Frequently Asked Questions for RFA-AG-23-019
The frequently asked questions below are related to RFA-AG-23-019 - Demonstration Projects to Promote Use of Interoperable Health Records in Clinical Research (R01).
Q: Are applicants required to partner with an active aging research study that will be enrolling or reconsenting participants?
A: Yes, the purpose of this funding opportunity announcement (FOA) is to support projects that will create an infrastructure to use electronic health records (EHRs) to inform fragmentation gaps in aging research participants’ health histories. Partner studies serve as the source for aging research participants, and study partner team members also may contribute valuable scientific expertise.
Q: Must the partner study have NIH support to be eligible for RFA-AG-23-019?
A: The partner study could be financially supported by NIH, another federal agency, or non-federal sources. The principal investigator (PI) of the partner study should provide a letter of support that affirms there is sufficient financial support to remain an active partner throughout the three years of the proposed project.
Q: I am the PI of an aging research study that will be enrolling participants soon. Can I apply to this funding opportunity to partner with my own study to obtain EHRs from participants?
A: All individuals with the skills, knowledge, and resources necessary to carry out the proposed research as Program Directors/Principal Investigators are invited to work with their organizations to develop applications for support. Applications from multiple principal investigators are also eligible.
Q: Can applicants propose projects that rely on existing EHR databases, like a database from a hospital or health network?
A: The purpose of this program is to examine the feasibility of utilizing FHIR APIs to address gaps and fragmentation in the health histories of partner study participants. This is a required element of this opportunity. Projects that propose to obtain and integrate electronic patient health information using FHIR APIs with EHRs from other sources are invited to apply.
Q: Does this funding opportunity have non-responsiveness criteria, or will all applications received under RFA-AG-23-019 be peer-reviewed?
A: Yes, there are non-responsiveness criteria. Applicants are strongly encouraged to reach out to scientific contacts to discuss their applications. Applications that are not responsive to this FOA, and will be withdrawn prior to review, include:
- Applications that do not propose plans to utilize FHIR APIs to obtain and integrate electronic patient health information from EHRs
- Applications that do not propose plans to partner with one or more active research studies that will be enrolling or reconsenting participants
- Applications that do not propose plans to invite study partner participants to share EHRs from their health care providers
Q: Using FHIR APIs is a required element of this FOA. Can other sources of data also be utilized?
A: FHIR APIs must be used to obtain and integrate electronic patient health information from EHRs from providers that are not already available through aggregated data sources, e.g., local and regional health networks.
Q: Are there any special review criteria that will be applied to applications submitted under RFA-AG-23-019?
A: Yes. There are additional review criteria listed in the FOA under the following peer review criteria: Section V. Application Review Information; Significance and Approach.
Q: Are there any special instructions for this FOA?
A: Yes, the following FOA sections contain additional instructions:
Section IV. Application and Submission Information.
- Letter of Intent
- SF424 (R&R) Senior/Key Person Profile
- R&R or Modular Budget
- Research Plan
- Resources Sharing Plan
Q. The FOA instructions direct applicants to describe in their research strategy the approach they will utilize to share and disseminate the products and results from this study. A Data and Resource Sharing Plan is also required. Are these sections expected to be redundant?
A. In the research strategy, please briefly summarize the approach you will take to data sharing and deidentification and provide information on the activities that will be undertaken to disseminate the results of this demonstration project. In the Data and Resource Sharing Plan, please provide a detailed plan for sharing the deidentified data and resources that result from this project.
Be advised that there are additional review criteria under this approach that would direct reviewers to consider sharing and disseminating the research products and results from this study.
Q. RFA-AG-23-019 states that the budget is limited to $750,000 in direct costs for three years. Is special permission still required to submit a budget requesting more than $500,000 in direct costs?
A. No, you are not required to request permission to submit the application. But applicants are encouraged to submit a letter of intent.
Q. RFA-AG-23-019 states that “EHRs from disparate sources must be included, such as out-of-network providers, past providers, remotely located providers and other data sources relevant to overcoming fragmentation in the context of the partner study.” What is considered an EHR in this context and what counts as disparate?
A. The Centers for Medicare and Medicaid Services defines an Electronic Health Record (EHR) as an electronic version of a patient’s medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports.
In this context, EHR’s from disparate sources are EHRs maintained by providers who do not synchronize their EHRs to a database the partner study already has access to through their own institution or a regional EHR database.
Q. RFA-AG-23-019 states that awardees are expected to participate in an Investigator’s meeting in years 2 and 3. Should we includes travel costs for this meeting in the proposed budget?
A. These two meetings will be held virtually and thus, no there will be no travel costs.
Q. Is it acceptable to use multiple aggregated FHIR-based sources of data, e.g., a provider network and claims data?
A. Yes, this is acceptable, but participants still must consent for the partner study to share their EHR data. A question to consider is how the use of multiple aggregated data sources would accommodate a participant whose data within the data source being utilized is limited. For example, they have recently relocated or otherwise had a change in circumstances.
Q. Must partner study personnel be involved for effort on the proposed study?
A. There is no specific requirement about how the study team will be comprised. However, there is a special review criterion under “Investigators” that peer reviewers are asked to consider: “Is there evidence of sufficient involvement and coordination with the partner study team to support the conduct of this project?”.
Q. Can study partners provide financial support from their own project? Conversely, will any of the budget for the proposed study be allocated to the partner study?
A. Activities supported by the proposed study must be distinct from those supported by the partner study.
Any use of grant funds must conform to grants policy, reflect a bona fide need, and judicious use.
Q. What if the partner study award period ends in 1 or 2 years (but not exactly 3 years)?
A. Applications must affirm that the partner research study has sufficient financial support to remain an active partner throughout the three years of the proposed project. If partner study is ending, but partner study personnel involvement is still needed on proposed study, they could be included for more effort in the last year.
Q. Should there be a plan to connect to any EHR using FHIR? Can we leverage patient authorization and patient login? Do we need to have pre handshake with EHR/healthcare organizations?
A. The 21st Century Cures Act Final Rule (https://www.healthit.gov/curesrule/) empowers patients by granting them access to their EHR through APIs. Patients can be invited to share their EHRs with the partner study and consented to do so. The AllofUs study is an example of an active study collecting EHRs through sharing with participants. https://www.joinallofus.org/learn-more
As a reminder, there are special review criteria under “Approach” that peer reviewers will be asked to consider:
- Are the plans for obtaining informed consent and managing the privacy and security of participant data rigorous and robust?
- Are the plans to utilize FHIR® APIs, aggregate and harmonize data across patients and providers well-reasoned and appropriate to advance the purpose of this RFA?
It is assumed that a “pre-handshake” means established data sharing agreements and linkages.
There is a provision in the FOA that “An initial goal that must be met by the end of the initial reporting period is establishing data sharing with all data sources that will be used for the study (i.e., study partner(s), health networks, insurers, etc.).” So it is not required that data sharing agreements be established at the time of application, although established agreements that can be shown in the application may strengthen reviewers’ assessment of feasibility.