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 Research Exploration Award Program

Frequently Asked Questions


What are the Research Exploration awards?
The Research Exploration Program seeks to advance the understanding of the basic mechanisms underlying the function of the lower urinary tract and the pathobiology underlying lower urinary tract symptoms and bladder dysfunction.

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Who is eligible to apply for Research Exploration?
Awards are US-based in scope. For this track, independent investigators (MD or PhD) at any academic level, with a record of success are eligible to submit proposals.

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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 Exploration 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 Exploration awards are available?
In 2011, it is anticipated that three awards will be granted with a maximum budget of $75,000 USD per award.

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When will the Research Exploration 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 consecutive 18 month research period.

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Does the funding include institutional overhead costs and indirect costs?
Yes; the maximum funding for each award ($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 Exploration 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 Exploration Program. However, a Research Exploration 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 Exploration funding be used to purchase equipment?
No. Research Exploration funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.

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

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

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What areas of research meet the criteria for Research Exploration funding?
Basic and pre-clinical research proposals with the primary objective of furthering our knowledge of fundamental molecular, cellular, genetic, or developmental processes that are operative in the normal function of cells and tissue of the lower urinary tract and in the pathogenesis of non-cancer diseases and conditions that affect the lower urinary tract.

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

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What project deliverables are required?
Projects are expected to lead to the development of a sound scientific basis to understand bladder dysfunction and to contribute to increasing our basic understanding of the molecular basis of lower urinary tract biology, function or pathobiology. 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 Exploration award?
Applicants must register online at through the Pfizer/Urology Care Foundation Female Urology and Voiding Dysfunction Research Exploration 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 Exploration" 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 Exploration application process?
Please refer to the Program Announcement 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 Exploration 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 Exploration Coordinator via email at grants@UrologyCareFoundation.org.

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