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Questions and Answers
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-10-009: Recovery Act 2009 Limited Competition OS ARRA: Comparative Effectiveness Research to Optimize Prevention and Healthcare Management for the Complex Patient (R21).
Application Development & Submission
Question 1: What should applicants do to prepare for submitting an application in response to this request for applications (RFA)?
Answer 1: A registration process is necessary before submission and applicants are highly encouraged to start the process at least 4 weeks prior to the grant submission date. Applicants are encouraged to check both Grants.gov (http://www.grants.gov) and eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm) first to determine if their institution is already registered. Applicants are advised to carefully read Section IV of this RFA. Applications submitted in response to this RFA must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
Question 2: Is there any possibility that the application deadline will be extended? Will there be other opportunities to apply for funding under this RFA?
Answer 2: Applications are due January 20, 2010; there will not be an extension. This is a one-time only solicitation.
Question 3: Can a co-Principal Investigator be included on the application?
Answer 3: No. Only one Principal Investigator may be designated on the application.
Question 4: Can a for-profit organization participate in the project?
Answer 4: 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 5: Who should be contacted for questions about the application or forms?
Answer 5: Applicants with questions about application procedures or form submissions can contact GrantsInfo at firstname.lastname@example.org or 301-435-0714.
Question 6: Have the members of the review panel been chosen?
Answer 6: 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.
Definition of Terms
Question 7: What chronic conditions can be considered?
Answer 7: 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:
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 8: What is meant by “otherwise healthy individuals”?
Answer 8: “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.
If an applicant would like to study a preventive intervention, such as colonoscopy, then “otherwise healthy” might be applied as a comparison between subjects with diagnosed coronary artery disease or chronic obstructive pulmonary disease and healthy control subjects. Thus, the definition of “otherwise healthy” depends on the intervention of interest in the study and how the appropriate control population would be constituted.
Question 9: If an applicant is proposing a descriptive epidemiologic study, must the study time period be limited to 18 months and the total budget limited to $375,000?
Answer 9: An application pursuing a descriptive epidemiologic study should be as efficient as possible in both timeline and budget.
Another important element for descriptive epidemiologic studies is for applicants to make the case that the population and set of conditions have not been already well described in the literature, or that the bulk of the existing literature was completed prior to certain developments/improvements in medical treatment and is thus out-of-date.
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.
Current as of January 18, 2010
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