RFA 67-211 Research Proposal and Letters of Support (III).pdf

RFA # 67-211, Attachment III (Section One)

RESEARCH PROPOSAL

Introduction

Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of which may harm the applicant, are to be be included in applications only when such information is necessary to convey an understanding of the proposed project. If selected for funding, the grant agreement, including the Research Proposal, will be accessible to the public though a Commonwealth website pursuant to the amendment to the Right to Know law (Act 2008-3; 65 P.S.§67.101 et seq.). Prior to placing the Research Proposal on the website, the Department will request applicants redact (black out) confidential and proprietary information.

Items II-IV of the Research Proposal will become part of the annual report to the legislature and will be posted on the Department’s website if this application is selected for funding. Do not include proprietary or confidential information or past accomplishments in these items. Do not repeat the same information in items II-IV. Do not include the names of the investigators or references to literature in Items II-IV. Spell out acronyms when first used. If a term is not universally known, spell out the term the first time it is used in the text and note the appropriate abbreviation in parentheses.

Do not delete or change, in any way, the instructions, headings or any information contained in this form.

This first page is not to be numbered. Subsequent pages must be numbered consecutively beginning with - 2 - at the bottom center of the page. Do not use suffixes, such as 3a and 3b, for page numbers.

Do not insert the name of the principal investigator on the top of any pages.

Except where otherwise noted, responses must not exceed the space indicated. Blank lines do not count as a line of text when determining whether or not text exceeds the line number limitation specified for some items.

The Research Proposal must be completed in Times New Roman typeface with a font size of 10 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies. A smaller font may be used for figures, graphs, diagrams, charts, tables, figure legends and footnotes, but the type must follow the font typeface and be readily legible.) Use black font color for text. Color may be used for figures. Type density, including character and spaces, must be no more than 15 characters per inch. Type must be no more than six lines per inch. Do not replace Yes/No Check boxes with images or an ‘X’.

Use standard paper size (8½ x 11 inches) with at least ½ inch top, bottom, left and right margins.

Internet website addresses (URLs) may not be used to provide information necessary to the review of the Research Proposal.

Reviewers are not required or advised to view the internet sites.

Appendices to the Research Proposal are not allowed.

I. Table of Contents – On the table below, specify the page numbers where information appears in the research proposal. If a section exceeds one page, insert the page number where the section begins and the page number where it ends. In the research design and methods section, list the page numbers for each specific aim. Add or delete lines for specific aims below, as needed.

Section Page Numbers Introduction 1 I. Table of Contents 2 II. Abbreviations III. Research Project Title, Purpose and Inclusion of Proprietary Information IV. Research Project Overview V. Expected Research Outcomes and Benefits VI. Health Disparities VII. Management and Staffing Plan VIII. Key Research Personnel IX. Research Plan

A. Specific Aims B. Background and Significance C. Preliminary Studies D. Research Design and Methods

Specific Aim 1 Specific Aim 2 Specific Aim 3

E. Timeline and Milestones X. Other Sources of Support XI. Research Project Performance Sites XII. Facilities and Resources XIII. Allocation of Costs for Biomedical, Clinical and Health Services Research XIV. Budget Narrative XV. Curriculum Vitae, Resumes and Biographical Sketches XVI. Evaluation Component and Research Evaluative Procedures XVII. Research Subjects and Materials XVIII. Protection of Human Subjects XIX. Clinical Trials and Data Safety Monitoring Plan XX. Targeted/Planned Enrollment Table XXI. Consortium/Contractual Agreements XXII. Consultants XXIII. Literature Cited XXIV. Reporting Requirements

II. Abbreviations – Provide an alphabetical list of abbreviations used in the Research Proposal. After each abbreviation spell out the words that the abbreviation stands for, for example, “ASD - autism spectrum disorders, MRSA - Methicillin-resistant Staphylococcus aureus, c. difficile – Clostridium difficile.” There are no space limitations. Insert list below.

III. Research Project Title, Purpose and Inclusion of Proprietary Information

(A) Title – The title of the research project may not exceed 81 characters including spaces and punctuation. Use Mixed Title Case, not UPPER CASE, for example, “Identification of ABC Binding Protein.” The research project title must convey the purpose of the research to be conducted and exclude the name of the applicant and Center of Excellence.

Insert Title here:

(B) Purpose – The purpose must emphasize the research studies that will be undertaken to discover new knowledge leading to new prevention or treatment approaches, rather that the establishment of a center of excellence. The purpose maynot exceed eight lines of text. Responses must be single-spaced, left aligned and in font styles and sizes as specified in the Introduction (first page) of the Research Proposal.

Insert Purpose here:

(C) Inclusion of Proprietary or Confidential Information

Does the Research Proposal contain proprietary or confidential information that Applicant desires to be redacted?

☐ Yes ☐ No

If yes, upon award, the Grantee will be given an opportunity to provide a redacted copy.

IV. Research Project Overview – State the broad research objectives, specific research aims and subaims. The research aims and subaims must be listed here and be the same as the aims and subaims contained in Item IX.

(A) of the Research Plan. The specific objective related to minority research training must be listed after the other research objectives.

Describe the methods for achieving the aims and subaims. Do not include information about the qualifications of the researchers to perform the research or expectations that the research will lead to publications and Grant awards. Information concerning publications and Grant awards must be placed in Item XVI. (B) Performance Measures. Responses must be single-spaced, left aligned, not exceed 25 lines of text, and in the font styles and sizes specified in the Introduction to the Research Proposal. Spell out acronyms the first time they are used. Do not include the names of investigators, footnotes, references to literature, graphics, or proprietary or confidential information.

(Insert Research Project Overview here):

V. Expected Research Outcomes and Benefits – Describe the expected outcomes and benefits of the research project. Include information on how the project will improve health status. Do not include information about the qualifications of the researchers to perform the research or expectations that the research will lead to publications and Grant awards. Information concerning publications and Grant awards must be placed in Item XVI. (B) Performance Measures. Do not repeat sentences contained in Items III and IV. Responses must be single-spaced, left aligned, not exceed 20 lines of text, and in the font styles and sizes specified in the Introduction to the Research Proposal. Do not include the names of investigators, footnotes, references to literature, graphics, or proprietary or confidential information.

(Insert Expected Research Outcomes and Benefits here):

VI. Health Disparities – Describe briefly how the research project will identify and address disparities in health status, outcome, prevention or treatment. Health disparities are differences in the incidence, prevalence, mortality and burden of disease or injury and related adverse events that exist among minority groups, rural populations, urban populations and other specific population groups.

The research priority states that the research project must hold potential for addressing the health needs of underserved segments of the population, including rural, urban, racial and ethnic minorities, or other high-risk populations. In order to address health disparities, applicants must conduct research on populations that are at high risk for the condition. By identifying risk factors and interventions that work with high-risk populations to reduce the burden of disease, the research must help to reduce health disparities. Responses must be single-spaced, not exceed 25 lines of text, and in the font styles and sizes specified in the Introduction to the Research Proposal.

(Insert Health Disparities here):

VII. Management and Staffing Plan – This section must be informative to scientists, researchers, clinicians and physicians who are working the same field as the proposed research. There is no required format for providing the information. Do not exceed two pages, including this page.

The Management and Staffing Plan must include the following items:

(A) Identify collaborating organizations and subcontractors and describe their specific roles in the project. A substantive and meaningful role must be described for every collaborating organization.

(B) Provide a diagram and a management plan that describes how the organizational units and principal investigators for each specific aim will communicate and work together.

(C) Include a description of personnel responsible for oversight of IRB protocols, oversight of supported research, mentoring of junior investigators, administrative and fiscal responsibilities and communication with the Department.

Insert Management and Staffing Plan below.

VIII. Key Research Personnel - Use the separate forms provided below to provide required information for the Contact Principal Investigator at the lead applicant organization, other key personnel at the lead applicant organization, key personnel at subcontractor organizations, and external consultants and advisory committee members (if the project includes an external advisory committee).

Key research personnel are defined as persons who contribute in a substantive way to the scientific development and execution of the research activities. Persons responsible for subject recruitment and enrollment are considered to be key research personnel.

Typically, key personnel have doctoral or other professional degrees, although persons with masters or baccalaureate degrees must be included if their involvement meets the definition. External consultants who are not employed by the applicant organization or subcontractors must be included only if their involvement meets the definition. Those persons providing technical or administrative services are not considered key research personnel.

The Contact Principal Investigator is the principal point of contact for all Grant-related reports and is responsible for ensuring compliance with all Grant provisions. The Contact Principal Investigator must be employed by the lead applicant organization at the time that the application is submitted to the Department. The research project may designate multiple Principal Investigators;

however, one person must be designated as the Contact Principal Investigator. The Contact Principal Investigator must be listed as Grant Coordinator (Contact Principal Investigator) on the Cover Page.

For each position listed, provide the name (first name, middle initial, last name) and no more than three degrees (for example, Jane E. Smith, MD, PhD, MPH – DO NOT put periods in the degrees). Describe the specific role of the person on the research project’s various specific aims, for example, principal investigator (PI) for aim 1, co-principal investigator (co-PI) for aims 2 and 4, project director for aim 3, biostatistician for entire project, project coordinator for study recruitment/enrollment in aim 1, research associate for aim 1, research assistant for aim 2, research technician for aim 1, external advisory committee member for entire project, external consultant for aim 2. DO NOT use “Postdoctoral Fellow,” “Doctoral Student” or “Graduate Student” because these titles do not adequately describe the person’s research role on the project. If any Grant funds will be used for a position as indicated by checking “Yes” below, the position must be listed in the budget. The role of the person in the budget and on this form must be the same. For example: if Susan Black, PhD is listed as a Co-Investigator and the “Yes” box is checked below, “Co-Investigator” must be listed in the budget. Names are not to be listed in the budget.

Indicate the percentage of effort that will be provided by each position to the research project. If the percentage varies by year, break down the percentage by year, for example, Years 1 & 2 – 20 percent, Year 3 – 15 percent, Year 4 – 5 percent.

Add or delete space as needed on the appropriate form in order to provide information on all key personnel. List all employees for a subcontractor together.

Responses must be single-spaced, in Arial font that is no smaller than 10-point type and left aligned.

DO NOT replace Yes/No Check boxes with images or an ‘X.’

CONTACT PRINCIPAL INVESTIGATOR AT LEAD APPLICANT ORGANIZATION

NAME (First Name MI Last Name) DEGREE(S)

RESEARCH ROLE ON PROJECT

Contact Principal Investigator

NAME OF EMPLOYER (APPLICANT ORGANIZATION)

EMAIL ADDRESS MAILING ADDRESS (Street, City, State, Zip Code)

Percentage of effort on the project: Will any Grant funds be used for this position? ☐Yes ☐No

CONTACT ALTERNATE PRINCIPAL INVESTIGATOR AT LEAD APPLICANT ORGANIZATION

EMAIL ADDRESS MAILING ADDRESS (Street, City, State, Zip Code)

OTHER KEY PERSONNEL AT LEAD APPLICANT ORGANIZATION

RESEARCH ROLE ON PROJECT (specify role on project and include aims on which person will work)

Percentage of effort on the project: Will any Grant funds be used for this position? ☐Yes ☐No

RESEARCH ROLE ON PROJECT (specify role on project and include aims on which person will work)

KEY PERSONNEL FOR SUBCONTRACTOR(S) List all the employees of a subcontractor together.

EXTERNAL CONSULTANTS AND ADVISORY COMMITTEE MEMBERS:

RESEARCH ROLE ON PROJECT NAME OF EMPLOYER

IX. Research Plan - The research plan must describe health research leading to the discovery of scientific knowledge that can be applied to improve health status. The research plan may include information on the development of cores or other research-capacity building activities; however, the focus and emphasis must be on the actual research to be conducted, that is, the data that will be collected and analyzed and methods that will be developed to test hypotheses and generate new knowledge that is intended to lead to improvements health related technologies, treatments, services or preventive interventions. The Research Plan must describe only the research to be accomplished within the Grant award period of funding, which may not exceed 48 months. No-cost extensions beyond 48 months are not permitted.

The Research Plan consists of the following sections: (A) Specific Aims, (B) Background and Significance, (C) Preliminary Studies, and (D) Research Design and Methods and (E) Timeline and Milestones.

The entire Research Plan must not exceed 25 single-spaced, single-sided pages. This page of instructions is not counted in the 25-page limit. Specific page limitations are provided for sections A, B and C.

(A) Specific Aims - List the research objectives and specific research aims that will be achieved during the Grant period as part of the research to be conducted. State the specific hypotheses to be tested and research objectives (for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop a product or new technology). The Research Plan must contain a specific aim related to minority training. The specific aim related to minority training must be listed after the other research aims. Do not exceed two pages.

(B) Background and Significance - Summarize the background leading to the project. Evaluate existing knowledge and identify the gaps in knowledge that will be addressed by the research project. Identify the significance of the research project and the contribution that it will make to improvements in clinical practice and health services. Do not exceed three pages.

(C) Preliminary Studies - Describe prior research and preliminary studies that are relevant to the proposed project and that have been completed by the Principal Investigator and key research personnel. Describe pilot studies that have been conducted to test and refine the methods proposed in this application. Include experience with and outreach to the racial and ethnic populations that are targeted by the research project. If the project involves human subjects, describe pilot studies which demonstrate feasibility of the project, including the feasibility of recruitment strategies and anticipated retention rates. Provide information that will enable reviewers to assess the Principal Investigator’s experience pertinent to the project and the experience of staff responsible for study recruitment and enrollment.

Do not include copies of publications. Do not exceed five pages.

(D) Research Design and Methods - Describe the conceptual framework, research design and limitations of the research design, definition and measurement of key variables, data collection methods, data sources and quality, randomization, analysis plan, sample size estimate, statistical power. Describe any new methodologies and their advantage over existing methodologies. Describe novel approaches, technologies, tools, and concepts. Discuss potential problems and alternative strategies to be used, if needed, to achieve the specific aims. For the minority training aim, describe recruitment plans and methods, including sources and availability of student trainees; anticipated number of students to be trained; and criteria and procedures by which students will be selected. Describe how students will be involved in the conduct of the research specific aims. Describe a plan to evaluate the training program including a method to obtain training program graduates’ recommendations on how to improve the program. Include a method to track the impact of the program on training program graduates’ applications for additional higher education and careers in the health sciences and research fields. For aim(s) involving human subjects, describe inclusion and exclusion criteria; outreach and recruitment methods; sites for recruiting subjects and the demographics of the clientele at those sites; alternative strategies to boost recruitment if problems occur;

justification for anticipated enrollment and retention rates; staff responsible for recruitment and enrollment; justification of anticipated differences in outcomes between experimental and control groups; and data management plan including where the data will be maintained and confidentiality procedures. For clinical trials, describe expected gender, race, and ethnicity differences in intervention effect and include supporting evidence from animal studies, clinical observations, epidemiology or other relevant studies. Include data analysis plans to determine intervention effect.

(E) Timeline and Milestones - For each specific aim, include a timeline, using the format shown below, to show specific, measurable milestone(s) that will be accomplished by the end of each state fiscal year. If there are subaims or more than one study under a specific aim, specify the number of the subaim or name of the study to which each milestone applies. Do not change the time periods in the timeline shown below. These time periods are the reporting periods for the annual progress report as explained in Item XVIII.

For aim(s) involving human subjects indicate on the timeline the number of persons to be recruited as cases and controls for each reporting period and the start and end dates for recruiting subjects.

State Fiscal Year Milestones for Specific Aim # 7/1/27 - 6/30/28 7/1/28 - 6/30/29 7/1/29 - 6/30/30 7/1/30 – 6/30/31

X. Other Sources of Support – Indicate other sources of support for the project.

A.) Are other funds being sought for this Project? ☐Yes ☐No

If yes, specify what sources are being sought here:

B.) Do other funds currently support this project? ☐Yes ☐ No

If yes, specify sources and amounts of other current funding and how the proposed project differs from currently funded research efforts:

Name of organization providing funding

Amount of funding

How does the proposed project differ from the currently funded research supported by this source?

C.) Does the applicant have letters of support for the project and or letters indicating commitment funds from other sources for this project? ☐Yes ☐No If yes, include copies of letters of support per the RFA, as Section Two to the Research Proposal using the Letters of Support form provided.

Name of organization from which other funds are being sought Amount of funding being sought

XI. Research Project Performance Sites – Beginning with the lead applicant organization, indicate the sites where the work described in the Research Plan will be performed. Explain the role(s) of the site in the project, for example, overall project coordination and Aim 1 clinical trial, Aim 2 animal study, Aim 3 minority research training program. Indicate county in Pennsylvania where the site is located.

For the additional project sites, indicate the mailing address of the organization. Add or delete space, as needed, following the format for Additional Project Site Location.

PROJECT SITE PRIMARY LOCATION

NAME OF APPLICANT ORGANIZATION

ROLE ON PROJECT

COUNTY

ADDITIONAL PROJECT SITE LOCATION

NAME OF ORGANIZATION

ROLE ON PROJECT

COUNTY MAILING ADDRESS (Street, City, State, Zip Code)

ADDITIONAL PROJECT SITE LOCATION

NAME OF ORGANIZATION

ROLE ON PROJECT

COUNTY MAILING ADDRESS (Street, City, State, Zip Code)

ADDITIONAL PROJECT SITE LOCATION

NAME OF ORGANIZATION

ROLE ON PROJECT

COUNTY MAILING ADDRESS (Street, City, State, Zip Code)

XII. Facilities and Resources – Describe the existing facilities and resources available to conduct the proposed research at all performance sites in the same order as the sites are listed in Research Project Performance Site Section. Describe the capabilities, capacities, and extent of availability to the project for only those facilities and resources that are applicable and will be used for the proposed work. This information will be used by reviewers to evaluate the adequacy of the facilities and resources to perform the proposed research. There is no required format for providing the information, and there are no space limitations, but be succinct.

The description of currently existing facilities and resources must include the following items:

(A) Performance Site. Indicate name of organization.

(B) Laboratory facilities and resources

(C) Clinical facilities and resources

(D) Animal facilities and resources

(E) Computer facilities and resources

(F) Office(s)

(G) Major Equipment. List important equipment to be used, noting location and capabilities.

Insert the Facilities and Resource information after this page.

XIII. Allocation of Costs for Biomedical, Clinical and Health Services Research - Using the following format and example, provide a breakdown by specific aim of expenditures for the entire project. For each specific aim, specify the costs by type of research (biomedical, clinical or health services research) to be conducted. If a specific aim consists of more than one study or subaim, list each study and subaim separately, as shown in the example below. Do not include indirect and overall project management costs under one specific aim; distribute these costs across all specific aims. See definitions of biomedical, clinical and health services research in Section D, Research Information and Priorities of the RFA. Patient oriented (clinical) research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects. Excluded from this definition are invitro studies that utilize human tissues that cannot be linked to a living individual and studies on animals.

Specific aims Total cost to complete the aim

Cost of biomedical research to complete the aim

Cost of clinical research to complete the aim

Cost of health services research to complete the aim

Specific aim 1 (one study

– 100% biomedical) Specific aim 2, study/subaim 1 (100% health services research)

Specific aim 2, study/subaim 2 (50% health services, 50% clinical)

Specific aim 3 (one study

– 100% health services) Specific aim 4, minority training program (half students involved in health services research, half students involved in clinical research study)

Total budget Percent of total budget

XIV. Budget Narrative - Provide a separate, detailed narrative for the budget of the lead applicant organization and each subcontractor. The narrative must be for the entire budget period, rather than a narrative for the first year of the project. Include an explanation for each budget line in the Excel budget. The dollar amount specified in the budget narrative must equal the amount for that budget line in the Excel budget. Do not provide a separate budget narrative for each specific aim. There are no space limitations for this section. The budget narrative must include the following items.

(A) Indicate the name of the organization.

(B) For each position listed in Category I A - Staff Personnel, provide the name of the person and a description of the person’s work on various specific aims. Include this information for “To Be Announced (TBA)” positions. Explain rationale if the percent of effort varies by year. Do not include information on the person’s qualifications or experience here. The Contact Principal Investigator must be included in the budget for the applicant organization.

(C) For each line listed in Category II – Consultant Services, provide the name of the consultant and a description of the services that the consultant will perform on various specific aims. If the consultant is from out-of-state, explain rationale for not using an in-state consultant.

(D) For each line listed in Category III – Subcontract Services, provide the name of the subcontractor and a description of the subcontractor’s work on various specific aims. If the subcontractor is from out-of-state, explain rationale for not using an in-state subcontractor.

(E) For each line listed in Category IV - Patient services, provide a narrative explaining the tests and services to be provided per patient. Explain number of tests with regard to number of participants in the experimental and control groups, pre-tests, and post-tests.

(F) For each line listed in Category V – Equipment, provide a justification of the need for the equipment. Allowable items are limited to research equipment and apparatus not already available for the conduct of the proposed research. Equipment is defined as an item of property that has an acquisition cost of $5,000 or more.

(G) For each line listed in Category VI – Supplies, provide a justification of the number of supplies needed relative to the number of subjects or laboratory animals involved in the research project, as appropriate.

(H) For Category VII – Travel, provide justification for travel by explaining the purpose of various trips, for example, travel to train personnel at performance sites and travel to present papers. For trips involving airfare, include the number of separate trips and their purpose, destination and number of individuals for each trip.

(I) For each line listed in Category VIII – Other Costs / Laboratory or Building Construction or Renovations, provide an explanation of the other costs, a rationale for number of items needed and any other information which explains the budget line item. Provide an explanation of the need for the new facility, including why the proposed work cannot be conducted in existing research facilities.

XV. Curriculum Vitae, Resumes or Biographical Sketches – Provide the following information for key personnel in the same order as they are listed in Research Personnel section. Biographical sketches are required for the Contact Principal Investigator, other key personnel at the lead applicant organization and each subcontractor’s key personnel. Biographical sketches are recommended, but not required, for external advisory committee members and consultants. On the top of the first page of the biographical sketches of subcontractor key personnel, insert the name of the subcontractor. On the top of the first pages of the biographical sketches of the external advisory committee members and consultants, insert “External Advisory Committee” or “Consultant,” as appropriate. Do not exceed four pages per biographical sketch. There is no required format for providing the information. NIH Grant application biosketches are compatible with the required information and may be used.

The biographical sketch must include the following items and may not exceed four pages:

(A) Name of Researcher (First, MI, Last);

(B) Position title. Indicate the current title of the position held at the researcher’s current place of employment;

(C) Education and training. Include degree(s), year(s) awarded and field(s) of study;

(D) Selected peer review publications. Do not include publications submitted or in preparation. URLs may accompany references only if the publication is available to the public. Reviewers are not required or advised to view the internet sites; and

(E) Research support. List research support received for current research projects or projects completed within the past three years.

Begin with projects which are the most relevant to the proposed research project. Indicate goals of projects and researcher’s role on the project.

Insert biographical sketches after this page.

XVI. Evaluation Component and Research Evaluative Procedures – Explain the evaluative procedures of the research project.

Responses must be single-spaced, in Times New Roman font that is no smaller than 10- point type and left aligned and must not exceed 40 lines of text.

(A) Oversight and Statistical Tests – Describe project oversight and evaluation by other researchers, and statistical tests to be used, if any.

(Insert oversight and statistical tests here):

(B) Performance Measures – Describe performance measures to be used to determine the impact and success of the research project.

Performance measures may include publications, changes in risk factors, grant awards obtained based on preliminary data obtained from the project and other measures of the project’s outcome, impact or effectiveness.

(Insert performance measures here):

(C) Evaluation/Performance Review – The research project will be evaluated by means of the performance review process. See Section XXIV, Reporting Requirements. This section requires no response.

XVII. Research Subjects and Materials - Research performed under this grant agreement and all individuals performing such research must adhere to federal ethical and procedural standards for conduct of research as prescribed by the National Institutes of Health (NIH).

DO NOT replace Yes/No Check boxes with an X. Click in the box to fill. Only complete one check box.

Complete items (A) – (E) below.

(A) Does the project involve human subjects research as defined in Application to the Pennsylvania Department of Health Institutional Review Board for Approval of Research Project under the Federal Policy for the Protection of Human Subjects?

☐Yes ☐No If answered Yes, complete Application to the Pennsylvania Department of Health Institutional Review Board (see Attachment VIII) and submit documentation of IRB approval or exemption from review. If answered No, but the project involves human specimens or data, complete Application to the Pennsylvania Department of Health Institutional Review Board (see Attachment VIII) and include documentation from Applicant’s IRB stating that the research does not constitute human subjects research.

If answered Yes, include a response to Item XVIII. Protection of Human Subjects.

(B) Does the project conduct a clinical trial as defined by the NIH? ☐Yes ☐No NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to:

drugs/small molecules/compounds, biologics, devices; procedures; delivery systems (for example, telemedicine, face-to-face); strategies to change health-related behavior (for example, diet, cognitive therapy); and treatment, prevention, and diagnostic strategies. A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters;

psychological or neurodevelopmental parameters; disease processes; health-related behavior; and well-being or quality of life.

If answered Yes, include a detailed data safety monitoring plan in Item XIX.

(C) Does the project’s research use human embryonic stem cells (HESC)? ☐Yes ☐No Only HESC lines that are approved by the National Institutes of Health and derived from outside of Pennsylvania may be used in the research project.

(D) Does the project’s research involve recombinant DNA? ☐Yes

(E) Does the project’s research involve vertebrate laboratory animals?

☐No

☐ Yes No

XVIII. Protection of Human Subjects – Applicants are responsible for safeguarding the rights and welfare of individuals who participate in research activities. All research involving human subjects must be reviewed and approved by the applicant’s appropriate institutional review board prior to the initiation of such research and use of Grant funds to pay for such research. The Certifications form for the Protection of Human Subjects and Regarding the Use of Human Embryonic Stem Cell Research is Attachment VI of Part Two of the RFA. The applicant is not required to file an Assurance of Certification with the National Institute of Health’s Office for Protection of Research Risks. If the research project involves human subjects, the Application to the Pennsylvania Department of Health Institutional Review Board (see Attachment VIII of Part Two of the RFA) must also be completed.

The following information must be provided in detail for each study involving research on human subjects. For this section of the application, use the same headings as listed in items (a) – (j) and include information on each item.

(a) Number of specific aim and study title;

(b) Risks to human subjects;

(c) Adequacy of protection against risks;

(d) Recruitment of subjects;

(e) Informed consent;

(f) Data confidentiality and provision for medical or professional intervention, if needed;

(g) Potential benefits of the research to the subjects;

(h) Importance of knowledge to be gained;

(i) Inclusion of women and minorities - Women and members of minority groups and their subpopulations must be included in Department-supported clinical research or health services research projects unless their inclusion is inappropriate due to the purpose of the research project or the health of the subjects. If women or minorities are excluded, describe the rationale for the exclusion; and

(j) Inclusion of children - Children (that is, individuals under the age of 21) must be included in Department- supported clinical research or health services research projects unless their inclusion is inappropriate due to the purpose of the research project or the health of the subjects. If children are excluded, describe the rationale for the exclusion.

There are no space limitations for this section. Insert required information for each applicable study below.

If answered Yes to Item XVII (A), insert Protection of Human Subjects information in (a) –

(j) below. Exception: if Applicant’s IRB determined that the project is exempt from IRB review because it uses de-identified human specimens or data, do not complete (a) - (j) below.

(a) Number of specific aim and study title:

(b) Risks to subjects:

(c) Adequacy of protection against risks:

(d) Recruitment of subjects:

(e) Informed consent:

(f) Data confidentiality and provision of medical or professional intervention, if needed:

(g) Potential benefits of the research to subjects:

(h) Importance of knowledge to be gained:

(i) Inclusion of women and minorities in the research:

(j) Inclusion of children in the research:

If answered Yes to Item XVII (B), include a detailed Data Safety Monitoring Plan in Item XIX.

XIX. Clinical Trials and Data Safety Monitoring Plan: Federal Public Law 110-85 mandates registration and results reporting of "applicable clinical trials" in ClinicalTrials.gov. Under the statute these trials generally include: (1) Trials of Drugs and Biologics, including controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices, including controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance.

The Department encourages registration of all clinical trials whether required under the Federal law or not.

For all Department-supported clinical trials, a detailed data safety and monitoring plan is required to provide oversight of the trial and ensure the safety of participants and the validity and integrity of the data. Include a plan which describes procedures for reporting adverse events, ensuring participant safety and maintaining the integrity of the data. A Data and Safety Monitoring Board (“DSMB”) is required for a multi-site clinical trial. If a DSMB is proposed, include the list of members and frequency of meetings. There are no space limitations for this section. If answered “Yes” to Item XVII (B), a data safety and monitoring plan must be described here.

XX. Targeted/Planned Enrollment Table – The table must be submitted in the following format for specific aim(s) involving clinical research and health services research, including outcomes research. Complete a separate table for each applicable study. Label each table with the number of the specific aim and study title.

Specific Aim #:

Study Title:

Total Planned Enrollment:

TARGETED/PLANNED ENROLLMENT: Number of Subjects

Ethnic Category Sex/Gender

Females Males Total

Hispanic or Latino

Not Hispanic or Latino

Ethnic Category: Total of All Subjects *

Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Racial Categories: Total of All Subjects *

* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”

XXI. Consortium/Contractual Agreements - Explain specific fiscal, programmatic and administrative arrangements with collaborative organizations and subcontractors that will carry out any of the research project activities. Include qualifications of subcontractors. The subcontractor investigator and the authorized official of the subcontractor must provide, in the application, a signed statement or confirming letter that the appropriate programmatic and administrative personnel are aware of the Department of Health requirements contained in the grant agreement and that they are prepared to establish the necessary inter-institutional agreements consistent with Department Grant requirements. Place the signed statements or confirming letters in Section Two of Attachment III Letters of Support. The awarded applicant is responsible for assuring that the subcontractor adheres to Department Grant requirements.

There are no space limitations to this section but be succinct. Insert requested information on consortium and contractual Agreements below.

XXII. Consultants – If consultants are included in the application, attach a letter from each consultant confirming the consultant’s role in the project. Place the letters in Section Two of Attachment III, Letters of Support.

Applicant is not required to provide information in this section.

XXIII. Literature Cited – There are no space limitations for this section. List references for literature cited in the Research Plan below.

XXIV. Reporting Requirements

The awarded applicant agrees to the following reporting and accountability requirements.

Awarded applicants are required to submit to the Department one copy of the following reports in electronic form.

1. A written Annual Progress Report is due 30 calendar days after the end of each state fiscal year (SFY) or 60 calendar days after the end of the grant agreement in the year that the grant agreement ends. The Awarded applicant shall submit the progress report in a format to be determined by the Department. The report must include a detailed summary of research completed during the SFY and other information as required by the Department.

Annual Progress Reports are posted to the Department’s Commonwealth Universal Research Enhancement (“CURE”) website in November as part of the Annual Report to the Legislature.

2. A written Interim Progress Report is due 12-15 months after the grant agreement effective date. The awarded applicant shall present their progress to a peer review panel. The interim report must, at a minimum, identify if activities are proceeding according to the project plan, and explain any deviations from the project plan. Any changes to the scope of research during the term of the grant agreement must be approved in writing by the Department. The awarded applicant shall submit a written response to the interim performance review report within 30 calendar days after the Department provides a copy of the report.

3. A written Final Progress Report and copies of any publications based on research funded by this award is due 60 calendar days after the end date of the grant agreement. The final report must provide a detailed summary of the progress achieved over the entire award period. The report must include a detailed description of the methods and findings and evidence of the data that were generated and analyzed including appropriate tables, graphs and figures. In addition, the final report must contain the following information and other information as required by the Department such as collaborative research activities, business and community involvement, research activities that lead to population-based applications addressing disparities in health status and access among various Pennsylvania populations, improvements in infrastructure and increased research capacity including new investigators, new grants, new discoveries, and new products.

a. Progress made in achieving expected research outcomes and benefits.

b. (If the project involves clinical research) Extent of clinical activities initiated and completed, including:

(1) the number of treatment, prevention and diagnostic studies initiated and completed;

(2) the number of hospital and health care professionals involved in the research project;

(3) the number of subjects relative to targeted goals; and

(4) the extent of penetration of the studies throughout the region or

Pennsylvania.

c. Number of peer-reviewed publications released.

d. Number of inventions and patents filed, including commercial development opportunities initiated and completed.

e. Any changes in risk factors; services provided; incidence of disease;

death from disease; stage of disease at time of diagnosis; or other relevant measures of outcome, impact and effectiveness of the research being conducted.

f. Any major discoveries, new drugs and new approaches for prevention, diagnosis and treatment, which are attributable to the completed research project.

4. A written response to a Performance Review Report is due 30 calendar days after the Department provides the awarded applicant with a copy of the Performance Review Report.

5. An Annual Expenditure Report for each SFY is due by July 31st and a final expenditure report within 60 calendar days after the end date of the grant agreement. The expenditure reports must be submitted using the forms contained in Part Two, Attachment XI of the

RFA.

6. The awarded applicant(s) shall submit to the Department’s Project Officer an annual assessment report once per calendar year throughout the term of the Grant Agreement, using the “CLAS Self-Assessment Tool for Grantees” template that can be found at the following link: https://www.pa.gov/en/agencies/health/resources/contractor-grantee.html. The annual report must summarize in detail how the awarded applicant(s) have met the Health Equity requirements contained in paragraph 22 of the Department Standard General Terms and Conditions (Grant) (Rev. 12/24).

An applicant that receives a health research grant agreement under the Tobacco Settlement Act 2001-77, is subject to an evaluation via a performance review by the Department upon completion of the research project, or more often if deemed necessary by the Department.

The performance review is based on the requirements specified by Act 2001-77 and criteria developed by the Department in consultation with the Health Research Advisory Committee.

As part of the performance review process, each research project funded as part of the grant agreement is reviewed by at least three experts who are physicians, scientists or researchers.

Reviewers are from the same or similar discipline as the research project under review and are not from Pennsylvania. Reviewers use the applicant’s strategic research plan, Annual Progress Reports, Final Progress Report and publications that resulted from the project and acknowledge Department funding to conduct the review.

Upon completion of the performance review process, the Department will provide each awarded applicant with a copy of the Performance Review Report containing the outcome of the review (outstanding, favorable, or unfavorable) for each project and for the grant https://www.pa.gov/en/agencies/health/resources/contractor-grantee.html https://www.pa.gov/en/agencies/health/resources/contractor-grantee.html agreement as a whole, strengths and weaknesses of each research project, and recommendations for future improvement. The awarded applicant must provide an electronic copy of a written Response to the Performance Review Report within 30 calendar days after the awarded applicant receives the Performance Review Report.

An applicant that receives an unfavorable final performance review by the Department may be subject to a reduction in funding, become ineligible for health research funding in the future or may be required to remit some or all of the funding for a grant agreement that received an unfavorable final performance review.

The Final Performance Review Report, as well as the awarded applicant’s written response to the Final Performance Review Report and the Final Progress Report will be posted on the CURE website approximately 12-16 months after the end of the grant agreement.

The awarded applicant may also be required to provide other written reports such as a brief progress report or a written report during the conduct of performance reviews.

In addition to written reports, the Department may request other information as needed and may conduct one or more site visits to review the progress of the health research project.

Awarded applicants may also be required to provide oral reports to an advisory committee to the Department at the request of the Department.

The awarded applicant shall inform the Department of any changes in principal investigator or administrative officer, within 14 calendar days after the change.

RFA # 67-211

Attachment III (Section Two)

LETTERS OF SUPPORT

Letters of support from subcontractors and consultants are inserted after this page, as a separate PDF.