What is the expected budget level for proposed CTN Nodes?
- NIDA expects that each Node will have an operating budget of up to $750,000 in direct costs per year
- NIDA may consider budget requests of up to $875,000 in direct costs per year for applications that propose multiple PIs from one or more institutions
- Total costs for a Node will depend on the negotiated F & A rate for the applicant institution
- Although this program is provided for in the financial plans of NIDA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose.
Has NIDA reduced the overall budget for the CTN?
- No. The current RFA reflects the principle that the bulk of the CTN funds will be obligated directly for protocol development and execution. The cost limits described in the RFA refer to support for the Node directly.
What types of CTPs should be included in a proposed Node?
- NIDA is seeking to expand the reach of the CTN into a variety of community treatment practices. Applicants should consider inclusion of primary care, emergency departments, HIV/STD clinics, HMOs, clinics seeing primarily minority or other special populations, etc.
Is each Node limited to collaborations with only five CTPs?
- No. The RFA asks for detailed information on five representative CTPs proposed as collaborators in the main body of the application and the appendices. Additional potential CTP collaborators can be listed in the application appendix.
- It will be critical for the Node to engage sufficient numbers and types of CTPs to participate in multiple simultaneous trials; the possibility of expanding the number and clinical focus of CTPs for Node affiliation should be addressed in the application.
When should the multiple PI model be considered?
- The multiple PI model is intended to encourage collaboration among equals when that is the most appropriate way to address the CTN scientific agenda. Please note that:
- All PIs share the responsibility and authority for leading and directing the project
- All listed PIs must be registered in eRA Commons with a "PI" role type
- The role type "co-PI" is not recognized by NIH
- Applications proposing a multiple PI model must demonstrate the need for a team science approach which does not fit the single PI model.
- A detailed leadership plan must be included
How does the application delineate the multiple PIs?
- All prospective PIs are named in the application. Further:
- The first PI listed must be affiliated with the institution submitting the application and will serve as the contact PI
- The contact PI will be responsible for communication between the leadership team and NIH
- Being contact PI does not convey any particular role within the leadership team
- The contact PI role can be rotated; however every contact PI must be affiliated with the awardee institution
- A grant awarded with a single PI cannot be converted to a multiple PI model afterwards as there would be no peer review of the multiple PI approach
What are the budget and financial management implications of the multiple PI model?
- Awards involving PIs at different institutions will use subcontracts through the applicant institution to fund project components that occur at the other institutions
- NIDA may consider an increased grant budget when the multiple PI option is used
Where can I get more information on the multiple PI model?
We have not previously been a CTN Node and consequently do not have a track record of participating in CTN protocols. How can we demonstrate our capabilities?
- Applications from institutions that have not previously been a part of the CTN should provide evidence that the proposed Node would be capable of active and engaged participation in CTN trials and in other CTN activities. Such applicants can demonstrate their potential for contributing to the mission of CTN through detailed descriptions of their experience and accomplishments in other multi-site clinical trial research and in productive collaborations with community-based treatment providers.
Applications for NIH funding typically require a detailed research plan, including hypotheses, methods, and analytic plans. Do responses to this RFA require a similar section?
- No. Responses to this RFA should include a broader Research Agenda which could be carried out to take advantage of the unique capabilities of the CTN, rather than a detailed plan describing a single proposed study with a discrete set of research questions.
- This Research Agenda should encompass a broader set of research ideas that address current public health needs in addiction treatment and describe how knowledge gaps would be filled if the agenda were to be pursued. It should discuss the types of critical research questions that must be addressed by the addiction treatment research field in order to advance scientific knowledge and improve practice.
- It is important that this discussion include the relevance and feasibility of the proposed research agenda to a broad array of community treatment practices, research methods that might be used, patient populations that might be studied, the potential for implementation and adoption by service providers, and how potential findings would lead to changes in clinical practice in addiction treatment settings and/or the mainstream medical system and other systems.
- The discussion should also address how the applicant proposes to ensure that the RRTC and the CTPs will work collaboratively at all levels to advance the research agenda, as well as how the Node will be able to work collaboratively with other Nodes and NIDA.
Does the proposed Research Agenda need to undergo review by our local IRB?
- No. The proposed research agendas do not need to undergo IRB review for the purposes of this application.
If two or more currently funded CTN Nodes decide to "merge" and submit a single application, would this be considered to be a "new" application or a "renewal" application?
- This would be a renewal application (formerly known as a "competing continuation" application). The application should use the grant number currently associated with the organization where the contact PI resides.
Can a currently-funded Node submit a renewal application with a different PI?
- Yes. The applicant organization can identify a different PI (or contact PI in the event of a multiple PI application) and still submit a renewal application.
If a previously-funded but no longer active CTN Node submits an application in response to this RFA, would that be considered as a "new" application or a "renewal" application?
- It can be either, depending on whether and how much the proposed Node activities are different than the activities of the previously-funded and now "closed" Node. If these activities have changed significantly since the Node closed, it would be considered a new application. If they haven't changed significantly, it can be considered a renewal even with a lapse of a few years. Please contact a NIDA Program Official to discuss specific situations.
Who may I contact for additional information?
Harold Perl, Ph.D.,
Senior Lead for Behavioral Research, Dissemination & Training,
Center for the Clinical Trials Network, at
hperl@nida.nih.gov 
