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Regarding: RFA HS-01-002, published in the NIH Guide on October 24, 2000
Agency for Healthcare Research and Quality
Letter of Intent Receipt Date: January 3, 2001
Application Receipt Date: January 24, 2001
Many questions were posed at the technical assistance meeting held December 15, 2000, regarding RFA HS-01-002, "Centers for Excellence for Patient Safety Research and Practice." These questions and the ensuing answers follow.
Posted December 22, 2000
Question: Can we describe some but not all projects (e.g., those that may be built on the outcomes of earlier projects)?
Answer: All projects in the application must be described. It is possible that modifications will need to be made during the period covered by the grant, but the initial application must include all projects the applicant proposes to complete.
Question: We are a major institution and we have done some, but not a lot of, work on patient safety. Should we apply?
Answer: This centers of excellence request for applications (RFA) is focused on institutions that have extensive experience in patient safety. You might consider submitting an application to the RFA for the Developmental Centers for Evaluation and Research in Patient Safety (DCERPS). It is a P20 mechanism with funding up to 3 years, may have up to 10 awards (total available for RFA, including direct and indirect costs, is $2,000,000), and has two phases: Planning (up to 1 year) and a pilot project.
Question: We are a for-profit organization. How can we contribute/get involved?
Answer: You must partner with a nonprofit group as either a member of a consortia or as a subcontractor.
Question: Will AHRQ accept an application from a hospital rather than a system-wide organization?
Answer: An organization must be a nonprofit to submit an application (or partner as part of a consortia or subcontractor). The special review criteria address, among other things, generalizability. A single hospital would be less likely to meet that criteria.
Question: Is the Veterans Administration (VA) eligible to apply?
Answer: As far as the solicitation and AHRQ are concerned, the VA may be considered eligible. However one of the requirements for a Public Health Service (PHS) grant is that the Federal institution must ensure that its own legislation allows it to receive grant funds. An interested party may want to apply through a VA Research Foundation that is designed to administer grants in conjunction with a VA hospital. In this case, personnel would be employees of the foundation and the limitations on allowable costs are no different from any other nonprofit organization. Additionally, no career status employees may receive salary support except under specific circumstances; only people hired specifically for the grant may be supported. (Note that the Department of Defense (DoD) has a similar foundation.)
Question: Can we partner with VA facilities beyond the VA's patient safety centers?
Answer: Yes, partnering with other VA sites is acceptable. However, recognize that grant funding cannot be used to support VA staff already on the Federal payroll. If you need information on the patient safety centers at the VA, call Dr. Jim Bagian, National Center for Patient Safety, (734) 930-4890, or visit the VA's Web site.
Question: Do all projects need to cover 5 years?
Answer: No, but there must be at least three ongoing projects at any one time.
Question: Does the RFA mean three to seven projects period, or three to seven projects running at any one time such that there may be a total of more than seven over the grant period?
Answer: There may be no less than three ongoing projects at any time. There can be no more than seven projects total. AHRQ guidelines for the Research Program Project Grant (P01, page 2) note that "Applicants desiring to conduct more than six individual projects should consider preparation and submission of individual R01 applications."
Question: Does the coordinating center only interact with the centers of excellence grantees?
Answer: No. The coordinating center will be working with grantees from most/all of the patient safety-focused RFAs released or to be released this year and the systems-related best practices grantees (six grants awarded last year). Additionally, there will be an evaluation center with which grantees must interact.
Question: What are the differences between the centers of excellence and developing centers RFAs?
Answer: In the centers of excellence, we are fueling the engine of organizations with demonstrated ability. It is $5,000,000 for the first year, the program can span 5 years. We anticipate 4 to 6 awards. Each application must contain at least three concurrent projects (up to limit of seven but preferably no more than six). In the developing centers, we are supporting the development of the research engine. It includes new researchers/new to patient safety research, has $2,000,000 for the first year, and the program can span 3 years. We anticipate 10 awards, each of which will have up to a one-year planning phase and will include one pilot study.
Question: How will a consortium that includes ordinary health care system participants (not embedded in universities, medical schools) be viewed?
Answer: AHRQ Guidelines for the Research Program Project Grant (P01) note that investigators will be judged based on how appropriately trained they are and how well suited they are to carry out the program work. RFA special review criteria assess the extent to which results will be applicable and generalizable to situations beyond that of the study.
Question: Is substantial use of secondary data (e.g., Medicare or nursing home) acceptable for use in answering the epidemiology question?
Answer: There are no pre-determined expectations/ requirements for sources and uses of primary and secondary data. It is important to use the best source of data. If an applicant is considering using data from the Health Care Financing Administration (HCFA), highlight that in the application as the Agency has special procedures it follows for acquiring HCFA data.
Question: Can a project include the participation/funding of a foreign entity?
Answer: Under eligibility requirements, the RFA states that foreign institutions are not eligible to apply. However, if the foreign component is neither applying for the grant nor receiving any funds from it, its involvement is acceptable. Additionally, a foreign entity is eligible for participation and receipt of funding (e.g., through a subcontrant) but it cannot be a "pass through" arrangement to the foreign institution/organization.
Question: Can supplemental funding be obtained from sources other than AHRQ?
Answer: Yes but award by AHRQ cannot depend on the potential funding from another source. If funding from AHRQ and another source are required to complete the program, the other/ supplemental funder must have provided a positive confirmation of funding as part of the application to AHRQ.
Question: Is the total research program budget the sum of the budgets of each individual research project and each core?
Answer: In submitting an application in response to this RFA, all budgets applicable to the application, i.e., each individual research project and each core, must equal the total amount referenced on the face page of the application.
Question: Will the Agency consider funding institutions/organizations that already have funding for other projects?
Answer: Yes. Having current grants with the Agency does not inhibit an application.
Question: Is it appropriate to include a previously funded project as one of the several projects in the program?
Question: If we are already a Centers for Education and Research on Therapeutics
(CERTs), is it appropriate to apply to this RFA?
Answer: Clearly show (a) work and funding for CERTs and (b) work and funding for this RFA. If there is synergy between the two, make that clear. It must be clear that no duplicate work is being conducted/funded.
Question: What is the role of the coordinating center?
Answer: While the Agency has limited leverage with P01s, grantees must do some collaborative activities through the coordinating center which will provide general guidance and will also be a means of dissemination of activities/findings. The coordinating center will be supported under a separate solicitation.
Question: What are the page limits for describing each project and the cores within the application?
Answer: Per the RFA, the Application Procedures state (in paragraph 7) that:
- There is a 25-page limit for the full program narrative.
- There is a maximum of five additional pages per project to describe each discrete research project.
The RFA is silent on the number of pages specifically identified for the core(s). However, the "Special Instructions for Preparation of Research Program Project (P01) Applications" refers the applicant to the RFA and notes that "For each core component, follow the specific instructions for the individual Research Project, Item I of the Special Instructions...." This means that there is a five-page limit for each core. For example, a project with two cores and three projects could have 25 pages for the full program narrative, an additional 10 pages for the cores (i.e., 5 pages per core), and an additional 15 pages for the individual projects (i.e., 5 pages per project).
Question: How much is the Agency considering institutional commitment?
Answer: It is important to show in-kind contributions.
Question: Because the Agency's budget has not been finalized, what impact does that have on funding available for this RFA?
Answer: Under the Funds Available section of the RFA, note that it states "...awards pursuant to this RFA are contingent upon the availability of funds for this purpose."
Question: Is it advantageous to have matching funds from an institution?
Answer: Outside funding is not necessarily advantageous. The issue is not considered during review of the grant but may be considered as part of the funding decision. If funding from an outside source is committed, include a letter of commitment as part of the application.
Question: Are there maximum/minimum number of cores?
Answer: Applicants should have a minimum of 1 core but a maximum number of cores has not been indicated. Individually, applicants must decide how to strike a balance between cores and projects.
Question: Education is mentioned in the RFA. Can you explain what you mean by that term?
Answer: This references applied issues such as developing education and dissemination efforts as part of the research effort. Applicants should refer to the patient safety research agenda on the QuIC Web site (http://www.quic.gov).
Question: Career development is mentioned in the RFA. Can you explain what you mean by that term?
Answer: Career development includes dissemination and leadership components. Dissemination relates to translating research into practice. Leadership interprets as developing current and new researchers to work in the center (i.e., building capacity and making it available internally to the center).
Question: Does error reporting refer to errors or to errors and close calls?
Answer: Applicant work can concentrate on one or both facets. We have an interest in both but it is the applicant's choice.
Question: Is there a balance/preference regarding errors defined as omission versus commission?
Answer: The Agency is open to both but the applicant must make a clear case about the link to patient safety rather than just quality. The case for omission is more difficult to make, but an applicant could concentrate on it.
Question: Could an applicant make one of their program resources available nationally?
Answer: Without having reviewed all applications, it is difficult to anticipate whether a resource is one that would be useful nationally. However, a national resource may be a plus as part of the coordinating center role.
Question: Is user/interface design of interest?
Answer: The Agency is interested in these types of issues. Applicants should refer to the QuIC Patient Safety Research Agenda.
Question: Is it important to include methodologies for the business case/return on investment?
Answer: It is not a requirement, but it would be advantageous to include it.
Question: How do other industries' expertise in patient safety apply to this RFA?
Answer: Applications including ties to other industries vis a vis safety expertise would be useful but is not required. However, keep in mind that the application must include a multidisciplinary team and fundamental expertise may lie outside patient safety.
Question: How will the review panel be selected?
Answer: The Agency is looking for individuals with expertise in patient safety who did not submit an application and we will supplement that with names from those who submit letters of intent but do not submit an application. The Agency will also include users of the research.
Question: Are the review criteria weighted?
Question: What is the balance between fundamental and innovative research?
Answer: The Agency anticipates a balance across centers which allows centers to be somewhat "unbalanced." The balance within a center should be targeted on the team with a spread across the 4 areas of interest noted in the RFA.
Question: How should/could an applicant deal with shifts in the focus of research within the 5 years of the grant?
Answer: Two possibilities exist to modify the grant. If there are dramatic changes, it may be required to go back out for review. If the changes are more moderate, it will undergo an administrative review. Applicants should reference the QuIC research agenda.
Question: What is included under the label of informatics?
Answer: It includes automation such as computer physician order entry, hand-held devices, scanners, machine readable devices.
Question: Is research on the dying included in this RFA?
Answer: It fits but you need to make the case for patient safety.
Question: What do you do if you are somewhere in between the centers of excellence and developing centers?
Answer: The applicant must decide where it fits and apply accordingly.
Question: Are the grants funded at face value?
Answer: It depends on decisions in the funding session.
Question: What do you mean by systems and cultures?
Answer: The terms are defined in the RFA under the definitions section.
Current as of December 2000