The Penn State College of Medicine Medical Student

The Penn State College of Medicine Medical Student Research Project Class of 2016 Michael F. Verderame, Ph. D. Director, MSRP Professor of Medicine Associate Dean for Graduate Studies September 2012

History l l 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. The MSR program gives each medical student an opportunity to participate in mentored medical research. Students gain an understanding of the research process, limitations and variability of data, and application of research to clinical practice.

Outline l l The basics The adviser-student relationship Important details Friendly advice

Outline l The basics n n n The Medical Student Research Project Exemption requests The Medical Student Research Symposium FAQ Class of 2015 Deadlines

The Medical Student Research Project l Completing an MSR Project is a graduation requirement n All College of Medicine medical students shall: u complete an approved MSR Project or u present qualifications for exemption.

The Medical Student Research Project l The MSR project can be completed using n Quantitative research methods u. A n testable hypothesis is required Qualitative research methods u well formulated research question is required

The Medical Student Research Project l The MSR project can be in n n basic science medical science translational science clinical medicine social medicine

The Medical Student Research Project l The MSR project can be in n n basic science medical science translational science clinical medicine social medicine

What is translational research? “To improve human health, scientific discoveries must be translated into practical applications. ” http: //nihroadmap. nih. gov/clinicalresearch/overview-translational. asp

The Research Continuum l The many steps from scientific discovery to improved patient care: n n n n New biological mechanism discovery Possible new drug conception Drug 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

Examples to look for in your first year… l CMBMP n Amino Acids (Keil) u n Cholesterol and steroid hormone synthesis u l Warfarin discovery discussed; now used as an important anticoagulant Discussion of the work of Brown and Goldstein on cholesterol that ultimately led to setting the LDL cholesterol guidelines at the level Brown and Goldstein found justsaturated cell surface receptors BBD n Principles of Translational Research - Herceptin ® as a model (Verderame)

The Medical Student Research Project l A satisfactory MSR project n n Must have a clearly defined hypothesis or research question Must have data collected analyzed by the student Must be summarized in a Final Report written by the student Must not be a case report

The Medical Student Research Project l The MSR Project process: n n 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 l l l 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 l l l Specific aims or objectives are NOT an hypothesis or research question Specific aims or research are NOT an hypothesis or research question

The Medical Student Research Project The MSR Final Report l l l l Abstract (no more than 500 words) Introduction (containing a statement of the problem and background information) Hypothesis or research question Materials and methods Results Conclusion(s) and discussion References

The Medical Student Research Project The MSR Final Report A manuscript or publication may be submitted in lieu of a Final Report only if the student is the first author.

Exemption Requests l l A student may request an exemption from the MSR requirement if the student has experience in biomedical research. Prior biomedical research experience in one of these categories typically will qualify for an exemption : n n A masters thesis A Ph. D thesis A published paper An honor or senior thesis if it is hypothesis driven and of sufficient depth

Exemption Requests l All exemption requests will be held to the same standard as students completing an MSR project: n n n Must have a clearly defined hypothesis or research question Must have data collected analyzed by the student Must be summarized in a report written by the student

Exemption Requests l Submitting a published paper for consideration of an exemption… If the student is NOT the first author of the paper, he/she will submit a report in the style of an MSR Final Report describing their role in the project

Medical Student Research Symposium l l l Held annually each spring Recognizes excellence in medical student research Typically 4 oral presentations, and 6 -10 poster presentations n l Selection is competitive from all MSR Final Reports received by the December 23, 2015 deadline. Awards given to all presenters at Commencement

FAQ l When is the best time to do my MSR Project? n n n Before December 31, 2014 ! Summer 2013 will be the last large block of “free” time you will have in medical school Beginning in the third year you will not always be on this campus

Deadlines - Class of 2015 l Exemptions Requests n Requests Due: November 30, 2013 (mid-MS II) u l Proposal Approval n August 31, 2014 (beginning of MS III) u l You will not be allowed to request an exemption after this date You will automatically be assigned the lowest value in the lottery to schedule 4 th year classes if you have not submitted a proposal or exemption request Final Report n December 31, 2015 (middle of MS IV) u You will not be allowed to undertake elective away rotations without your Final Report submitted

Outline l l The basics The advisor-student relationship

How do I Find an Advisor? l What ever you do, pick an area in which you are interested n n Consider faculty members who lecture in that area Ask your academic advisor for suggestions Ask the relevant department chair or division chief about opportunities Check out the MSR website Available projects u Past Projects u n Check out Profiles u https: //profiles. psu. edu/Profiles/Search. aspx

Student Responsibilities l l Select a research topic Make arrangements to perform the research Be sure that all regulatory approvals are obtained Submit a proposal for approval n l l Work on a project without approval risks wasted time and effort Complete the research Analyze the data Write the MSR report Meet all deadlines

Faculty Advisor Responsibilities l l Provide intellectual support and guidance Provide material support Provide project-specific training Ensure all research compliance requirements (IRB, animal welfare, r. DNA Guidelines, etc) are met

Faculty Advisor Responsibilities Please note… Some faculty members are more experienced than others at advising students through MSR Projects – remember that it is your responsibility to complete all the requirements of the MSR Project in a timely fashion

Before Beginning l Students and advisors should have a clear understanding of n n n Project goals The timetable Medical Student Research Project deadlines u If your advisor is not experienced in MSR projects please be sure they understand the consequences to you if deadlines are missed n Who is responsible for different aspects of the project

Outline l l l The basics The sponsor-student relationship Important Details n n n n Human Subjects Collegiality Patient Medical Records Off-campus Projects International Research Biostatistical Consulting Funding

Human Subjects l What constitutes human subjects research… Giving an experimental drug to a patient? YES

Human Subjects l What constitutes human subjects research… Performing a physical examination of a patient for your research project? YES

Human Subjects l What constitutes human subjects research… Reviewing patient charts for your research project? YES

Human Subjects l What constitutes human subjects research… Conducting a survey of patients for your research project? YES

Human Subjects l What constitutes human subjects research… Conducting a survey of faculty for your research project? YES

Human Subjects l What constitutes human subjects research… Conducting a survey of medical students for your research project? YES

Human Subjects l What constitutes human subjects research… Conducting a survey of middle school kids for your research project? YES

Human Subjects l What constitutes human subjects research… Conducting a survey of anyone for your research project? YES

Human Subjects l 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.

Human Subjects l 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 MAY NOT and DOES NOT GRANT RETROACTIVE IRB APPROVAL

Human Subjects Human subjects work conducted without proper IRB approval will NOT be approved for your MSR project

Human Subjects l For any questions about human subjects research, please contact Dr. Kathy Hay, Associate Director of the Human Subjects Projection Office n n n X 5687 khay@psu. edu http: //www. hmc. psu. edu/irb/

Human Subjects l There will be a detailed presentation about human subjects research by the Human Subjects Protection Office on October 30, 2012

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

Patient Medical Records l l All Medical Records are maintained by Health Information Services All applicable HMC policies regarding handling of medical records will be followed n 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 l Students performing their research offcampus must identify a Co. M faculty sponsor who can provide guidance

Off-campus Projects l ALL human subjects research at offcampus sites REQUIRES approval by BOTH the host site AND the MSHMC/Co. M IRB BEFORE the work can be initiated. n Human subjects work conducted at off-campus sites without proper IRB approval will NOT be approved for your MSR project

International Research l l l International research projects are encouraged All MSR and IRB policies must be followed You MUST work through the Office of Global Health n n n 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/Co. M IRB BEFORE the work can be initiated.

Biostatistical Consulting l Limited biostatistical consulting is available from the Department of Public Health Sciences (PHS) free of charge n n l 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: n http: //www. hmc. psu. edu/phs

Funding for your MSR l MSR awards n availability announced in the spring

Funding for your MSR l MSR awards n Mellinger Medical Student Research Scholarship (1) u n Naugle Family Medical Student Research Scholarship (1) u n Limited to projects in cancer research, especially cholangiocarcinoma ---------------------------------------------The Finkelstein Award (2) u n Limited to a project conducted in a country other than the United States Hill Family Medical Student Cancer Research Fund (3) u n For research in Pediatrics Lloyd Scholarship for International Medical Research by Penn State Medical Students (1) u n Unrestricted Bedrick Family Medical Student Research Program Award (1) u n Unrestricted Limited to research related immunologic or rheumatologic diseases K. Danner Clouser Student Research Endowment Award (1) u Limited to research projects in the medical humanities

Funding for your MSR l MSR awards n l Work-study n l availability announced in the spring limited number available; eligibility requirements Wage payroll n departmental or grant funds

Outline l l The basics The adviser-student relationship Important details Dr. V’s friendly advice

Dr. V’s Friendly advice - #1 l Everyone here is very busy, so… Don’t wait until the last minute

Dr. V’s Friendly advice #2 l You are working on your MD degree… No one should be more concerned about meeting your requirements than you. (This includes the MSR Requirement!)

Dr. V’s Friendly advice #3 l If you aren’t sure about something… a) Check out the MSR web site Almost all the answers are there All the common answers are there b) Ask. We are here to help you achieve your goals. But don’t wait until the last minute (see # 1)

Dr. V’s Friendly advice #4 l If you run into a problem… Ask for help. u We are here to help you (see # 3) u But don’t wait until the last minute (see # 1)

Dr. V’s Friendly advice #5 l Please be sure any forms you submit are completed n n l Yours Your advisor’s Dr. V’s Friendly Observation #1 n If your forms aren’t completed, I can’t complete the regulatory review of your proposal, and your approval will be delayed.

Everything you always wanted to know about the PSU Co. M MSR Project http: //www. med. psu. edu/web/msr/ Available projects Proposal and Report outlines, and forms too!

Other Research Opportunities l Summer experience n l NIH - Summer Internship Program in Biomedical Research “Year out” experiences n NIH Medical Research Scholars Program NIH - Clinical Research Training Program u HHMI-NIH Research Scholars Program u n HHMI - Medical Scholars Program u n Stipend and Expenses Doris Duke Clinical Research Fellowship u Stipend, Health Insurance Expenses

Contact Information l Jenifer Benovy - MSR Administrator, C 1704 jbenovy@hmc. psu. edu x 285233 NOTE: Ms Benovy works part time

Contact Information l Prof. Michael Verderame - MSR Director mxv 8@psu. edu x 8892

Questions ?