Notice Number: NOT-DK-09-007

Key Dates
Release Date: March 3, 2009

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)

This Notice is to inform the scientific community that the NIDDK is amending the application and submission information for RFA-DK-08-011: Type 1 Diabetes TrialNet: Clinical Centers (U01), (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html), released on December 24, 2008 and amended on January 27, 2008, as follows. The FOA is being amended to allow submission of applications by multiple Principal Investigators (Multi PI/PDs).

 The sections in bold have been added or changed in the subject FOA, along with revisions to other sections as noted.  NIDDK has also developed a Frequently Asked Questions page related to this RFA. Please see http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_FAQ_T1D_TrialNet_Clinical_Centers for additional information.

1. The Executive Summary has been amended to include the following section:

Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.

1. Section III – Eligibility Information, Part 1.B – Eligible Individuals has been amended to include the following paragraphs:

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, 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 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 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 multiple PDs/PIs, 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.

Due to the nature of the science in this particular FOA, if the institution decides to submit an application including multiple PDs/PIs, one PI should be an endocrinologist with demonstrable experience in the conduct of T1D clinical research and the other should be an immunologist with substantial expertise pertinent to the study of immunologic approaches to T1D prevention/early intervention.

1. Section IV – Application and Submission Information, Part 2 – Content and Form of Application Submission has been amended to include the following section:

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

All other aspects of RFA-DK-08-011 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html) remain unchanged.

Inquiries

All inquiries related to this announcement should be directed to:

Ellen W. Leschek, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Diabetes, Endocrinology and Metabolic Diseases
Room 603, MSC 5450
6707 Democracy Boulevard
Bethesda, MD 20892-5450
Telephone: (301) 402-8291
FAX: (301) 480-3503
Email: [email protected]