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

Notice Number: NOT-AI-05-038

Key Dates
Release Date: April 29, 2005
RFA-AI-05-002 Release Date: February 10, 2005
Letters of Intent Receipt Date(s): June 10, 2005
Application Receipt Date(s): July 11, 2005
Peer Review Date(s): November, 2005
Council Review Date(s): January, 2006
Earliest Anticipated Start Date: April, 2006
Expiration Date: July12, 2005

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

This Notice Supersedes Prior Notice NOT-AI-05-031

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 (MTCT) 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 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.) The use of a satellite or mobile clinic provides an opportunity for rural residents who would otherwise be unable to participate.  2.) All clinical research activities at the satellite/mobile clinic are performed by qualified Clinical Research Site staff, 3.) All study product is dispensed from the Clinical Research Site pharmacy. 4.) No study product or clinical research records are stored at the satellite/mobile clinic. 5.) All routine and safety laboratory tests are either performed in CLIA certified labs or equivalent or the specimens are transported to the Clinical Research Site for timely processing. 6.) Results of laboratory or other diagnostic evaluations are available in a timely manner. 7.) Emergency medical care appropriate to the risks associated with trial participation is available in the community. 8.) The number of persons participating in the clinical research at a satellite clinic location is sufficient to warrant its use and is no less than an average of 8 participants on study/ month over a 12 month period. 9.)The utilization of satellite/mobile clinics is cost-effective when considering transportation, staff travel time, equipment and supplies. This applies to Clinical Research Sites in the U.S. or in resource-limited settings.

2. The criteria for inclusion of a Clinical Research Site in more than one CTU application has been clarified.  In Section IV, Application and Submission Information, Part 6 Other Submission Requirements, Subpart III Submission and Award Options, Subpart C. the sentence, "A Clinical Research Site can not be included in more than two Clinical Trial Unit awards and in no more than one CTU application for a particular high priority research area." has been revised to read:

"A Clinical Research Site can not be included in more than two Clinical Trial Unit awards. Furthermore, a Clinical Research Site can not be proposed in more than one CTU application for a particular high priority research area unless there is no overlap of its proposed contributions to the separate Networks' research plans, and that both scientific and resource capacity is sufficient to ensure optimal performance in each proposed Network."

3. 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. “

4. 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 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 areas.

5. 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.

6. Applicants proposing Clinical Research Sites that include separate facilities or staff for mothers and infants or that will utilize satellite or mobile clinic facilities must provide justification for the use of such arrangements. MTCT clinics must demonstrate adequate communication and coordination, including IRB oversight. Applicants proposing the use of satellite or mobile clinics must clearly demonstrate the ability to reach participants who would otherwise be unable to participate, that protections to ensure participant safety are adequate, and also demonstrate that these clinic operations are cost-effective.

7. 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.

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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