Multiple PI Update to RFA-DK-05-014: The Obese and Diabetic Intrauterine Environment: Long-term Metabolic or Cardiovascular Consequences in the Offspring

Notice Number: NOT-DK-06-007

Key Dates
Release Date: February 27, 2006
Modified Letter of intent receipt date: April 11, 2006
Modified Application receipt date: May 11, 2006
Modified Expiration date: May 12, 2006

Issued by
National Institute of Diabetes , Digestive, and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov)

The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), the National Heart, Lung, and Blood Institute (NHLBI), and the National Cancer Institute (NCI) announce their participation in a pilot program at the National Institutes of Health (NIH) to allow more than one principal investigator (PI) to be named on a research grant application. This Notice serves to modify the previously released RFA-DK -05 -014, allowing multiple PIs and providing instructions for multiple PI applications. In order to accommodate this change, the Deadlines for Receipt of the Letter of Intent and Application have been extended as indicated under Key Dates.

Background:

The multiple PI model may be particularly suited to studies on maternal environment and risk for disease in the offspring.  In addition to spanning the clinical disciplines of Obstetrics, Pediatrics, and Internal Medicine, studies to elucidate mechanisms of fetal programming may involve many disparate tissues and organ systems as well as a range of methodologies from molecular genetics to in vivo imaging.  Thus, it is likely that some applications will employ the collaborative efforts of investigators from complementary disciplines.  The ability to utilize the multiple PI model should facilitate such partnerships and ensure appropriate recognition of the contributions of equal partners.

More than one principal investigator, or multiple PIs, may therefore be designated on the application. 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 http://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).

The decision of whether to apply for a single investigator 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, investigator and environment will be modified as indicated below. A weak or inappropriate PI can have a negative effect on the review.

Multiple PIs may be located at the same institution or at different institutions and may request budget apportionment between the PIs (see 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.

All Multiple PI projects will be required to include a section within the Research Plan (section H) describing the leadership of the project. This section, entitled “Multiple PI Leadership Plan,” should describe the governance and organizational structure of the research project, 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 PHS Policy on Humane Care and Use of Laboratory Animals as defined by the Office of Laboratory Animal Welfare (OLAW).

For Applications Involving a Single Institution:

When all PIs are within a single institution, follow the instructions for PHS 398. The contact PI should be listed on the face page. Under Key Personnel, the contact PI should be listed first followed by other PIs listed in alphabetical order. Note the eRA Commons User Name (e.g., the Commons ID) is required for all PIs when any multiple PI model is chosen. A new form page will be provided for additional information on each PI prior to the application submission date. In the budget justification, PIs may indicate the percentage of the award to be allocated to each PI.

For Applications Involving Multiple Institutions:

When multiple institutions are involved, PIs and their institutions may submit linked applications and request linked awards. Alternatively, they may designate one institution as the prime institution and request funding for the other institution(s) via a subcontract to be administered by the prime institution. When linked awards are desired, each institution should submit only one application; multiple PIs within each institution should be listed in the key personnel section. Note the eRA Commons User Name (e.g., the Commons ID) is required for all PIs when any multiple PI model is chosen.

Subcontract 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. The application should be prepared according to the PHS 398 instructions for consortium/subcontract applications.

The following special instructions apply ONLY to those multiple institution applicants requesting linked awards:

Submission:

Linked applications should be submitted individually from the separate institutions, not as a combined set.

Cover letter:

All linked applications should be submitted individually with a cover letter that lists the contact PI, all other PIs, their institutions, and the project title.

Overall Application Format:

The application from the contact PI's institution will include all information necessary for the scientific review of the application. The RESEARCH PLAN section should be included only in the application from the contact PI. All of the remaining applications within the project should refer to the RESEARCH PLAN from the contact PI application, rather than duplicate the RESEARCH PLAN. Those applications that do not include, but only refer to, the RESEARCH PLAN must include the following in their application: FACE PAGE, Form Page 2 (DESCRIPTION, PERFORMANCE SITES, KEY PERSONNEL), RESEARCH GRANT TABLE OF CONTENTS, BUDGET PAGE(S), BUDGET JUSTIFICATION, and CHECKLIST. Sections for Human Subjects Research and/or Vertebrate Animals must also be completed by each institution, if appropriate.

Face Page. Item 1. Title:

There should be a signed face page for each participating organization when linked awards are involved. To facilitate proper processing and review, the title for each linked application should end with the designation MP#/#, indicating 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). The application from the Contact PI should be first in the series. Note that the total number of characters in the title MUST be 81 characters or fewer (including the MP designation and numbers).

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, Performance Sites, and Key Personnel:

All linked applications must include an identical description. All performance sites should be listed on each application. The key personnel section should also be identical for each application. The contact PI should be listed first followed by other PIs listed in alphabetical order. Other key personnel and their organizations should follow.

Modular or Non - modular budget:

The contact PI application must include a summary budget for the entire project as well as an individual budget for the work done at his/her institution. Each of the other linked applications should include individual budgets for the work done at that institution. 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. For modular budgets, the individual budgets do not need to be presented in $25,000 modules but should be rounded up to the nearest $1000. Multiple PIs working within the same institution may wish to indicate the portion of the budget to be allocated to each PI. This should be included within the budget justification.

Biosketches:

All biographical information for PIs and key personnel should be included only in the contact PI application.

Research Plan:

The research plan should be included only in the application from the contact PI's institution.

Checklist:

The checklist for the contact PI's application should reflect total Indirect Cost calculations for the entire project. The checklist for each of the other applications should reflect their individual estimated Indirect Costs.

REVIEW CRITERIA for ALL APPLICATIONS in the Multiple PI Pilot

There will be no additional review criteria for multiple PI applications. The existing 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://grants.nih.gov/grants/multi_pi/.

Inquiries

1. Scientific/Research Contacts:

Philip F. Smith, Ph.D.
Deputy Director
Division of Diabetes, Endocrinology, and Metabolic Diseases
Co - Director, Office of Obesity Research
National Institute of Diabetes and Digestive and Kidney Diseases
6707 DEMOCRACY BLVD RM 689 MSC5460
BETHESDA MD 20892 - 5460
phone:  301.594.8816
FAX:    301.480.3503
Email: ps56z@nih.gov

Cristina Rabadan - Diehl, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10186
6701 Rockledge Drive
Bethesda , MD 20892
Telephone: (301) 435 - 0550
FAX: (301) 480 - 2858
Email: cr225k @nih.gov

Cindy Davis, Ph.D.
Nutritional Science Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard , EPN Room 3159
Bethesda , MD 20892
Rockville , MD 20852 (express/courier service)
Telephone: (301) 594 - 9692
FAX: (301) 480 - 3925
Email: davisci@mail.nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Democracy II, Room 752
Bethesda, MD 20892
Telephone: (301) 594 - 8897
FAX: (301) 480 - 3505
Email: FC15Y@NIH.gov

3. Financial or Grants Management Contacts:

Millissa Lee
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard , Room 721
Bethesda, MD 20892
Telephone: (301) 594 - 0417
FAX: (301) 594 - 9523
Email: ml306e @nih.gov

Mary S. Baylor
Grants Management Officer, Heart Team
National Heart, Lung, and Blood Institute
Division of Extramural Affairs
Grants Operations Branch
Two Rockledge Center
6701 Rockledge Drive , Room 7162
Bethesda , MD 20892
Phone: (301) 435 - 0152
FAX: (301) 480 - 3310
Email: mb652v@nih.gov

Connie Murphy
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard , EPS Room 243
Bethesda , MD 20892
Phone: (301) 496 - 8657
FAX: (301) 496 - 8601
Email: ca114e@nih.gov


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