NINDS Guidelines for Conversion of Multi-Center Clinical Research Studies into Cooperative Agreements

Notice Number: NOT-NS-05-003

Key Dates
Release Date: December 10, 2004

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

The purpose of this notice is to inform NINDS grant applicants who intend to submit research applications for major clinical trials (e.g., phase III clinical trials and multi-center clinical trials) and large epidemiological or other multi-center clinical research studies, with yearly direct costs for all components/sites exceeding a total of $1,000,000, that

(1) applications for these studies require approval before being accepted for submission by the NINDS (see: http://grants.nih.gov/grants/guide/notice-files/NOT-NS-01-012.html), and

(2) the NINDS may award the project as a Cooperative Agreement, rather than a grant.

In deciding whether grant applications will be converted, the NINDS will consider the complexity of the project, the major resource commitments from the Institute, and the need for assisting the awardees by substantial NINDS scientific and programmatic involvement during conduct of the project. Substantial NINDS involvement may include, but is not limited to, participation in the design or direction of research or training activities, coordination or participation in collection or analysis of data, membership on the leadership committees, and assistance in the management and technical performance of the activity.

Under a Cooperative Agreement, the prime responsibility of the NINDS is to support the recipient's activity by facilitating the performance of the awardee in a partner role. The NINDS program management of the grant will generally involve at least two NINDS scientific program officials. One NINDS Extramural Program Director will serve as the Program Scientific Officer for the grant, and will have substantial scientific-programmatic involvement during conduct of the study, through technical assistance, advice, and/or other coordination above and beyond normal program stewardship for grants. He/She will also have voting membership on the primary leadership committee of the study. A second NINDS Extramural Program Officer will serve as the Administrative Program Official for the Cooperative Agreement and will provide normal program stewardship as carried out for grants so as to assure prudent stewardship of funds in compliance with relevant policy and regulation.

It is anticipated that this mechanism will enhance the relationship between the NINDS staff and the Principal Investigator(s), and will facilitate the successful conduct and completion of the study. The standard cooperative agreement terms and conditions that NINDS may apply to these awards are available at: http://www.ninds.nih.gov/funding/research/clinical_research/terms.htm).

Inquiries

Any further questions regarding these guidelines should be addressed to:

Frances Yee, Ph.D.
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Rm. 2227, MSC 9525
Bethesda, MD 20892-9525
Phone: (301) 496-9135
Fax: (301) 480-1080
E-mail: fy17t@nih.gov


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