Notice Number: NOT-DK-07-006

Key Dates
Release Date: March 12, 2007

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

The purpose of this announcement is to include the following information under Section 6. Other Submission Requirements:

Justification of the Need to Access the Parent Study: The applicant must clearly state the need to access the parent study.

The goal of the proposed study must complement but not overlap or interfere with the primary and secondary objectives of the parent study. Each applicant must abide by the procedures for conducting ancillary studies established by the parent study group. Descriptions of the NIDDK and NHLBI supported clinical trials, epidemiological studies, and disease databases eligible for ancillary studies in response to this initiative can be found on the following website: http://www2.niddk.nih.gov/Research/ClinicalResearch/AncillaryStudies/. Ancillary studies to other NIDDK or NHLBI supported studies will be considered, but must include strong justification. For many of the studies eligible for this initiative, ancillary study policies are described at their websites, which are noted in these descriptions. For those studies without such a website, ancillary study policies may be found at the same website listing descriptions of eligible studies. Note that some studies are undergoing protocol development and have not yet established their ancillary study policies. They will be posted on the website noted above. Each of the studies for which ancillary study proposals may be submitted has limitations on the type of investigation permissible and each has specific requirements for partnership with parent study investigators. You may not request support for activities that are part of the core protocol for the parent study. Likewise, you may not seek funds for analysis of existing data or for studies that substantially duplicate ongoing ancillary studies to the parent studies. In most cases, expansion of intervention protocols for clinical trials will not be permitted; however, in certain limited circumstances, this might be considered by the parent study.

The goal of this Program Announcement is to support projects that are designed to provide additional information concerning the primary and secondary objectives of the parent study. It is required that the proposed ancillary studies be integrated with and complement the studies carried out by the parent study, and there be close collaboration between ancillary study and parent study investigators.

You must provide documentation at the time of the grant submission that you have received approval from the appropriate governing body of the parent study to conduct your proposed ancillary study. Applications not containing documentation will be considered non-responsive to this announcement and will be returned to the Investigator, without having undergone peer review by the NIDDK. You must include a statement of your willingness to work collaboratively with the parent study and to abide by all parent study policies, publication restrictions, data access provisions, etc.

All applicants must include a data and safety monitoring plan for the ancillary study activities even if the ancillary study is of minimal risk. If the parent study already has a central Data and Safety Monitoring Board or comparable oversight committee, it is preferred that the ancillary study use the existing Data and Safety Monitoring Board or comparable oversight committee. If the plan is to utilize the existing Board or committee, it must be clearly stated.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

For applications submitted to NIDDK (ancillary studies related to diabetes, digestive diseases and kidney diseases in NIDDK or NHLBI cohorts):

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
For applications submitted to NHLBI (ancillary studies related to heart, lung, blood, or sleep disorders in NIDDK cohorts): follow the instructions at http://www.nhlbi.nih.gov/funding/policies/500kweb.htm, Applications with Direct Costs of $500,000 or More in Any One Year. Note that requests to submit applications with direct costs that are greater than the NHLBI allowable direct costs for program project grants in any one year will only be considered by the NHLBI once a year.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

All other aspects of PAR-07-024 remain unchanged. The full text of the PAR, which was published on November 20, 2006, can be accessed at: http://grants2.nih.gov/grants/guide/pa-files/PAR-07-024.html

Inquiries

For further information regarding this notice, please contact:

John W. Kusek, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 617
Bethesda, Maryland 20892-5460
Telephone: 301-594-7735
FAX: 301-480-3510
E-mail: [email protected]