Transcript The Penn State College of Medicine Medical Student

The Penn State College of Medicine
Medical Student Research Project
Class of 2017
Ira J. Ropson, Ph.D.
Director, MSRP
Associate Professor of Biochemistry and Molecular Biology
September 17, 2013
History
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Dr. George Harrell, the founding Dean of
the Penn State College of Medicine,
established the principle that student
research is an integral part of this medical
school's curriculum.
Purpose
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Participate in mentored medical research
Understand the research process, and
the limitations and variability of data
Potential application of research to
clinical practice
Understand that the practice of Medicine
is continuously changing, and research
drives that change
Basic Information
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The Medical Student Research Project
Exemption requests
Finding a Project
Qualitative or Quantitative Research
Deadlines
The Medical Student Research Project
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The MSR is a graduation requirement –
No Project, no graduation, no exceptions
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All College of Medicine medical students must:
 complete
an approved MSR Project
or
 present
qualifications for exemption
Exemption Requests
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A student may request an exemption from the
MSR requirement if the student has experience
and competence in biomedical research.
Prior biomedical research experience in one of
these categories will typically qualify for an
exemption :
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A masters or PhD thesis
An honor or senior thesis of sufficient depth
A peer-reviewed published paper
Even if you qualify for an exemption, it is in your
best interest to be involved in research
Exemption Requests
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All exemption requests will be held to the
same standard as students completing an
MSR project:
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Must have a clearly defined hypothesis or
research question
Must have data collected and/or analyzed by
the student
Must be summarized in a report which the
student has written
Research advisor must agree that your effort
was sufficient to meet the requirement
Exemption Requests
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Submitting a peer-reviewed published
paper for exemption
The first author of a published paper is expected to
have had the primary role in collecting and analyzing
the data and writing the manuscript. If you are NOT
the first author of the paper, the student must also
submit a document similar to the MSR report that
clearly states their role in the project.
Your research advisor will be contacted to help
evaluate whether your contribution meets the
requirements for an exemption.
The Medical Student Research Project
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The MSR project can be completed using
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Quantitative research methods
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A testable hypothesis is required
Qualitative research methods
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well formulated research question is required
The Medical Student Research Project
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The MSR project can be in
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basic research
medical research
translational research
clinical research
social research
The Research Continuum
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The many steps from scientific discovery
to patient care:
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Biological mechanism discovery
Possible new drug target
Target validation
Candidate drug search
Preclinical testing
Phase 1 clinical testing
Phase 2/3 clinical testing
Post-FDA approval testing
The pathway to new and better treatments...
http://www.cancer.gov/trwg/TRWG-definition-and-TR-continuum
The Medical Student Research Project
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A satisfactory MSR project
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Must have a clearly defined hypothesis or
research question
Must have data collected and analyzed by the
student
Must be summarized in a Final Report written
by the student
Must not be a simple case report on one patient
The Medical Student Research Project
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The MSR Project process:
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Identify a project
Write an MSR Proposal, and submit it for
approval
Complete your MSR project
Write your MSR Final Report, and submit it for
approval
The Medical Student Research Project
The MSR Proposal
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Hypothesis to be tested or research question to
be answered
Background (with 4-10 salient references)
Specific Aims/Objectives to test the hypothesis
Methods/Subjects*
References
Statement of Student's Responsibilities
Statement of Sponsor's Responsibilities
*There are specific additional requirements
for human subjects research
Note
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Specific aims or objectives are NOT a
hypothesis or research question
Specific aims or objectives are NOT a
hypothesis or research question
Specific aims or objectives are NOT a
hypothesis or research question
Why are you doing the research is
critical, not what you are going to do
How do I Find a Project?
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Whatever you do, pick an area in which you are
interested
 Join your favorite interest group, and ask the
faculty advisor and the more senior medical
students in the group for ideas
 Ask the relevant department chair, division
chief and/or research coordinator about
opportunities
 Consider faculty members who lecture in
that area
 Ask your academic advisor for suggestions
How do I Find a Project?
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Whatever you do, pick an area in which you are
interested!
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Check out the MSR website
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Available projects
Past Projects
http://www.pennstatehershey.org/web/msr/home/projects
Check out Profiles
https://profiles.psu.edu/
How do I Find a Project?
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Whatever you do, pick an area in which you are
interested!
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Don’t be afraid to go outside the Penn State College
of Medicine
Students have completed projects at the main
campus
Students have completed projects at other
institutions (NIH, CDC, other medical schools and
hospitals)
Students have completed projects overseas
Penn State Hershey Global Health Center
http://www.pennstatehershey.org/web/globalhealth/
home
Student Responsibilities
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Select a research topic
Make arrangements to perform the research
Be sure that all regulatory approvals are obtained
Submit a proposal for approval
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Work on a project without approval risks wasted time and effort
We can help make the project better.
Complete the research
Analyze the data
Write the MSR report
Meet all deadlines
Faculty Advisor Responsibilities
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Provide intellectual support and guidance
Provide material support (does not
necessarily include a salary!)
Provide project-specific training
Ensure all research compliance
requirements (IRB, animal welfare, rDNA
Guidelines, etc) are met
Faculty Advisor Responsibilities
Please note…
Some faculty members are more
experienced than others at advising
students through MSR Projects –
It is your responsibility (not your
advisor’s) to complete the requirements
of the MSR Project in a timely fashion
Before Beginning
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Students and advisors should have a
clear understanding of
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Project goals
The timetable
Medical Student Research Project deadlines
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Be certain that your advisor understands the
consequences to you if deadlines are missed
Who is responsible for different aspects of the
project
Collaboration
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In a perfect world, each student would identify a topic
do the background research, devise a testable question
or hypothesis, write a proposal, obtain funding, do the
research, statistically validate the results, publish in a
peer-reviewed journal and win the Nobel Prize.
Realistically, the advisor, fellow students and other
individuals will have significant input into all stages of
the project. Willingness to get help and giving credit is
critically important to research today.
If you are using the same patient database and advisor
as another student for their MSR, LET US KNOW!
Your research problems must be significantly different
and your report must be written individually.
The MSR Final Report
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Abstract (no more than 500 words)
Introduction (containing a statement of the problem,
hypothesis or research question and background
information)
Materials and methods
Results (use figures whenever possible)
Discussion and Conclusions
References
Typical length (8-15 pages, depending on number and
content of figures)
Must be written independently, although your advisor
should be involved in correcting the first draft.
The MSR Final Report
A submitted manuscript or publication may be
substituted for the Final Report only if the student
is the first author.
If you are NOT the first author of the manuscript
or publication, the student must submit that
document and an additional report that clearly
states your role in the project and shows an
understanding of the entire manuscript. This
document is similar in content to a MSR report.
Your research advisor will be asked to evaluate
your MSR Project and/or publication.
Deadlines - Class of 2015
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Exemptions Requests
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Requests Due: November 30, 2014 (mid-MS II)
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Proposal Submission
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August 31, 2015 (beginning of MS III)
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You will automatically be assigned the lowest value in the lottery to
schedule classes and electives if you have not submitted a proposal
or exemption request
Final Report
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December 31, 2016 (middle of MS IV)
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You will not be allowed to request an exemption after this date
You will not be allowed to undertake elective away rotations without
your Final Report submitted
Extensions on the final report deadline are possible, but
you will endanger your graduation date and future. YOU
WILL NOT GRADUATE WITHOUT COMPLETION.
Timing for Research
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When is the best time to do my MSR
Project?
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Before December 31, 2016!
Summer 2014 will be the largest block of “free”
time you will have in medical school
Beginning in the third year you will not always
be on this campus
Start preparing to do research now!
Write the report while the research is still “fresh”
in your mind, don’t wait until December of 2016
to write because you won’t remember it
Important Details
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Human Subjects
Patient Medical Records
Off-campus Projects
International Research
Biostatistical Consulting
Funding
Human Subjects
What constitutes human subjects
research…
Giving an experimental drug to a patient?
Performing a physical examination of a
patient for your research project?
Reviewing patient charts for your
research project?
YES!!
Human Subjects
What constitutes human subjects
research…
Conducting a survey of patients, faculty
or other medical students for your
research project?
Conducting a survey of ANYONE for your
research project?
YES!!
Human Subjects
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If your project involves human beings
(other than you and your advisor!) in any
way, including their parts, their body
fluids, their medical records, their other
personal information, or their opinions…
then it IS human subjects research and
needs to be reviewed by our Institutional
Review Board BEFORE any research
involving them is begun or the research is
illegal and none of that data can be used in
the project.
Human Subjects
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The College of Medicine Institutional
Review Board (IRB) MUST review ALL
research involving human subjects IN
ADVANCE. This includes all surveys.
It is a violation of federal regulations and
the policies of the MSHMC and PSU to
conduct human subjects research without
IRB approval
Human Subjects
The College of Medicine
Institutional Review Board
CAN NOT and DOES NOT
GRANT RETROACTIVE IRB APPROVAL
Human Subjects
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For any questions about human subjects
research, please contact Dr. Kathy Hay,
Associate Director of the Human Subjects
Projection Office
She plans to talk to you in detail about
human subjects protection on October
24th, 2013.
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x5687
[email protected]
http://www.hmc.psu.edu/irb/
Clinical Research
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Students may not conduct research in
clinical areas without the approval of the
unit administrator
Patient Medical Records
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All Medical Records are maintained by
Health Information Services
All applicable HMC policies regarding
handling of medical records will be
followed
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If you undertake a project involving patient
records in MS 1 or MS II, you will need to apply
for access to Connected™ and Powerchart™
Off-campus Projects
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Students performing their research offcampus must identify an on-campus
faculty advisor who can provide guidance
and help make sure the paperwork is
completed.
Off-campus Projects
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ALL human subjects research at offcampus sites REQUIRES approval by
BOTH the host site AND the
MSHMC/COM IRB BEFORE the work
can be initiated.
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Human subjects work conducted at off-campus
sites without Penn State IRB approval will NOT
be approved for your MSR project (although it is
not illegal)
International Research
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International research projects are encouraged
but require significant extra effort
All MSR and IRB policies must be followed
You MUST work through the Office of Global
Health
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Faculty Sponsor
Proposal approval before initiating research
ALL human subjects research at international sites
REQUIRES approval by BOTH the host site
(following local procedures) AND the MSHMC/CoM
IRB BEFORE the work can be initiated.
Biostatistical Consulting
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Limited biostatistical consulting is
available from the Department of Public
Health Sciences (PHS) free of charge
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This can be for design as well as analysis
Data must be in an Excel spreadsheet in the
proper format
Click the “Consulting Request” link at the
PHS website:
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http://www.hmc.psu.edu/phs
Funding for your MSR
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Medical student research awards
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Mellinger Medical Student Research Scholarship (1)
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Naugle Family Medical Student Research Scholarship (1)
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Limited to projects in cancer research, especially cholangiocarcinoma
-----------------------------------------------------------------------------------------The Finkelstein Award (2)
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Limited to a project conducted in a country other than the United States
Hill Family Medical Student Cancer Research Fund (3)
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For research in Pediatrics
Lloyd Scholarship for International Medical Research by Penn State Medical Students (1)
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Unrestricted
Bedrick Family Medical Student Research Program Award (1)
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Unrestricted
Limited to research related immunologic or rheumatologic diseases
K. Danner Clouser Student Research Endowment Award (1)
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Limited to research projects in the medical humanities
Funding for your MSR
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Work-study
limited number available; eligibility requirements
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Wage payroll
departmental or grant funds
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Other Granting Foundations, Societies
and Agencies
More on this next week
Friendly advice - #1
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Everyone is very, very busy, so…
Don’t wait until the last minute
Friendly advice #2
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You are working on your MD degree…
No one should be more concerned about
meeting your requirements than you.
(This includes the MSR Requirement!)
Friendly advice #3
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If you aren’t sure about something…
a) Check out the MSR web site
All the common questions and answers are there
Many other questions and answers are there
b) Ask. We are here to help you achieve your goals.
But don’t wait until the last minute (see # 1)
Friendly advice #4
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If you run into a problem…
Ask for help.
We are here to help you (see # 3)
 But don’t wait until the last minute (see # 1)
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Friendly advice #5
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Please be sure any forms you submit are
correct and complete
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Yours
Your advisor’s
IRB Forms!
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If your forms aren’t correct and completed, the
regulatory review of your research will be
delayed, and you won’t be able to do the work.
Other Research Opportunities
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Summer experience
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NIH - Summer Internship Program in Biomedical Research
“Year out” experiences
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NIH Medical Research Scholars Program
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HHMI - Medical Scholars Program
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NIH - Clinical Research Training Program
HHMI-NIH Research Scholars Program
Stipend and Expenses
Doris Duke Clinical Research Fellowship
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Stipend, Health Insurance Expenses
Contact Information
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WEB site
http://www.med.psu.edu/web/msr
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Elizabeth Hamen - MSR Administrator
[email protected]
x8563
C1704
Contact Information
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Dr. Ira Ropson- MSR Director
[email protected]
x4064
C5744
Questions ?