Targeted RFP – Biomedical Research:
Gene therapy for the treatment and potential eradication of HIV infection
Deadline: Closed
Available Support
amfAR, The Foundation for AIDS Research, is pleased to announce the availability of targeted support for biomedical research projects relevant to the role of gene therapy in the eradication of HIV infection.
Funding will be available for:
Research Grants—$100,000 for direct costs plus up to 20 percent for indirect costs. The performance period for grants awarded under this RFP will be for one year starting March 1, 2010.
Fellowships—Each fellowship is funded for a total of up to $125,000: A maximum of $110,000 is allowed for project-specific direct costs ($45,000 per year for salary and fringe benefits and $20,000 over two years for laboratory supplies). It is expected that fellows will devote a minimum of 85 percent time and effort to the approved fellowship project. An additional $3,636 is provided to support attendance at amfAR-designated consultations for a direct cost maximum of $113,636. Institutional indirect costs may not exceed 10 percent of direct costs. The performance period for fellowships awarded under this RFP will be for two years starting March 1, 2010.
Background and Areas of Interest
amfAR's research program is driven by the Foundation's mission to end the global AIDS epidemic through innovative research. amfAR plays a uniquely important role in AIDS research, identifying critical gaps in our knowledge of HIV and AIDS and supporting groundbreaking studies that often lack the preliminary data required by more traditional funders. The Foundation's research program focuses on efforts to prevent HIV infection among vulnerable populations and to improve treatment, with the ultimate goal of eradicating the virus in people living with HIV infection.
This RFP solicits proposals relevant to the role of gene therapy in the treatment and potential eradication of HIV infection. While gene therapy holds much promise against HIV as well as other diseases, setbacks for the gene therapy field have hindered progress. Recently, there has been renewed interest in gene therapy following a report in the February 2009 NEJM of a patient in Berlin with acute myeloid leukemia. He underwent allogeneic stem cell transplantation with complete replacement of recipient stem cells with CD34+ peripheral stem cells from an HLA-matched unrelated donor who was also homozygous for the CCR5 delta32 mutation. Despite being off all antiretroviral therapy for more than two years and off all immune suppressive medications, to date no HIV has been detected in this patient. amfAR wishes to support basic research exploring the potential for gene therapy in HIV infection and studies of clinical cases aimed at understanding of the role of transplantation conditioning versus graft cell type.
Specific areas of interest include:
- Targets for gene therapy: CCR5 is one target—are there others? Do HIV genes or cellular genes or some combination represent the best targets? Are there genes whose function could be enhanced to treat HIV infection?
- Which are the best vectors for gene therapy in the context of HIV infection? How can efficiency be improved?
- Can the life of gene therapy interventions be extended?
- In the Berlin patient’s case, was the conditioning regimen or the gene therapy key to the apparent eradication of HIV? Can use be made of the existing literature, as well as unpublished data from central and local transplant centers and registries, which could be searched to identify HIV-positive individuals who have undergone allogeneic stem cell transplants and have stored pathologic material to assess whether HIV eradication has occurred?
Definitions and exclusions:
Basic research
Applicants are encouraged to submit proposals using appropriate in vitro or ex vivo techniques.
Pre-clinical research
Applicants proposing studies involving animal (humanized mice or non-human primates) are particularly encouraged to apply.
Clinical research
amfAR funding may be used to gather clinical data on HIV-positive patients who have undergone transplantation with conditioning. Data should include the type of conditioning, type of transplant, medical condition for which the transplant took place, availability of samples from those patients pre- and post-transplantation, and results of any HIV and other testing that has taken place using those samples.
Types of Funding and Qualifications
Research Grants—Principal investigators for research grants must be faculty-level researchers affiliated with a nonprofit institution. Research grants are given to nonprofit institutions worldwide to support investigator-led projects approved by the Foundation. In general, funds are applied to direct costs of salaries and fringe benefits for professional and technical personnel, laboratory supplies and equipment, travel, and the publication of findings. Research grants are awarded for one year without assurance of continued funding.
Fellowships—An amfAR fellowship is a grant that encourages the postdoctoral (M.D., Ph.D., or equivalent) investigator with limited experience in the field to advance a career in HIV/AIDS research. Fellowship grants are applied to direct costs incurred in the course of an amfAR-approved research project. Allowed costs are limited to laboratory supplies, the fellow’s salary and fringe benefits, and costs incurred by participation in amfAR-designated consultations. Fellowships are awarded for two years and may not be renewed for additional funding. amfAR fellows and mentors must be affiliated with the same nonprofit institution. The applicant’s interest in a career in HIV/AIDS will be demonstrated by previous relevant work at the postdoctoral fellow or instructor level and will be carefully evaluated. The fellowship applicant must be mentored by an experienced investigator who: (a) is qualified to oversee the proposed research; (b) has successfully supervised postdoctoral fellows; and (c) is at the associate professor level or higher. See “Available Support” above for additional information.
Collaboration—In circumstances where collaboration between two principal investigators (PIs) working on distinct areas of a single research project might result in enhanced research productivity or significance, the combined scope of work may fall outside the $100,000 of a single research grant. In such instances, collaborating PIs may each submit an letter of intent (LOI) describing how their project would merit independent funding and the potential added value of funding both projects. The budget for each component could be up to $100,000 in direct costs plus not more than 20 percent in indirect costs. Collaborative proposals are NOT accepted from fellowship applicants.
Deadlines and Other Important Dates
E-mailed Preliminary Information Form due (required):
No later than September 25, 2009, 5:00 p.m. EDT
E-mailed LOI due (required):
October 12, 2009, 5:00 p.m. EDT
Signed hard copy of LOI due (required):
October 16, 2009, 5:00 p.m. EDT
Other dates:
Applications solicited
November 20, 2009 (tentative)
Applications due
January 6, 2010 (tentative)
Grants announced
Mid-February 2010 (tentative)
Future requests for proposals:
Click here to sign up for e-mailed grant opportunity announcements.
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Submission Requirements
Applicants must submit a preliminary information form and an LOI. Both are required.
Preliminary Information Form (required):
Qualified scientists who are considering the submission of an LOI must first submit a preliminary information form providing basic information about the applicant institution, proposed research, and applicant qualifications. While submission of this form is required, its submission does not obligate the researcher to submit an LOI.
Detailed instructions are provided on the form itself.
E-mail the completed preliminary information form as an attachment to grantapps@amfar.org.
Make sure the body of the e-mail includes the investigator name and contact information.
Preliminary information forms are due no later than September 25, 2009, 5:00 p.m. EDT
Letter of Intent submission:
LOIs may be submitted by qualified applicants who have properly submitted a preliminary information form. LOI forms and instructions will be sent to applicants who have submitted a preliminary information form. The LOI must be prepared on amfAR-provided forms in conformance to the instructions and must include:
Face sheet: completed and signed by the fellow and fellowship mentor.
Abstract: No more than 200 words describing the proposed research plan.
Relevance description: 200 words or less addressing the significance of the proposal to the RFP target and priorities in HIV/AIDS research.
Biographical sketch(es) of the fellow and mentor.
Research plan (submitted as a separate document): Three single-spaced pages (one-inch margins, Times New Roman 12 point font) covering background and rationale, preliminary studies, specific aims, experimental design, procedures, and data analysis to be used.
Please see the LOI INSTRUCTIONS for detailed directions.
E-mail the LOI forms and research plan as attachments to grantapps@amfar.org.
Please make sure the body of the e-mail includes the investigator name and contact information.
Due no later than October 12, 2009, 5:00 p.m. EDT
Important Notice
Electronic (e-mailed) LOIs that are received late, are incomplete, or exceed page limitations (please see instructions for details) will not be accepted for review. Fax submissions are not accepted.
Send one signed hard copy of the LOI (forms and research plan) to:
amfAR Grants
120 Wall Street, 13th Floor
New York, NY 10005-3908, USA
Due no later than October 16, 2009, 5:00 p.m. EDT
A preliminary information form and both e-mailed (electronic) and signed hard copies of the LOI are required of all applicants.
Submission of an LOI is not a guarantee of eligibility to submit a full application. The pre-application process is highly competitive. Only a limited number of investigators submitting an LOI will be invited to submit a full application.
If you are not able to download the preliminary information form, contact the grants administrator at grantapps@amfar.org.
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Forms and Instructions
Use the links below to download the preliminary information forms and instructions. Please read the instructions thoroughly as they contain all of the information necessary for completion of the form.
Save the preliminary information form to your hard drive.
LOI forms and instructions will be e-mailed to applicants who have submitted a preliminary information form.
PRELIMINARY INFORMATION FORM AND INSTRUCTIONS (DOC)
SAMPLE PRELIMINARY INFORMATION FORM (PDF)
LETTER OF INTENT INSTRUCTIONS AND SAMPLE FORMS (PDF)
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Policies and Conditions
Descriptions
Research grants satisfy various financial obligations incurred in the course of an HIV/AIDS-related investigation. In general, a research grant is applied to direct costs of salaries for professional and technical personnel, laboratory supplies and equipment, travel, and the publication of findings. Support for institutional costs is limited to a maximum of 20 percent of total direct costs.
Fellowships are grants that encourage the postdoctoral investigator with limited experience in the field of HIV/AIDS to embark on or redirect a career in HIV/AIDS research. The applicant’s interest in a career in HIV/AIDS will be demonstrated by previous relevant work at the post-doctoral fellow or instructor level and will be carefully evaluated. An amfAR fellow must be mentored by an experienced investigator who: (a) is qualified to oversee the proposed research; (b) has successfully supervised postdoctoral fellows; and (c) is at the associate professor level or higher.
An amfAR fellowship is applied to direct costs of the fellow’s supplies and salary and to transportation and lodging costs (pursuant to amfAR policies) for participation in amfAR-designated consultations (no additional travel costs may be included in a fellowship budget). It is required that the fellow devote at least 85 percent time and effort to the approved research project. Requests for salary support in excess of the current stipend levels set by the U.S. National Institutes of Health for the Kirchstein National Research Service Awards will be carefully evaluated for adherence to the effort and consistency requirements and are subject to peer review and administrative approval. Support for indirect institutional costs is limited to a maximum of 10 percent of total direct costs.
To Whom Grants Are Made
Grants and fellowships are awarded to nonprofit institutions; they are not awarded to individual investigators. Accordingly, an application, if solicited, must bear the signature of an official authorized to sign for the institution and, if requested, the applicant institution must submit proof of its nonprofit status. Applications are neither requested nor accepted from for-profit entities. Institution endorsement is not required for Letters of Intent.
By accepting an amfAR grant or fellowship, the recipient institution will accept full responsibility for the conduct of the investigation and for the acts of the investigator(s). Both are under the direction of the institution and are subject to its medical and scientific policies. Similarly, project personnel compensated in full or in part with funds awarded by the Foundation are employees of the recipient institution; they are not amfAR employees.
Applicants need not be U.S. citizens, and there are no restrictions as to age, color, creed, gender, medical condition, handicap, national origin, parental status, political affiliation, race, religion, marital status, or sexual orientation.
Members of the Foundation’s board of trustees are not eligible as investigators in Foundation-supported research. They may, however, sponsor fellowship applicants. Members of the Scientific Advisory Committee (SAC) are eligible. Members of the board of trustees and SAC must comply with the Foundation’s policies regarding the avoidance of conflicts of interest.
Restrictions
Funds are not awarded for the following:
- Major construction or the remodeling of facilities (minor alterations are allowed with adequate justification);
- The direct cost of support services normally available at a sponsoring institution (e.g., telephone, office furniture, and supplies) except when directly allocable and essential to carrying out the proposed research;
- The purchase, lease, rental, or servicing of office equipment;
- Funding for dissertation research;
- Indirect costs in excess of 20 percent for research grants or 10 percent for fellowships.
Foundation grants and fellowships are not meant to cover the total cost of a proposed research project. A grantee institution is expected to provide the necessary physical facilities and administrative services, as well as other supporting services normally available at a sponsoring institution. Expenses generally considered to be indirect costs may be budgeted as direct costs only when required for the operation of remote sites deemed necessary and leased or rented exclusively for conduct of the funded research. Such requests will be carefully assessed for appropriateness and are subject to peer review and administrative approval. Because indirect costs are a function of direct costs, the budget for indirect costs may not be modified, and in no case will the Foundation reimburse any indirect costs beyond the stated 20 percent of direct cost expenditures for research grants and 10 percent for fellowships.
When an application for project support is submitted to amfAR and also to other grant making agencies, accepted support from the Foundation and from another agency cannot be in duplication.
Recipient institutions agree not to promote or engage in violence, terrorism, or the destruction of any state, and to take prudent measures to insure that they do not provide support through sub-grants or other financing to any entity that engages in those activities.
Restrictions on the Use of Funds Awarded to Foreign Organizations
Unless written authority is obtained in advance from amfAR, funds from grants awarded to organizations outside of the United States (U.S.) may not be used to support (a) services performed in the U.S., or (b) travel to or from the U.S. Authorization to use funds for such purposes may be obtained by providing either of the following sets of documentation: (1) a copy of U.S. Internal Revenue Service (IRS) form W-8EXP bearing a valid International Taxpayer Identification Number or Employer Identification Number and either (a) an IRS determination letter or (b) written opinion of U.S. counsel that the organization is described in IRS Code section 501(c)(3); (2) alternatively, an applicant organization in a country that benefits from an exemption under a tax treaty with the U.S. should provide (a) a completed copy of IRS form W-8BEN and (b) an affidavit stating the treaty provision under which benefits are claimed and asserting facts pertinent to the treaty provision (e.g., facts to establish that the organization would qualify under IRS code section 501(c)(3)).
Although these documents are not required for LOIs, applicants should anticipate and prepare for their submission as part of the application or award process.
Source of Funds
Funds available to the Foundation are obtained principally from private donations.
Review and Approval Process
amfAR intends to encourage and support HIV/AIDS research of the highest quality. Therefore, every properly prepared and submitted LOI or application received in response to an amfAR solicitation is peer-reviewed by members of the Foundation’s Scientific Advisory Committee (SAC). Each is subject to an overall conformance review by the Foundation staff. Those found to be inconsistent with the guidelines and instructions are eliminated at that time, and the investigator and the applicant institution’s grants official are notified. Applications are solicited from investigators and fellows whose letters of intent have been recommended by the Foundation’s SAC. Unsolicited applications are not accepted for consideration.
The SAC, a volunteer body of scientists who are experts in various fields of HIV/AIDS research, evaluates (1) the scientific merit of LOIs and applications; (2) the relevance of the research to the control of the epidemic or to the benefit of patients with AIDS or HIV/AIDS-related conditions; (3) the qualifications, experience, and productivity of the investigator/sponsor; (4) the facilities available; and (5) the likelihood of success. The SAC’s determinations are considered by the amfAR board of trustees, which holds the sole authority to approve project funding.
Submission of an LOI does not guarantee invitation to submit a complete application. The LOI process is very competitive and only a limited number of proposals are approved for additional review.
Written critiques are not available for LOIs.
Confidentiality
Throughout the review and award process, the Foundation respects the privacy of the applicant and endeavors to protect from disclosure any confidential or proprietary information contained in a submitted proposal. However, amfAR has in place no mechanisms to maintain or guarantee confidentiality and, as a not-for-profit corporation, lacks the financial resources to (1) institute such mechanisms or (2) accept liability for the disclosure of information. At the same time, the Foundation does not consider information on an application’s project description form (lay-language summary) to be confidential. That information may be made public as a description of the project being funded by amfAR. Submission of an application or LOI is deemed acceptance of these provisions.
Human and Animal Subjects / Biohazards
Applicants are required to submit documentation of institutional approvals for research involving human or animal subjects or the use or production of biohazards. Research activity may not begin, nor may expenditures be made, until such approvals are received and forwarded to amfAR. Although these approvals are not required at the LOI stage, investigators should prepare to submit them with full applications.