Technical Assistance Call for Applications to AHRQ's Health IT Announc
Rebecca Roper: So if you'll just give us a few minutes, and while you're getting ready, we will go over the ground rules for the open forum.
If you want to ask a question, just press star 1. We'll take the first five questions. She'll queue up the first—[Julie] will queue up the first five questions. And then we'll put everybody on mute.
Collectively, we will respond to your questions around the table. And then we will open up the call again and provide you our answers. [For purposes of clarity in the transcript, the questions and AHRQ's responses have been paired together.]
Please keep your questions brief. If you have really specific questions to your particular institute or study design, I would suggest that you contact project officers from AHRQ at a later time.
And if we run out of time, or as you're going home today if another question pops into your head, I'd encourage you to submit that question to the health IT grant at ahrq.hhs.gov E-mail address, which is the E-mail address through which you let us know that you're interested in participating in this technical assistance call [healthITgrants@ahrq.hhs.gov]. And, if you pose those questions by today we will include responses in the transcript that we will be developing and publishing on January 23. Okay, so we'll just take a few minutes for those who have questions to let Julie know and then we'll respond.
Coordinator: Again, if you would like to ask a question from the phone, press star 1. Please mute your phone and record your name. To withdraw your question, press star 2. Once again it's star 1 to ask a question. Are you ready for the first question?
Rebecca Roper: If we wait until we have five in a row and then we'll take all five.
Coordinator: Okay. At this time, there are about 30.
Rebecca Roper: Yes, we're ready.
Coordinator: Okay. The first question is from Michael Fallon. Michael Fallon your line is open if you'd like to ask a question.
Question: Yes, why were Emergency Departments eliminated from the FOA? Did you hear that?
Answer (Rebecca Roper): We carefully considered the merit and role of care in the emergency department. And given the spirit of specifying ambulatory settings for the purpose of these three health funding opportunity announcements, we excluded at this time, an emergency department as an acceptable healthcare setting. But as a reminder, if you have a study that involves health IT that is in a setting such as an emergency department, you can precede with an application through the general AHRQ announcements which are number PA-09-070 and also PA-09-071. Also as a point of information, Ryan Mutter—and we'll give you his E-mail—is one of the emergency department experts here at AHRQ [firstname.lastname@example.org].
Coordinator: The next question is from Richard Phillips.
Question: Yes. I just wanted to know on the Attachment 7 for the proposal response RFP sheet, if I just identify myself as not submitting a proposal, will that be able to open me up to subcontracting or any future proposal? And can this be faxed?
Answer (Rebecca Roper): It seemed to us it wasn't quite clear that the person understood that these are FOAs. All applications must be submitted electronically via eGOV. And they have to be submitted by the applicant institution. So if you are not connected with a potential principal investigator who could be submitting proposals, you need to contact them and see if you can hook up with them and get involved in some of these research activities.
Jon White: The only other thing I'd add is that the question specifically sounded kind of like a contracting issue [a Request for Proposal (RFP)] as opposed to a grant application issue. So if the person who asked that question is more experienced with a contract offering type of situation, we just want to make it clear that this is not that. This is a peer reviewed grant application process that we're describing.
Coordinator: The third question is from William Kernz.
Question: Thank you. Yes, under Section IV.6 and research design methods, the applications must describe the components of the health IT implementation and use plan. I wonder how that would apply for a specific application which is being. developed as a modification of a piece of hardware or software which is being used.for the first time as an aide to clinical decisionmaking? I wondered if you might be able to speak about that.
Answer (Rebecca Roper): The third question was [with respect to] the requirements of a description of the health IT intervention implementation and the use of the modification in Section IV. 6, excuse me. And the concern rests with how you address modification to an existing piece of hardware or software?
Jon White: So this is Jon White again. If the modification is of an existing system, it is allowed under this funding opportunity. It is up to the applicant to describe the modification that they're going to undertake. And they also need to describe their implementation plan for that modification as described also in the funding opportunity. But finally we just wish to reemphasize that such modification must be associated with a research question and must be associated with an evaluation. So whatever you're going to change and whatever you're going to implement you've got to then evaluate it. And it will be reviewed and scored according to those criteria as they are laid out in the FOA.
Coordinator: The next question is from John Olson.
Question: My question is whether the following scenario qualifies for an R03? It's a system designed to enhance public health agency followup of high- risk mothers by contacting primary care providers.
Answer (Rebecca Roper): In general, you need to demonstrate the appropriateness of your research setting and your research topic as you put forth your proposal. And for purposes of clarification on these types of issues to be raised through our widely attended technical assistance call that we're currently engaged in, if you could refrain from asking such specific questions that would be appreciated. Instead, you should contact the appropriate contact person as identified at the end of each FOA.
Coordinator: The next question is from Tom Walls.
Question: Good morning. Thank you for spending the time with us this morning. And it's been very informative. It occurs to me that we put our proposals together that we may have additional questions. So I'm wondering if AHRQ will be able to respond to additional questions down the road. Thank you.
Answer (Rebecca Roper): We suggest that you contact individuals specified in the FOAs, should we have subsequent questions. If you have additional questions today, please send them to us at email@example.com. We would appreciate it. I imagine this is an ongoing process and other questions will come up and we'll be happy to respond to them as we can. So if you have additional questions you can send them, in addition to the individuals identified in the funding opportunity announcements, you can send them to the following address, firstname.lastname@example.org. And that's the same E-mail address that you used to let us know you would be participating in this call.
Coordinator: The next question is from Armando Valdes.
Question: Good. I'm calling because we've been doing health IT work in the past. And generally we run into a situation where because our work is prevention focused and it's patient focused directly we're not doing EMRs, we're not doing PHRs, the primary audience that we're trying to reach is not the physician or the medical staff, rather, but the patients themselves and the patient education preventive interventions. I read the [FOA]. And, you know, if I read between the lines this would be an appropriate research question for us—or research area for us to answer. But I have one clarification whether indeed it does meet your criteria for this FOA.
Answer (Rebecca Roper): Yes, that research area would fall under our research area too, patient-centered care.
Coordinator: The next question is from Robin McCarthy.
Question: Hi. My question is regarding the setting of the research project. Specifically, I want to know specifically whether a project would be considered if it transitions from an acute setting to a home, to the member's home, a patient's home or, you know, wherever they're living. In other words, [it is] not just a living situation like residential care or foster care or a patient's home.
Answer (Rebecca Roper): Yes, that would be considered responsive.
Coordinator: Are you ready for the next question?
Rebecca Roper: Yes, please.
Coordinator: The next question is from Dawn Wells.
Question: Hi. We have a 501(c)(3) nonprofit clinic. And we'd like to partner with a university on this project who will be doing the actual research. If we are the lead applicants [applicant institution], can the PI be an employee of the partnering university? She will be the one actually doing research about the health information technology at (Aqua net).
Answer (Rebecca Roper): Michelle Burr of grants management will respond.
Michelle Burr: Yes. That arrangement is allowable. You would have to have a consortium agreement in place with the PI's organization. In your application you're going to want to be sure to explain the logistics of the arrangement and assure that there will be accountability of the PI to the applicant organization; just explain clearly how that's going to work when the PI's not at your organization.
Coordinator: The next question is from Peire Justlin.
Question: Hi. Will the K submissions [career-grants] be electronic?
Answer (Rebecca Roper): Yes. AHRQ is in the process of republishing and reposting the K announcements [PA-08-022; PA-07-444; and PA-07-443]. And they will be published in the near future.
Coordinator: The next question is from Barry Brogin.
Question: Hi. Thank you for this call by the way. My question is I'm one of those folks who is a nonpublished researcher. I'm a network director of a behavioral network healthcare, rural behavioral healthcare network of providers. And what we were looking for is where would we go to find definitions of research methodologies or design so that we can answer that part of the application appropriately? Thank you.
Answer (Rebecca Roper): As stated in the funding opportunity announcements, we encourage multidisciplinary teams. We encourage you to partner with established researchers with experience in analytical methods. The actual PI can solicit support from a variety of key personnel. Applicants must put forth a competitive proposal.
Coordinator: The next question is from Jeff McCollow.
Question: Hi. Thanks for taking my call. Can we use secondary data analysis in the R21 context?
Answer (Rebecca Roper): With respect to a secondary data analysis as part of an R21, if the secondary data analysis is just one component of a larger R21 study, that can be quite fine. But if [the focus of the study is] it's solely a secondary data analysis, then you should use the R03 health IT FOA. [Clarification added: To facilitate health IT portfolio's tracking of questions, please submit all your questions to healthITgrants@ahrq.hhs.gov.]
Coordinator: Next question is from Helene Kopal.
Question: Thank you. Hi. I wondered if you could elaborate on the differing levels of scientific rigor among the three types of grants? I'd be interested in conducting some PDSAs cycles which is the plan to study act methodology in which clinic staff or observers measure basic process functions and use simple calculations and qualitative measures to evaluate success. And I wondered whether this type of analysis in particular at the R03 type of grant whether that would be acceptable?
Answer (Rebecca Roper): With respect to the very specific question about scientific rigor and qualitative measures and different type of (methodological) approaches, we encourage you to submit your specific questions to the E-mail account healthITgrants@ahrq.hhs.gov and we will followup with you.
Coordinator: Next question is from Tamara Hatch.
Question: I wanted to make sure of the following: Can an Agency or PI accept R03 funding from both the National Institutes of Health (NIH) and AHRQ for health IT research that's similar but has somewhat different [foci] in terms of population site and information matters?
Answer (Rebecca Roper): As long as they are distinct research projects, then yes, you can receive funding from both institutions. Should there be some overlap identified, some adjustments may be necessary to make sure that there isn't dual funding for the same activity.
Coordinator: Next question is from Barbara Surando.
Question: Hello. Thank you very much for taking the question. We're part of a big network. Our flag hospital is Sister Mary Medical Center. We're going to do a study in the six family practice offices which is completely outpatient. I understand that the application says that they don't want inpatients. And we're not only working on inpatient we're only working in clinical (admission) patients. [Would] the fact that the applicant [institution] is a hospital * * * jeopardize [the ability of] our application [to be acceptable/reviewed]?
Answer (Rebecca Roper): [Clarification provided] The question was with respect to there being a big [health care] network that involves six family practice offices that see patients on an outpatient basis but whose facilities happen to be part of an institution that is a hospital complex. As long as the research being conducted is an ambulatory setting that happens to be in that hospital complex that's fine.
Coordinator: The next question is from David Kirby.
Question: Hi. I've understood the discussion about submission dates and the cycles to mean that for example if we were intending to submit under the R03 component and we didn't think we could be ready for February 16 that we could submit on the 6th of - I'm sorry on the 16th of June or even the 16th of October. So would you confirm or correct that impression?
Answer (Rebecca Roper): The recurring due dates apply for both this year and the next 2 to 3 years. Yes, if you do not meet this February 16, 2009 [due date] for the R03, for example, you are free to submit a proposal for the next due date, June 16. And as Debbie Rothstein said earlier there's a 1-month window for submissions for each of the three-cycle due dates [see: http://grants1.nih.gov/grants/funding/submissionschedule.htm].
Coordinator: The next question is from Eileen Early.
Question: Our question is around the definition of a medication management system as one of the areas. We're wondering if you're specifically referring to devices that help patients track actual taking doses or its more of a medication management module within an EMR would be appropriate for that.
Answer (Rebecca Roper): The definition of medication management systems, information tools and systems [span the] continuum of medication management, from prescribing, pickup of the medication, and taking the medication. All of these activities are included in our [broad] use of the term medication management.
Coordinator: And the next question is from Thomas Candin.
Question: Hello. My question is whether or not you can submit proposals both to the R21 as well as the R01 in that the proposal for the R21 would be wrapped into the proposal for the R01? And the question is as a result of the due dates being within 3 weeks of each other.
Jon White: Actually can we just ask for a little clarification?
Thomas Candin: Sure.
Jon White: Are you asking if you can submit an application to the R21 opportunity and then submit a larger application later to the R01 that includes the work that's proposed in the R21 application?
Thomas Candin: Exactly.
Answer (Rebecca Roper): No, you cannot have proposals that have the same research project in two different applications concurrently.
Coordinator: Thank you. The next question is from Diane Hauser.
Question: Hi. I have a question about the nitty-gritty of putting together the research plan and the submission. In the 398 forms there are four sections to upload, beginning with specific aims and ending with research design and materials. And I'm looking specifically at the R18, which includes more fundamental features, including the health IT intervention, the dissemination, and the project administration. And I'm assuming those get wrapped up into the research design and methods upload. But perhaps you have another thought about that. So please let me know.
Answer (Rebecca Roper): Yes, the Research Plan form for the 398 can expand to 25 pages. This should provide you ample space to address the extended requirements of the R18.
Coordinator: The next question is from Archie Alexander.
Question: Yes, I have a question for you about eligibility requirements. If an entity is a governmental entity that is a 501(c)(3) governance structure that might be considered a person legally, if they are coordinating ambulatory care through health information technology connections and so forth, could they possibly qualify for one of these submissions?
Answer (Rebecca Roper): With respect to the questions solicited regarding governance structure for the 501(c)(3), it would be more informative if you would put this question in writing and we can get back to you.
Jon White: Okay, thank you. Next question?
Coordinator: The next question is from Sanili Bunea.
Question: Hi. I had a question about the R21. It says that [applicants] should describe and (report) [R21] projects that are distinct from [those projects that are] supported with the R03 and R18 [health IT FOAs]* * * So, if an applicant * * * is looking [evaluating] the same [type of] health IT application or implementation [project] but is (tracking) [different elements or] problems of the same IT [being] implemented, can we apply for R21 and R03 at the same time? But the project definitions of the two IT implementations [being evaluated] are to be different [within each proposal] * * *.
Answer (Rebecca Roper): You're welcome to apply to an R03 and an R21 at the same time as long as they are distinct research questions.
Rebecca Roper: With that, we have exhausted 2 hours and we hope you're not exhausted. But if you have additional questions, feel free to send them to the E-mail address, email@example.com. If you get those questions to us today we will do our best to include our response in our transcript that will be published on February - excuse me, on January 23.
I thank my colleagues and thank you very much for taking the time out of your day to sit with us. And we look forward to your grant applications. Thank you.
General Questions Submitted after the Technical Assistance Call
Question a: I missed their response to the question of if an organization was NOT working on EHR [electronic health record]-type issues but rather on software/hardware for direct patient education (perhaps for the home setting), would that qualify for funding?
Answer a: Yes. As stated in the FOAs: "Health IT is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management. Health IT can support patient care-related activities such as order communications, results reporting, care planning, and clinical or health documentation (Shortliffe, 2006). Health IT applications can use a variety of platforms, such as desktop computer applications, cellular phones, personal digital assistants (PDAs), touch screen kiosks, and others. Examples of health IT applications are electronic health records (EHR), electronic medical records (EMR), personal health records (PHR), telemedicine, clinical alerts and reminders, computerized provider order entry, computerized clinical decision support systems, consumer health informatics applications, and electronic exchange of health information."
Question b: Will AHRQ accept an R18 proposal from a Chartered Value Exchange (CVE) that is a 501(c)3, and would there be any restrictions on what a CVE could propose other than those stated in the announcement?
Answer b: Yes, you would be eligible based on the information provided. All grant applications must comply with Department of Health and Human Services (HHS) Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm and other application requirements as articulated in the Health IT FOAs.
Question c: In projects for ambulatory chronic inebriates, is time spent in voluntary residential treatment between other outpatient services allowed? As I read the ambulatory definition, the answer is yes, a project with residential alcohol and drug treatment still qualifies.
Answer c: Appropriateness of voluntary residential treatment facility would depend on the extent to which you demonstrate that the care provided is commensurate with care that would be provided in an ambulatory setting, rather than an acute care facility.
Question d: Regarding quality and safety of medication management, for a population of ambulatory chronic inebriates, do we need to be implementation ready with new health information technology, or can we include meetings with prescribing practitioners for purpose of refining and finalizing that technology before we begin its implementation?
Answer d: The adequacy of the activities planned would depend on the FOA to which you are responding and the objectives of the grant activity. Both the Health IT R03 and R21 could support preliminary work that could be used to inform more robust R18 implementation and use research studies.
Question e: On the Eligibility Criteria in your Web site, it listed in 1B-Eligible Individuals. Does that mean that individuals can apply but not as a business?
Answer e: Individuals are not precluded from applying to these FOAs, but must score competitively in order to be considered for funding. The review and funding criteria are the same for all applications. For-profits are not eligible.
Question f: If the main emphasis of a study for an R18 grant is to see if the technology can improve patient outcomes and save the health care system money, is AHRQ interested in this?
Answer f: As described, such a study is consistent with the scope of the health IT R18 FOA.
Question g: Can you elaborate on the level of scientific rigor for a R03 and R01 grant? We are considering a project (for a R03 grant, I think) involving the use of PDSA (plan-do-study-act) wherein IT and process changes are evaluated by users and/or observers using simple data collection and analyses as well as qualitative data. For example, if we wanted to evaluate patient and provider satisfaction with computer-generated patient education information during the visit, and used quick surveys and change in cycle time (in minutes) would that be an acceptable way to evaluate the IT intervention?
Answer g: Applicants must demonstrate the appropriateness of an analytical plan pursuant to the proposed research plan. The appropriateness of the analytical plan proposed would in part be determined based on the health IT FOA to which you are responding (R03, R21, R18), as well as your self-specified research objects and specific aims.
For purposes of transparency, for both applicants and reviewers alike, AHRQ cannot provide additional instructions on expectations or guide the specifications of the development of a given grant proposal.
Question h: Would a project that involves use of Health IT to improve the management of testing and test results in primary care practices fall within the scope of the ambulatory Health IT program? I believe it might because it would study the interfaces between labs and imaging and primary care offices, and it could also include electronic communication of results to patients.
Answer h: In general, the type of health IT implementation proposed is consistent with the health IT FOAs.
Question i: If the only funding cycle eligible for 2009 fiscal year funds is the first funding cycle, will you continue to consider applications on the same topics under future 2009 funding cycles, contingent on receiving 2010 funding or will you be generating new topics for 2010 fiscal funds? In other words, are you still interested in additional applications on these same topics in future funding cycles scheduled during 2009?
Answer i: Yes. Within a year, there are three receipt cycles for each of the three Health IT FOAs (PAR-08-268; PAR-08-269; PAR-08-270) and each health IT FOA is authorized for 3 years. As such, AHRQ looks forward to receipt of new grant proposals for each of the nine authorized funding cycles over the authorized 3-year period for these health IT FOAs. For example, we anticipate receipt of new R18 grant submission by January 25, May 25, and September 25 in 2009, 2010, and 2011.
Question j: Could you please post the presentation slides along with the transcript or otherwise make them readily available?
Answer j: Yes. The PPT is currently posted at http://www.ahrq.gov/fund/tacall.htm
A Transcript of the TA call will be posted by January 23 there and at http://www.ahrq.gov/fund/grantix.htm
Question k: Is there a resource for identifying Indiana-based groups that have received funding from AHRQ from other FOAs?
- Go to http://healthit.ahrq.gov.
- Select AHRQ-Funded Projects.
- Either point and click on the State of interest to you (such as Indiana) and a list of ongoing and completed AHRQ-sponsored grants will be displayed or select from the drop-down lists: technology, care setting, State, community, PI.
Question l: Is there a "grant writer help line" for questions from rookies like me?
Answer l: AHRQ does not support a grant writer helpline, however, several links to resources are provided in the health IT FOAs. For example, within the body of the instructions for SF-424 various examples such as research and related budgets and plan for protection of human subjects are provided. SF-424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
Please keep in mind that each of the health IT FOAs supports resubmissions. AHRQ anticipates that the first-time application process for would-be grantees and those grantees' receipt of critiques (Summary Statements) of those proposals will be extremely informative. Other resources include:
- Go to reference slides 50, 51, 52 53 of PowerPoint® Presentation that accompanies this Technical Assistance Call: http://www.ahrq.gov/fund/tacall.htm.
- One can view a narrated tutorial on how to complete a grant application package using either PureEdge® Viewer or Adobe® Reader®.
- View narrated tutorial on how to complete a grant application package using PureEdge Viewer:
- View narrated tutorial on how to a complete a grant application using Adobe® Reader®: http://grantsgov.tmp.com/static2007/flash/AdobeReaderApplicationTutorial_skin.swf.
Question m: To clarify my proposal methodology and data/subject protection measures for IRB review I created a graphical representation as a .jpg file. Is it permissible to insert that into the grant application?
Answer m: Electronic Grants process has specific requirements for submitting forms. The PHS Research Plan form (OMB Number 0925:0001) includes attachments 8-11 which are dedicated to Human Subjects Sections. You should consult the NIH Electronic Submission of Grant Applications Web site: http://era.nih.gov/ElectronicReceipt/ and/or the Grants.gov Web site (Applicant Resources): http://grants.gov/applicants/app_help_reso.jsp to identify the current file formats that would be acceptable. To the best of our knowledge at this time, a picture file, JPEG, would not be acceptable.
Question n: Can the R21 mechanism be used to support research associated with the preimplementation planning and testing phases? How does AHRQ define "short-term" planning?
Answer n: Theoretically, the R21 mechanism could be used to support pre-implementation planning and testing phases of health IT implementation and use. In the description of the R-21, the term short-term" was used in terms of types of studies that would be appropriate for the R-21. Since the R-21 health IT FOA would fund grants that were up to 2 years in duration, short-term refers to up to 2 years.
Question o: Are applicants required to use prenegotiated Federal indirect cost rates?
Answer o: Applicants that have a valid federally negotiated indirect costs rate agreement may not request indirect costs at a rate in excess of the negotiated rate.
Applicants that do not have a federally negotiated indirect cost rate agreement at the time of application must determine if they intend to enter the negotiation process if their application is selected for funding (refer to the Division of Cost Allocation Web site for additional information on rate negotiation: http://rates.psc.gov), and must estimate their indirect costs for purposes of budgeting direct and indirect costs appropriately in the application. If selected for funding, the level of funding for direct costs will not exceed the level of direct costs requested in the original application. The level of direct costs recommended for funding will not be increased, should actual indirect costs be less than estimated.
Question p: Are there any special considerations for minority or women applicants?
Answer p: As stated in the health IT FOAs, "Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for AHRQ support."
"A variety of factors are taken into consideration with respect to making funding decisions, including:
- Scientific merit of the proposed project as determined by peer review.
- Availability of funds.
- Responsiveness to goals and objectives of the FOA.
- Relevance to program priorities.
- Programmatic balance of the Health IT Portfolio within AHRQ and HHS."
Question q: The slide for R21 requirements lists the following sections that are NOT listed as separate sections in the PHS 398 research plan that we are to upload: Health IT intervention, Software, hardware and/or equipment, Purchases, Personnel, Project Administration and Dissemination. Where should we include these items in terms of the upload of the application?
Answer q: In December 2008, eGOV instituted a new forms process (after the health IT FOAs were published). AHRQ does not specify in which of those forms you must address the information requested in Section IV.6. In general, the information to be included in response to the Section IV.6 requirements would be in one of the attachments in the PHS 398 Research Plan such as 1. Introduction to Application; 2. Specific Aims; 3. Background and Significance; 4. Preliminary Studies/Progress Report; 5. Research Design and Methods.
Question r: Does the budget include indirect costs, or are indirect costs on top of the budget limitations? For example, in the R18 FOA, does the total limit of $1.2 over 3 years and $500,000 for any 1 year include the indirect costs? The reason I am asking for clarification is that our institution usually charges about 50 percent indirect costs for NIH projects.
Answer r: The total cost budget limitations for all of the FOAs include both indirect and direct costs.
Question s: We're interested in using the R21 to expand our current health information exchange project to integrate additional measures (enabling services) into our electronic data repository shared by multiple community health centers and health plans. We plan to evaluate this implementation as well as assess the impact of the additional enabling services measures on our existing PIC clinical quality measures (e.g., diabetes care measures) for the purpose of improving quality of care. Would this qualify us for the R21?
Answer s: In general, this is consistent with the scope of an R21 proposal.
Question t: I am working on a K01 application that is to develop a medication management system for ambulatory settings (e.g., outpatient clinics). But we want to collect patients' medication data from nonambulatory settings (e.g., discharge summaries from hospitals) as well, which will be one of the input sources for the medication management system at ambulatory settings. Will this project meet the requirement about ambulatory settings?
Answer t: Yes. Since the health IT intervention is in an ambulatory healthcare setting it would be responsive to the health IT FOAs. AHRQ recognizes that clinical data from nonambulatory sources may be integrated in a health IT implementation and use research study conducted in an ambulatory setting.
Question u: AHRQ may wish to consider one additional possibility for settings. Hypothetically, what about the case of a public-private, state-based governance structure created to promote the adoption organization of statewide health IT initiatives. These entities are 501(c)(3), nonprofit, corporate structures who are responsible for assembling stakeholders to promote health information technology adoption and utilization. A corporation in many jurisdictions will be legally treated as a person and depending on the enabling legislation, such entities may be able to seek out grant funding to help further these activities. Did AHRQ consider this possibility, and if so could the entity submit such a competitive proposal and be considered for funding?
Answer u: As indicated in the Eligible Institutions section of each FOA, public or private nonprofit organizations may apply. For-profit organizations are not eligible to apply. Note: Organizations described in section 501 (c)4 of the Internal Revenue Code that engage in lobbying are not eligible.
Question v: Can individuals with H1-B visa status be PI on the "Small Research Grant to Improve Health Care Quality through Health Information Technology (IT)—R03—Program Announcement: PAR-08-268.
Answer v: As stated in the HHS Grants Policy Statement, for research grants, the applicant is required to determine that individuals identified as key personnel possess visas that will allow them to remain in this country long enough for them to be productive on the research project. Recipient organizations are expected to have policies, consistently applied regardless of the source of funds, to address this area. If a grant is awarded and an individual's visa will not allow a long enough stay to be productive on the project, the grant may be terminated.
Question w: I'm in the process of developing an IT system that will use local and patient-tailored * * * data to assist emergency room (ER) physicians in choosing [appropriate] medication [prior to the delivery of more conclusive diagnostic information] * * *. These decisions are made in the ER, prior to patient admission to the hospital. I'm not certain whether PAR-08-269 would be appropriate in that I'm not certain ER qualifies as an "urgent care" ambulatory setting or as a transition point from the outpatient to the inpatient settings. Might you be able to clarify?
Answer w: Since the focus in your proposed health IT implementation study is on care provided in an emergency room, it would NOT qualify for the three health IT FOAs (PAR-08-268; PAR-08-269; PAR-08-270).
Yet, given the extent to which your study could be using health IT to address one of AHRQ's other portfolios (Value, Comparative Effectiveness, Prevention/Care Management, Patient Safety, and Innovations and Emerging Areas) you may wish to consider applying to one of the following AHRQ FOAs:
- PA-09-071: AHRQ Health Services Research Demonstration and Dissemination Grants (R18).
- PA-09-070: AHRQ Health Services Research Projects (R01).
- PAR-08-136: Researching Implementation and Change While Improving Quality (R18).
Question x: We are wondering how the language in the "Sharing Research Resources: Rights in Data" affects [our institution's] ability to license inventions made under the award. The language appears similar to Bayh-Dole but doesn't specifically describe March-in Rights. Rather, it appears that AHRQ can use and permit others to use patented inventions and copyrighted data and so on for Government purposes if it would increase the public's health benefit. May I ask how often this actually occurs? It seems that this provision could be a big obstacle for institution obtaining a license to develop new products.
Answer x: This is a standard concept for all government grants. We recommend you consult with your organization's legal counsel.
Question y: I am interested in supporting a development of a Clinical Decision Support expert rules database for [numerous organizations including ambulatory and non-ambulatory health care settings] * * *. Many of the rules support preparations for discharge and reminders for health maintenance and prevention of cancers, diabetes, etc. We have an existing data set that needs [to be] remodernized with the current environment to serve the multiple settings more efficiently but also allows[those] that have yet to manage this—someone to learn this process from. We would evaluate this and the CDS rules across the sites using data warehouse already in place. Would you accept this type of proposal?
Answer y: It is difficult for AHRQ to say definitively if a particular study would be acceptable based on the abbreviated information provided at the time of receipt of the proposal. It is incumbent on each applicant to demonstrate that each particular proposal meets all the requirements of the health IT FOAs.
With respect to "remodernization," a grant that seeks to modernize AND EVALUATE a current health IT system could be appropriate, if it meets the health IT FOA requirements with respect to healthcare setting and research area and other requirements. For example, the health IT R18 FOA states: Applications responding to this FOA [PAR-08-270] must seek to evaluate and demonstrate how to optimize functionality of existing health IT; implement health IT in new settings or with new providers and patient populations; or, demonstrate sustainability of health IT.
A research project that seeks to have the upgrade of a modernization of existing health IT that does not have a research evaluation would NOT be responsive to any of these health IT FOAs.
A proposal that features health IT research and evaluation thereof that does adhere to the healthcare settings specified in the health IT FOAs would not be responsive to these health IT FOAs.
Question z: This grant would be used to support research on (X), a practice-based research network (PBRN) based at University of "Higher Learning". I sit on the Board of this PBRN, but I am at the College of "Know-How." The grant would be used to partially offset my salary, to pay at least one consultant in health information technology, and possibly offset the salaries of some other faculty at University of Higher Learning. Before we begin work on the grant, does this sound feasible?
Answer z: The costs mentioned are allowable costs for a research grant if they are appropriate to the proposed research project.
Current as of January 2009