CONVERTING SELECTED RESEARCH PROJECT GRANTS TO COOPERATIVE AGREEMENTS Release Date: July 19, 2002 NOTICE: NOT-AI-02-040 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) PURPOSE OF THIS NOTICE 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. BACKGROUND 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 http://grants.nih.gov/grants/guide/notice-files/not94-139.html). 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 http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. 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 protected. INQUIRIES 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 http://www.niaid.nih.gov/ncn/staff/default.htm). General inquiries related to this notice may be directed to: Director 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: ac20a@nih.gov or jm80c@nih.gov

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