall score based on the scores of individual projects and the degree to which they are responsive to the new criteria for multiple project grants. Any program in which one or more subprojects receives a poor review would be penalized in its overall score.

2.  Core Grants (P30)

   The WGSMPG recommends that NIDCD staff formulate specific review criteria and review mechanisms and standards for P30 applications using those established by the National Eye Institute and other NIH institutes as guidelines. The CDRC membership should also reflect the expertise needed to carry out the review of these Core Grants. Further, it is recommended that each module be separately evaluated and rated with regard to the way in which it will facilitate the research effort of the participating investigators.

3.  IRPG (R01)

   As indicated earlier in this report (See Section V above), the WGSMPG embraces this program for its potential to enhance collaboration while retaining the benefit of having the individual projects (R01) reviewed in relevant CSR study sections.

   The WGSMPG recommends that when two or more R01 applications from an IRPG group application are of sufficient technical merit to warrant funding, that the NIDCD develop a rapid review capability to determine the additional resources, if any, that would be required to optimize performance for those collaborating grantees.

VII.   Conclusions

The WGSMPG recommendations in this report should serve to: 1) enhance opportunities for collaboration among extramural investigators, whether their principal research activity is derived from a single project or multiple project award. 2) increase opportunities for more extramural scientists to become independent investigators and 3) provide a more equitable initial review path for those research activities that are supported independently as R01s with, or without, additional resources provided through Core Grant or IRPG support.

The successful implementation of these recommendations will require close interactions between the principal investigators of the currently funded P01, P50 and P60 grants and NIDCD staff responsible for program, review and grants management functions. It is anticipated that most, if not all, of these grants will have certain ongoing activities that do not meet the new criteria for multiple project grants. The NIDCD should develop guidelines for phasing in these new criteria. This needs to include a transition period during which time current grantees are able to consider, and act on appropriate alternatives.

Please direct comments to the WGSMPG Executive Secretary:

Dr. Craig Jordan
Division of Extramural Activities, NIDCD
6120 Executive Boulevard, Suite 400C
Bethesda, MD 20892-1780
Telephone: (301) 496-8693
Fax: (301) 402-6250
E-mail: jordanc@nidcd.nih.gov

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