Q1: This is a limited competition. How do I join the HMORN?
A: For information about HMO Research Network (HMORN) membership, please look at the HMORN website http://hmoresearchnetwork.org/.
Q2: Do the following items count toward the 30 page limit for the Research Strategy section?
- Specific aims
- Bibliography/Reference List
- Protections for Human Subjects
- Multiple PI leadership plan
- Consortium / contractual arrangements
- Letters of support
- Resource Sharing Plan
A: None of these sections count against the 30 page limit for the research strategy. However, the specific aims are limited to one page, and the abstract (project description) is limited to about a half-page.
Q3: Is it appropriate to include other relevant information in the research plan (e.g., an overview, description of HMORN sites)?
A: Yes, an overview could be useful to the reviewers. The description of the HMORN sites could be presented in the resources section, which the reviewers will read to evaluate the “environment” review criteria.
Q4: Regarding the stated requirements for the Appendix “Include a data dictionary for existing EHR and VDW systems in current use.” The Data Dictionaries for the EHRs are unique to each site, and may comprise hundreds of pages per site. Please advise about whether this is really what is intended by this requirement. Please also address how to submit Appendix material.
A: Appendices, including full data dictionaries for the EHRs, are not required materials. In general, inclusion of materials in the appendices is at the discretion of the applicant. Appendices are not subject to page limits. Appendices, if they are submitted, are to be submitted as pdfs on CDs. Please see the current PHS398 instructions (Part 1, section 5.7) for more information (http://grants.nih.gov/grants/funding/phs398/phs398.html). URLs should not be used anywhere in the application and reviewers are instructed not to click on any links, or visit any websites mentioned in an application (this is to protect the reviewers’ anonymity, and to prevent applicants from circumventing page limits).
Q5: Is it acceptable to divide the minimum required 30% FTE across multiple PIs?
A: Yes; however, reviewers expect to see a level of effort they feel is sufficient for the amount of work proposed in the application. Applicants need consider the multiple PI model and read the guidance and FAQs on the OER website http://grants.nih.gov/grants/multi_pi/index.htm
Q6: Are the Use Cases examples or pilot studies that will actually be implemented? Are they part of the milestones?
A: Use Cases are hypothetical examples provided to illustrate the kinds of studies that might be conducted and the capacities and/or limitations of the HMO Collaboratory to support such studies.
Q7: The FOA is very general and broad reaching with regards to data sharing and information systems work. Please acknowledge that you are not talking about existing health and medical information from health plans and health care delivery organizations as research organizations are guests within these organizations. Much previous software and systems infrastructure work, some supported by DHHS and many not, are requested to be part of the dissemination plan.
A: We recognize that in a distributed network data sharing may be dependent upon carefully constructed collaborations and agreements between research organizations and health care delivery organizations. These collaborations are an important and valued feature of the HMO Collaboratory.
One goal of this solicitation is to provide clinical research teams and health care providers at health service delivery organizations with processes and tools to enhance collaborations. Applicants are asked to submit feasible dissemination plans, and the FOA describes expected letters from the relevant institutions expressing support and agreeing to abide by the software dissemination plans put forth in the application. Reviewers will comment on the appropriateness of the proposed plan for data sharing and the proposed plan for software sharing.
Q8: Could you discuss in some greater detail your expectations around human subjects protections?
A: The applicant should describe the processes they propose to ensure optimum protection of human subjects, data safety and data privacy, both within participating institutions and for the Collaboratory as a whole. Topics to address include regulatory requirements, oversight and consent issues, data and safety monitoring and review, and plans to insure community input and dialog.
Some of the “bullets” under the different sections of the application directly relate to human subjects protection. The applicants have the option of addressing those issues in the human subjects protection section (no page limits), to leave more space in the research strategy for addressing other bullets. If applicants decide to do that, they should reference the human subjects section, where appropriate, so that the reviewers can find the information more easily. Reviewers will be instructed to look for that type of information in either the strategy section OR the human subjects section.
Surveys, protocols, and informed consent documents are permitted in the appendix. Again, if applicants put these in an appendix, they should reference that in the text of the research strategy (e.g. see Appendix 1….) so the reviewers know where to find the information. However, Appendix materials are optional both for an applicant to include and for reviewers to review.
Q9: Please clarify the scope of what is included under “clinical studies”. Clearly this includes trials, but does it also include prospective cohort studies and even possibly case-control studies?
A: Clinical studies could also include prospective cohort studies and case control studies.
Q10: What is mega-epidemiology?
A: By mega-epidemiology we mean large scale epidemiology research that includes participant numbers in the 10’s or even 100’s of thousands.
Q11: Are trials meant to include patient contact and/or data collection beyond administrative databases while mega epidemiology would not? Is there potential overlap between mega-epi and clinical studies in that some primarily epidemiology studies may collect some limited patient data on subsets?
A: Both types of studies could involve some data collection depending on the study question.
Q12: Please explain bullet 2 in Section 3.3 Clinical Studies Section, “Develop (within the guidelines set forth by OMB A-21) or make available information needed by investigators to develop pilot projects.”
A: The OMB circular details the policy that prevents federal grant direct costs from being used to prepare bids or proposals for federally-sponsored projects.
Q13: Concerning Section 3.3 (3rd bullet point), while there are common elements from study to study, resources such as randomization schemes, study visit reminder systems, web-based data entry would need to be customized for each study. Is this item directed more toward developing or making available generic tools that can be customized?
A: The goal is that tools developed should be of broad utility and to the maximum extent practical be able to be repurposed.
Q14: Should the response to Section 3.3 bullet 4 only address data availability or aspects of "clinical study operations"?
A: The application should address both.
Q15: Does Section 3.4 Biospecimen Repository Processes, bullet 1 refer to management of specimens? Does it refer to the management of data (e.g., GWAS, sequence)? To what extent is this intended to just plan for this activity versus actually implementing the coordination? If it involves implementing, for what scale? We are envisioning that the activity includes harmonization of data across sites, data cleaning, imputation of genotypes, and depositing into dbGaP. Is this what is meant?
A: A potential use case may address whether a distributed network will allow implementation of large studies with substantial numbers of biospecimens and assorted data more cost effectively than other models. Implementing an infrastructure for the specimens themselves is outside of the scope of this RFA. The bullet refers to data about the specimens –such as when, where and how the specimen was processed, and where and how it is currently stored – and genotype or phenotype data associated with the people from whom the specimens were taken. As stated in the RFA, the authorized sites are not limited to VDW and dbGaP.
Q16: Does Section 3.4 bullet 2 refer to specimens that are available in the existing biorepositories?
A: A potential use case could involve both existing reposited specimens and specimens that potentially would be collected using the proposed infrastructure.
Q17: What is intended beyond the current ability to link biospecimens with clinical data via the medical record number (and thus to the VDW) in Section 3.4 bullet 5?
A: One example of a category of data currently not in the VDW that may be of interest is patient reported outcomes. The RFA states “including but not limited to VDW data, in particular PRO data…” as defined earlier in 3.1 in the FOA.
Q18: Whose programmatic priorities are referred to in the first sentence of Section 4.4?
A: The NIH Programmatic Priorities are spelled out in the background and goals sections of the FOA. A short overview is available on the Common Fund HMO Collaboratory website. This is a NIH Common Fund Program, thus the programmatic priorities are not linked to a single NIH Institute or Center.
Laura Lee Johnson, Ph.D.
National Institutes of Health, DHHS
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475 (For FedEx, etc., use 20817)
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