Questions and Answers Regarding CTSA RFA RM-07-007

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NCRR held a CTSA pre-submission meeting on Monday, May 14, 2007. A webcast of the meeting, with a total running time of 1 hour 11 minutes, is available on the Web at videocast.nih.gov/Summary.asp?File=13819.

This document summarizes many of the questions from meeting participants and NIH’s responses.

Planning a CTSA application:

Q: How many "extra" key functions may be proposed beyond the topics described in the RFA (RM-07-007), and do they have page limits?

A: Additional key functions may be described in up to 50 pages of the application, with a limit of 15 pages on any one of these.

Q: Would smaller medical schools with CTSA planning grants potentially benefit from a combined submission if the schools have documented interactions and overlapping strengths?

A: A CTSA will assist an institution "to create a uniquely transformative, novel, and integrative academic home for Clinical and Translational Science that has the resources to train and advance a cadre of well-trained multi- and inter-disciplinary investigators and research teams with access to innovative research tools and information technologies to promote the application of new knowledge and techniques to patient care." The scope of a CTSA proposal extends so far beyond a General Clinical Research Center that, regardless of size, successful applicants have included affiliations to extend their interactions well and articulating their strengths in specific areas in their applications.

Q: Can a CTSA program have a formalized interaction with another federal funding agency such as EPA, CDC, or OSHA?

A: Federally funded agencies are free to collaborate with one or more CTSA applicants. Interactions that go beyond collaboration should be described in sufficient detail for reviewers to be able to assess the merits of the approach and governance of the plan.

Q: When is the deadline for CTSA submissions that would be funded in FY2009?

A: No date has been announced, but it is likely to be in September or October of 2008.

Questions relating mainly to the review process:

Q: What materials do the reviewers see? Do reviewers read the full grant, or do they only see the section assigned to them?

A: All reviewers are provided with all grant applications unless there is a conflict of interest. Reviewers are expected to read the full grant application.

Q: To what degree will the next cycle of reviewers be looking for shared metrics/data sets for evaluation with current awardees?

A: Reviews are based on the published review criteria. There are criteria about interacting at the consortium level, but specifically interacting with current awardees is not specified in the review criteria.

Q: How will applications that propose a separate pediatric PI and a separate pediatric research and training budget be reviewed? Will there be reviewers with pediatric research experience assigned to review any section focused on pediatric research? What review criteria will be used for this section (there are none listed in the RFA for Child Health Research)? Will there be updated instructions for how to construct this portion of the grant application if a program decides to do this?

A: Pediatric components of an application, along with other specialized key functions, will have appropriately experienced peer reviewers. As with other parts of the RFA, it is up to the applicant to provide their rationale and objectives for the composition of the CTSA. To be consistent and avoid being prescriptive, NIH will not issue instructions for pediatric activities at CTSAs, relying instead on the statement that CTSAs need to "enable applicants to innovate and to transform their own environment to develop and advance clinical and translational science as a distinct discipline."

Q: What guidance will be given to the reviewers of applications with multiple PIs?

A: The RFA includes criteria for applications with multiple PIs, asking "[f]or applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the CTSA and the expertise of each of the PD/PIs? Is the governance structure designed to ensure both accountability of multiple PIs, and integration of the components of the C/D/I into a coherent program? Will the leadership and governance plans accommodate changes in the direction of research and allow for the efficient use of funds?" It is up to the applicant to make a convincing case for their leadership plans and how to best govern their CTSA in creating a home for clinical research.

Questions relating to submission of amended applications

Q: When will institutions that applied in January 2007 know whether they will be funded or whether they will need to submit an amended application?

A: Summary statements will be posted to the NIH Commons toward the end of July 2007. Funding decisions will not be made until September 2007.

Q: Will unsuccessful applicants be able to apply more than three times?

A: NIH will accept up to two resubmissions of amended applications, in which an introductory section summarizes the applicant’s responses to the prior summary statement. Institutions that are not successful after three submissions should review the scope and affiliations that constitute their CTSA proposals, seeking the advice of NIH program staff where appropriate. A new application should be under new leadership and employ new approaches and/or affiliations.

Questions relating to career development:

Q: The new RFA states that the T32 program can only include students who are obtaining advanced degrees in a "clinical research-related doctoral degree program" (prior RFA said "research-related" without specifying "clinical research"), or a combined doctoral professional degree and an advanced clinical research related degree. Does this now mean that a PhD student in a laboratory based, basic science program is no longer eligible for the T32 program? We were planning to develop a T32 translational training program for basic science PhD students (MSTP and others) in our CTSA, however, the new RFA appears to limit participation by pre-doctoral PhD students to those obtaining a PhD through a clinical research-related degree program.

A: The CTSA program has always emphasized career development in clinical and translational research. A T32 component could comprise a clinical research experience for basic science PhD students (MSTP and others) or it could provide up to three years of support for graduate students registered for a Ph.D. (or, under certain circumstances, a Masters) in translational sciences. The didactic training and thesis topics of trainees supported through a CTSA should include "the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans."

Q: Can a new degree program that is still going through the governance system at the university be proposed as part of the CTSA application? What additional assurances or letters of support would be appropriate to include in this scenario?

A: Applicants are required to have a program that awards higher degrees in clinical research related topics (e.g., PhD, DNSc) in place to be eligible to apply. Applicants are free to propose to expand the degree courses offered. The proposed new courses should be described in sufficient detail for reviewer assessment.

Q: What is the situation regarding taxation of student tuition benefits?

A: For K12 post-graduate students, the tax treatment of tuition remission is discussed at: http://www.whitehouse.gov/omb/memoranda/m01-06.html.

The T32 component of a CTSA is awarded subject to NRSA rules and regulations. Recent guidance stated:

"Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization."

An NRSA stipend is provided by the NIH as a subsistence allowance to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. NIH takes no position on the status of a particular taxpayer and does not provide tax advice. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Questions about pediatric applications and/or components:

Q: Must a pediatric application be part of a larger institutional application or can it stand alone—i.e., essentially two applications for one institution? Could a meritorious pediatric component of an unsuccessful CTSA application be separately funded?

A: The RFA emphasizes program integration as a means to promoting interdisciplinary and multidisciplinary training and clinical research environments. The RFA uses the NIH multi-PI initiative (described on the Web at grants2.nih.gov/grants/multi_pi) to comply with the requirement in the NIH Reform Act that pediatric PIs appointed under a single Clinical and Translational Science Award may have direct authority over a separate budget and infrastructure for pediatric clinical research. As an NIH Roadmap for Clinical Research program, CTSAs are required to support the research interests of multiple Institutes and Centers, so NIH will not be supporting pediatric-only CTSAs.

Questions regarding informatics:

Q: Current CTSA awardees have formal biomedical or clinical informatics departments, programs, or centers. Is this a requisite for a successful CTSA application, and would preference be given to an application that includes a specific bioinformatics research component as opposed to one with simply strong service components?

A: It is indicated in the RFA that faculty "might pursue funded research into … clinical informatics" and goes on to state "Biomedical Informatics support is expected to be flexible and innovative. Interoperability, security, workflow, usability, and standards are essential areas of work."

Q: The biomedical informatics components are required to collaborate at a national level and informatics directors will be part of a national CTSA informatics steering committee. Does this committee exist at this point so that one can see what is happening in the committee and make contact to align the CTSA application with the consortium goals?

A: The National CTSA Informatics Steering Committee meeting materials and minutes are posted on the Web at www.ctsaweb.org.

Q: Our impressions of the NIH roadmap indicate a need for novel academic-private partnerships, and a focus on informatics. Is it appropriate for a site applying for a CTSA award to include in their proposal plans for using a software provider as part of their translational informatics solution?

A: CTSAs are free to develop research partnerships with private industry–and these partnerships could extend to software providers and small businesses. . The Small Business Innovation and Technology Transfer Research (SBIR/STTR) funding opportunities promote novel academic-private partnerships and are provided by HHS agencies including NIH (http://grants1.nih.gov/grants/funding/sbir.htm). The intent of the CTSA consortium is to work toward the adoption of common standards that promote data exchange between clinical and translational researchers.