The Penn State College of Medicine Medical Student Research Project Class of 2018

Ira J. Ropson, Ph.D.

Director, MSRP Associate Professor of Biochemistry and Molecular Biology

August 14, 2014

History

 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

     Participate in mentored medical research Understand the research process, and the limitations and variability of data Application of research to clinical practice Understand that the practice of Medicine is continuously changing, and research drives that change Helps you stand out when you are applying for residency and fellowships

Basic Information

    The Medical Student Research Project Finding a Project Qualitative or Quantitative Research Deadlines  Starting with the class of 2018, no exemptions

The Medical Student Research Project



The MSR is a graduation requirement – No Project, no graduation, no exceptions

 All College of Medicine medical students must: Complete an approved MSR Project or Participate in a dual degree program (MD/PHD, MD/MBA, MD/MS) with a significant research component

The Medical Student Research Project

 The MSR project can be completed using  Quantitative research methods  A testable hypothesis is required  Qualitative research methods  Well formulated research question is required  More on this on August 25th

The Medical Student Research Project

 The MSR project can be in       basic research medical research translational research clinical research social research behavioral research etc.

The Research Continuum

 The many steps from scientific discovery to patient care:         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 Medical Student Research Project

 A MSR project     Must have a clearly defined hypothesis or qualitative 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 a single patient

The Medical Student Research Project

 The MSR Project process:      Identify a project Write a Proposal, and submit it for approval Complete your MSR research Write your Final Report, and submit it for approval Approval of your final report completes the requirement

The Medical Student Research Project

          The MSR Proposal – More on this later Title Page Abstract Research Theme Hypothesis/Specific Research Question/Specific Aims and Goals: Background and Significance Methods Statement of Student's Responsibilities Statement of Sponsor's Responsibilities References Typically 4-6 pages in length

How do I Find a Project?

 Whatever you do, pick an area in which you are interested     Join your favorite medical 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?

 Whatever you do, pick an area in which you are interested!

 Check out the MSR website  Available projects  Past Projects  http://www.pennstatehershey.org/web/msr/home/projects  Check out Profiles https://profiles.psu.edu/ More on Profiles later

How do I Find a Project?

 Whatever you do, pick an area in which you are interested!

 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, people they worked with before) Students have completed projects overseas Penn State Hershey Global Health Center http://www.pennstatehershey.org/web/globalhealth/ home

Student Responsibilities

        Select a research topic Make arrangements to perform the research Be sure that all regulatory approvals are obtained Submit a proposal for approval  Working 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

    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

Student Responsibilities

Please note…

It is your responsibility (not your advisor’s) to complete the requirements of the MSR Project

Before Beginning

 Students

and

advisors should have a clear understanding of     Project goals The timetable Medical Student Research Project deadlines  Be certain that your advisor understands the consequences to you if deadlines are missed Who is responsible for different aspects of the project

Collaboration

   In a perfect world, each student would independently identify a topic, do the background research, devise a question or hypothesis, write a proposal, obtain funding, do the research, validate the results, publish in a peer-reviewed journal and win the Nobel Prize.

In reality, the advisor, fellow students and other individuals will have significant input into all stages of the project. Willingness to give credit where credit is due is critically important to research today.

If you are using the same patient database, equipment and/or advisor as another student for their MSR,

LET US KNOW!

individually.

Your research efforts can be related (and you can help each other in data collection for complex problems) but your analysis and report must be written

Collaboration anecdote

    Three students in the class of 2014 (Natalie Dogal, Judith Lin, Ryan Mathis) worked with the same advisor (Akif Undar) and equipment to study various aspects of oxygenation methods in neonatal cardiopulmonary bypass surgery Three peer reviewed publications and five meeting abstracts Each student 1 st author on one publication, second or third author on others Shared award at graduation for research efforts

The MSR Final Report

         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 (6-15 pages, depending on number and content of figures) Must be written independently, although your advisor (and others) may be involved in editing and correcting each draf t.

Evaluated by a faculty committee

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, the student must submit that manuscript and a short report that clearly states your role in the project and shows an understanding of the entire manuscript. This document is usually similar in overall content to a MSR report, but shorter.

Your research advisor must approve of your role in that publication as described in your short report.

Timing for Research

 When is the best time to do my MSR Project?

    Before January 15, 2018!

Summer 2015 will be the largest block of “free” time you will have in medical school You can select a research rotation the summer between your 3 rd and 4 th years Write the report while the research is still “fresh” in your mind, don’t wait until December of 2017 to write because you won’t remember the work you did

Deadlines - Class of 2018

 Proposal Submission    Six weeks prior to the beginning of your chosen research period April 1 st , 2015 (for research in the summer of 2015) If you are not doing your research in the summer of 2015, you need to tell us when you plan to do your research by April 1 st , 2015  Final Report  January 15, 2018 (middle of MS IV)

Deadlines - Class of 2018



YOU WILL NOT GRADUATE WITHOUT APPROVAL OF YOUR REPORT! (You get to tell your mom why!)



FAILURES TO MEET THESE DUE DATES WILL BE REPORTED TO THE ACADEMIC PROGRESS COMMITTEE

Important Details

 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?

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

 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, 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 (and you and your advisor could face legal consequences)!

Human Subjects

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 THE IRB CAN NOT and DOES NOT GRANT RETROACTIVE IRB APPROVAL

Human Subjects

  For any questions about human subjects research, please contact Dr. Kathy Hay, Associate Director of the Human Subjects Projection Office More detail on the IRB and human subject protections will be presented at our meeting on August 25 th , 2014.

   x5687 [email protected]

http://med.psu.edu/web/irb/home

Off-campus Projects

 ALL human subjects research at off campus sites REQUIRES BOTH the host site AND approval by the MSHMC/COM IRB can be initiated.

BEFORE the work  Human subjects work conducted at off-campus sites without Penn State IRB approval will NOT fulfill your MSR requirement (although it is not illegal if the host site has IRB approval)

Clinical Research

 Students may not conduct research in clinical areas without the approval of the unit administrator

Patient Medical Records

  All Medical Records are maintained by Health Information Services All applicable HMC policies regarding handling of medical records will be followed  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™ and obtain IRB certification

Off-campus Projects

  Students performing their research off campus must identify an on-campus faculty advisor who can provide guidance and help make sure the paperwork is completed The on campus advisor can be your academic advisor or any other faculty member who might have interest in your work

International Research

   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    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

  Limited biostatistical consulting is available from the Department of Public Health Sciences (PHS) free of charge  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:  http://www2.med.psu.edu/phs/

Funding for your MSR

 Medical student research awards        Mellinger Medical Student Research Scholarship (1)  Unrestricted Naugle Family Medical Student Research Scholarship (1)  Unrestricted Bedrick Family Medical Student Research Program Award (1)  For research in Pediatrics Lloyd Scholarship for International Medical Research by Penn State Medical Students (1)  Limited to a project conducted in a country other than the United States Hill Family Medical Student Cancer Research Fund (3)  Limited to projects in cancer research, especially cholangiocarcinoma ----------------------------------------------------------------------------------------- The Finkelstein Award (2)  Limited to research related immunologic or rheumatologic diseases K. Danner Clouser Student Research Endowment Award (1)  Limited to research projects in the medical humanities New this year - Center for clinical and translation research (4-6) 

Funding for your MSR

    Work-study limited number available; eligibility requirements Wage payroll departmental or grant funds Other Granting Foundations, Societies and Agencies Partial List of External Research Funding Opportunities on Website

Friendly advice

 Everyone is

very, very

busy, so… Don’t wait until the last minute No one should be more concerned about meeting your requirements for the MSR than you.

Friendly advice

 If you aren’t sure about something or run into a problem a) Check out the MSR web site

All

the frequent questions and answers are there Many uncommon questions and answers are there b) Ask. We are here to help you achieve your goals.

a) But don’t wait until the last minute

Friendly advice

 Please be sure any forms you submit are correct and complete   Yours Your advisor’s 

IRB Forms!

 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

  Summer experience  NIH - Summer Internship Program in Biomedical Research – Great for MSR  Yale, Vanderbilt, other sites also look for medical students from other medical schools to participate – Great for MSR “Year out” experiences will fulfill the requirement    NIH Medical Research Scholars Program   NIH - Clinical Research Training Program HHMI-NIH Research Scholars Program HHMI - Medical Scholars Program  Stipend and Expenses Doris Duke Clinical Research Fellowship  Stipend, Health Insurance Expenses

Contact Information

 WEB site http://www.med.psu.edu/web/msr  Renee Seibel - MSR Administrator msr @hmc.psu.edu

x280809 CG603

Contact Information

 Dr. Ira Ropson - MSR Director [email protected]

x4064 C5744

Questions ?