Application Requirements 2017-2018 Grant Cycle Jeffrey Kahn, M.D., - - PowerPoint PPT Presentation

Center for Translational Medicine

Translational Pilot Program

Application Requirements 2017-2018 Grant Cycle

Jeffrey Kahn, M.D., Ph.D. Professor and chief of pediatric infectious disease Director, CTM Translational pilot program

Agenda

• Overview
• Award Information
• Pre-requisite Requirements
• Application and Submission Information
• Office Hours/Staff Contact
• Questions and Answers

Overview

Program Goals

• Promote and support the development and testing of

new research ideas;

• Stimulate novel translational ideas of young investigators;
• Encourage interdisciplinary collaboration; and
• Assess the feasibility of new approaches to translational

research through inter-disciplinary collaboration that lead to extramural funding.

Overview

Project must address at least one of the following:

• Translational Research: Includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in

preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.

• Clinical Research: Includes clinical trials with human subjects to test intervention safety and effectiveness, behavioral and observational studies,
• utcomes and health services research, and the testing and refinement of new technologies. The goal of many clinical trials is to obtain regulatory approval for an

intervention.

• Community-Based Research: Is a collaborative effort between academic researchers and non-academic based community members that

aims to generate social action and positive social change through the use of multiple knowledge sources and research methods. Ideally, the research questions

• riginate from off-campus communities and the process involves meaningful participation by all partners in every stage of the research.
• Health Services Research:

Examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety.

• Team Science: Is used to refer to a collaborative approach that draws concepts and technologies from multiple fields to develop a new perspective on

answering research questions or solving complex problems. While traditional single-investigator driven approaches are ideal for many scientific endeavors, coordinated teams of investigators with diverse skills and knowledge may be especially helpful for studies of complex social problems with multiple causes.

Overview

Review Criteria

The main criteria for funding will be the scientific quality, innovation, sustainability (i.e., the likelihood of obtaining future extramural funding), and environment. Therefore, it is particularly important for mentored applicants to provide details of the sustainability of the research environment to ensure a high likelihood of success. Applicants will also be judged based on their career trajectory and the quality and suitability of the research-training environment.

Overview

• Protection for Human Subjects, Inclusion of Women, Minorities, and

Children, as applicable to 45 CFR Part 46 and according to NIH guidelines for the review of human subjects found in: http://grants.nih.gov/grants/how-to-apply- application-guide/forms-d/supplemental-instructions-forms-d.pdf

• Vertebrate Animals according to NIH guidelines found in:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html

• Overall Impact: Reviewers will provide an overall impact score to reflect their

assessment of the likelihood for the project to exert a sustained, powerful influence

• n research field(s) involved.

Additional Review Criteria

Award Information

SOURCE National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) ANTICIPATED NUMBER OF AWARDS Approximately six (6) awards AWARD BUDGET Not to exceed $50,000 AWARD PROJECT PERIOD May 1, 2017 to April 30, 2018

Funding

PERSONNEL

May be used for any of the following salary support: non-PI research personnel such as research nurse, technician, data entry personnel, consultants, etc. Personnel costs must include the appropriate amount of fringes.

SERVICE PROVIDERS

Funds may be used to offset costs for laboratory analyses, data collection, database design/support, research coordinator services, or other services provided by core facilities on the UT Southwestern campus. A list of UTSW Service Providers is provided on the Application Forms spreadsheet. Applicants should seek consultation with proposed service providers to ensure sufficient funds are requested and that all related services are included. A price quote must be attached to the application if core service funding is requested in the budget. Price quotes are price estimates based on discussions with the core(s) of your choice. Price quotes must be generated by and come from the core facility.

EQUIPMENT

Equipment is an article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds $5,000. Equipment may be purchased only if such equipment is essential and allocable and not otherwise available for use by the applicant through a core facility on the UT Southwestern

• Campus. All equipment purchases must comply with the NIH Grants Policy Statement and UT Southwestern purchasing

requirements.

SUPPLIES

Funds may be used to offset materials and supplies necessary to carry out the proposed research.

INPATIENT AND OUTPATIENT CARE COSTS

Funds may be used to offset costs for inpatient or outpatient research visits, including hospital fees, nursing, metabolic services and meals, facility usage fees, investigational drug services, lab processing, etc.

OTHER EXPENSES

Funds may be used to offset costs for study subject payments, publication-related expenses, and expenses not included in the other budget categories.

Approved uses of Funds

PI SALARY AND FRINGE

Not allowed.

TRAVEL

Not allowed.

INDIRECT COSTS (F&A) Including subcontracts with CTSA partnering institutions. NOTE: Applicants from partnering institutions should

• btain a waiver for F&A from their institution as a condition
• f award (contact the CTM for assistance in obtaining this letter).

Non-approved uses of Funds

Requirements

• Must have eRA Commons Account.
• To obtain go to*:

http://www.utsouthwestern.net/intranet/administ ration/sponsored-programs/. Click on NIH eRA

Commons User Account Request form, complete and submit.

*If not from UTSW, contact institution.

Registration

• IRB or IACUC approval must be in place prior to

submission of an application for funding.

• Strongly recommended that study approval be submitted to the

review office to allow sufficient time for board to review/approve by the submission deadline of December 15, 2016.

IRB/IACUC Approval Required Pre-requisites

NOTE: If having difficulty getting timely approval, please contact CTM when IRB is submitted and we will work with contacts to expedite.

Application and Submission Information

• Face Page
• Current Committed Effort
• Budget
• Budget Justification

Form

Face Page: Budget Request

Total Budget Request Do not enter in amount. This amount will automatically populate from the budget page.

Face Page: Principal Investigator/Application Information

Name

Last name and first name of applicant.

eRA Commons ID

Indicate eRA Commons ID.

Degree

Indicate highest degree obtained.

Academic Rank

Official rank as designated by applicant’s primary institution. NOTE: A mentor is required for applicants who are post-doctoral fellows, residents, and fellows.

Proposed Effort %

Indicate amount of effort devoted to the project. Effort must be sufficient to achieve the proposed aims during the project. Must be reported in the current committed effort tab.

Department/Division

Full official name of institutional department where applicant holds primary appointment.

Institution

Institution where applicant holds primary appointment.

Phone

Applicant’s office phone.

E-mail

Applicant’s institutional e-mail address.

Administrative Contact/Phone

Administrative official who will serve as contact for administrative matters in the event that CTM has questions/concerns during the application/review process.

Department Financial Contact/Phone

Financial official who will work with the CTM (if funded) on subledger set-up and who is involved with processing HCM forms and budgetary information in the Department.

______________________________________________________

Face Page: Project Information

Title of Project

State the title of project exactly as it appears in the IRB or IACUC approval letter.

Type of Project

Using the definitions from the FOA, select which type(s) of research most appropriately describes your proposed project.

Human Subjects Research

Provide IRB number, if applicable. NOTE: Must have IRB approval at the time the application is submitted.

Vertebrate Animal Research

Provide the status/number of IACUC approval, if applicable.

Project/Performance Site Primary Location

Physical address and name of lab (if applicable) that will serve as the primary performance site for the work being performed under the proposed request.

Face Page: Co-Investigators and Collaborators

Name

Last Name and First Name of Co-Investigator or Collaborator.

eRa Commons ID

Indicate eRA Commons ID.

Degree

Indicate highest degree obtained.

Academic Rank

Official rank as designated by applicant’s primary institution.

Proposed Effort %

Indicate amount of effort devoted to the project. Effort must be sufficient to achieve the proposed aims during the project. Must be reported in the current committed effort tab.

Department/Division

Full official name of institutional department and division where applicant holds primary appointment.

Institution

Institution where applicant holds primary appointment.

Respond to Questions

Mark YES or NO on question regarding junior investigator, KL2 and Clinical Scholar.

Role on the Project

Indicate role (Co-Investigator or Collaborator).

Describe Role on Project

Provide a description of what role the Co-Investigator/Collaborator will perform on project.

Key Personnel

Indicate whether the Co-Investigator/Collaborator is a Key Personnel. NOTE: A biosketch must be provided for all Key Personnel.

________________________________________________________

Current Committed Effort: PI/Co-Investigator(s)/Collaborator(s)

Principal Investigator/Applicant

Indicate name of Principal Investigator/Applicant.

Project

State the title of project.

Grant Name

State the official name of the award.

Funding Source

State the funding source of the award.

% Effort Devoted to Project

Indicate the percentage effort that is devoted to the project.

Co-Investigator/Collaborators

Indicate name of Co-Investigators/Collaborators.

Project

State the title of project.

Grant Name

State the official name of the award.

Funding Source

State the funding source of the award.

% Effort Devoted to Project

Indicate the percentage effort that is devoted to the project.

__________________________________________________________

Budget: Direct Costs Only

__________________________________________________________

• Enter LAST NAME, FIRST NAME at the top of the page.
• Enter SALARY AND WAGES and personnel information and Total (Role on Project, Calendar Months, Calendar

Months, Institution Base Salary as of 5/1/18, Institution Base Salary as of 9/1/18, Salary Requested, Fringe Benefit). TOTAL AL PER ERSONNEL EL REQ EQUES UEST will automatically calculate and populate. Do not enter in amount.

• List SERVICE PROVIDERS (itemize by Core or Individual) and amount on second to last column. Note: Do not

enter in total amount on the last column—the total amount will automatically calculate and populate. NOTE: Remember to include price quotations for all core services requested in the budget as an attachment.

• List EQUIPMENT (itemize) and amount on second to last column. Note: Do not enter in total amount on the last

column—the total amount will automatically calculate and populate.

• List SUPPLIES (itemize by category) and amount on second to last column. Note: Do not enter in total amount on the

last column—the total amount will automatically calculate and populate.

• List INPATIENT CARE COSTS (itemize) and amount on second to last column. Note: Do not enter in total amount
• n the last column—the total amount will automatically calculate and populate.
• List OUTPATIENT CARE COSTS (itemize) and amount on second to last column. Note: Do not enter in total

amount on the last column—the total amount will automatically calculate and populate.

• List OTHER EXPENSES (itemize by category) and amount on second to last column. Note: Do not enter in total

amount on the last column—the total amount will automatically calculate and populate. Note: TOTAL BUD BUDGET ET R REQ EQUES UEST will automatically calculate and populate. Do not enter in the total.

Budget Justification:

• Enter LAST NAME, FIRST NAME at the top of the page.
• Enter NAME/TYPE and provide JUSTIFICATION for each category

under the following:

• PERSONNEL
• SERVICE PROVIDERS
• EQUIPMENT
• SUPPLIES
• INPATIENT CARE COSTS
• OUTPATIENT CARE COSTS
• OTHER EXPENSES

__________________________________________________________

Budget Justification: TIPS

Budget Justification helps reviewers determine why the costs are necessary for the project/and

• r program and how they are calculated.

SALARIES AND WAGES: Provide the name, degree(s), title, time commitment and duties and responsibilities in relation to the project goals and objectives. Example:

Jane Doe, M.D., Evaluation Specialist/Research Associate (effort=12 Calendar Months).

The Evaluation Specialist is responsible for developing and implementing the evaluation component of the project. This position will develop instruments for the collection of evaluation data gathered for presentation to the project staff, advisory committee, and stakeholder groups. This individual will work with content specialists in the assessment and validation of student mastery of the curriculum and course

• content. The position has responsibility for the summative evaluation of the training

program.

Ref efer eren ence: https://health.usf.edu

__________________________________________________________

Budget Justification: TIPS

FOR ALL OTHER BUDGET REQUESTS: (Service providers, equipment, supplies, inpatient care costs, outpatient care costs, other expenses). Indicate the following:

1.

Item Description

2.

Quantity (number, time/period, mileage)

3.

Unit Cost and Total Cost

4.

Justification (why is it necessary for the project and how is it directly allocable to the project [if applicable]. NOTE: Remember to include price quotations for all core services requested in the budget as an attachment.

__________________________________________________________

Research Plan

• Requirements:
• Single-Spaced
• ½” Margin
• Arial 11 Font
• Applicant’s name in header on the right-hand margin of each page
• Paginated in the bottom-right corner of each page

NOTE: All sections of the Research Plan should be combined and submitted as a single PDF file.

Format

Type What to include (Research Plan) Page Limits Hypothesis and Specific Aims

Include ONLY those aims which can be completed within the twelve month budget period.

1 Page Background and Rationale

Provide sufficient and properly cited source documentation of previous research related to the proposed topic of study. Define precisely why the proposed work is innovative; how it challenges current concepts or paradigms that would make extramural funding unlikely in the absence of preliminary data; how it fosters collaborations that would otherwise not take place; or how it establishes the feasibility of an idea in order to support a future grant application.

1 Page Study Design and Methods

Describe how the experimental approach relates to the aims and how the data will be interpreted. Provide a clear understanding of how the investigator will approach the testing of the hypotheses, sufficient detail in the execution of the experiments, and how the data will be interpreted, specifying alternative experimental and/or analytical provisions when pertinent. Must include an outline of potential experimental problems and the solutions devised to overcome them, clinical significance, and a timetable for the performance of the studies. Should focus on the details of the study design, including patient populations and inclusion/exclusion criteria (where appropriate), methods of data collection and analysis, and must include a statistical analysis plan.

4 Pages Multidisciplinary Team Approach

Describe the specific contributions of all co-investigators and collaborators, and include their primary discipline and describe how each is uniquely qualified to perform in their respective roles (co-I, mentor, study coordinator, nurse, pharmacist, or other member of the translational workforce). Additionally, collaboration with a biostatistician regarding the study design and analysis is encouraged for most investigators.

2 Pages Next Steps

Describe the next steps in your research project after these services have been completed. Include resources available to you to ensure success and plans for progression to extramural funding.

2 Pages Literature Cited

List literature cited.

No Limit

Human Subjects Research

• Requirements:
• Single-Spaced
• ½” Margin
• Arial 11 Font
• Applicant’s name in header on the right-hand margin of each page
• Paginated in the bottom-right corner of each page

NOTE: All sections of the Human Subjects Research Plan should be combined and submitted as a single PDF file.

Format

__________________________________________________________

Human Subjects Research

• Examples(including but not limited to):
• Collection of specimens or biological material or data (including health or clinical data, surveys, focus groups,
• r observations of behavior)
• An intervention, such as the administration of a medication, collection of biological data (such as blood

collection, MR imaging, EER, or EKG), cognitive behavioral therapy, a clinical trial, or manipulating a subject’s environment to record the reaction

• An interaction with subjects, such as playing a computer game
• Exceptions:
• The use of secondary analysis of biological material/tissue/specimens or data not collected specifically for the

proposed project

• The specimens or data is provided without identifiable information by someone whose sole role in the

proposed project is providing the specimens or data

• The specimens or data previously collected are de-identified for the purposes of this study by someone

involved in the research study that collected the specimens or data. For example, your collaborator will provide you with aliquots of specimen that are no longer linked to the subject identifiers or you are extracting clinical data from medical records without retaining the subject name or medical record number.

• Materials/specimens of data from deceased individuals only

Type What to include (Human Subjects Research) Page Limits Funding Support Explanation

With regard to the approved IRB protocol, explain exactly what portion(s) of the protocol or amendment will be supported by the CTM pilot award.

2 Pages Human Subjects Section

A “Protection of Human Subjects” section for the pilot project that (1) clearly describes the risk, protections, benefits, and importance of the knowledge to be gained by activities (as detailed in “Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” of the NIH competing application instructions), and (2) clearly identifies the information relevant to the pilot project.

1 Page Inclusion Plans for Women, Minorities, and Children, if applicable

As required by federal law (42 USC 289a-2) and NIH policy, applications that propose to involve human subjects must address the inclusion of women, minorities, and children in the proposed research.

1 Page

Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable

As required by federal law (42 USC 289a-2) and NIH policy, applications that propose to involve human subjects must address the inclusion of women, minorities, and children in the proposed research.

3 Pages Required Attachments

• Complete approved IRB protocol.
• Funding Support Explanation (Explain exactly what portion(s)/amendments of the IRB protocol

is supported by funds from the Center for Translational Program [CTM] pilot award).

• The informed consent document (and/or assent document, if applicable).
• Product information such as the clinical investigator brochure, package insert, or description of

the device, if a clinical trial is proposed.

• Documentation that an IND or IDE has been obtained or a letter from the FDA that the study is

IND-exempt or the IDE has been waived, if a clinical trial is proposed.

• Targeted Enrollment Table or Inclusion Data Record (IDR), if applicable.

No Limit

Additional Required Attachments

• Requirements:
• Completed for the applicant PI and all Co-investigators or Collaborators who will be

working on the proposed project as Key Personnel.

• Current NIH Form (https://grants.nih.gov/grants/forms/biosketch.htm)
• 5 pages maximum.
• All biosketches MUST include the link to the personalized MyBibliography

NOTE: Combine all biosketches and submit as a single PDF file.

Biosketch

Additional Required Attachments

• Requirements: Applications submitted by pos
• st-doct

ctoral f fel ellows, s, resid esiden ents, s, o

• r fel

ellows s must attach a letter from applicant’s prim imary y resea esearch ch m men entor in PDF format. Letter must include all seven points:

1.

Describing the trainee’s potential as an investigator;

2.

Explaining the ability of the trainee to carry out the work as proposed;

3.

Describing the environment;

4.

Explaining how the study will contribute to the applicant’s professional goals;

5.

Stating he/she has evaluated and approved the submission of the research proposal;

6.

Stating he/she will provide scientific oversight throughout the duration of the project and will be responsible for the conduct of the study and describing his/her role in the team science approach, if applicable;

7.

Assuring access to resources needed to conduct the research.

Letter of Support

Additional Required Attachments

• Requirements: Must attach letter from De

Department C Chair or Division Chief ief.

Applicant must submit a letter of support from his/her department chair

• r division chief documenting that the PI has his/her time protected,

his/her salary supported to conduct the proposed research, and a

commitment to return unspent funds if the project is determined

to be unfeasible.

Letter of Support from Department

THINGS TO AVOID:

• Not completely filling out the Face Page.
• Including unallowable expenses in the budget.
• Not providing or having an insufficient budget justification.
• Not providing required attachments for price quotes.
• Not matching quotes with budget.
• Exceeding page limitations.
• Incomplete Human Subjects Research section and attachments.
• Using incorrect and outdated biosketch form not in conformance to NIH current form.
• Not providing biosketches for all key personnel listed on the application.
• Not providing MyBibliography on the biosketch.
• Not providing letter of support that addresses FOA requirements.
• Not getting a letter of support from acceptable source as required in FOA.

Common Application Mistakes

Application Assistance & Administrative Support

• Provide assistance and administrative support on applications.
• Held during the months of October 18th through December

8th 2016.

• By Appointment Only. Schedule an appointment by email to:

ctmtranslationalpilotprogram@utsouthwestern.edu.

Application Submission Contact Grants Management Contacts Financial Management Contact Debbie Diaz

Coordinator, Translational Pilot Program debbie.diaz@utsouthwestern.edu McDermott (Building B) 3rd floor 5323 Harry Hines Blvd. Dallas, TX 75390-9007 214.648.2726 phone 214.648.6710 fax

Debbie Diaz

Coordinator, Translational Pilot Program debbie.diaz@utsouthwestern.edu McDermott (Building B) 3rd floor 5323 Harry Hines Blvd. Dallas, TX 75390-9007 214.648.2726 phone 214.648.6710 fax

Lisa Fleming

Manager, Center for Translational Medicine lisa.fleming@utsouthwestern.edu McDermott (Building B) 3rd floor 5323 Harry Hines Blvd. Dallas, TX 75390-9007 214.648.2718 phone 214.648.6710 fax

Sarah Christian

Financial Analyst Center for Translational Medicine sarah.christian@utsouthwestern.edu McDermott (Building B) 3rd floor 5323 Harry Hines Blvd. Dallas, TX 75390-9007 214.648.0328 phone 214.648.6710 fax

Submit application on or before December 15, 2016 to: CTMTranslationalPilotProgram@utsouthwestern.edu.

Questions and Answers

THANK YOU