The College of Medicine Medical Student Research Project Guidelines
All M.D. students at the Penn State College of Medicine must complete an approved Medical Student Research (MSR) project, or present qualifications for exemption to satisfy the research requirement. Details for requesting an exemption can be found here.
The selection of an MSR project topic is the responsibility of each student. Students are strongly encouraged to participate in a project in an area of interest to them, and are encouraged to consider projects in clinical or social medicine, basic medical sciences, or education research (case reports are not acceptable MSR projects).
A number of resources are available to assist the student in identifying an appropriate project. Projects can be identified by:
• Exploring the MSR Project List – click here • Exploring the Faculty Research Expertise Database – FRED • Through discussions with faculty members with expertise in areas of interest • Exploring the Work Study Project database – information on this resource is announced each Spring
Students who have identified a general area of interest but have not found a specific faculty research advisor may discuss possible research advisors with their Academic Advisors, or may wish to contact Vice Chairs for Research (found in many clinical departments), or Department Chairs in basic science departments or smaller clinical departments. A list of MSR project department contacts can be found here [IN PROGRESS].
MSR projects are usually initiated in the first two years. In general, students are not permitted to work on the same project. Questions concerning MSR projects should be directed to Dr. Michael Verderame (x8892, email: mxv8@psu.edu)
MSR Proposal Guidelines
MSR projects must have a clearly stated hypothesis and result in data collection and reduction.
When you have identified a project area and obtained a faculty sponsor, a MSR project proposal is required (typically 2-4 pages). Lists of representative past projects can be found here.
The proposal must include:
Hypothesis to be tested. Background (with 4-10 salient references) Specific Aims/Objectives to test the hypothesis Methods/Subjects
For studies involving any human subjects, the following issues must be addressed (additional details about human subjects research can be found here [link to Human subjects tab]):
1. Performance Site 2. Data sources other than the sponsor's 3. Institutional Review Board Approval of Project 4. Patient Selection/Study Population Issues 5. Prospective Power Analyses
References Statement of Student's Responsibilities Statement of Sponsor's Responsibilities
For hypothesis-driven Medical Education research, the following sections must be included in the methods section:
Description of the baseline measurement
Description of the intervention
Description of the post-intervention assessment
Description of the assessment of retention (≥ 6 months post-intervention)
Because approval of the MSR Proposal ensures the student that the project meets the goals of the Medical Student Research requirement, students art strongly encouraged to seek approval by the MSR committee before extensive work is begun on the project.
When your proposal is complete, please submit your proposal AND completed, signed copies of the following two forms:
Proposals both signed forms must be submitted to Mr. Ed Ruth in the Office of Medical Education (C1704).
Submissions with incomplete forms or those lacking all required forms or all required signatures will be returned to the student without review.
Biostatistical Consultation and Support
Adequate statistical analysis is an essential part of most research projects, and required of all human subjects research. The Department of Public Health Sciences (PHS) provides limited free biostatistical support for MSR Projects (http://pennstatehershey.org/web/phs/home/coreservices/consulting ). Students should seek biostatistical support before submitting their MSR proposal, as follows:
After completion of the PHS consultation request form, the MSR project will be assigned to a statistical consultant. The student should bring their proposal and relevant materials to the consultation meeting.
The student will get advice from the assigned statistical consultant to determine if changes are necessary for their MSR project with respect to design and analysis.
After the statistical consultant agrees with the proposed design and analysis, the statistical consultant will place the student's MSR Approval Form in Allen Kunselman's mailbox for a signature.
Allen Kunselman, or his designee, will sign the MSR Approval Form and return to the statistical consultant.
The statistical consultant will return the MSR Approval Form to the student.
MSR Final Report
The final step in completing your Medical Student Research requirement is submission of an Medical Student Research Final Report. If your work has been submitted for publication or published, and you are the first author, you may submit the manuscript or reprint as your Final MSR Report. If you are not the first author on the manuscript or publication, or if their will be no publication from this work before the deadline for final report, you must submit an MSR Report.
This report should contain the elements of a scientific report:
• abstract (no more than 500 words) • introduction (containing a statement of the problem and background information) • hypothesis • materials and methods • results • conclusion(s) and discussion • references
Examples of approved reports are on reserve in the library.
Your Final Report and a completed MSR Final Report Submission Form must be submitted to Mr. Ed Ruth in the Office of Medical Education (C1704).
Submissions with an incomplete form or those lacking all required signatures will be returned to the student without review.
All Exemption Requests (or requests for Preliminary Approval of an Exemption) must be submitted by May 31 of the student’s first year.
MSR Proposals
All MSR Proposals must be submitted by August 31 of the student’s third year (i.e., the beginning of the student’s third year). Third-year students who have not submitted an MSR Proposal by the August 31 deadline will not be eligible to register for fourth year classes.
MSR Final Reports
All MSR Final Reports must be submitted by December 23 of the student’s fourth year. Fourth-year students who have not submitted a Final Report by December 23 will not be able to undertake away rotations in January until the Report is received.
Specific deadline dates for each class can be found here.
Research Advisor Responsibilities
It is the responsibility of research advisor to provide guidance as well as intellectual and material support for MSR projects. Medical students should not be sent on low-yield "fishing trips" or asked to develop new methodologies. MSR projects should be thoroughly discussed by the student and advisor so that they agree upon the project goals, a realistic timetable, and division of responsibilities, all of which should be described in the MSR Proposal. Considerations such as clearance of the project by the Institutional Review Board (IRB) and/or Animal Resource Facility are ultimately the responsibility of the research advisor, however, student participation provides a valuable learning experience.
The MSR Proposal Research Advisor Form must be completed and signed by the Research Advisor, and included with the student's Proposal submission.
Financial Assistance
Full-time employment during the summer may be supported by work-study funds or wage payroll from a sponsor’s grant or department if the research supervisor is willing and able to do so.
In addition, several MSR awards are offered each spring. A description of the various awards, along with application information is sent to all first and second year students in mid-February of each year. (Additional Information is here.) The due date for applications is the first week of April, and awards are announced in the first week of May. Titles of projects receiving scholarships in the past are here (scroll down).
The MSR Committee
Members of the Committee are available for advice and consultation at any step of the project. The Committee Roster can be found here
Proposals and Reports are typically assigned for review within one week of submission. Our goal is to provide a decision on Proposals in 14-21 days.
Reports are first submitted to the research advisor for evaluation, and then are reviewed by the Medical Student Research Committee. The MSR Committee has no control over the research advisor review, which can delay MSR Committee review; Medical Student Research Committee review generally takes 14-21 days.
Students are notified of the results of the reviews by letter and email, and are advised to retain a copy for their records.
Special Requirements for Human Subjects Research
ALL research involving human participants MUST be reviewed by the Penn Stated Hershey Institutional Review Board (IRB) before interactions with the subjects can begin; this is required by federal rules and regulations carrying the weight of law. Violations of these rules and regulations are a serious matter, and can put all human subjects research at Penn State Hershey in jeopardy.
Human research is any interaction with humans that involves data collection and analysis. This includes questionnaires, surveys, interviews, focus groups, etc., as well as scientific studies of normal or abnormal physiology and development, studies that evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and studies that involve any invasive procedures. Research in medical education that you intend to report publicly (for example, in an MSR Final Report) does require IRB approval.
The rules and regulations governing human subjects research can be complex and confusing. Your research advisor should be your primary source of information. Students desiring guidance with the IRB application process may receive individualized assistance by appointment from the Human Subjects Protection Office (717-531-5687). Specific questions can be directed to Dr. Kathleen Hay, Associate Director of the Human Subjects Protection Office: khay@psu.edu
If you need to access patient records stored in PowerChart™ for your IRB-approved human subjects research project, you will need access to Connected™. Students in their 3rd and 4th year have access as part of their clerkships, and no additional action is required. Students in their 1st or 2nd year with IRB-approved MSR projects can apply for access by completing the following two steps:
1. Complete Connected™ training (you will only need to do this once as a medical student). The Medical Student training module can be accessed here.
a. When you have successfully completed training, go to the Office of Medical Education and ask for a “Training Verification Form”; the library will not release your Password without this form
b. Complete the IT Account Request Form as follows:
i. Page 1
1. Section 1: Check “New user” 2. Section 2: Check “Connected/Powerchart” and “DocFinity/Intraviewer” 3. Section 3: Complete personal information
ii. Page 2 - Delete
iii. Page 3 – Section C: for Department, enter “HIS;” for Group, enter “MRVIEW”
iv. Page 3 – Section D: select “Research Staff” from the drop-down menu.
v. Print out the form and complete Section 4
1. Sign and Date as applicant 2. Have your Research Supervisor sign and date as “authorized Signature”
c. Submit Pages 1 and 3 of the IT Account Request Form to Account Management using ONE of the following methods:
i. Scan and email to acctmgmt@hmc.psu.edu (after all signatures are complete) ii. Fax to 717-531-0261 iii. Deliver to drop box in the George T. Harrell Library iv. Interoffice mail to Account Management, mail code HS80
d. When you are informed that your application has been processed, take your Training Verification Form to the library to retrieve your information packet.
Access to paper patient records (older patient records)
If you need to access older paper patient records for your IRB-approved human subjects research project, you will need to complete three steps:
1. Complete Connected Training as described above (if you have not done so; see step 1).
2. Complete and submit an IT Account Request as described above (See step 2), requesting access only to Docfinity/Intraviewer in Section 2 and completing only Section C – DocFinity / Intraviewer (as described above).
3. Have your Medical Student Research proposal form signed by the Supervisor of Record Storage and Retrieval (Bobbie Ginder, x8038)
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Human Subjects Research: What Is Required and Why"
Medical Student Research Projects outside the US are encouraged, and the same policies and deadlines apply, including having an approved MSR proposal before leaving the country. The proposal needs to be signed by the research advisor and an HMC faculty member who will serve as the student’s local advisor. To discuss specific issues around MSRs abroad, please contact Dr. Verderame (mxv8@psu.edu) when the project is conceived.
Important policy note regarding Human Subjects research abroad
The IRB must review and approve research conducted outside the United State of America by PSU students, even if the foreign research receives no U.S. governmental funding. Such collaborative research activities must meet ethical standards similar to those required at PSU. The IRB may approve such research, provided it determines that (1) the research conforms to proper codes of ethics (e.g., the Declaration of Helsinki or the Belmont Report) and (2) the research is approved by the local ethical review authority. Requirements for the informed consent process will follow the laws and customs of the country in which the research is being conducted. If a U.S. department or agency funds the research, then it is probable that the foreign research site will need to file a Federal Wide Assurance (FWA) application through OHRP. For more information, see http://ohrp.osophs.dhhs.gov.
Guidance on important IRB issues in international human subjects research can be found in the University Park Office of Research Protections “Guideline II, International Research Involving Human Participants”:
Additional questions can be directed to Dr. Kathleen Hay, Associate Director of the Human Subjects Protection Office: khay@psu.edu
Exemption Requests
Students who have participated in hypothesis-driven biomedical research prior to entering medical school may petition the MSR Committee for Exemption. To be eligible for consideration of an exemption, the student must submit one of the following:
• A doctoral or master's thesis in the biomedical sciences • A published peer-reviewed paper in the biomedical sciences on which the student is a co-author status on a research project (meeting reports do not qualify) • An extensive undergraduate honors or senior research project in the biomedical sciences
Masters degree holders who did not complete a thesis may have their capstone project considered for an exemption provided it meets the regular standards for a Medical Student Research project (i.e., a hypothesis-driven research project in the biomedical sciences).
Please note that not all masters capstone projects or senior or honors theses will qualify for an exemption. To qualify for an exemption, the work must be equivalent to an MSR project; in particular is must:
• Be hypothesis-driven • Include data collection by the student • Include data analysis by the student
Descriptive or other non-hypothesis projects are not acceptable.
If you are seeking an exemption based on a published paper…
• If you are the first author of the paper, you may submit a reprint of the article and a completed MSR Exemption Request Form for consideration of an exemption.
• If you are NOT the first author, in addition to a reprint of the article, please also submit a standard Medical Student Research Report (details can be found here) focused on your role in the project along with the MSR Exemption Request Form for consideration of an exemption.
Students seeking exemption must submit all materials to Mr. Ed Ruth in the Office of Medical Education by May 31 of the student's first year. The student must submit a completed Medical Student Research Exemption Request form, and a copy of his/her report (report, published paper, thesis, or submitted manuscript). Submissions with incomplete forms or those lacking all required signatures will be returned to the student without review.
Students who have completed research potentially qualifying for an exemption before matriculating at the College of Medicine, but who wish to undertake an MSR Project run the risk of their prior research not qualifying for an exemption if they change their mind about requesting an exemption at a later time. Students with potentially qualifying prior research may submit their project for a preliminary review to ensure that it will qualify for an exemption.
The student must submit a completed Medical Student Research Preliminary Review Request form, and a copy of his/her report (report, published paper, thesis, or submitted manuscript). Submissions with incomplete forms or those lacking all required signatures will be returned to the student without review.
Requests for Preliminary Exemption Review must be submitted by May 31 of the student’s first year. Only students who have an approved Preliminary Exemption Review may request an exemption after the first year of medical school.
