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AHRQ ARRA PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research

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Questions and Answers


Updated with questions received through January 8, 2010.

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 8, 2010, about the Agency's funding opportunity announcement for RFA-HS-10-005: ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01).


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 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: What organizations are eligible to apply?
Answer 2: As per instructions provided in Section III of this RFA, the following organizations may apply:

  • Public or non-profit private institutions, such as a university, college, or faith-based or community-based organization.
  • Units of local or State government.
  • Eligible agencies of the Federal Government.
  • Indian/Native American Tribal Governments (federally recognized).
  • Indian/Native American Tribal Governments (other than federally recognized).
  • Indian/Native American Tribally Designated Organizations.

Question 3: Does “Limited Competition” imply any restrictions beyond what is listed under “Eligible Institutions”?
Answer 3: There are no other restrictions implied by “Limited Competition” beyond those listed in Section III of this RFA.

Question 4: Should applicants focus only on the first quartile of the 100 Institute of Medicine (IOM) topic recommendations in their proposals?
Answer 4: Applicants can propose work on any one of the 100 IOM topic recommendations or priority conditions established by AHRQ.

Question 5: Where can applicants find a list of AHRQ priority conditions for comparative effectiveness research?
Answer 5: The list of AHRQ priority conditions for comparative effectiveness research can be found at: http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/.

Question 6: Can the proposed project build on existing infrastructure that has been initiated by non-federal funding?
Answer 6: Yes. Section I.1. Research Objective, second paragraph, states: “Projects selected for funding shall develop new electronic data infrastructure by building on existing electronic databases.” Therefore, proposed projects building on infrastructure established or funded by another study are eligible. However, applicants are advised to ensure that their proposed study is a distinct and discrete effort and that it can be assessed on its own merits.

Question 7: Is it required to have an existing Electronic Health Records infrastructure in place before submitting an application?
Answer 7: While it is not required to have an existing Electronic Health Records infrastructure in place before submitting an application, applicants are advised to consider the likelihood that the project will require an electronic infrastructure, which will need to be established from scratch, connected to different databases and institutions, tested and validated, and then used for a comparative effectiveness study that can provide useful conclusions, all within the timeline of this RFA.

Question 8: Can a for-profit organization participate in the project?
Answer 8: 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.

The determination of whether a third party arrangement is a consortium or subcontract is based on the type of involvement of the third party.If the third party organization is programmatically involved and performs a substantive portion of the project, then it would be considered a consortium. If the third party's involvement is purely contractual—that is, the agreement is for the acquisition of property or services or the conduct of prescribed activities or functions, and there is no substantial programmatic involvement—then a contract might be appropriate. Please see other relevant information under Section III.

Question 9: Should the proposed project have protections in place to prevent the release of individually-identifiable data or other proprietary and confidential data?
Answer 9: The infrastructure and clinical data developed from this grant are expected to be a national resource for qualified researchers, so applications should include a plan for data sharing and access so that other qualified researchers may conduct research on relevant clinical topics. The plan should ensure protection of individually-identifiable information or other confidential information. Federally-funded research requires protection of confidential information. For example, AHRQ's policy on the use of Centers for Medicare & Medicaid Services (CMS) data states:

“Applicants should be aware that for individually-identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the confidentiality provision in the AHRQ statute 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.”

Update as of 1/21/10

Question 10: How can applicants determine if their proposed topic is of interest to AHRQ?
Answer 10: The technical merits of the application will be assessed by a nonfederal peer-review panel. All applications that meet the requirements listed under the Research Objectives in Part II (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-005.html#PartII) are considered to be of interest to AHRQ and responsive to the RFA. Research topics that are either one of the AHRQ priority conditions for comparative effectiveness research (http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/) or one of the 100 IOM topic recommendations (http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.ashx)Exit Disclaimer are eligible for consideration. Please note that the emphasis of this RFA is on comparative effectiveness and the development of a sustainable, scalable, clinical informatics infrastructure, as outlined in the requirements.

Question 11: Can a co-Principal Investigator (PI) be included on the application?
Answer 11: No. As noted in the RFA, the Project Director or PI must devote a minimum annual effort of 20% (2.4 calendar months) to the project. One person should be responsible for the overall conduct of this project and be able to devote sufficient time to it. That responsibility is not meant to be shared.

Question 12: Is it a problem if the proposed industry partnership in the application is a new collaboration for the applicant?
Answer 12: A new collaboration with a for-profit organization is permissible, within the bounds of the eligibility criteria of the RFA. Please also see the response to Question 8.

Question 13: Given the nature of this RFA, are applicants best served by having a PI with expertise in informatics or a PI with expertise in clinical investigation?
Answer 13: There is no one set of expertise required for the PI. The PI, other investigators, and the project management team should have the adequate skills, time, availability, and expertise to meet the goals of the RFA, especially those goals described in the requirements and in the application review information.

Question 14: Is AHRQ staff willing to review a one-page synopsis of a potential application to provide feedback?
Answer 14: The timeline and process do not allow for a review of a synopsis or for providing feedback.

Question 15: What percentage of the proposed budget is expected to apply to the execution of comparative effectiveness studies, as opposed to the development of information infrastructure?
Answer 15: There is no prescribed percentage of budget that should be allocated to building infrastructure or to conducting research. The special emphasis panel and AHRQ staff will determine if the proposed budget allocations can reasonably achieve the aims of the RFA.

Question 16: The RFA refers to "studies" when discussing the comparative effectiveness research. Is there a requirement to conduct more than one such study in a given proposal?
Answer 16: One large comparative effectiveness research study that meets the requirements of the RFA is adequate. More than one study, although not required, may be proposed.

Question 17: What aspects of the technical description can go in the Appendix?
Answer 17: There should be an adequate overview of the technical design and approach in the main proposal, and the additional details may be provided in the Appendix. The applicant should determine when too much detail is likely to overwhelm a reviewer and what information should be included in the Appendix.

Question 18: What supporting information should be included in the application and what can be submitted later under “just-in-time” procedures?
Answer 18: AHRQ uses “just-in-time” procedures, which allow limited information (e.g., a budget justification or a biographical sketch) to be submitted with an application. Later, if the application is under consideration for funding, AHRQ staff will request the additional information needed before a notice of grant award can be issued. For example, just-in-time procedures allow an applicant to defer certification of institutional review board approval of the project's proposed use of human subjects and evidence of compliance with the requirement for education in the protection of human research participants until after completion of the application's peer review and just prior to the award of funding.

Question 19: Are cost outcomes included in the definition of health outcomes?
Answer 19: Cost outcomes are not included in the definition of health outcomes and are not required.

Question 20: What is meant by “governance structure”?
Answer 20: For an example of a governance structure, please see the products of two projects mentioned as examples in the RFA at: http://effectivehealthcare.ahrq.gov/ehc/products/53/151/2009_0728DEcIDE_DARTNet.pdf (PDF File, 581 KB; PDF Help)and http://effectivehealthcare.ahrq.gov/ehc/products/54/150/2009_0728DEcIDE_DesignSpecNetCoopPopSafety.pdf. (PDF File, 548 KB; PDF Help)

Question 21: What is the intended scope of the data collection? Is more emphasis placed on data from 1) more care settings, 2) more institutions, or 3) more information from fewer care settings?
Answer 21: There is no one prescribed approach. The comparative effectiveness research study should use the data infrastructure to advance knowledge. This means that for some topics, more organizations with more patients will be needed, whereas for other topics, more information from the same number of patients will be adequate.

Question 22: How much detail is needed on the proposed comparative effectiveness studies? Would AHRQ be open to an internal competitive review process to choose the best project in order to provide some exemplary topics?
Answer 22: The applicant must try to efficiently communicate all relevant information on the proposed study (more than one may be proposed but is not required) so reviewers may thoroughly judge the merits of the application. Simply proposing exemplary topics is not adequate.

Question 23: Should the proposed comparative effectiveness research study commence at the end of the project or should it be conducted while constructing the data resource?
Answer 23: The comparative effectiveness research study should be completed by the end of the project.

Question 24: Does “data sharing” imply that protected health information will be shared beyond the applicant institution?
Answer 24: The data access plan should allow qualified researchers access from other institutions, as described in the RFA.

Question 25: Could AHRQ provide guidance on budgeting for CMS data acquisition?
Answer 25: The total costs of the project—that is, the funds awarded from AHRQ to the recipient plus the costs of identifiable CMS data—can not exceed any total cost dollar limit(s) stated in the RFA. Applicants should not include the costs of identifiable CMS data in the requested budget, but identifiable CMS data needs and estimated costs should be included in the budget justification. Applicants will need to use the best available estimate for identifiable CMS data costs when compiling the budget request. AHRQ will not allow the re-budgeting of funds originally estimated as necessary for identifiable CMS data but not subsequently needed for that purpose. AHRQ will not allow the total costs of a project to exceed the total costs dollar limit(s) stated in the RFA. Therefore, if identifiable CMS data costs have been underestimated, the amount of funds awarded from AHRQ will be adjusted down so that the total project costs do not exceed any applicable total cost limit(s). As stated in the RFA:

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

Question 26: The grant requires that at least one person from the awarded institution attend annual Electronic Data Methods (EDM) forum activities. Could AHRQ clarify whether there will be one annual meeting for each grant year (i.e., three total) or three annual meetings for each grant year (nine total)?
Answer 26: The precise number of meetings organized by the EDM forum that PROSPECT investigators are required to attend may change over time, but for planning and budgetary purposes, a useful estimate is nine meetings over 3 years.

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Current as of January 2010

The information on this page is archived and provided for reference purposes only.

 

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