Amendments to RFA-AI-05-002 "Units for HIV/AIDS Clinical Trials Networks”

Notice Number: NOT-AI-05-031 (This Notice has been superseded by, NOT-AI-05-038)

Key Dates
Release Date: March 31, 2005

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)

The National Institute of Allergy and Infectious Diseases (NIAID) is amending RFA-AI-05-002, “Units for HIV/AIDS Clinical Trials Network,” as follows.

1 . The description of a Clinical Research Site has been expanded to accommodate two special circumstances: Clinical Research Sites in the U.S. participating in studies to prevent the transmission of HIV from mother to child and U.S or foreign Clinical Research Sites enrolling underrepresented populations living in remote locations. The following two paragraphs have been added to Section I Research Objectives, Part B. Clinical Trials Units, Subpart headed Clinical Research Sites:

Clinical Research Sites located in the U.S. and proposing to implement research plans for the prevention of Mother to Child Transmission of HIV may need to utilize separate clinical facilities and clinical research staff for optimal participation of mothers and infants.  Close coordination between the two clinical research staff and facilities, including coordination of local Institutional Review Board approvals and communications, must be maintained at all times.  Sharing of other resources to the extent practicable is required.  These Clinical Research Sites must meet the core Clinical Research Site capacity requirements described below, but may do so through the combined enrollment of mothers and infants.

Clinical Research Sites reaching rural communities that are highly impacted and/or threatened by HIV/AIDS may utilize satellite clinics or mobile clinics under the following circumstances: 1.) All clinical research activities at the satellite/mobile clinic are performed by qualified Clinical Research Site staff. 2.) All study product is dispensed from the Clinical Research Site pharmacy. 3.) No study product or clinical research records are stored at the satellite/mobile clinic. 4.) All routine and safety laboratory tests are either performed in CLIA certified laboratories or transported to the Clinical Research Site for timely processing. 5.) Results of laboratory or other diagnostic evaluations are available in a timely manner. 6.) Emergency medical care appropriate to the risks associated with trial participation is available in the community. 7.) Satellite/mobile clinic usage is infrequent (no more than one day/week). 8.) The utilization of satellite/mobile clinics is cost-effective when considering transportation, staff travel time, equipment and supplies, and provides opportunities for rural residents who would otherwise be unable to participate.  This applies to Clinical Research Sites in the U.S. or in resource-limited settings.

2. A paragraph describing the required assembly of application budget pages was inadvertently omitted from the published RFA. The paragraph is in Section IV. Application and Submission Information, Part 6. Other Submission Requirements, Subpart IV. Supplementary Instructions. This section reads as follows:

4. PHS 398 Form Page 4: Detailed Budget for Initial Budget Period. Provide a Composite Budget covering all component budgets. Next provide an individual detailed budget for each component indicated below. All budgets must be calculated using U.S. dollars. Applicants proposing affiliation with more than one Network and/or high priority research area must identify the percentage of overall expenditures for each Network/high priority research area in the budget justification.

3. The Research Plan page limits for applicants proposing to conduct clinical research in more than one high priority research area or in more than one Network have been increased based on concerns expressed by participants at NIAID-sponsored pre-application meetings. The stated limit is 10 pages in total for descriptions of the Overall Clinical Trials Unit and Administrative Component, Contributions to Network Clinical Research Plans and Community Interactions. The new page limits are as follows:

a.) Applicants proposing affiliation with more than one Network Leadership by prior agreement may increase the stated limit by a total of two pages for each additional Network proposed by prior agreement with Network Leadership.

b.) Applicants proposing to conduct research in more than one high priority clinical research area but without prior agreement to affiliate with a Network may increase the stated limit by a total of two pages for each additional research priority area.

4. The Research Plan page limits for applicants proposing to implement research plans of more than one high priority research area or of more than one Network at a Clinical Research Site have been extended based on concerns expressed by participants at NIAID-sponsored pre-application meetings. The stated limit is 10 pages to describe each Clinical Research Site. The description of a Clinical Research Site may be increased by one page for each additional Network or priority research area for which the Clinical Research Site affiliation is proposed.

5. NIAID issues further instructions for the assembly of the required application section titled Resources. Applicants are instructed to utilize the standard PHS 398 form for Resources and to include a separate page for Resources for the Administrative Component and for each unique Clinical Research Site.

The revised application instructions are available at the application website (http://www.niaid.nih.gov/daids/rfa/network06).

Inquiries

For questions or further information, contact:

Office of the Director
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4142, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-451-2729
FAX: 301-402-1505
Email: FY06CTURFA@niaid.nih.gov


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