ACTIVITIES TO PROMOTE RESEARCH COLLABORATIONS

in AIDS-ASSOCIATED MALIGNANCIES - (APRC-AAM) - RECEIPT DATE JUNE 16, 2008 (REVISED)

FY2008 Guidelines and Information for Applicants

PURPOSE

The National Cancer Institute (NCI) announces for Federal fiscal year 2008 an opportunity for grantees to seek supplemental funding for existing NCI-funded AIDS-associated malignancy research projects to support and encourage multidisciplinary scientific collaboration among NCI grantees, as well as with other members of the scientific community. This initiative, known as the Activities to Promote Research Collaborations in AIDS-Associated Malignancies (APRC-AAM), can support novel collaborative activities in research that bring together new ideas and approaches from disparate scientific disciplines. The proposed supplement activities should be within the overall scope of the active parent NCI grant.

The program is anticipated to be highly competitive with limited funding. Before submission of a request, all interested grantees must call their NCI Program Director to discuss whether the planned collaborations are responsive.

This document describes the: (1) purpose, (2) background, (3) the administrative mechanism available to promote research collaborations under this program, (4) eligibility requirements, (5) review considerations and criteria, (6) application procedures, (7) post-award requirements, (8) application deadline, (9) mailing address, and (10) contact information for inquiries.

BACKGROUND

The purpose of this initiative is to stimulate collaborative research on AIDS-associated malignancies between NCI-funded investigators and AIDS researchers. For the purposes of this initiative, the term “AIDS-associated malignancies” is taken to include both AIDS-defining malignancies and other malignancies whose incidence is increased in the setting of HIV infection. The incidence of cancers not often associated with AIDS such as anal, skin, lung and Hodgkin disease appear to be increasing in the era of Highly Active Antiretroviral Treatment (HAART) and is projected to increase as the HIV positive population ages. The NCI is interested in encouraging applications in areas such as the study of the etiologic factors, cofactors, pathogenesis, and consequences of clinical outcome of cancers in the HIV positive population. Identifying specific contributions for the development and pathogenesis of these cancers with respect to an AIDS association will both serve to inform screening approaches and therapies targeted to the HIV infected population and increase our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying HIV infection.

Many of the novel and important advances in AIDS-associated malignancies stem from the integration of previously disparate fields of research. New collaborative research interactions involving researchers with varying interests (possibly in differing fields) can lead to further advances. Through the APRC-AAM program, the NCI can promote such interactions by providing administrative supplements to NCI grantees.

Examples of desirable collaborations include (but are not limited to) the following situations:

· Collaborations that allow the participants to move into emerging and important areas of AIDS-associated malignancy research;

· Collaborations that bring in expertise from other research fields, and thereby have the potential to expand the pool of talented scientists working in AIDS-associated malignancies and non-AIDS defining cancers; and

· Collaborations that bring a novel approach to an important area of AIDS-associated malignancies.

ADMINISTRATIVE MECHANISM FOR PROMOTING RESEARCH COLLABORATIONS

It is expected that, collaborations will be composed of 2-5 investigators (often from complementary fields). The collaborative efforts should be focused on achieving specific research objectives that require pooling respective expertise and/or technical capabilities. Collaborative joint projects proposed for the administrative supplements should enable research that would not be possible to conduct expeditiously, if at all, in the absence of these collaborators and this additional funding support.

The PI on this request for the administrative supplement must have active NCI funding as detailed below. The collaborative research project: (1) must focus on AIDS-associated malignancies (2) be within the general scope of the PI’s active NCI-funded grant; and (3) cannot be duplicative of any active or previously funded research topic for any of the collaborators (listed as consortium members).

Important: The collaboration on the research project proposed must be NEW. Investigators with prior history of collaboration with the P.I. on the proposed supplement (including joint publications) in the past 5 years are not eligible as individual (separate) “collaborating units”. If the collaboration has occurred within 5 years, these particular collaborators will be considered a single (combined) “collaborating unit”. In this instance, another collaborator or “collaborating unit” is required for APRC eligibility.

· The maximum total direct costs allowed for a collaborating unit within a consortia is $40,000 per year.

· The maximum combined consortium direct cost is $120,000 per year, regardless of the number of collaborators or “collaborating units”.

ELIGIBILITY REQUIREMENTS

· Only investigators with active NCI funding either in the area of AIDS-associated malignancies, or who will collaborate with investigators engaged in 100% AIDS research, are eligible to apply for an APRC-AAM. Not all NCI grantees are eligible. Before submitting an application, grantees must call their NCI Program Official to discuss their eligibility and planned application.

· The PI must have an active R01, R37, P01, U01, R33, R42, or R44 grant, with at least one full year remaining at the time of anticipated funding (September 1, 2008). No other grant mechanisms are eligible.

· NCI grantees may seek scientific collaboration with NCI intramural scientists who would serve as unpaid consultants.

· All members of the consortium must be Principal Investigators with active research funding support at the time of this supplement funding, but it may be from other peer-reviewed sources.

· Investigators may come from the same or different departments within an institution, or from different institutions.

· Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to participate in this opportunity for supplemental support.

REVIEW CONSIDERATIONS AND CRITERIA

The number of awards and level of support will depend on the number and diversity of meritorious applications received, and the availability of funding for the program. Applications will be evaluated on the following criteria:

· Relevance to AIDS-associated malignancies. For this purpose, the key parameter will be the study of the tumor in the context of HIV infection, or a focus on certain tumors (such as Kaposi’s sarcoma) that predominantly occur in the setting of HIV infection.

· The importance of the specific questions to be asked and the potential benefit to research on AIDS-associated malignancies.

· The novelty or uniqueness of the opportunity presented by the proposed activity.

· The novelty or uniqueness of the collaboration, and the extent to which disparate scientific disciplines are represented within the collaboration.

Proposed activities should also demonstrate:

· Additional value to the underlying funded research (parent grant) of the PI and the collaborating investigators.

· Sound experimental design.

· Realistic scope of work, given the time and budget requested.

Include the following:

(1) Cover Letter – Identify the eligible parent grant(s). Provide a supplement title (must be different from that of the parent grant). The cover letter must be signed by the PI, collaborating investigators at the same institution as the PI, and the appropriate official from the parent grantee institution.

(2) PHS Form Page 1 (Face Page).

(3) PHS Form Page 2 (Abstract and Key Personnel) – Include the specific aims, objectives, and projected outcomes.

(4) Summary of Each Collaborator’s Specific Contributions – [1 page total for all collaborators combined]. Specify the contribution to the research project.

(5) PHS Biographical Sketch Format Page – Each collaborator.

(6) PHS Other Support Format Page – Documentation of active research funding (i.e., NIH, other federal, private sources, etc.) for all collaborating investigators.

(7) PHS Form Page 4 (Detailed Budget for Initial Budget Period):

Budget Specifications

a. Funding will be in the form of administrative supplements to existing active NCI funded research grants.

b. The applicant institution may subcontract to the outside collaborators.

c. Funding is limited to the project period of the PI’s active grant. At least one full year must remain on the parent grant at the time of supplement funding; two full years must remain for two-year requests. Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.

d. Collaboration requests should be for no more than 24 months. Requests for longer periods will not be considered.

e. A detailed budget explanation and justification must be included in the application with each year’s budget clearly detailed. Include justified budgets for each collaborating unit.

f. Facilities and Administrative costs (indirect costs) are permitted at the grantee institution’s current negotiated rate. These must be clearly annotated.

g. These supplements are not subject to the modular grants requirements.

h. PI and/or collaborators salary support is not permitted under these supplements.

i. Supplements will be funded with a start date of September 1, 2008.

(8) PHS Form Page 5 (Budget for Entire Proposed Period of Support) – Entire consortia.

(9) Relationship to Parent Grant – [1 page maximum] Describe how the consortia research project relates to the parent grant.

(10) Research Plan [strictly limited to 5 typed pages]

a. Specific aims, background, and significance (not to exceed 2 pages).

b. Preliminary studies and experimental design (not to exceed 3 pages). Experimental design must be presented in adequate detail to allow scientific evaluation of the feasibility.

(11) Appendices and supplemental material will not be accepted or forwarded to reviewers.

(12) Literature Cited.

(13) Letters of Intent to Collaborate – Provide a letter for each collaborating investigator located at an institution different from that of the PI, cosigned by the appropriate official from that institution.

(14) Assurances – All human and animal studies must receive the appropriate IRB or IACUC review and approval prior to funding authorization for the APRC-AAM supplement. Verification of this approval must be sent to your DCB Program Director. Note that since APRC- AAM funded projects are supplemental to existing projects and within the scope of those studies, modifications to assurance approvals are usually all that are needed.

POST-AWARD REQUIREMENTS

Final Report:

· Within 90 days after the conclusion of the funded activity, the PI must submit a Final Progress Report that includes a description of the activities and outcomes and an assessment of the success in meeting the stated aims and objectives to their NCI Program Director

· Principal Investigators funded in FY08 will be expected to attend the NCI-sponsored International Conference on Malignancies in AIDS and Other Acquired Immunodeficiencies (ICMAOI) to present their research under this supplement. You will be notified of the scheduled date of the meeting. Collaborators will be encouraged to attend.

REQUEST DEADLINE and SUBMISSION

Requests for the supplements must be submitted to as described in these AIDS-Associated Malignancies APRC Program Guidelines. This is a one-time announcement and formal requests must be received on or before Monday, June 16, 2008 (Revised) . Late applications will not be accepted. Electronic applications (as PDF file) via e-mail are strongly encouraged. The applications must be signed by the Authorized Official Representative. Do not submit via Grants.gov. Note that the NIH Center for Scientific Review (CSR) is NOT involved in receipt and processing of these requests.

E-mail to:

Stephen White

Special Assistant to the Director and Programs Coordinator

Division of Cancer Biology, NCI, HHS

301-496-5307

whitest@mail.nih.gov

An electronic receipt will be provided.

Applicants may also submit applications in paper format (original and 5 copies) to:

Activities to Promote Research Collaborations in AIDS-Associated Malignancies (APRC-AAM)
c/o Stephen White
Special Assistant to the Director and Programs Coordinator
Division of Cancer Biology
National Cancer Institute, NIH, HHS
6130 Executive Boulevard
Executive Plaza North, Room 5048
Bethesda, MD 20892-7150 (US Postal Service) or 20852 (non-USPS delivery)

INQUIRIES

Direct program/scientific related questions or inquiries to your NCI Program Official or to:

Betsy Read-Connole, Ph.D.

Program Director

Division of Cancer Biology

National Cancer Institute, NIH, HHS

301-496-9740

bconnole@mail.nih.gov

Direct all grants management related questions or inquiries to:

Joy Kearse

Grants Management Specialist

Office of Grants Administration

National Cancer Institute, NIH, HHS

Telephone: 301-846-1010

kearsej@mail.nih.gov