1. 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

2. History 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.

3. Purpose l Participate in mentored medical research l Understand the research process, and the limitations and variability of data l Potential application of research to clinical practice l Understand that the practice of Medicine is continuously changing, and research drives that change

4. Basic Information l The Medical Student Research Project l Exemption requests l Finding a Project l Qualitative or Quantitative Research l Deadlines

5. The Medical Student Research Project l The MSR is a graduation requirement – No Project, no graduation, no exceptions n All College of Medicine medical students must: u complete an approved MSR Project or u present qualifications for exemption

6. Exemption Requests l A student may request an exemption from the MSR requirement if the student has experience and competence in biomedical research. l Prior biomedical research experience in one of these categories will typically qualify for an exemption : n A masters or PhD thesis n An honor or senior thesis of sufficient depth n A peer-reviewed published paper n Even if you qualify for an exemption, it is in your best interest to be involved in research

7. Exemption Requests l All exemption requests will be held to the same standard as students completing an MSR project: n Must have a clearly defined hypothesis or research question n Must have data collected and/or analyzed by the student n Must be summarized in a report which the student has written n Research advisor must agree that your effort was sufficient to meet the requirement

8. Exemption Requests l 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.

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

10. The Medical Student Research Project l The MSR project can be in n basic research n medical research n translational research n clinical research n social research

11. The Research Continuum l The many steps from scientific discovery to patient care: n Biological mechanism discovery n Possible new drug target n Target validation n Candidate drug search n Preclinical testing n Phase 1 clinical testing n Phase 2/3 clinical testing n Post-FDA approval testing

12. The pathway to new and better treatments... http://www.cancer.gov/trwg/TRWG-definition-and-TR-continuum

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

14. The Medical Student Research Project l The MSR Project process: n Identify a project n Write an MSR Proposal, and submit it for approval n Complete your MSR project n Write your MSR Final Report, and submit it for approval

15. The Medical Student Research Project The MSR Proposal l Hypothesis to be tested or research question to be answered l Background (with 4-10 salient references) l Specific Aims/Objectives to test the hypothesis l Methods/Subjects* l References l Statement of Student's Responsibilities l Statement of Sponsor's Responsibilities *There are specific additional requirements for human subjects research

16. Note l Specific aims or objectives are NOT a hypothesis or research question l Why are you doing the research is critical, not what you are going to do

17. How do I Find a Project? l Whatever you do, pick an area in which you are interested n Join your favorite interest group, and ask the faculty advisor and the more senior medical students in the group for ideas n Ask the relevant department chair, division chief and/or research coordinator about opportunities n Consider faculty members who lecture in that area n Ask your academic advisor for suggestions

18. How do I Find a Project? l Whatever you do, pick an area in which you are interested! n Check out the MSR website u Available projects u Past Projects u http://www.pennstatehershey.org/web/msr/home/projects http://www.pennstatehershey.org/web/msr/home/projects n Check out Profiles https://profiles.psu.edu/ https://profiles.psu.edu/

19. How do I Find a Project? l Whatever you do, pick an area in which you are interested! n Don’t be afraid to go outside the Penn State College of Medicine n Students have completed projects at the main campus n Students have completed projects at other institutions (NIH, CDC, other medical schools and hospitals) n Students have completed projects overseas Penn State Hershey Global Health Center http://www.pennstatehershey.org/web/globalhealth/ home http://www.pennstatehershey.org/web/globalhealth/ home

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

21. Faculty Advisor Responsibilities l Provide intellectual support and guidance l Provide material support (does not necessarily include a salary!) l Provide project-specific training l Ensure all research compliance requirements (IRB, animal welfare, rDNA Guidelines, etc) are met

22. 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

23. Before Beginning l Students and advisors should have a clear understanding of n Project goals n The timetable n Medical Student Research Project deadlines u Be certain that your advisor understands the consequences to you if deadlines are missed n Who is responsible for different aspects of the project

24. Collaboration l 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. l 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. l 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.

25. The MSR Final Report l Abstract (no more than 500 words) l Introduction (containing a statement of the problem, hypothesis or research question and background information) l Materials and methods l Results (use figures whenever possible) l Discussion and Conclusions l References l Typical length (8-15 pages, depending on number and content of figures) l Must be written independently, although your advisor should be involved in correcting the first draft.

26. 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.

27. Deadlines - Class of 2015 l Exemptions Requests n Requests Due: November 30, 2014 (mid-MS II) u You will not be allowed to request an exemption after this date l Proposal Submission n August 31, 2015 (beginning of MS III) u 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 l Final Report n December 31, 2016 (middle of MS IV) u You will not be allowed to undertake elective away rotations without your Final Report submitted l Extensions on the final report deadline are possible, but you will endanger your graduation date and future. YOU WILL NOT GRADUATE WITHOUT COMPLETION.

28. Timing for Research l When is the best time to do my MSR Project? n Before December 31, 2016! n Summer 2014 will be the largest block of “free” time you will have in medical school n Beginning in the third year you will not always be on this campus n Start preparing to do research now! n 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

29. Important Details n Human Subjects n Patient Medical Records n Off-campus Projects n International Research n Biostatistical Consulting n Funding

30. 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!!

31. 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!!

32. 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 or the research is illegal and none of that data can be used in the project.

33. 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

34. Human Subjects The College of Medicine Institutional Review Board CAN NOT and DOES NOT GRANT RETROACTIVE IRB APPROVAL

35. Human Subjects l For any questions about human subjects research, please contact Dr. Kathy Hay, Associate Director of the Human Subjects Projection Office l She plans to talk to you in detail about human subjects protection on October 24 th, 2013. n x5687 n khay@psu.edu khay@psu.edu n http://www.hmc.psu.edu/irb/ http://www.hmc.psu.edu/irb/

36. Clinical Research l Students may not conduct research in clinical areas without the approval of the unit administrator

37. Patient Medical Records l All Medical Records are maintained by Health Information Services l 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™

38. Off-campus Projects l 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.

39. Off-campus Projects l ALL human subjects research at off- campus sites REQUIRES approval by BOTH the host site AND the MSHMC/COM IRB BEFORE the work can be initiated. n 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)

40. International Research l International research projects are encouraged but require significant extra effort l All MSR and IRB policies must be followed l You MUST work through the Office of Global Health n Faculty Sponsor n Proposal approval before initiating research n 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.

41. Biostatistical Consulting l Limited biostatistical consulting is available from the Department of Public Health Sciences (PHS) free of charge n This can be for design as well as analysis n Data must be in an Excel spreadsheet in the proper format l Click the “Consulting Request” link at the PHS website: n http://www.hmc.psu.edu/phs http://www.hmc.psu.edu/phs

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

43. Funding for your MSR l Work-study limited number available; eligibility requirements l Wage payroll departmental or grant funds l Other Granting Foundations, Societies and Agencies l More on this next week

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

45. 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!)

46. Friendly advice #3 l 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)

47. 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)

48. Friendly advice #5 l Please be sure any forms you submit are correct and complete n Yours n Your advisor’s l IRB Forms! n 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.

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

50. Contact Information l WEB site http://www.med.psu.edu/web/msr http://www.med.psu.edu/web/msr l Elizabeth Hamen - MSR Administrator msr@hmc.psu.edu@hmc.psu.edu x8563 C1704

51. Contact Information l Dr. Ira Ropson- MSR Director iropson@hmc.psu.edu x4064 C5744

52. Questions ?