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ITHS Research Innovation Award

Improving the Conduct of Clinical Trial Research

ITHS Research Innovation Award – Improving the Conduct of Clinical Trial Research

ITHS is offering a Research Innovation Award to support specific clinical or translational research questions that can also act as a vehicle to develop new methods, policies, or procedures that will aid in the conduct of research. Examples might include a new type of clinical trial design, statistical method, or a participant recruitment instrument to improve the conduct of clinical trials. The research project is a vehicle by which the new method can also be developed, tested, and validated. This pilot award will provide up to $100,000 in total costs for 1 year. No-cost extensions are not permitted.

Application Period Closed

Application deadline: November 1, 2016
Awardees Notified: March 3, 2017
Period of Performance: June 1, 2017 – May 31, 2018

Priority for support will be given to projects that, within the conduct of a specific research hypothesis, 1) address an important research barrier, 2) have the potential for achieving the goal of developing a new approach that could be generalized to different types of research, and 3) have a strong dissemination plan for that method or approach.

Key Dates
Key Dates

The following key dates apply to this funding opportunity:

  • Application deadline: November 1, 2016
  • Awardees Notified: March 1, 2017
  • Period of Performance: June 1, 2017 – May 31, 2018

Focus of RFA
Focus of RFA

  • Applicants should describe plans to develop, evaluate and disseminate an innovative approach that could improve participant engagement in clinical trials.
  • Project proposals could seek to
    • Improve patient or community awareness of or interest in translational research
    • Engage patients, communities or special populations as active partners in
      • Identifying community health needs and priorities,
      • Providing input on relevant research questions,
      • Contributing to appropriate research design and methods,
      • Developing culturally sensitive and ethical proposals,
      • Enhancing the recruitment and retention of research participants, or
      • Implementing and disseminating research findings more effectively.
  • Whenever possible, applicants should propose an experimental approach. Projects should not only address a specific translational research question, but also provide insights that could be generalizable to other projects. Projects are expected to yield improved methods of engaging subjects for enrollment and full participation in clinical trials. Metrics to evaluate this outcome may include the numbers of individuals approached, proportions of approached individuals who consent to participate, proportions of enrolled participants who complete trial-related activities, proportions of anticipated data actually obtained from each participant, and costs of recruitment per enrolled participant. All metrics should be evaluated by comparing different approaches in a controlled way.
  • Plan to spend your money in 1 year. No-cost extensions will not be allowed.

Eligible Investigators
Eligible Investigators

Faculty members at ITHS Partner Institutions, including the University of Washington, Fred Hutch Cancer Research Center, Seattle Children’s Research Institute, and other academic institutions affiliated with the ITHS in the WWAMI (Washington, Wyoming, Alaska, Montana, Idaho) region are eligible to apply for this pilot award. Collaborations may extend outside the WWAMI region; however, funds may not be transferred outside the United States.

All Investigators on the research team must be ITHS Members to apply. Membership is free. To become a member, please complete the ITHS Membership Form.

Application Process
Application Process
Application

The application must be submitted through the ITHS website.

Applications will follow National Institutes of Health (NIH) formatting guidelines (see FAQ) and include:

121 KB1) Cover Page
2) Abstract (250 word maximum)
3) Research Plan, 6-pages (references do not count toward page limit)
65 KB4) Project Timeline – 1-page 35 KB6) NIH format Biosketches for all investigators (senior/key personnel)
Timeline

  • Application Deadline – November 1, 2016
  • Scientific Review – January – February 2017
  • Awardees Notified – March 1, 2017
  • Just-in-Time Process – March – May 2017
  • Period of Performance – June 1, 2017 – May 31, 2018

ITHS is funded through a CTSA grant from NIH’s National Center for Advancing Translational Sciences (NCATS). NCATS recently instituted a new policy requiring the review and approval of all pilot grants involving human subjects research prior to funds being released. Therefore, if your proposal is selected for funding and involves human subjects research, additional documentation is required to send to NCATS. The NCATS review can occur concurrently with the IRB review; however, final NCATS approval is contingent upon IRB approval.

Frequently Asked Questions
FAQs

Research Innovation Awards

How could I find out whether my idea is a good fit for a research innovation award?

All investigators considering whether to submit an application for this award are encouraged to contact Bonnie Berry (see below). ITHS can provide referrals to possible collaborators and consultants who could assist with the development of your project.

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Are there any restrictions on indirect costs applied to these awards?

 Applicant institutions must use a rate no higher than the approved, federally recognized indirect cost rate negotiated between the applicant institution and the federal government. ITHS would like to maximize funds to directly support the investigator’s research and encourages investigators to work with their Office of Sponsored Programs to obtain a waiver to reduce indirect costs on the project.

The Fred Hutchinson Cancer Research Center and Seattle Children’s have agreed to consider requests for indirect cost waivers for ITHS pilot awards from their faculty.

  • ITHS members whose research program is based at Fred Hutch, who wish to apply for ITHS pilot awards are required to go through the standard institutional procedure for requesting a waiver of facilities and administrative (F&A) costs, as described here: http://centernet.fhcrc.org/CN/depts/osr/policies/forgonefaa/
  • ITHS members whose research program is based at Seattle Children’s, who wish to apply for ITHS pilot awards are required to go through the standard institutional procedure for requesting a waiver of facilities and administrative (F&A) costs, as described here: http://www.seattlechildrens.org/pdf/RIA-410.pdf

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Do our suggested reviewers need to be a part of the University of Washington?

No. A reviewer may come from any academic institution or industry leader. A general note about conflict of interest: A reviewer would have a conflict of interest if they are the applicant’s mentor, dept. chair, spouse, or close relative; or if they currently work together on manuscripts, grants, or business ventures. Simply being in the same department or Division is not, in and of itself, a conflict of interest.

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University of Washington specific question: Does this award have to go through the Office of Sponsored Programs (OSP)? Is an eGC1 required?

No, this is an internal grant and does not need to be routed through OSP and does not require an eGC1.

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Are supplemental documents allowed?

No, supplemental documents are not allowed.

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Are there any formatting requirements?

Applications will follow National Institutes of Health (NIH) formatting guidelines (https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm), including the following:

Font (size, color, type density) and Line Spacing

  • Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%).
  • Type density: must be no more than 15 characters per linear inch (including characters and spaces)
  • Line spacing: must be no more than six lines per vertical inch.
  • Text color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable).
  • We recommended the following fonts, although other fonts (both serif and non-serif) are acceptable if they meet the above requirements:
    • Arial
    • Garamond
    • Georgia
    • Helvetica
    • Palatino Linotype
    • Times New Roman
    • Verdana

Citations

  • We do not require a specific citation format.

Paper Size and Margins

  • Use paper size no larger than standard letter paper size (8 ½” x 11”).
  • Provide at least one-half inch margins (top, bottom, left, and right) for all pages. No applicant-supplied information can appear in the margins.

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Do figures and references count toward the 6-page Research Plan limit?

Figures DO count toward the 6-page limit, but references can be in addition to the 6-page Research Plan.

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Can non-faculty apply as a Co-PI or Co-I?

Yes, however the main or Contact PI must be a faculty member at an academic institution.

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What is a Contact PI?

ITHS requires the applicant to designate one of the PD/PI(s) as the Contact PD/PI. This person is responsible for communication between the PD/PIs and ITHS, but has no special authorities or responsibilities within the project team. In many ways, a contact PD/PI is analogous to a corresponding author on a publication. The Contact PD/PI must serve as a member of the PD/PI team and must meet all eligibility requirements for PD/PI status. In those projects where there is an identified project coordinator, the coordinator could serve as Contact PD/PI or that role could be assigned to another PD/PI. It will be possible, and may even be desirable, for the grantee institution to periodically designate a change in Contact PD/PI. For example, it may be desirable to rotate the role of Contact PD/PI among the multiple PD/PIs on an annual basis at the time of grant renewal. Note that the Contact PD/PI must be associated with the applicant/awarde institution.

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Do you expect the PI or Co-PI to have a specific amount of effort committed in the form of salary?

ITHS will follow NIH Policy: Each PD/PI must have measurable effort (greater than zero), and the level of effort must be adequate to achieve the proposed goals. The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. “Zero percent” effort or “as needed” are not acceptable levels of involvement for those designated as Senior/Key Personnel.

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Can there be more than 2 Co-PIs or Multiple PIs?

Yes, you may have more than 2 PIs, however 1 person will be identified as the Contact PI for administrative purposes.

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Can a community or industry partner be my collaborator?

Yes, we as long as the main, or Contact PI must be a faculty member at an academic institution.

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Could an investigator apply for this program with a pending faculty appointment?

Pilot recipients must be a faculty member at an academic institution by June 1, 2017.

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I have previously been awarded funds by the ITHS. Am I still eligible to receive this award?

Yes, previous ITHS awardees are eligible to receive additional funding.

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Does the NIH cap apply to this application?

Yes, these funds come from the NIH through the National Center for Advancing Translational Sciences (NCATS) and so the NIH cap does apply.

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Can funds be dispersed prior to IRB approval to aid the application process?

No, funds cannot be dispersed until IRB approval is confirmed. Applicants will have the opportunity to provide Just-in-Time approvals prior to the start date.

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Contact Us
Contact Us

To learn more about this opportunity, please contact Bonnie J. Berry, PhD, via the following form.

Cite ItThe Institute is supported by grants UL1 TR000423, KL2 TR000421, and TL1 TR000422 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA). Please help us continue to support your research by citing our grant number(s) in publications we supported.