Funding Opportunity Announcement: Evaluation of a New Specimen Biorepository Utility Providing Access to External Investigators to Pedigreed Specimens for Collaborative Research with the DAIDS ACTG Network
Deadline: September 30, 2016
I. Introduction
The National Institutes of Health/Division of AIDS (NIH/DAIDS) and the AIDS Clinical Trials Group (ACTG) Network would like to increase non-network and international DAIDS Network investigator access to stored specimens available at the ACTG Biomedical Research Institute (BRI) repository in Rockville, Maryland to encourage the use of banked specimens for new laboratory based scientific proposals. Specimen types stored at the BRI repository include blood, serum, plasma, sputum, peripheral blood mononuclear cells (PBMC), tissue, and other body fluids such as cerebrospinal fluid (CSF), semen, endocervical and cervicovaginal lavage fluid, many of which are now available for testing by external investigators. Public access to this specimen repository is available at the Specimen Repository website www.specimenrepository.org.
II. Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage collaboration between external investigators and the ACTG Network by providing access to pedigreed ACTG specimens stored at BRI to facilitate continued and novel research. This FOA is open to all qualified investigators, regardless of whether they are affiliated with the ACTG or IMPAACT. However, preference will be given to new and early investigators (https://grants.nih.gov/policy/new_investigators/index.htm). Laboratory investigators already receiving funding from the ACTG as part of the Network Laboratory Center are not eligible to apply.
The purpose of this FOA, which will complement the existing New Works Concept Sheet (NWCS) process, is to provide limited total direct funding to support laboratory-specific research projects that use these repository specimens as described in the NWCS proposal. There will be no support from the ACTG Statistical Data Analysis Center (SDAC) for this specimen search or for subsequent data analysis.
In addition to opportunities for increased collaboration with the ACTG Network through approved research with ACTG stored specimens, external collaborators will be given the opportunity to evaluate the usefulness and usability of the website and provide feedback on the request process to provide the Networks with data to evaluate the tool and to potentially improve it or streamline the process in the future. This evaluation will be kept separate from the NWCS submission.
Building on this open web resource, the ACTG Network has put forward this FOA to stimulate interest in and support for laboratory-based studies that will benefit from the use of these pedigreed clinical trial specimens.
III. Background
To help facilitate access to these well-characterized specimens, the ACTG Data Management Center, Frontier Science & Technology Research Foundation, Inc. (FSTRF), was funded by NIH/DAIDS to create a public website, database, and search utility to allow investigators the opportunity to search the characteristics of approximately 2.4 million stored specimens collected from ACTG clinical research trials that are now five years or more past the time of protocol closure. The interactive public website at www.specimenrepository.org allows any user to search for available specimens according to certain criteria such as material type, study characteristics and participant characteristics. The search will generate a report of the number of specimens available meeting the search characteristics, provide information about the studies for which they were collected, and a list of the manuscripts already published using the collected data. This report can be saved and information will need to be used to submit a NWCS, the mechanism by which samples are requested and approved for use, through the scientific review committees of the ACTG Network. NWCS details are available on the website under “Submit a Proposal” (http://www.specimenrepository.org/submit.html). Proposals submitted under this FOA must use samples that are currently in the repository.
IV. Funding Source and Mechanism
We anticipate up to six ACTG awards of $50,000 each (total direct cost in US dollars) for one year. Institutional facility and administrative (F&A) costs should be added to the total direct cost using the appropriate negotiated indirect cost rate for your institution in order to determine total cost for each proposal. The cost of shipping specimens from BRI to the testing laboratory also must be included in the total testing cost.
Final decisions will be announced after November 3, 2016.
V. Scope of Work
Propose laboratory-based studies that utilize the stored BRI Repository specimens to address an important question about the molecular epidemiology, viral pathogenesis, antiretroviral therapy, or immunology of HIV-1 infection and associated conditions.
VI. Application Procedure
All applicants should submit the following no later than 5:00 PM ET on September 30, 2016:
1. A NWCS via https://submit.actgnetwork.org/
a. The NWCS form may be downloaded here:
https://submit.actgnetwork.org/files/NWCS.zip
2. One PDF application via https://actgnetwork.org/node/436952 a. The application forms may be downloaded from
https://actgnetwork.org/node/436952
Applicants MUST complete the forms found in the ACTG Repository Submission Packet and the posted at https://actgnetwork.org/node/436952. The scope of work is limited to 5 pages (single- spaced, 11 point Arial font) and needs to describe the specific items listed below that augment information already presented in the NWCS. A description of any assay validation or external quality assurance (EQA) proficiency results/tables associated with the proposed laboratory must be included within the 5-page limit. References, Facilities and Equipment, Budget and Biographical Sketch are excluded from the 5-page limit.
- VII. Evaluation Criteria, Review Process, and Scoring ScaleProposals will be evaluated on the basis of originality, creativity, overall significance, and relevance to the HIV/AIDS field. An independent review committee, comprised of members from the respective Network scientific committees, using a score system of 1.00 to 5.00 as defined below, will score each application:
1.00 = Outstanding:
2.00 = Excellent:
3.00 = Good:
4.00 = Fair:
5.00 = Unacceptable:
Exceeds requirements for these criteria. Provides supporting information demonstrating substantial benefit and unique contribution to the HIV/AIDS field.
Meets or exceeds requirements for these criteria. Supporting information reflects history of strong performance.
Meets requirements. Supporting information is acceptable.
Only partially meets requirement. Marginal supporting information provided.
Does not address or respond to criteria. No supporting information.
Specific review criteria will include:
Investigators: Is the investigator appropriately trained and well suited to carry out this work? Are suitable collaborations in place to support the proposed laboratory work? This FOA prioritizes new and early investigators.
Environment: Does the scientific environment in which the laboratory work will be done contribute to the probability of success? Is there evidence of institutional support?
Feasibility: Is the study feasible given the duration of one year and the budget?
Potential for new collaborations: Although we prioritize Network links and target particular countries that are affiliated with the ACTG Network, we are also encouraging
relationships with new investigators who are not currently linked to the ACTG Network. We welcome new investigators who bring expertise in new, relevant areas to forge interdisciplinary collaborations within the ACTG Network.
Potential for new research projects and career development: The projects should aid in the development of the investigator by providing important data for a larger NIH (or other) funded study such as an R21 or R01.
VIII. Key Dates/Timeline
Release of solicitation: after August 1, 2016
Letter of intent due date: August 31, 2016
Application due date: September 30, 2016 5:00 PM ET Review timeline: after November 3, 2016
Award issued: after December 1, 2016
IX. Contact Information
Questions regarding this FOA and the application process may be addressed to: Katie Lammersen
c/o: ACTG Laboratory Sciences Group
Social & Scientific Systems, Inc.