NIH GUIDE, Volume 22, Number 43, November 26, 1993

P.T. 34



  Grants Administration/Policy+ 

  Clinical Trial 


  Disease Prevention+ 

  Disease Control+ 

National Cancer Institute

The National Cancer Institute (NCI) announces that any new or

competing continuation investigator-initiated clinical trial,

prevention or control intervention, or epidemiological study in which

direct costs exceed $500,000 in any year (at a single institution or

in the aggregate for a study proposing multi-institutional

collaborative arrangements submitted as either subcontracts to a

single application or as separate applications) will usually be

awarded only as a cooperative agreement (U01).  For single

applications, the dollar limit excludes indirect costs of any

subcontracts that are reported as a direct cost on the application

budget page summary.  Separate U01 awards usually will be made for

individual applications submitted concurrently by institutions

proposing a study involving a coordinated research effort.

In addition, studies falling under the above guidelines requesting in

aggregate in excess of $1,000,000 in direct costs in any single year

will be administratively evaluated by the NCI prior to peer review to

determine if such a potential award(s) could be accommodated within

the Institute's scientific and fiscal plans for that budget year.  If

a potential award of such scope cannot be contemplated, the

application(s) will be returned without review.

This policy is effective immediately with publication of this

announcement and covers all current pending unfunded applications as

well as all future submissions in these categories.

The cooperative agreement is an assistance instrument similar in most

ways to a grant.  It differs in that, in addition to the standard

stewardship role, an Institute extramural program director is

expected to have a continuing substantive role in one or more

scientific aspects of the study, in an assisting, not directing,

relationship.  The type and degree of such involvement is to be

appropriate to the specific cooperative agreement.  The awardee will

have lead responsibilities in all aspects of study, including any

modification of study design, conduct of study, quality control, and

analysis of results.  The Institute program director may have

assistance roles in one or more of those areas and will have a shared

lead responsibility in facilitating the interim data and safety


In order to facilitate the above interactions, it will be necessary

for awardees to plan for periodic regular meetings with NCI staff in

the Bethesda, MD area.  Accordingly, respondents must request and

will be allowed sufficient funds within the submitted budgets to

accommodate expenses for participants at these meetings, as well as

for expenses incurred in the conduct and monitoring of the trial.

All awards made as cooperative agreements under the above

circumstances shall be subject to the applicable terms of award.

Specific terms, conditions, and arbitration procedures pertaining to

the scope and nature of the interaction between the NCI and their

awardees will be incorporated in the Notices of Award.  It is

anticipated that these terms and conditions will enhance the

relationship between the National Cancer Institute and the principal

investigator(s), and will facilitate the successful conduct and

completion of the study.  Therefore, applications falling under these

guidelines, but not accepting the stated conditions, will not be

considered for funding.


Potential applicants for research of this magnitude are strongly

encouraged to contact the NCI prior to making detailed plans or

submitting their application(s).  Questions regarding this notice and

requests for generic sample terms and conditions of award may be

directed to:

Director, Division of Extramural Activities

National Cancer Institute

Executive Plaza North, Suite 600

Bethesda, MD  20892

Telephone:  (301) 496-5147

FAX:  (301) 402-0956

Potential applicants will be referred for further consultation to the

appropriate NCI Program and Grants Administration staff.


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