Release Date:  July 19, 2002

NOTICE:  NOT-AI-02-040

National Institute of Allergy and Infectious Diseases (NIAID)


To inform the research community that any new or competing continuation 
investigator-initiated clinical trial; prevention, education, or 
control intervention; or epidemiology study (all research involving 
human subjects) may be awarded as a cooperative agreement (U01). 

This policy is effective immediately with publication of this notice 
and covers all pending applications as well as all future submissions.


NIAID has a long-standing policy of converting certain types of 
applications to be funded from grants to cooperative agreements when 
there is substantial substantive involvement of NIAID staff (see

When it is in the best interest of the NIAID and the applicant 
institution, NIAID and applicant institution will negotiate terms and 
conditions of award of a cooperative agreement.  Grant applications 
will be converted to cooperative agreements when one or more of the 
following conditions exist:

1.  Investigational New Drugs. The NIAID holds the IND and/or provides 
regulatory technical assistance to the awardee.

2.  Clinical Studies and Trials when there is more than minimal risk to 
study subjects in clinical studies and clinical trials. Additionally, 
NIAID's policies for monitoring clinical studies and trials will apply. 
Please see

3.  Safety and Security. When dangerous biological agents are to be 
acquired, stored, modified, or otherwise used in NIAID supported 
studies, awards will be made as cooperative agreements with terms and 
conditions requiring adequate security and safety. The biological 
agents to be studied are extremely dangerous and, unless adequately 
contained, could pose significant health risks to those investigating 
them, to the surrounding communities, and to the general public. It is 
imperative that the public safety and the national security be 


Inquiries are strongly encouraged. Opportunities to clarify any issues 
or questions from potential applicants are welcome.  

Based on the area of research, direct inquires regarding scientific and 
technical issues to the appropriate NIAID staff member (See

General inquiries related to this notice may be directed to:

Division of Extramural Activities, NIAID
Room 2142, 6700-B Rockledge Drive – MSC 7610
Bethesda, MD 20892-7610
Telephone: (301) 496-7291
FAX: (301) 402-0369
E-mail: or

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