Development of a Successful
Research Program:
From Concept to Award
Fundamentals of Medical Research
July 15, 2014
Kenny J. Simansky, PhD
Vice Dean for Research
Drexel University College of Medicine
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Our Journey
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Target Audience
The Idea
The Team
Categories of Research
Translational Medicine and Research at DUCOM
Foundations and Industrial Sources
NIH: The Gold Standard
More Resources for DUCOM Researchers
Target Audience
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Residents
Fellows
New faculty with limited experience
More accomplished basic and clinical scientists
welcome!
Please note that most funding mechanisms will
require a faculty PI or sponsor.
The Idea
Focused biomedical question
Overarching theme
Major aims that serve the theme
Hypothesis driven experiments
Emphasize mechanism
Target a specifiable medical problem or basic
biomedical mechanisms related to disease
• https://commonfund.nih.gov/
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Passion
You must want to know the answer to
the problem you have targeted.
The Team
You can’t do this thing by yourself
Supporting scientific staff is essential
Colleagues are critical (and should be)
Clinicians should partner with scientists who do
basic research
• Collaborations involving clinical and basic
scientists can have a competitive advantage
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Categories of Research
• Basic science
• Clinical research (evaluate mechanistic
hypotheses in human subjects)
• Clinical trials (evaluate drugs, devices and
other treatments)
• Merge into one another
• NIH emphasis for translational projects
• https://commonfund.nih.gov/
Translational Research
and the Climate at DUCOM
Enhance existing strengths in basic research
Broaden foundation for clinical investigations
Partner basic and clinical scientists
Mentor residents, fellows and junior clinical
faculty in research
• Increasing emphasis on collaborations across the
university
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Sources of Support
• Institutional
– Coulter, CURE, Simulation Grants, PHEC, Other
– CTRI
• Foundations
– American Heart Association, American Cancer
Society, W.W. Smith
• Industry
– Pharmaceutical, Biotechnology, Applied Engineering
• Government
– NIH, NSF, DOD, AHRQ, PCORI
DUCOM Research Portal
https://sharepoint.drexelmed.edu/research
Resources for Researchers
https://sharepoint.drexelmed.edu/research
NIH: The Gold Standard
What is Funded?
• RePORTER (Research Portfolio Online Reporting
Tool Expenditures and Results)
– Single repository of reports, data, and analyses,
along with several tools for searching.
– Apply different filters to find information specific to
a particular NIH Institute or Center, funding
mechanism, or topic of interest.
– Download hit lists to Excel.
– Shows publications and patents that have
acknowledged support from each project.
RePORTER Search
http://projectreporter.nih.gov/reporter.cfm
RePORTER Search Results
Types of NIH Grant Programs
• Research Grants
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R01 - Research Project
R03 - Small Grant
R13 - Conferences & Meetings
R15 - Academic Research
R21 - Exploratory/Developmental
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R34 - Clinical Trial Planning
R41/R42 - STTR
R43/R44 - SBIR
R56 - High Priority, Short-Term
U01 - Cooperative Agreement
K99/R00 - Pathway to Independence
• Resource Grants
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• Program Project / Center Grants
R24 - Resource-Related Projects
R25 – Education
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P01
P20
P30
P50
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Research Program Project
Exploratory
Center Core
Specialized Center
Fellowship Grants
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F30
F31
F32
F33
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Predoctoral MD/PhD Fellows
Predoctoral Fellows
Postdoctoral Fellows
Senior Fellows
• Training Grants
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T32 – Institutional
T34 – Minority Undergraduate
T35 – Short-Term Institutional
OER Homepage
http://grants.nih.gov/grants/oer.htm
NIH Funding Opportunities
http://grants.nih.gov/grants/guide/index.html
New Investigator Policies
http://grants.nih.gov/grants/new_investigators/index.htm
NIH Tutorials
• The NIH website offers assistance in planning,
writing and applying for grants.
• Tutorials include:
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New Investigator Guide to NIH Funding
Advice on NIH SBIR and STTR Applications
Preparing Multiproject Research Applications
Writing an Application Involving Research Animals
Drafting a Human Subjects Grant Application
Advice on Research Training and Career Awards
The Application
The Path at Drexel University
Office of Research
www.drexel.edu/research
ORA: Finding Your
Program Administrator
Pre/Post Award Structure
Coeus
• Electronic research administration application for
proposal submission and grants award management
• Open-source software written by MIT
• Used by major institutions across the country
• Features:
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Copy/Paste from archived proposals to new
Standard automated budget forms
Electronic approval system
System-to-System (S2S) submission to federal agencies
• http://www.drexel.edu/research/coeus/
Proposal Submission
• Only ORA may submit proposals for sponsored funding.
• Contact your ORA pre-award program administrator (PA)
as soon as a submission is anticipated.
• In order to submit to a sponsor, ORA must receive:
– A completed proposal transmittal in Coeus Proposal
Development with all required approvals obtained, including the
department head(s) and the dean(s) for all investigators
– Project Budget (in Coeus)
– Project Abstract (in Coeus)
– Completed Conflict of Interest Statement for each investigator
(in Coeus)
– Completed sponsor application forms (in Coeus)
– Copy of the solicitation or the web address for the solicitation
(in Coeus)
Conflict of Interest (COI)
• Drexel Policy describes its commitment to manage conflicts of
interest in sponsored projects supporting research, scholarly, and
creative activities, where the sponsor may be any external sponsor or
the University itself
• All University personnel must complete an annual disclosure
• All University personnel must complete training
• COI responses must be provided for each specific project
• Significant financial interests must be disclosed
The following 5 slides contain detailed information.
Please read them and follow the links to more information.
Conflict of Interest (COI)
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An Individual Conflict of Interest in a Sponsored Project occurs when a
person engaged in the project has a professional or financial interest
that might adversely affect, or appear to a reasonable person to
adversely affect, the University’s responsibility to the public, to the
safety of human subjects participating in the sponsored project, to the
sponsor, or to the integrity of research, creative, and scholarly activities.
Conflicts of interest are broadly divided into two categories:
– intangible, i.e., those involving academic activities and scholarship;
– and tangible, i.e., those involving financial relationships
Disclosing the required information at the earliest possible time will
afford the best protection of an investigator's interests
http://www.drexel.edu/research/compliance/financial/coi/
Required COI Training
• All University Personnel must complete training
• Initial training required at time of hire
• Retraining is required at least every 4 years after initial
training; AND
• IMMEDIATELY when Drexel Policy changes, personnel are not
in compliance with Drexel Policy or the management plan,
and any situation in which an individual or corporation is in a
position to exploit a professional or official capacity in some
way for their personal or corporate benefit
What is an SFI?
SFI is a financial interest of a value exceeding a Defined Threshold* that is reasonably
related to your Institutional Responsibilities** and/or could reasonably affect or be affected
by the outcome of the sponsored project, and has been/will be possessed and/or received
during a 12-month period prior to and/or after the disclosure.
*Defined Threshold means:
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A $5000 aggregate amount, on an entity-by-entity basis, for each of the
following categories: 1) income from and equity in a publicly traded entity;
2) income from a non-publicly traded entity; and 3) reimbursed or sponsored
travel; and
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A $0 aggregate amount, on an entity-by-entity basis, for each of the
following categories: 1) equity in a non-publicly traded entity; and 2)
income from any intellectual property rights and interests.
** Institutional Responsibilities means University Personnel’s professional
responsibilities on behalf of the University, which may include for example: current or
proposed activities such as research, research consultation, research-related student
supervision, teaching, professional practice, institutional committee memberships, and
service on panels such as Institutional Review Boards or Data and Safety Monitoring
Boards.
SFI Disclosures
SFI Disclosure Form 1 must be submitted:
• Prior to proposal submission or the expenditure of funds,
whichever is applicable.
• For sponsored projects involving human or animal subject,
when the project is being designed for implementation.
• Within 30 days from the date that a new SFI arises in an
active sponsored project.
• Annually for each active sponsored project.
SFI Disclosure Form 2 must be submitted:
• if answered “Yes” to any question in Part B of Form 1.
http://drexel.edu/research/formsPolicies/Financial%20Compliance/
Applicable Exclusions
The following financial interests are excluded from the definition of a SFI:
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Salary, royalties, or other remuneration paid by the University to University Personnel (UP)
if UP are currently employed or otherwise appointed by the University, including
intellectual property rights assigned to the University and agreements to share in royalties
related to such rights;
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Income from investment vehicles, such as mutual funds and retirement accounts, as long
as UP do not directly control the investment decisions made in these vehicles;
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Income from seminars, lectures, or teaching engagements sponsored by a Federal, state,
or local government agency (Government Agency), an Institution of higher education as
defined in 20 U.S.C. 1001(a) (Higher Education Institution), an academic teaching
hospital, a medical center, or a research institute that is affiliated with a Higher
Education Institution;
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Income from service on advisory committees or review panels for a Government Agency, a
Higher Education Institution, an academic teaching hospital, a medical center, or a
research institute that is affiliated with a Higher Education Institution;
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Travel reimbursed or sponsored by a Government Agency, a Higher Education Institution,
an academic teaching hospital, a medical center, or a research institute that is affiliated
with a Higher Education Institution; and
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Grants and contracts administered through the University.
Understanding Indirect Costs
• Total costs for a sponsored project can be categorized as either
direct costs or indirect costs
– Direct costs are specifically tied to a particular sponsored
project
 e.g., Portion of salary and fringe benefits for individual performing
an experiment
– Indirect costs relate to common or joint objectives and
cannot be tied to a particular sponsored project
 e.g., Libraries, physical plant operation and maintenance, utility
costs, general, departmental, unit/school and sponsored projects’
administrative expenses, depreciation for buildings and equipment,
etc
• Only the Office of Research or DUCOM’s Vice Dean for Research
is permitted accept less than full government rates on indirect
costs
Guardians at the Gate:
Your Friendly Study Section
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http://public.csr.nih.gov/Pages/default.aspx
The IRG (Integrated Review Group)
Study sections within review groups
Chartered or not?
What is an ad hoc panel?
Who reviews research grants?
Who reviews career awards?
Who reviews fellowships?
Study Section Rosters are
Public Information
http://public.csr.nih.gov/RosterAndMeetings/Pages/default.aspx
Resources for
DUCOM Researchers
CITI Training for
Human Subjects Research
• All investigators and their staff engaged in the use
of animals and human subjects for research,
education, and testing must complete CITI training
• Three training groups:
• Medical, biomedical, nursing, public health, and
psychology research investigators
• Social, behavioral, and educational research investigators
• IRB members, administrative staff
• Six to eight hours to complete
• www.citiprogram.org
CITI = Collaborative Institutional Training Initiative
University Laboratory
Animal Resources
(ULAR)
• Animal facilities at New College Building,
Queen Lane, University City
• Quarantine and barrier facilities
• Clinical consultation
• Veterinary technical support
• Collaboration with other universities
• High end surgical suites
IACUC Training
• All personnel listed on an IACUC (Institutional
Animal Training Association)protocol must
complete:
• Occupational Health & Safety Training
• Species-Specific Training
• LATA (Laboratory Animal Training Association) Online
Animal Training
• CITI Training
http://www.drexel.edu/research/compliance/regulatory/IACUC/
Biostatistics Service Center
• Comprised of Masters level statisticians and affiliated
faculty members from the Department of Epidemiology
and Biostatistics, School of Public Health
• Provides high quality data analysis, biostatistical
computing, and data management services on a short
term, per hour basis or long term within an ongoing
contractual arrangement
– First hour consultation is free
– Vice Dean’s Office will pay the costs for up to four (4) hours per
project for DUCOM faculty
http://publichealth.drexel.edu/academics/departments/epid
emiology-biostatistics/biostatistics-service-center/