AHRQ Expansion of Research Capability to Study Comparative Effectiveness in Complex Patients

Questions and Answers

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The following set of questions and answers features responses from the Agency for Healthcare Research and Quality (AHRQ) to questions from the public submitted on or before January 11, 2010, about the Agency's funding opportunity announcement for RFA-HS-10-001: Recovery Act 2009 Limited Competition OS ARRA: Expansion of Research Capability to Study Comparative Effectiveness in Complex Patients (R24).

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Application Development & Submission

Question 1: Is there any possibility that the application deadline will be extended? Will there be other opportunities to apply for funding under this RFA?

Answer 1: Applications are due January 20, 2010; there will not be an extension. This is a one-time only solicitation.

Question 2: Can a co-Principal Investigator be included on the application?

Answer 2: No. Only one Principal Investigator may be designated on the application.

Question 3: Can a for-profit organization participate in the project?

Answer 3: Portions of the work proposed in the application may be subcontracted to a for-profit research institute and/or other contractor, provided the applicant performs a substantive role in the conduct of the project and does not merely serve as a conduit of funds for an otherwise ineligible organization.

Question 4: Who should be contacted for questions about the application or forms?

Answer 4: Applicants with questions about application procedures or form submissions can contact GrantsInfo at grantsinfo@nih.gov or 301-435-0714.

Question 5: Have the members of the review panel been chosen?

Answer 5: No. The applications will be reviewed by a special emphasis panel. Applicants may submit a letter with the application about any special areas of expertise that they feel should be represented on the review panel.

Question 6: The RFA instructs that an additional two copies of the application be sent to AHRQ. Should these copies be paper forms or can they be sent electronically?

Answer 6: The instructions in the RFA should be explicitly followed. This is a paper application, except for the submission of Appendix material.

Question 7: Which version of the PHS 398 application instructions should be used for this submission?

Answer 7: Applicants should use the 11/07 revised version of the PHS 398 application instructions.

Definition of Terms

Question 8: What chronic conditions can be considered?

Answer 8: Applicants should refer to Section I, Part 1 of this RFA, which indicates that topic areas must be one of the 100 Institute of Medicine (IOM) topic recommendations, one of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) 14 priority conditions identified by AHRQ, and/or one of AHRQ's identified evidence gaps. Further:

• When selecting two or more chronic conditions, applications must include one from the MMA 14 priority conditions.
• After satisfying the above requirement, other chronic conditions may be studied as co-morbid conditions, even if they are not included on the list of MMA 14 priority conditions.

The study of a single condition with complex manifestations or sequelae or a condition that involves a complex management program is not the aim of this RFA. The study of a chronic condition for which there are no evidence-based, established treatments is also not the aim of this RFA.

Question 9: What is meant by “otherwise healthy individuals”?

Answer 9: Otherwise healthy” refers to the absence of co-morbid conditions; that is, not the index condition. For example, if an applicant would like to study cardiovascular risk reduction associated with hypertension therapy, it would be useful to know if the individuals with hypertension plus X and Y experience similar benefit with treatment as individuals who have hypertension as their sole condition.

Design

Question 10: This RFA seems targeted toward adult populations with chronic illness. Will studies focusing on pediatric populations also be considered?

Answer 10: Yes, studies focusing on pediatric populations will also be considered.

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Current as of January 18, 2010