amfAR, The Foundation for AIDS Research

Impact Grants: Gaining Insights from the Clinic

Letter of Intent (LOI) Components

 

LOIs must include the following:

Entered on the Details tab in the portal:

  • Abstract (maximum 2,000 characters/spaces)
  • Clinical research implementation statement (maximum 2,000 characters/spaces)
  • Hypothesis/specific aims (maximum 1,700 characters/spaces)
  • Timeline (maximum 450 characters/spaces for each year)

Uploaded to the Attachments tab in the portal:

5-page Research Plan with the following sections in this order:

A. Background and Rationale: Concisely describe the background and rationale for the project and how it addresses either: identifying pre-ATI predictors of post-treatment control (PTC) or delay to rebound; OR diversifying the HIV cure clinical study population. If your LOI addresses specific area of interest 1.2, 1.3, or 2.1, include a description of the existing clinical trial and timeline in this section.
B. Preliminary Studies: Summarize the investigator’s preliminary studies.
C. Experimental Design Proposed: Clearly and concisely describe the experimental design and the procedures to be used. Include, where applicable, sample size, power analyses and other relevant statistical analyses.
D. Pitfalls/Alternatives: Describe potential difficulties or pitfalls that might arise and alternate strategies you would employ to achieve the specific aims and research goals.

Figures and Legends should be embedded throughout the research plan. Figure legends should be concise and in a font size large enough to be easily read in printed copies of the LOI.  

Literature Cited (not counted toward research plan’s page limit)

Biographical sketches for all key personnel

Addenda: The Addenda should begin with a face page titled "ADDENDA" and a list of the contents.

Required addenda:
[Requirement A—description of existing clinical plan and timeline—is included in the research plan.]

B. LOIs addressing specific areas of interest 1.2, 1.3, and 2.1 are required to include documentation in the addenda which demonstrates that the existing trial is already funded and that all necessary institutional (e.g., IRB) and regulatory (e.g., FDA or equivalent non-U.S. agency) approvals have been received.

C. LOIs addressing specific areas of interest 1.2, 1.3, and 2.1 are also required to include documentation in the addenda which demonstrates that the trial investigators are willing and able, as applicable, to (a) add another study arm, (b) share samples, or (c) obtain incorporate the proposed intervention.

D. All areas of interest: describe the procedure and provide a timeline for obtaining all necessary institutional approvals (e.g., IRB, IBC) required for the research proposed in the application. If the institutional approvals have already been obtained, include the documentation.

E. All areas of interest: describe the procedure and provide a timeline for obtaining all regulatory (e.g., FDA or equivalent non-U.S. agency) approvals required for the research proposed in the application. If the regulatory approvals have already been obtained, include the documentation.

Grant funding will be rescinded if documentation of items D and E are not received by amfAR within 3 months following the performance period start date.
 

Optional addenda:

  • Protocol for an existing clinical trial on which the proposed research builds.
  • Additional Letters of Support/Collaboration.

 

Signature Page