Request for Applications (RFA) for Nonformula Health Research

Addendum #1

RFA67-32

Questions and Answers to the Pre-Application Conference for the

Request for Applications (RFA) for Nonformula Health Research

1.Question: The question is concerning the following paragraphB. Clinical research - patient-oriented research which involves direct interaction and study of the mechanismsof human disease, including therapeutic interventions, clinical trials, epidemiological and behavioral studiesand the development of new technology.

Would genetic research to determine the etiology of spina bifida fall under the above statement?

Answer: This question refers to the definition of clinical research on the first page of the Preface of the RFA. The Department will not elaborate on or interpret the definition of clinical research as contained in Act 2001-77 and on thefirst page of the Prefaceof the RFA.As stated on page iv of the RFA, at least 50 percent of each grant’s funds must be spent on clinical research or health services research or both clinical research and health services research. It is unclear whether the proposed research would meet this requirement. It is also unclear whether the proposed research would be considered in scope by the peer reviewers who will review and rank the proposals and decide whether or not the proposals are consistent with the research priority as stated on pages iv-v in Part One of the RFA. However, you may submit the proposal for consideration.

2.Question: In reference to pages ii-v of the RFA, where can we find the minutes of the Health Research Advisory Committee meeting of November 4, 2014, at which the research priority was set?

Answer: The minutes of committee meetings are posted on the Department’s Web site after they have been approved by the Health Research Advisory Committee at a subsequent meeting. The Committee has not met since November 4, 2014 and hasnot approved the minutes. However, an unapproved, draft copy of the minutes is attached, beginning on page 12.

3.Question: The RFA states on page 3 that the applicants must be from two major research institutions. Please provide the criteria that will be used to define "major research institutions."

Answer: The Department will not define what is considered to be a major research institution. The peer reviewers, who will review and rank the proposals, will determine the extent to which proposals are consistent with the research priority on pages iv-v and with the guidance contained in the RFA on page 3.

4.Question: The RFA states on page ii that the collaborative research project will bring together established research scientists with proven records of scientific excellence. Please describe the criteria to be used to define "established research scientists with proven records of scientific excellence."

Answer: The Department will not define what are considered to be “established research scientists with proven records of scientific excellence.” The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA.

5.Question: The current Executive Level II amount is $183,300. The RFA67-32 reflects $181,500. Please confirm which rate is be used.

Answer: The salary rate cannot exceed $181,500.

6.Question: Mycompany, which is testing a next-generation Transcatheter Aortic Valve Implantation (TAVI) device – the Optimum TAV,is very interested in pursuing the CURE Grant, but first seek your confirmation that our medical device company does, in fact, qualify under this year’s Research Priority for Nonformula Funded Research.At this time, we seek to use the CURE funds for first-in-human implantations of Optimum TAV in Aortic Stenosis patients in about 15 patients.We would greatly appreciate your written confirmation, including the specific language and section (s) that state that we qualify. We are particularly concerned because the term “Big Data” and other language in the application indicate we won’t qualify.

Answer: This RFA solicits research to develop methods, software, and other technologies designed to analyze vast data sets at the level of molecules, proteins, organelles, cells, tissues, organs, physiological systems, organisms, populations, health care systems, and ecosystems. The Department cannot answer whethera particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

7.Question (4 parts):

(7a) See the final paragraph of the Non-formula Health Research Priority for 2014-2015 FY (p 22), the 5th sentence reads: “Collaboration with a minority-serving academic institution or a minority-serving community-based organization in Pennsylvania is strongly encouraged and should include the meaningful mentoring and training of students.” AND In the Research Proposal application forms, Section IX (Research Plan, Research Design and Methods – p 13) instructions state: “The Research Plan must contain a specific aim related to minority training. The specific aim related to minority training should be listed after the other research aims.”

Is the minority training aim required? (not all past awards include one)

Answer: Yes, a minority training specific aim is required. Section 4 on page 4 inPart One of the RFA explains the requirements for minority training.

(7b) If so, what level of trainee should be targeted (K-12, undergrad, grad, postdoc, junior faculty)?

Answer: See page 4 in Part One of the RFA, “All research applications must include the involvement of minority college students in research through the development of a minority research training program for racial and ethnic student populations that are underrepresented in biomedical, health services and clinical research, such as African Americans and Hispanics. The minority research training program must include, at a minimum undergraduate summer internships or academic semester internships or both. A graduate student training program for underrepresented minority students is encouraged, but not required.” Also, see page 5 of the RFA, “Funds may not be used for educational programs designed to interest school children in careers in biomedical, health services or clinical research.”

(7c) If so, what proportion of the budget is expected to be dedicated to minority training?

Answer: The Department has not established a specific required percentage for the amount of funds for minority training.

(7d) Does the example budget given on p 17 of the instructions serve as an appropriate guideline ($400K for minority training out of $3.2M total requested)?

Answer: No. The example on p. 17 of the Research Proposal, which is Appendix A, Attachment 2 in Part Two of the RFA,is not intended to serve as a guideline for the amount of funds that should be directed to minority training. It is intended to serve only as a guideline for the format of the table in which applicants must provide a breakdown of costs by specific aims and subaims and by categories of research.

8.Question: (Section XVII, Item A, p 21): Does research involving data from previously collected (under an IRB_approved protocol & informed consent) biospecimens, research questionnaires, and/or electronic health records “involve human subjects” (Item A question) and /or require approval by the Pennsylvania Department of Health Institutional Review Board (Section VIII, p 22)?

Answer: See Part One on page 16, item i of the RFA, “all research involving human subjects must be approved by the applicant’s IRB prior to the initiation of the research involving human subjects and prior to the use of grant funds to pay for research involving human subjects.” If the project proposes to use only previously collected data from human subjects for which IRB approval has been obtained from the applicant’s Institutional Review Board (IRB) and the IRB approval is up to date, that is, the expiration date occurs after the start date of the grant, the applicant does not have to resubmit the project to the applicant’s IRB for review and approval. However, the applicant must adhere to all federal guidelines concerning the conduct of research, including the requirement that IRB approvals are kept up to date in accordance with federal guidelines. Further information about the requirements regarding human subjects research are explained in item i on page 16 and items k and l on page 17 of the RFA and in Part Two of the RFA, Appendix D, Attachment 2 and Appendix D, Attachment 5.

Research involving previously collected biospecimens, research questionnaires and/or electronic medical records requires approval by the Pennsylvania Department of Health’s Institutional Review Board. In making its decision to approve the conduct of research involving human subjects, the Department will review the information contained in the Research Proposal, Appendix D, Attachment 2 and Appendix D, Attachment 5, and documentation of IRB approval from the applicant’s IRB.

9.Question: We are developing a new technology - a Transcatheter Aortic Valve (TAV) - to replace the aortic valve without open heart surgery in patients with aortic stenosis. Preclinical tests on the technology have been completed, and the next step is to perform first-in-human feasibility studies (before clinical trials.) Can the (nonformula) CURE Funds be used for the implantation of our TAV in first-in-human studies in 15 patients?

Answer: This RFA solicits research to develop methods, software, and other technologies designed to analyze vast data sets at the level of molecules, proteins, organelles, cells, tissues, organs, physiological systems, organisms, populations, health care systems, and ecosystems. The Department cannot answer whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA. However, you may submit the proposal for consideration.

10.Question: The applicant and collaborating organizationsmust be separate institutions. What is the definition of “separate”?

Answer: This question refers to pages 2 and 3 in Part One of the RFA. Organizations must be owned and operated by different entities. If two organizations are owned or operated by the same entity, they would not qualify as separate organizations.

11.Question: At least two of the collaborators must bemajor research institutions which are located in Pennsylvania. What are the major research institutions inPennsylvania?

Answer: This question refers to page 3 in Part One of the RFA. The Department will not define what is considered to be a major research institution. The peer reviewers, who will review and rank the proposals, will determine the extent to which proposals are consistent with the research priority on pages iv-v and with the guidance contained in the RFA on page 3.

12.Question: Research areas that will not be consideredinclude “Focus on data collection/generation”. Does that preclude ANY datacollection/generation. Please define“focus” for the RFA.

Answer: This question refers to page v in Part One of the RFA. Data collection and generation is not precluded. However, if any data collection and generation efforts are proposed, they should be minimal.See page iv of the RFA, the research priority is the development of methods, software, and other technologies designed to analyze vast data sets. The focus of the research project should be on the development of methods, software and other technologies to analyze vast data sets.The Department will not further define “focus” or “minimal.”

13.Question (2 parts):

(13a): Research areas that will not be consideredinclude, “Secondary statistical or epidemiological analysis of single largedata sets (or multiple comparable data sets of the same type of data)”. Does that mean secondary statistical orepidemiological analysis of large datasets composed of different data types isallowed?

Answer: No. This RFA is not intended to support secondary statistical or epidemiological analysis of data sets.

(13b): What types of data areconsidered “comparable”.

Answer: The Department cannot answer this question based on the information provided.

14.Question: Research areas that will not be consideredinclude, “Design and development of registries, tissue banks, and other healthdata systems”. The RFA instructions also state: Funds maynot be used to establish registries, patient databases or tissue banks unless the research project includes at least one specific hypothesis-driven researchstudy that uses the registry, patientdatabase or tissue bank and is completedwithin the grant period. Please clarify.

Answer: This question refers to page v and page 5 in Part One of the RFA.All proposed research projects must be consistent with the research priority, see pages iv and v in Part One of the RFA. The priority states that the design and development of registries, tissue banks, and other healthdata systemswill not be considered (p. v) and that all research projects submitted in response to this RFA must be consistent with the following research priority (p. iv). The Department cannot determine whether a particular research proposal is consistent with the research priority as stated on pages iv-v of the RFA and will qualify. The peer reviewers, who will review and rank the proposals, will make that determination as part of the evaluation process, as described on page 8 in Part One of the RFA.

15.Question: Research in the following areas will not beconsidered: Focus on enhancing computing infrastructure.TheRFA instructions also state: Funds maysupport personnel and services directly related to the research project and maybe used to purchase computer hardware and software.Please clarify.

Answer: This question refers to page v and page 5 in Part One of the RFA.See page iv of the RFA, the research priority is the development of methods, software, and other technologies designed to analyze vast data sets. Computer hardware and software can be purchased in order to carry out this work. However, the focus of the research project should be on the development of new software and technologies to analyze vast data sets, rather than on the purchase of existing software and hardware to enable an organization to analyze vast data sets.

16.Question: My question pertains to the research priority areas. Our research team is considering several areas of clinical and health services research focus that will be of interest to the Department of Health. At least one area of focus will be a prevalent health condition(s) that will has wide health impact across the Commonwealth. We are additionally considering an area of focus on a rare disease, idiopathic pulmonary fibrosis (IPF). Our research team has been expanding the work of the Pennsylvania-wide IPF patient registry (PA-IPF) that was initially funded by the PA DOH ( We believe that we could greatly advance the work initiated out of the PA-IPF though the CURE funding, but would only do so if there was interest from the DOH.

Answer: This question refers to the research priority on pages iv and v in Part One of the RFA. Your organization must determine which area ismost consistentwith the research priority. Peer reviewers will review and rank the proposals and decide whether or not the proposals are consistent with the research priority.We will not comment as to whether there is interest from the Department.

17.Question: I was wondering if we could submit 2 Letters of Intent for the Nonformula funds. This question is regarding the Letter of Intent which is in the cover letter of the RFA. We will probably need a downselect to choose which application we will be submitting. We realize we will only be submitting 1 application.

Answer: An applicant may submit only one Letter of Intent. See page 3 in Part One of the RFA, “An organization may submit only one application as a lead agency in response to this RFA.” As the Letters of Intent are used to beginthe peer review planning process, it is critical to minimize efforts spent on multiple letters of intent submitted by one applicant.

18.Question: In regards to RFA 67-32, can you please provide the definition of a major research institution?

19.Question (2 parts):

(19a): Regarding the requirement to train minority students. The RFA states that: “These requirements shall be achieved only by one or more of the following approaches: (1) collaborating with Pennsylvania’s Historically Black Colleges and Universities (HBCU), which are Cheyney University and Lincoln University, to develop a minority research program, or (2) developing a minority research program at the applicant’s institution, or (3) expanding an existing minority research program at the applicant’s institution.” For options 2 and 3, does this have to be at the lead applicant’sinstitution or can it be at a collaborating institution?

Answer: This question refers to page 4 in Part One of the RFA. For options (2) and (3) the minority research program must be at the lead applicant’s institution.