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1. What is the UM1 NIH grant activity code?
The UM1 activity code is a research project Cooperative Agreement to support large-scale complex clinical trials with multiple components (e.g., clinical networks). The components represent a variety of supporting functions and are not independent of the research projects. Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of the award.
2. As a foreign investigator, am I permitted to participate in the new Leadership Group for a Clinical Research Network on Antibacterial Resistance?
As stated in the funding opportunity announcement, non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the lead Program Director of the Leadership Group. However, foreign investigators are welcome to participate as a foreign component, as defined in the NIH Grants Policy Statement. Therefore, we encourage you to utilize the research networks and organizations that you collaborate with to seek a partnership with a U.S.-based institution that could serve as the lead Program Director on an application. Your institution could be included as a component of the Leadership Group’s overarching research agenda.
3. Can the LG accept independent bids from industry?
Yes, it is possible for the LG to include industrial partners and leverage the resources provided by those sources to accomplish its research agenda.
4. I assume that the page limitations for the components of the research plan for the Leadership Group for a Clinical Research Network on Antibacterial Resistance (UM1) FOA (i.e., research overview-30 pages; Leadership and Operations Center (LOC)-30 pages; Laboratory Center (LC)-12 pages, Statistics and Data Management Center (SDMC)-12 pages) replaces the Research Strategy section in the research plan instructions of the PHS 398? Is that correct?
Yes, that is correct.
5. In addition, the following sections must also be addressed in an application for the AR Leadership Group FOA, which DO NOT have page limits, correct?
5. Bibliography and References Cited/Progress Report Publication List
6. Protection of Human Subjects
7. Inclusion of Women and Minorities
8. Targeted/Planned Enrollment Table
9. Inclusion of Children
10. Vertebrate Animals
11. Select Agent Research
12. Multiple PD/PI Leadership Plan
13. Consortium/Contractual Arrangements
14. Letters of Support (e.g., Consultants)
15. Resource Sharing Plan(s)
Yes, you are correct that we expect to see these sections addressed as well, and there are no stated page limits for these sections. However, these sections should include only the information requested, and should not be used as a repository for information that will not fit within the page limits of the other sections of the application. In addition, please note that with regard to item 5 on the list, Bibliography and References Cited/Progress Report Publication List, there is no Progress Report for a new application.
6. Should there be a Preliminary Studies section, and do the references cited for that section fall within the page limits of the Research Plan?
There should be a Preliminary Studies section (as part of the Approach) which may have some reference citations, and these would fall outside of the stated page limits for that section of the application. The Form 398 instructions say specifically that “The references should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research.”
7. Are there page limitations for personal bibliographies of key investigators?
Personal bibliographies of Key Personnel are limited by the instructions and page limits for the Biosketch sections of the application. Each Biosketch is limited to four pages. Regarding peer-reviewed publications within the biosketch the instructions say “NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation.”
8. I understand there was a webinar for the Leadership Group for a Clinical Research Network on Antibacterial Resistance funding opportunity in March but I missed it. Is it still possible to view the webinar?
Yes, the webinar, which provides information on scientific and administrative issues related to this funding opportunity, is still accessible through the NIH Videocasting and Podcasting website at this link: http://videocast.nih.gov/Summary.asp?File=17143.
9. Would an application focused on TB be responsive to the NIAID antibacterial resistance Leadership Group funding opportunity?
Yes, provided that the application focuses on the antibacterial resistance aspects of TB and addresses the scientific scope of the RFA, which is to design, prioritize, implement and manage an integrated, clinical research program that could lead to the treatment or reduction of AR. It is expected that data arising from these studies would have application to management and control of TB in the United States.
10. I am confused about how the antibacterial resistance trials network is to be incorporated into the NIAID Clinical Trials Network. Is response to RFA-AI-12-018 and subsequent participation as a CTU in the HIV-associated networks the only opportunity to participate as a CRS/CTU in the antibacterial trials network? Will there be an additional RFA coming out for sites that wish to participate only in the antibacterial trials network?
NIAID does not plan to issue an additional RFA to support clinical sites that would exclusively serve the new antibacterial resistance Leadership Group. The AR LG may access patients through appropriate NIAID CTU sites or through other NIAID-supported clinical research sites (e.g., Vaccine and Treatment Evaluation Units). In addition, the LG may opt to obtain access to appropriate specialized populations necessary to carry out the proposed research agenda via subcontract (LG-affiliated site).
As articulated in the RFA, applicants should assume that up to $10 million in total costs will be available per year to carry out the awarded research agenda through the AR LG, and should develop their research plan and budget accordingly. DMID is also prepared to provide up to $7.5 million in-kind support for use of existing NIAID resources, e.g., data management and other appropriate NIAID-supported clinical research sites, such as those noted above. The final determination of sites and in-kind DMID support to be used for each approved clinical trial will be made in collaboration with NIAID/DMID post award.
11. The budget table is requested in terms of direct costs and total direct costs (pg. 12), but in other areas it refers to $10M/yr. as “total costs,” which implies direct plus indirect. We have been assuming that the $10M would include indirect costs but wanted to confirm.
Yes, the $10 million covers both direct and indirect costs, including any consortia direct and indirect costs.
12. The budget table (pg. 12) requests costs for the “functional components” LOC, LC, SDMC only. In other areas (pg. 5) it describes the performance sites who will implement the agenda as "separately awarded NIAID-supported clinical research sites," and pg. 28 reads that NIAID will "lead the negotiation of Clinical Trials Agreements" with network investigators. This implies that NIAID will support the sites outside of the $10M/year network funds. Is this correct?
Yes. See the answer to question 8 for additional information.
13. If NIAID will support the sites outside of the $10M/year network funds, does this support cover all costs for implementation of the proposed studies at the sites and the $10M/year is to be used only for running the network infrastructure (protocol development, network oversight, data/stats/monitoring for low resource studies, lab, QC, etc.)?
No, not necessarily. See the answer to question 8 for additional information.
14. If it is true that NIAID supports the sites beyond the $10M/year, do the sites have to either be in an existing network (e.g., VTEUs), win one of the upcoming CTU awards or can we request that NIAID contract with some “fee for service” type sites that specialize in only one area, rather than being an integral part of a related network?
When developing an application, applicants must include specific clinical research studies and trials that support the research agenda proposed. Applicants should assume that up to $10 million in total costs will be available per year to carry out the research agenda through the LG, and should develop their research plan and budget accordingly. The LG may opt to obtain access to appropriate specialized populations necessary to carry out the proposed research agenda via subcontract. DMID is also prepared to provide up to $7.5 million in-kind support for use of existing NIAID resources, e.g., data management and other appropriate NIAID-supported clinical research sites. If you propose use of existing NIAID-supported clinical research sites in the application, their use must be justified. The final determination of sites and in-kind DMID support to be used for each approved clinical trial will be made in collaboration with NIAID/DMID post-award.
15. Is this proposal supposed to provide a scientific agenda or the capacity to support a clinical network, or both?
It is both. It will depend upon the research agenda and resource level of the studies proposed.
16. We have questions about the level of support and options for the high resource studies. We assume EMMES is the group that will be providing NIAID-funded activities for data/monitoring/stats for the high resource studies. Any flexibility there? It is stated that NIAID will ultimately determine which studies are high and low resource but that will obviously have a large impact on the budget and number of studies we can propose. Do you have any idea how this process will work?
When developing an application, applicants must include specific clinical research studies and trials that support the research agenda proposed. Applicants should indicate a resource level (high or low) for each clinical study and trial proposed and a brief justification for the designated resource level. The budget should reflect the resource levels proposed. After award, the final determination of resource level will be done in collaboration with NIAID staff, as allowed for under the cooperative agreement mechanism.
We recommend that you visit NIAID Leadership Group for a Clinical Research Network on Antibacterial Resistance, which provides additional information and examples of high and low resource studies and trials.
The NIAID Statistical and Data Coordinating Center (SDCC) active at the time a study is initiated will be the group that conducts related services for high resource trials.
17. For high-resource projects, who pays the effort on the key personnel who are PIs on the trial but who also happen to be supported members of the Leadership Group? In other words, DMID provides data management, site auditing, CRF design, etc., but who pays personnel costs on the high-resource project: Leadership Group or DMID?
In the event the awarded research agenda includes a study or trial that requires patient populations that may be accessed through the NIAID-funded clinical networks, for example the Vaccine and Treatment Evaluation Units or the HIV/AIDS Clinical Trials Units or Clinical Research Sites, the DMID Program Official can assist the Leadership Group in securing necessary arrangements to conduct the study or trial. Under this scenario, NIAID will cover the cost at the sites of the study or trial up to the amount referenced above.
In the instance that the LG Principal Investigator is also the Principal Investigator of another NIAID clinical research network that will be utilized to carry out the LG research agenda, personnel-related costs will be apportioned in accordance with contract and grant requirements.
Last Updated February 24, 2012
Last Reviewed February 03, 2012