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Technical Assistance Call
This document is a transcript of a technical assistance teleconference call that took place on October 15, 2007, from the Agency for Healthcare Research and Quality (AHRQ) on the Agency's funding opportunity announcement (FOA), "Optimizing Prevention and Healthcare Management for the Complex Patient."
Coordinator: Thank you all for holding. At this time I would like to inform all parties today's conference is being recorded, and if anyone does need further assistance you may press star 0. Thank you.
Mary Barton (Moderator): Good afternoon. This is Mary Barton from the Agency for Healthcare Research and Quality. And this is the Technical Assistance Conference Call for (the) funding opportunity announcement (FOA) on optimizing prevention and health care management for the complex patient. We are joined today by a number of folks out there who have expressed either questions or have some interest in learning more about this FOA. At this time, I want to introduce to you who is here at the table at AHRQ.
I'm joined by David Atkins from the Center on Outcomes and Evidence; Tess Miller who, along with me, is contact person for information about this FOA; Sherry Cochran and Deb Rothstein who are from the Office of Grants and Contracts here at AHRQ; and David Myers who is the Acting Director of the Center for Primary Care.
We are also joined by Carl Ohata from the Division of Scientific Review Office of Extramural Research, Education, and Priority Populations. So (if) any particular questions pertain to details about the grant we may share (them) with folks who have the expertise to answer those questions. But, at this time, I'm going to go over the slides that were sent around last week. We will pause at the end of this time to solicit questions from the participants on the call.
So, to start with, as I said we have this early Fiscal Year 2008 (FY08) announcement of a funding opportunity. I'm going to give you the overall picture of what we're looking to fund, we'll talk about some frequently asked questions, and then have an open forum for discussion and hear your questions and answer them.
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Mary Barton: The first slide about eligible institutions, I think, is pretty self explanatory. The next has the RFA Number, HS-08-003, and (it) restates, as we say in our announcement, that we are soliciting applications at this time to expand the understanding of how to optimize decisions about preventive care and the management of chronic diseases in complex patients, especially in primary care.
The next slide lists, separately, three different goals. And these would be (the) ultimate goals of the funding opportunity announcement, not necessarily (the) specific results of studies that we might fund, but the ultimate goals of the whole program.
First, we would mention that we are looking to support the ability of AHRQ and of the medical system, in general, to prioritize evidence-based services, both testing and treatment, for patients who have multiple simultaneous co-morbidities. So (we're looking at) including both mental and physical conditions with a consideration to how the timing or the frequency of those recommended tests and treatments might be adapted in guidelines that relate to these complex patients.
Secondly, we would want the research funded under this FOA ultimately to help clarify how coexisting chronic conditions modify the safety or effectiveness of proven treatments for chronic diseases and recommended preventive interventions.
And, finally, an additional goal—maybe after this funding announcement, maybe after the funding announcement that follows this funding announcement—would be to provide evidence that would allow us to refine chronic disease quality measures for complex and frail patients.
The objective of this FOA then, more specifically, is to provide a foundation for further studies. And it probably goes without saying, that this is an R21 mechanism and, therefore, we are looking for preliminary studies. The studies that we will fund now should be preliminary to studies that test the impact of guideline adaptations (and) assess the barriers and facilitators to implementing adaptations, examine tools, implement tailored interventions for individuals, and finally, investigate the implications for patient-centered health care of personalized approaches to prevention and care management.
Now that I've told you a little bit about our objective, I'm going to give you some definitions. Again, this is all in the FOA that is available on our Web site. First, a definition of what is a complex patient. So for ease of definition, (we) consider a person who has two or more chronic conditions to be a complex patient.
But more specifically for this FOA, the interest is in two or more chronic conditions in which each condition might influence the care of the other condition, either through a limitation on life expectancy imposed by one of the conditions or because these two conditions generally entail therapies which are likely to have interactions with each other, or thirdly wherein one of these conditions might be requiring therapies that are contraindicated by the presence of the other conditions.
While we recognize that demographic characteristics such as poverty, education, (and) language might make the medical care of individuals much more complex in the current system, we are not for the purposes of this funding announcement including demographic characteristics—characteristics such as lack of insurance or poverty—in our definition of a complex patient.
(For) the next slide, I'm going to tell you a little bit about what we mean by a chronic condition. Hopefully this is not something that is surprising to anyone, we consider physical and mental illnesses or impairments to be potential chronic conditions if they are by nature persistent or have recurring health consequences that last for years as opposed to months or days. And, in most cases, our definition of chronic conditions would be ones for which that condition contributes to early mortality.
So I've listed some examples here on the slide. These are common and sometimes morbid conditions; asthma, COPD (chronic obstructive pulmonary disease), diabetes, hypertension, coronary artery disease, congestive heart failure, inflammatory bowel disease, autoimmune disease, arthritis, depression, and chronic or relapsing malignancies.
(The) next slide, number 9, is the definition of co-morbid conditions. So you have to have one condition first and then all the others you have at the same time are co-morbid. As we've said here, (you have to have the) chronic diseases in addition to the index condition, where the index condition is the one to which a particular therapeutic intervention is targeted.
Next, on Slide 10, we are emphasizing that there are two types of preventive services which are of interest for this funding opportunity announcement. Primary prevention, i.e., those that are provided to asymptomatic individuals to prevent the onset of a targeted condition, and secondary prevention, or interventions used to identify or treat persons who already have developed risk factors or preclinical disease or in whom a condition of interest has not yet become clinically apparent.
Examples of primary and secondary prevention of interest potentially for this funding announcement are colonoscopy, mammography, Pap smears, behavioral counseling regarding obesity or smoking cessation, and preventive medications, such as aspirin used to prevent myocardial infarction in men and stroke in women.
On the next slide, number 11, we give a high-level description of the three types of studies that we are looking to fund with this announcement. First, (we're looking to fund) epidemiologic descriptions based on secondary data analysis; second, analytic epidemiologic studies; and third, modeling studies. And I will spend the time now talking about each of those three types of studies.
First, epidemiologic descriptions based on secondary analysis must start off by documenting the lack of published information describing the epidemiology of the condition or a pressing need to update our understanding of the epidemiology of the condition due to recent developments in treatment that may have altered that epidemiology.
These projects must describe at least two or three different conditions, ideally in combination, and must describe the natural course of the diseases and the cumulative burden of the therapies for the conditions over time. We would envision that these projects would be proposed with budgets in the range of $100,000 to $150,000 and timelines that were approximately a year in duration and no longer.
The second type of project that we're looking to fund are analytic epidemiologic studies. And for these we envision a rather more complex look at a set of conditions. So starting with a cohort or available clinical data, we would want projects that target at least one chronic disease or preventive intervention and then describe the study population's health status with regard to at least two additional co-morbid conditions and, using that data, use innovative statistical techniques to determine the relative positive and negative impacts of the preventive or therapeutic intervention in a population with co-morbid illness as compared to an otherwise healthy population.
These projects would be expected to come in with budgets in the range of $200,000 to $250,000 total and a duration of up to 2 years.
The third type of project that's envisioned in this FOA are modeling studies. These would start from a framework of either a specific co-morbidity cluster and, building out from that, an approach to chronic disease interventions in those diseases and prevention in others or, starting from a particular clinical preventive service or chronic disease intervention, show how the appropriateness frame for that service might be altered by various consolations of co-morbid conditions.
With either type of approach, the models should simultaneously look at two or more chronic conditions and one or more preventive or chronic disease interventions. And the models are strongly encouraged to include age as a cofactor. Furthermore, studies that propose this kind of project must describe what are the chronic conditions that they are going to be looking at, what treatment guidelines they are going to use for selecting the therapeutic interventions to be modeled, and which preventive services they are going to model.
Modeling approaches including decision analysis or cost effectiveness analysis might be appropriate to this FOA. The model should be sufficiently comprehensive to be able to model the impact of the co-morbid condition on issues of competing morbidity and mortality and on (the) benefits and harms of the intervention. (The) envisioned budget for these projects would be in the range from $200,000 to $250,000 dollars and the duration of these studies would be expected to be between 18 months and 24 months in duration.
Moving on to the next slide, for each of these three study types, we are looking for applications that describe what would happen next in terms of translating the research into information that can improve health care decisions made by clinicians and their patients. All investigators would be encouraged to describe if and how current treatment guidelines and quality of care measures might need to be adjusted as a result of their findings.
We encourage investigations that include mental health co-morbidities. We encourage investigators also to include priority populations, including racial and ethnic groups, when sufficient related data are available.
All study types must fit within the total cost of $300,000 and a project period of 2 years. And I'll just mention (it) now, and again when we probably talk about questions, we're talking about total cost, meaning direct plus indirect, and over the entire project period.
On the next couple of slides I'll mention a few key highlights of the things that should be in an application, because they're going to be looked at very closely during the review of applications. (On) the slide, number 17, titled "Highlights of the Research Design and Methods Section," you'll see in yellow the word "must," so do keep track of those as you're writing your applications.
Applications must describe the selective project type: which of the three that I described are going to be pursued. And the design must include a timeline with specific milestones for achievement. The narrative description of the study application should describe what data set is going to be used or what data collection plans there are, if any, and as well, a very well developed analysis plan.
Modeling studies, in particular, must include sufficient detail about the model structure, the underlying assumptions, discussion about the natural history of the index condition, (how) the co-morbid conditions will be included in the model, and possible data sources to allow rigorous evaluation.
We expect all proposals to discuss anticipated limitations or cautions in generalizing the results of their findings and also, as mentioned before, to discuss potential next steps to how expected results would inform future research and how results could be adapted and integrated into quality of care and treatment guidelines for complex patients.
The next slide, 18, reminds us all that the funding considerations for research proposed to AHRQ follows some criteria and overall policies. So, first of all, the scientific merit of the proposed project will be determined by peer review, and that is the first of the funding considerations.
However, that is followed by important other issues, such as the availability of funds; the responsiveness of all applications to the FOA goals and objectives; the relevance of (the) applicant's proposal to program priorities; programmatic balance across all of the studies that meet scientific review criteria, including geographic and institutional diversity; and, finally, portfolio balance within AHRQ and the Department of Health and Human Services more broadly.
(The) next slide, 19, mentions again some of those yellow-highlighted "musts." The responsiveness of the application to the FOA will be judged especially on whether the application describes the next steps in translating research. Applications must fit within the total cost of $300,000 and a project period of 2 years.
All applications must meet the study type specific requirements as outlined in the funding announcement, so depending on which type of study you're going to do, you have to describe the number of conditions and the number of interventions you are going to study, and these must be consistent with the requirements. The "Method" section must include a timeline. And for those studies that are proposing models, the appropriate description of the model structure and inputs (must be included).
Applications that might fail to meet these requirements will be returned without scientific review. The next slide, 20, reminds us of the general review criteria. The scientific review process will be charged with evaluating each incoming proposal with regard to the significance of the problem, the approach that is proposed, the degree to which the proposed approach is innovated, the qualifications of the investigators, and the environment in which the investigators are working, as well as the overall fit of the budget to the proposed work.
So on the next slide (21) the information about study populations and protections, this is also detailed in the FOA. Applicants are told to prepare a separate paragraph and heading for each and describe clearly what their plans are for inclusion or exclusion and protections that would be instituted. And we're talking here about inclusion by gender, inclusion of minority populations, AHRQ priority populations, and the protection of human subjects from research risk (all) need to be clearly described in this section.
The next slide (22) is about the mechanism of support. This is an R21 exploratory developmental grant. We're looking to encourage new exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. This is a one-time solicitation as far as we know.
We project that $3.7 million will be spent in total costs in FY08. We hope to be able to fund 15 to 20 grants with that money. We anticipate that the size and duration of the accepted proposals will vary. But as we've mentioned the upward ceiling of duration is 24 months.
A little specifics here about the costs: While the total costs are limited to $300,000 over a 2-year period, no more than $200,000 in total costs can be allowed in any single year. And I will mention while we expect that this is a one-time solicitation, we do hope to be able to offer additional funding through limited competition for projects that have findings that are particularly important or fruitful to look at how to further the dissemination of those findings.
So as we go on to the next slide (23), these are some important generic reminders about how things work at AHRQ. AHRQ does not accept modular budgets. AHRQ uses only the detailed research and related budgets. Please do not use the modular budget form available in PHS 398, because if you do that, your application will be returned without review.
(A) second point about the SF424 Research and R&R: All applications must be submitted electronically, and there are some details in the funding announcement about how to obtain the electronic forms and how to register your institution and PI (principal investigator) in order to perform the electronic submission which can take some time, so it bears looking at that early.
The next slide (25) goes over the eligible institutions. Just quickly, public and nonprofit private institutions are eligible. Units of local and state government or eligible agencies of the Federal government are eligible. Indian Native American Tribal Governments or Tribally designated organizations are eligible to apply.
Foreign institutions are eligible to apply under this FOA. Although if a foreign institution were to apply they must be able to justify and confirm that the population disease characteristics are comparable, that the disease or severity estimates in their population are derived from either U.S. data or closely match what would be observed in a U.S. population.
For-profit organizations are not eligible to lead applications, but they may participate in projects as members of consortia or as subcontractors.
The principal investigator [PI] should be an experienced senior-level individual and devote a considerable portion of time which we would consider 20 percent or more. And, in fact, there needs to be explicit justification if less than 20 percent is devoted by the PI. Individuals from underserved racial and ethnic groups and individuals with disabilities are encouraged to apply. Applications should describe what the PI responsibilities and background are.
Okay, (here are the) key dates for this FOA. The opening date is October 28. We want letters of intent to be here by November 2. Applications are due by November 28. We expect that a peer review will occur in March of 2008 and with an earliest anticipated start date of June 2008.
So just to remind you: Now I'm going to talk about some frequently asked questions. Please start writing down your questions, so that when we get to the end of these slides—and I'll describe the rules that we're going to use for this open forum—you'll have them written down and ready in front of you.
The first slide (29) we have here is a question about hospitals. And I think it suffices to say that if you're a public or nonprofit health care institution, including public or nonprofit hospital, you're eligible to apply. Again (I'll) repeat that for-profit organizations are only eligible to come in as consortia members, not to lead applications.
Second FAQ: Does AHRQ accept modular budgets? No, it does not accept modular budgets. So use only the detailed research and related budgets, otherwise the application will be returned without review. And you'll be sad, and we'll be sad. So don't do that.
Next, can there be co-PIs? This is not something allowed for under AHRQ grant regulations. AHRQ requires that the lead institution designate one—and only one—individual as the project's principal investigator. But I would say that, especially with the kind of projects that we are hoping to fund, in particular under the categories of analytic epidemiology and modeling, we are extremely interested in collaborations between folks with statistical expertise and folks with clinical expertise. So we wouldn't want this—the fact that there can't be co-PIs—to make it sound like we're not interested in collaboration across fields because we are extremely interested in that.
Next slide, (32) what are the page limits? Because this is an R21 exploratory grant mechanism the page limit is 15 for the research plan and human subject inclusions and protections. And the parts of the research plan specifically that have to fit into that 15-page limit are the specific aims, background and significance, (and) preliminary studies, if any. So, as you know, for R21 it's not required that you include preliminary studies but if you happen to have preliminary data you're welcome to put it in. And then, finally, research design and methods (should be included in the 15 pages). But not included in this page limit would be the descriptions of the investigators, the budget, any appendix material, and references.
Questions and Answers
You will each have an opportunity to ask questions. I think what we'll do is take down all the questions first and then answer them as many as we have time for in either the order they came in or the order that we're ready to answer them.
Please try to keep your questions brief, and we will in turn try to keep our responses brief. And if you have a question that is very specific to your particular institution or situation, you can say it now. We'll take note of it. But we probably will not answer it during this call. Certainly if you know that your question is very specific, you can also just put it aside now and plan to make contact with a project officer from AHRQ at some time later in this process to get the answer for your particular situation.
And then, finally, if you did not get an opportunity to ask a question, please E-mail your question to our mailbox which is listed there: firstname.lastname@example.org. And then on the last slide (34), if I don't come back later to say it, we've listed here the particular E-mail addresses for the contact folks here at AHRQ. If you joined the call late and didn't hear me introduce everybody, I'll repeat that these important people are here: Carl Ohata from Scientific Review to talk about peer review issues, Sherry Cochran who can explain about financial and grant management issues, as well as Therese Miller and myself on the scientific research side.
So with that said, I would ask for the questions to be asked now.
Participant: On Page 7, the bottom (of the) slide "Study Populations and Protections," in part of my proposal I would be using laboratory and other diagnostic tests to be able to assemble the model. The Privacy Act is not mentioned here, although protection of human subjects from research risk is in this slide.
I think Privacy Act is terribly important, and in a population which is uninsured there are certain rules for Privacy Act outside hospitals. Have you considered that, and is there some way that we could use data and get some kind of a blanket permission to use Privacy Act? And I'm kind of lost here. Have you thought about the fact that even though an uninsured population from an ethnic or minority group that is cared for under a public health venue (that group) still is subject to the Privacy Act?
Mary Barton: That is an excellent question. I've taken note of that, and we'll do our best to answer that during this call. Next question?
Participant: Yes, thanks for taking the call. One question that I was not sure of was: We are looking for the modeling strategies, and it seemed to us that the intent is to fund only retrospective studies, studies on existing data sources, and model-based economic analysis based on available data sources. So my question is: Would this RFA plan on funding any prospective data collection that we can do during the study as a part of the analysis?
Mary Barton: Excellent question. I think I've got that detail down. What's the next question? Okay, are there any other folks on the call who want to state a question?
Participant: My question is regarding the eligibility criteria for investigators. The FOA said "senior-level investigators," so what would be your definition of senior? I'm an assistant professor on faculty for three years, but I have a couple of publications which are related to the complex patient which I would like to build on. And my question is: What would be the definition of senior-level investigator?
Mary Barton: Thank you for that question. Are there more questions out there?
Participant: Thanks. The second question would be: For epidemiological descriptive studies, would it be appropriate to include as a co-investigator individuals with statistical expertise? Because I did hear that for analytical and modeling studies you would encourage co-investigators with clinical and statistical expertise.
Mary Barton: Very good point. Okay, and are their other questions out there?
Participant: Can I ask one more?
Mary Barton: You may.
Participant: Okay, the other question is about the letter of intent. Is there a format or is there a limit or a structure to it? And would that have to be submitted electronically or via paper? And any other formalities that would go with that?
Mary Barton: Good. We'll answer that for sure. Okay, are there any other folks that want to raise a question in this forum?
Participant: I just wanted to ask a question on the epidemiologic descriptions based on secondary analysis. You say it must describe the natural course of disease. Are you implying longitudinal data? Could cross-sectional data be used in that aim?
Mary Barton: Can you say that again?
Participant: Yes, in the third bullet and also in the RFA you say you must describe the natural course of disease as an accumulative burden of therapies. As we were reading that, it seemed to imply a longitudinal data analysis. And I'm just wondering whether cross-sectional data would meet the needs of this (part) of (the) RFA. In the next slide, in the second major category, you talk about using cohorts, which clearly implies some kind of longitudinal data analysis. I was just wondering about whether you were requiring that, implying that, or had any thoughts about that for that first analytic epidemiologic study? Or am I just reading too much into it?
Mary Barton: Okay, I think I've got that question now. And are there other folks or folks who have already spoken and have other questions?
Okay, bear with me as I put you on mute as we sort out whose going to answer which question, and we'll be right back with you, okay?
Mary Barton: Hello?
Mary Barton: Hi, this is AHRQ back with you. This is Mary Barton again. I'm going to restate the questions as we understand them, and then various experts who are here will introduce themselves and respond to the questions.
Just to summarize now, we plan to have the transcript of this entire conversation available on our Web site. And if you have other questions that you think of later today, if you E-mail them to the complex patient FOA inbox (email@example.com) by the end of today, we will see that they are also answered in a document that is available to everybody on our Web site.
So with that said, the first question that came in had to do with how the Privacy Act might influence the approach to get data about populations that may be uninsured, potentially with high prevalence of chronic illnesses, and/or highly enriched with ethnic minorities. If they are being cared for in community health settings or they're uninsured, what are the issues particular to these populations in terms of the Privacy Act and the availability of lab and other diagnostic test data?
Carl Ohata: This is Carl Ohata from the Division of Scientific Review to answer this question. Certainly when you use data or information of people you need to get their consent. So it would be an informed consent that you'd obtain from these individuals, and hopefully these individuals will represent the entire population available so that both genders and minorities would be included and, therefore, your study would be diversified in that regard.
And if you do have data from these people, then you could include that in your study. We would greatly appreciate the proportions of people—the number in different genders as well as the different minorities—so that the review committee can determine whether you have appropriately included both genders and minorities in your study.
One final thing is that you need to get IRB [Institutional Review Board] approval for the use of these people, and they (the IRB members) would ensure that the protections of the individuals are following the regulations. And this is listed in Section 2C of the program announcement.
Mary Barton: Thank you very much. The next question that we will respond to asks whether we are interested only in funding modeling studies that use retrospective data or available data sources and would we consider funding projects that propose to do prospective data collection.
And I would say that the answer to this is that if investigators feel that, within the budgetary constraints and the duration constraints, they are able to propose a sufficiently rigorous data collection then more power to them. And we would be willing to receive applications that did that, although we don't think that it's highly likely that one would have. It's not an ample amount of time, generally speaking, to collect prospective data. So that's why we wrote that we imagine that what we'll be seeing are analyses of existing data sets.
Okay the third question is actually the three-part question on eligibility of principal investigators, the appropriateness of including co-investigators with statistical expertise, and thirdly, about whether there's a format or structure for a letter of intent.
Debbie Rothstein: Hi. This is Debbie Rothstein, the adviser for extramural research. Regarding eligibility and who might serve as a PI: As indicated in the FOA, it does not say senior investigator. What it does is say (is) that anyone who thinks that they have the skills, knowledge, and resources to carry out the project is invited to apply, although we do expect that they will devote a considerable portion of time to the project.
So I would say it's up to the individual to just make the case that they have an appropriate background and also keep in mind it's not just the PI, but what is evaluated is the entire team that will be contributing to the project. So it doesn't necessarily have to be a senior-level person, just someone who thinks that they could, along with their co-investigators, conduct the project and complete it.
In terms of co-investigators with statistical expertise, yes we do encourage collaborators and part of the study team to have statistical expertise. But just to clarify, at the current time AHRQ is not following the model where there are multiple principal investigators on a single project, so we will not accept any applications that have multiple PIs. We will, however, have a study team and collaborators and co-investigators, but one PI per application at the current time.
And I think the third part of the question had to do with the letter of intent, which is actually a section of the FOA. So you can find all the information in the FOA. But basically what it says is that you are welcome to submit it electronically. And it does give the E-mail address, which is the same one, the firstname.lastname@example.org.
There's no specific format, but you'll see in the FOA that it does say we would appreciate a few sentences related to what your project is going to be about and please put the title and the number of the FOA in your letter. These are voluntary. They're not required. And we use these just to do some initial screening in thinking about who might be on the review committee, things of that sort. But they are voluntary. And you can send them via E-mail.
Mary Barton: Thank you. The fourth question that we here all jotted down was whether cross-sectional data might be appropriate for use in epidemiologic-descriptive epidemiologic studies.
David Atkins: Hi. This is David Atkins, medical officer in the Center for Outcomes and Evidence. The FOA does not specify only the use of prospective or longitudinal data. You're free to propose whatever data set you think is appropriate. The peer review committee will be making judgments about whether your approach to data sources and data analysis is adequate. And so you should justify your use of data and make the case for why you think it's adequate and actually the best approach to the data, and the analysis that you propose.
Mary Barton: Thank you. Okay, well we do have just a few more minutes left in this hour. I would say if anyone does have another question that they've thought of now or if you need clarification on one of the questions we just answered, we can entertain those kind of questions for at least the next 6 or 7minutes.
Participant: Following up on this prospective economic analysis: You know, this being (an) R21, we were thinking of just building up a strategy for (a) long-term study and hence the kind of intervention that we proposed may not be retrievable from an existing data source.
And secondly, we wanted to include racial minorities, and so the second part of the question—which I didn't ask—was what if we want to collaborate with other institutions in trying to make our model more generalizable?
Mary Barton: Yes, so the R21 mechanism while it is exploratory is designed to have findings at the end of the period. So it is not a planning grant and it would not be appropriate to spend these 2 years collecting the data that would allow you to later have findings based on a model. The R21 has to have methods and findings and finish them by the end of roughly 2 years. That being said, we fully expect this being a relatively new area of inquiry that there will be some teams that are just getting together to respond to this FOA.
And so I think making the best case for what you're doing and the size of your project is and (ensuring) that it matches the budget that you've put in is the best way to have success with an application like this. I don't think it behooves anybody to make the "Methods" section look like it's a 5-year R01 with a $200,000 budget. I don't think you need to worry that anybody else is going to be doing that either.
In terms of collaborations with other institutions to improve the generalizability, that is explicitly, I think, the kind of thing that we envision. I mentioned that there might be supplements available for dissemination. And I think that is the general direction that we are thinking of either as supplements to this grant or possibly in a follow-on grant in FY 2010 where promising approaches might then be expanded to other populations in that next round. So I would not necessarily expect to see that in this round.
David Meyers: Dr. Barton, I think it is correct to say that applicants may link and come in as a consortium with one institution as the lead with one PI and that the budget needs to explain how it's going to be spent within the consortium. But it is acceptable to build the data set under this RFA by bringing together multiple institutions? A consortium or an individual institution are under the same budgetary constraints, and if anyone is thinking of doing that and needs more guidance they're welcome to call Sherry Cochran. Sherry, would you just introduce yourself?
Sherry Cochran: Sherry Cochran, Grants Management. If you have any questions about budgets, feel free to give me a call or (send) an E-mail. I'll help you out with that.
Participant: I have another question. In the populations that we serve who do not speak English, the Privacy Act was my question. But now I'm concerned because I may need translators to be able to translate anything from Chinese to Pakistani to Ukraine to Spanish to whatever. And the cost of translators I'm currently using in my clinics is quite expensive.
I'm looking for some guidance here. We do want to do underserved populations, but I do have to tell you that in most underserved populations this is the problem we run into of having to pay for translators. And this can really run down your grant budget. Any comments?
David Meyers: Hi, this is David Meyers from the Center for Primary Care Prevention and Clinical Partnership. We're very excited to hear that folks are seriously considering how in their data to work with populations that aren't necessarily part of our mainstream data set. And to do that there are several options as Carl Ohata explained earlier. Under HIPAA [Health Insurance Portability and Accountability Act] privacy laws, the preferred way when collecting new information from individuals is to get their individual consent.
But the law is far more broad than that. And under this FOA we expect that many people will do this using data that's already available and using things such as de-identified data sets or other forms of secondary data analysis which, under HIPAA, you can either be exempted from getting individual consent or possibly don't even require consent from individuals because of the de-identified nature of the data set you would be analyzing. And so working towards using that kind of data-sharing agreement is a way that we hope many people will be able to participate in this FOA.
We recognize that translation and getting true informed consent is an expensive process. Under this beginning pilot exploratory mechanism, we don't have additional funds available to allow supplements that might help for this specific situation.
Participant: Thank you. I appreciate your answer.
Mary Barton: Thank you. Well I want to thank everybody who has taken time to participate in this Technical Assistance Call, both my colleagues here at AHRQ and those of you on the phone. As I said before, if you have other questions that you think of today please do E-mail them to the complex patient FOA mailbox (email@example.com) and they will be included in a document that includes a transcript of this call. After today, you are welcome to use that mailbox to reach us as well, and we'll answer your questions as they come in.
As I mentioned before, on the last slide in the presentation, there are the E-mail addresses for some key individuals related to this funding announcement and we're all happy to hear from you and to talk more about it. So thank you all and have a good day.
Current as of November 2007
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