Notice Number: NOT-LM-06-004

Key Dates
Release Date: February 28, 2006

Issued by
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)

The National Library of Medicine (NLM) announces its participation in a pilot implementation of an NIH-wide initiative to allow multiple principal investigators (PIs) to be named on a research grant application submitted in response to NLM Research Grants in Biomedical Informatics and Bioinformatics (R01)  (see https://grants.nih.gov/grants/guide/pa-files/PA-06-094.html).
  
Beginning June 1, 2006, in addition to the usual single PI applications, NLM also will accept multiple PI applications for projects submitted in response to PA 06-094.  Note, this feature is a part of a pilot as described at https://grants.nih.gov/grants/multi_pi/index.htm.   Applications involving multiple PIs are not yet available to all applicants for NIH support.  During this pilot, multiple PIs may be within a single institution or at different institutions. For multiple PI applications that involve multiple organizations, the applicant may propose a subcontract arrangement, or may request linked awards, as described below.

This notice serves to modify the previously released PA 06-094, allowing multiple PIs and providing instructions for multiple PI applications. This Notice applies only to PA 06-094, NLM Research Grants in Biomedical Informatics and Bioinformatics (R01).  Both new and competing continuation applications are permitted to identify more than one PI. 

Background:

NLM believes that permitting multiple principal investigators will foster interdisciplinary and team science. If an award is made to a multiple PI grant, each named PI will be listed on the Notice of Grant Award, and each will be listed in the NIH CRISP database of federally-funded research (http://crisp.cit.nih.gov).  All named PIs will have access to summary statements and review status information through the NIH eRA Commons. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research projects can be found at https://grants.nih.gov/grants/multi_pi.  All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Deciding whether to apply for a single or multiple PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PI grants will require additional information, as outlined in the instructions below, and the NIH review criteria for approach and investigator will be modified as indicated below. Inclusion of a weak or inappropriate PI can have a negative effect on the review of an application.
 
Multiple PIs may be located at the same institution or at different institutions.  If all PIs are at the same institution, the PIs and the applicant institution may request budget apportionment among the PIs on a Just-in-Time basis upon notification by NLM.  If allocation is requested, it will be included in a footnote to the Notice of Grant Award.  For multiple PIs located at different institutions, a subcontract arrangement or linked awards are possible options as described in special instructions below.

Definition of Principal Investigator:
The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award. The applicant organization may designate multiple individuals as principal investigators who share the authority and responsibility for leading and directing the project, intellectually and logistically.  Each principal investigator 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 all required reports.

Special Instructions for Applications with Multiple PIs:

When multiple PIs are proposed, NIH requires one PI to be designated as the contact PI, who will be responsible for all communication between the PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PI must meet all eligibility requirements for PI status in the same way as other PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above. The application should be submitted with a cover letter that lists the contact PI, all other PIs, their institutions, and the project title.

PIs at the Same Institution:
When multiple PIs are located at the same institution, the usual application guidelines should be followed with these additions:

• Face page. Item 1. Title: To facilitate proper processing and review, a single title should be given to a multiple PI application ending with the designation MP1/1. Note that the total number of characters in the title MUST be 80 characters or fewer (including the MP designation and numbers).
  
  
• Face page. Item 3a. Name of Principal Investigator: The name of the contact PI should be listed in block 3 of the Face Page. All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions.   A new PI continuation page is not currently available but should be ready by the application submission date.
  
  
• Form Page 2. Key Personnel: The Key Personnel section should list all PIs and Key Personnel. Start with the contact PI, then list the additional PIs and their organizations in alphabetical order by PI last name. Then, list all Key Personnel, giving name and organization.
  
  
• Modular or Non-modular Budget: Follow the instructions in PHS 398 for completing the budget materials. The percentage of effort should be provided for each PI. Modular budgets are to be used for projects involving direct costs of $250,000 or less, regardless of the number of PIs or institutions involved. For projects involving direct costs exceeding $250,000, the non-modular budget format must be used. If the applicant wishes to have grant funds apportioned to the different PIs, indicate the proposed allocation in the Budget Justification Section. If an award is made, this information will be included in the Notice of Grant Award as a footnote. The summary budget must be presented in $25,000 modules.
  
  
• Research Plan. The Research Plan should provide clear delineation of the role and responsibilities of each PI.
  
  
• Section H. Multiple Principal Investigator Leadership Plan: For applications designating multiple PIs, a new section entitled Leadership Plan must be included following the research plan. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs. The Leadership Plan should also address the responsibilities of the Multi-PI(s) and their institutions for the protection of human subjects as defined by 45 CFR 46 and the Office for Human Research Protections (OHRP) and the care and use of laboratory animals complies with the PHS Policy on Humane Care and Use of Laboratory Animal and the Office of Laboratory Animal Welfare (OLAW)..".

PIs at More than One Institution:
When multiple institutions are involved, PIs and their institutions may request linked awards or they may designate one institution as the lead organization and request funding for the other institution(s) via subcontract(s) to be administered by the lead institution. The application from Contact PI’s organization should include comprehensive information for all participating organizations and sites, as described below. Those seeking a subcontract arrangement should follow the PHS 398 instructions for consortium/subcontract applications, plus additional instructions listed below. In addition to the usual information required for subcontract arrangements, a linked award requires a Face page, Description, Performance Sites, Key Personnel, budget page(s), budget justification, resources and environment, and checklist for each participating organization.

• Face page. Item 1. Title:
  
  
• There should be a signed face page from the Contact PI’s institution, and another for each participating organization. To facilitate proper processing and review, a single title should be given to a multiple PI application ending with the designation MP#/# which indicates the total and sequential number for participating organizations (e.g., MP 1/6, 2/6, 3/6 for an application that involves PIs at six organizations). Note that the total number of characters in the title MUST be 80 characters or fewer (including the MP designation and numbers).
  
  
•  Face page. Item 3a. Name of Principal Investigator: The name of the contact PI should be listed in block 3 of the Face Page from his/her institution, followed by the phrase (contact MP).  All other Face Pages should list the PI and organizational information for other institutions.   All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).  A new PI continuation page is not currently available but should be ready by the application submission date.
  
  
• Face Page. Item 4. Human Subjects Research:
  
  
• If human subjects (including identifiable specimens or data) are involved in the proposed research project, all linked applications within the project must check the “yes” box. Face Page. Item 5. Vertebrate Animals:
  
  
• If vertebrate animals are to be used in the project, all linked applications within the project must check the “yes” box.
  
  
• Form Page 2: Description: A single description should be provided that covers the scientific goals, per PHS 398 instructions. This description should be the same for each participating organization.
  
  
• Form Page 2. Key Personnel:  In the Contact PI’s application, the Key Personnel section should list all PIs and Key Personnel at all participating sites.Start with the contact PI, then list the additional PIs & their organizations in alphabetical order by PI last name. Then, list all Key Personnel, giving name and organization. For linked awards, each organization’s component of the application should include PI and Key personnel only for the participating site.
  
  
• Form page 2: Performance Sites: In the Contact PI’s application, all performance sites should be listed for all participating organizations.
  
  
• Biographical Information: The Contact PI’s application should provide a biographical sketch for all named PIs and Key Personnel at all organizations.
  
  
• Modular or Non-modular Budget: Follow the instructions in PHS 398 for completing the budget materials. The percentage of effort should be provided for each PI. Modular budgets are to be used for projects involving direct costs of $250,000 or less, regardless of the number of PIs or institutions involved. For projects involving direct costs exceeding $250,000, the non-modular budget format must be used. If PIs are at multiple institutions and linked awards are to be requested, the contact PI application must include a summary budget that covers the entire project and all participating organizations, as well as an individual budget and summary budget for the contact PI’s institution. Each of the other applications must include an individual budget for that organization only. For applications with modular budgets, the individual budgets do not need to be presented in $25,000 modules but should be rounded up to the nearest $1000. The summary budget must be presented in $25,000 modules.
  
  
• Research Plan.  The Contact PI’s application should include the RESEARCH PLAN. In the research plan, there should be a clear delineation of the role and responsibilities of each PI, and the activities that will take place at each organization.
  
  
• Section H. Multiple Principal Investigator Leadership Plan: For applications designating multiple PIs, a new section entitled Leadership Plan must be included following the research plan. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts.  The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs, including responsibilities for human subjects or animal studies as appropriate.  For competing continuation applications, the application should state how the research will be enhanced by employing a multiple-PI approach
  
  
• Consortial/Contractual Arrangements: If multiple institutions are involved and a subcontract arrangement is proposed, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.
  
  

REVIEW CRITERIA for all Multiple PI Applications

There will be no additional review criteria for multiple PI applications.  The existing NIH review criteria will be used, with the added language for multiple PI applications as indicated in bold font below:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

 Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the principal investigator(s) and key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the principal investigator(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

Multiple PI Website: The NIH Portal for the Multiple PI project contains background materials and information about programs participating in the pilot.  http://grants2.nih.gov/grants/multi_pi/

Point of Contact:
Dr. Valerie Florance, Deputy Director
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
florancev@mail.nih.gov
301-594-4882
Fax 301-402-2952

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