Urology Care Foundation The Official Foundation of the American Urological Association

Urology Care Foundation The Official Foundation of the American Urological Association

http://www.urologyhealth.org/

2011 Pfizer/Urology Care Foundation OAB LUTS Research Training Award Program

Frequently Asked Questions


What are the Research Training awards?
The Research Training Program seeks to advance medical knowledge in understanding female urology and voiding dysfunction while encouraging academic research careers of new investigators.

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Who is eligible to apply for Research Training?
Awards are US-based in scope. For this track, mentors with established research programs in female urology and voiding dysfunction are eligible to submit proposals that will be completed by established or to-be-named physicians. These physicians should be enrolled in an accredited fellowship program in female urology or bladder dysfunction.

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What are the roles of Pfizer, the Urology Care Foundation and the Society for Urodynamics and Female Urology (SUFU) in the award?
Pfizer is providing full funding support for the Research Training awards Program. The Urology Care Foundation, in collaboration with SUFU, will advertise and promote the program. The Urology Care Foundation will also work with the external review committee to manage the peer review process of all submitted proposals. Pfizer will then contract with award recipients and manage the grants and payments.

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How many Research Training awards are available?
In 2011, it is anticipated that three awards will be granted with a maximum budget of $37,500 USD per year for up to 2 years (total $75,000 USD) per award.

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When will the Research Training awards for 2011 be announced?
The successful awardees will be notified in March 2011.

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Is the funding a per-annum or per-study amount?
Each award funds the entire research period.

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Does the funding include institutional overhead costs and indirect costs?
Yes; the maximum funding for each award ($37,500 per year, for up to 2 years, totaling $75,000 USD) includes direct costs, indirect costs, and institutional overhead costs (overheads on direct costs may not exceed 28% of the total funding). Travel should not be included in the submitted budget. Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins.

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What are indirect costs?
Indirect costs are additional study expenses, such as costs for publication, IRB/IEC review fees, software license fees, etc.

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What are institutional overhead costs?
Institutional overhead costs are costs to the institution for the support of your study. They are not easily identifiable in an economically feasible way as exclusively related to a particular project but are necessary to conduct the grant. Some examples of these costs are human resources department costs, payroll processing and accounting costs, janitorial services, utilities, property taxes, property and liability insurance, and building maintenance. Pfizer will not provide overhead over 28% on direct costs, and will not pay overhead on any indirect costs.

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How are the funds dispersed?
The awards will be paid in milestones. Initial payment will be up to 50% of the total grant, and additional payments will be made based on enrollment or other milestones depending on study type. Final payment will be 15% upon receipt of study results.

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How may the Research Training funding be used?
Funds may be used to cover the awardees' salary and fringe benefits, as well as other direct expenses incurred during the research project. Direct expenses may include the salary of technical associates; the purchase of relevant laboratory supplies; direct expenses necessary for proper conduct of research (e.g., subject-related costs, study-related personnel costs, diagnostic fees/services, data management expenses). Indirect costs may include software licensing fees, publication costs, IRB fees etc.

No other government, non-government-, or industry-sponsored projects may cover the same work scope as the grant application to the Research Training Program. However, a Research Training Program grant may be related to other funding from foundations or government agencies as long as there is no direct overlap. It is the responsibility of the Applicant to justify the novelty of the proposal and provide evidence that the application does not overlap with any current or pending funding.

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Can Research Training funding be used to purchase equipment?
No. Research Training funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.

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Are the Research Training awards renewable?
No. Each Research Training award is a one-time, nonrenewable research grant.

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Are the Research Training awards open to researchers outside the United States?
No.

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What areas of research meet the criteria for Research Training funding?
Clinical and basic science research proposals with the primary objective of furthering understanding of issues relating to female urology and/or voiding dysfunction will be considered.

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Are there any specific research areas that are excluded from Research Training funding?
The following topics fall outside of the scope of the Research Training Program:

  • General education and/or training
  • Public health
  • Support for ongoing clinical programs that are part of an organization's routine operations
  • Construction funds to build new facilities
  • Proposals that do not address issues relating to female urology or voiding dysfunction

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What project deliverables are required?
Projects are expected to yield results that will advance the knowledge of female urology and voiding dysfunction. It is expected that results will be presented at scientific meetings and published in peer-reviewed journals. Study results must be provided to Pfizer in order to initiate final payment.

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Will nondrug research proposals be considered?
Yes. Both drug and nondrug proposals will be considered for funding.

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If the study uses a Pfizer drug, what are Pfizer's procedures for reporting of Serious Adverse Events (SAEs)?
For all studies using a Pfizer product and/or device: Pfizer requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Pfizer by facsimile any SAE that occurs during the SAE reporting period in a study subject assigned to receive the Pfizer product. In addition, for studies using a Pfizer device or Pfizer product packaged with a device, reportable events include not only SAEs but also Device Incidents and Device Near-Incidents.

  • Reporting Forms: The principal investigator will report such SAEs using the Pfizer IIR SAE reporting form or the approved local regulatory form (i.e., FDA MEDWATCH form, CIOMS, etc) and the Reportable Event Fax Cover Sheet provided by Pfizer. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available.
  • Reporting Period: The Reportable Events that are subject to this provision are those that occur from after the first dose of the Pfizer product through 28 days after discontinuation of the Pfizer product.
  • Follow-up Information: The institution and/or principal investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  • Regulatory Reporting: Reporting an SAE to Pfizer does not relieve the institution and/or principal investigator of the responsibility for reporting it to the FDA or local regulatory authority, as required.

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What if the sponsoring faculty member leaves the institution during the Study?
Pfizer must be notified in writing that the department will continue to provide support for the completion of the research.

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I'm still not sure if my proposed research topic meets the criteria. How can I find out?
Please contact the Program Manager with a brief description of your proposed research area. Email: grants@UrologyCareFoundation.org.

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Is there a time limit for conducting the funded research?
Study results are expected before December 31, 2013.

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How do I apply for a Research Training award?
Applicants must register online at through the Pfizer/Urology Care Foundation Female Urology and Voiding Dysfunction Research Training Award's URL – www.UrologyHealth.org/researchawards2011. After viewing the Program Announcement and information regarding the program, the applicant will click on the "Online Application" icon to be linked to the portal application page. All submitted proposals must have "2011 OAB-LUTS Research Training" included in the Study Title field of the Study Details section of the online submission portal.

The following documents must be uploaded in the online application in order for your grant to be reviewed:

  • Proposal (single-spaced, up to 8 pages)
  • Abbreviated curriculum vitae (limited to 3 pages)
  • Detailed Budget for proposed research in.

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Where can I get an application form?
The Program Announcement and application information are available at: www.UrologyHealth.org/researchawards2011.

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What if I don't fully understand the Research Training application process?
Please refer to the application at www.UrologyHealth.org/researchawards2011. If you still have questions, please e-mail the coordinator at grants@UrologyCareFoundation.org.

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I'm having difficulty submitting my application online. Whom do I contact for technical assistance?
Receive assistance by contacting IIR@pfizer.com or call the IIR Hotline
In the US: 877-447-5670 (Mon–Fri 9:30 AM to 3:30 PM EST).

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What is the deadline for application?
Applications must be received by December 22, 2010, 5:00 PM EST.

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If my application is successful, when will the funding commence?
Awards are expected to commence no later than November/December 2011, pending receipt of all required documents noted in the application guide. Contracts that are unable to be executed by the end of the calendar year are subject to loss of funding.

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Will I receive a copy of the Review Committee's evaluation of my grant proposal?
Unfortunately, we are not able to provide Applicants with comments by the Research Training Review Committee. Our objective is to keep our administrative costs as low as possible, preserving the bulk of our budget for actual grants.

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What if I have a question that is not covered here?
If you require clarification on an issue not addressed here, please contact the Research Training Coordinator via email at grants@UrologyCareFoundation.org.

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