The College of Medicine Medical Student Research Project Guidelines
Students graduating in 2018 and beyond
All M.D. students at the Penn State College of Medicine must complete an approved Medical Student Research (MSR) project. Research done prior to entrance into the College of Medicine will not exempt students from the MSR project. Students participating in a dual degree program such as: MD/PhD, MD/MBA, or MD/MS, will usually fulfill the requirement for the MSR as part of his or her dual degree requirements.
Students graduating in 2017
Exemption submissions are due by December 31, 2014 and will not be accepted beyond that date.
Identifying an MSR project
The selection of an MSR project topic is the responsibility of the student. Students are strongly encouraged to participate in a project in any area of interest to them, and can perform projects in clinical or social medicine, basic medical sciences, or education research (reports on a single case 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
- Explore the completed MSR projects list from preceding classes – click here
- Through discussions with fellow students and advisors for any medical interest group you join
- Through conversations with fellow students and advisors in your societies
- 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
MSR Proposal Guidelines
A typical proposal is less than 5 pages long, including the title page. The same overall proposal format can be used for both quantitative and qualitative research projects.
- Title of Project
- Name and contact information of author
- Name and contact information of advisor
Proposal Abstract: (250 words or less)
Summary of research project:
- What is the question?
- Why is this important?
- How will I approach this?
Research Theme – The Overall Research Goal (typically 50 words or less)
Concise statement of the broad area of research.
A good theme has aspects of the significance of research in this area as well as the intended long term goal.
Hypothesis/Specific Research Question/Specific Aims and Goals: (500 words or less)
It will not be possible to address the entirety of your research theme in the amount of time you have available to do your research. As such, you need to narrow your focus to what you can realistically accomplish in the time you have available. This section will typically include 3-5 sentences that introduce the topic and the significance of work in this area, followed by a summary of your plans and how this work will address some specific aspects of the overall goals of the research theme described above.
Depending on the type of research you are doing you may be able to formulate testable hypotheses and specific aims that are best addressed by quantitative research. In other types of projects, qualitative research may best address your question. Alternatively, some combination of quantitative and qualitative methods may be required to achieve your research goals.
Background and Significance: (2-4 paragraphs, 500 words or less, <10 references)
Use this section to address the following questions:
- What previous work has been done on the overall research area that is pertinent to your research question?
- What gap in knowledge is your research project designed to fill?
- What makes your efforts significant in advancing the field?
- Do you have a journal in mind where you can publish your work?
Methods: (1500 words or less)
Use this section to address the following questions:
- What data do you need to collect to address your specific aims, goals, and/or hypothesis?
- If your project involves a survey, what questions are you planning to ask?
- How are you going to collect this data?
- How are you going to analyze your data?
- What barriers do you or your advisor anticipate and how will you overcome them?
For clinical studies:
- Where are you going to perform the work?
- How are you going to select your subjects (sex, age, subgroups, etc.)?
- How will you determine the number of participants needed to make your study significant?
Statement of Student Responsibilities:
You may have assistance from your advisor, laboratory technicians or other staff people associated with your advisor, other medical and/or graduate students or residents in data collection and/or analysis. Acknowledge their expected contributions, and state what you expect to have responsibility for. Specifically:
- What do you expect to do as your part of the overall effort?
- Who do you expect to help you and what will they be doing?
- How will you acknowledge authorship? Please remember that all participants must be acknowledged for their contributions.
- What journal would be appropriate to publish your work?
Statement of Advisor Responsibilities:
State the expected contribution from the advisor and make sure that any specific parts of the project that can only be done by the advisor are noted.
Typically 4-10 references
When your proposal is complete, please submit the following documents:
• A completed and signed Student Proposal Submission Form
(Submission of a document from your e-mail address can serve in place of a physical signature on the document)
• A completed and signed Advisor Proposal Review Form
(Submission of a document from your advisor's e-mail address can serve in place of a physical signature on the document)
In addition, if your proposal involves human subjects, you must also submit your Collaborative Institutional Training Initiative (CITI) certificate.
TO SUBMIT: All documents must be e-mailed to MSR@hmc.psu.edu (preferred) or brought to Renee Seibel in CG603 (Penn State College of Medicine crescent basement near mailroom). Submissions with incomplete forms will be returned to the student without review.
If you are conducting your research at another institution, your advisor from the other institution will be your primary advisor. In addition, you must select an internal advisor to help deal with any complications that might arise from working at another site. Both advisors are required to review your proposal and complete an advisor form.
Approval of the MSR Proposal ensures that the project meets the goals of the Medical Student Research requirement, and you must have approval of your project before extensive work is performed on the project. The ability to plan research is an important part of the development of your skills.
Biostatistical Consultation and Support
Adequate statistical analysis is an essential part of most research projects, and usually required of all human subjects research. If your advisor or other members of the research team do not have the statistical expertise to assist you in this aspect of your project, the Department of Public Health Sciences (PHS) provides up to 4 hours of free biostatistical support for MSR Projects. Students will benefit by seeking biostatistical support before submitting their MSR proposal to ensure that the planned study is likely to have statistical relevance.
In order to obtain assistance, the student completes the Department of Public Health Sciences (PHS) consultation request form at http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm
MSR Final Report
The final step in completing your Medical Student Research requirement is submission of a Medical Student Research Final Report. If your work has been submitted for publication or has been 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:
- Introduction (containing a statement of the problem and background information)
- Specific Aims/Objectives to test the hypothesis
Examples of approved reports are shelved behind the theses in the open shelving area of the Harrell Health Sciences Library.
Your Final Report and a completed MSR Final Report Submission Form must be submitted via email to email@example.com (preferred) or brought to Renee Seibel in CG603
Submissions with an incomplete form will be returned to the student without review.
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 Advisor Proposal Review Form must be completed and signed by the Research Advisor, and included with the student's Proposal submission.
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.
Proposals and Reports are typically assigned for review within one week of submission. Our goal is to provide a decision on Proposals in 3-4 weeks, although it can take longer.
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 4-6 weeks; times can be longer, especially in the spring when the Committee is occupied with other MSR-related activities, and in the summer when folks may be on vacation.
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 MSR research involving human participants conducted by Penn State Medical Students MUST be reviewed by the Penn Stated Hershey Institutional Review Board (IRB) before interactions with the subjects can begin; this is Penn State policy, and 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: firstname.lastname@example.org
Penn State Hershey Human Subjects Protection Office website: http://pennstatehershey.org/web/irb/home
Human subjects research educational requirements must be met by key research personnel, including medical students working on their MSR Project, for ALL type of human research - this includes projects categorized as "expedited" or "exempt" research. Current human research protection education requirements (effective January 1, 2012) can be found here.
Additional Information required for human subjects research conducted at non-PSU sites
As a Penn State student working on a graduation requirement, any human subjects research conducted to fulfill your MSR requirement must receive IRB approval from BOTH the host institution where the research will be conducted, as well as by the Penn State Hershey IRB. To receive Penn State Hershey IRB approval, please submit the following documents in a single email to the Human Subjects Protection Office at HSPO@hmc.psu.edu. In the Subject line state: MSR Project - YOUR NAME - Attention Dr. Kathy Hay
1. A copy of the MSR proposal
2. A copy of the IRB approval from the other institution
3. A copy of an email or letter from the principal investigator at the other site stating that he/she agrees to supervise your work on your IRB-approved project.
You must receive Penn State Hershey approval before initiating any work with human subjects or data.
Access to patient records stored in PowerChart
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).
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
2. Complete and submit an IT Account Request Form
a. Download the IT Account Request Form to request permission to use Powerchart: http://infonet.hmc.psu.edu/it/services/accounts/accountmanagement/account%20request%20form.pdfb. Complete the IT Account Request Form as follows:i. Page 11. Section 1: Check “New user”
2. Section 2: Check “Connected/Powerchart” and “DocFinity/Intraviewer”
3. Section 3: Complete personal informationii. Page 2 - Deleteiii. 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 41. 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 email@example.com (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 HS80d. 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)
Human Subjects Research: What Is Required and Why"Download the PowerPoint Presentation
Special Requirements for MSRs Abroad
Medical Student Research Projects outside the US are encouraged.
In addition to the standard MSR policies and deadlines, all MSR projects in foreign countries must receive approval from the Penn State Hershey Global Health Center.
Click here to download a flowchart describing the approval process for international MSR Projects.
To discuss specific issues regarding MSRs abroad, please contact The Global Health Center:
- Email: firstname.lastname@example.org
- Phone: 717-531-8187
Important HSPO information regarding Human Subjects research abroad
Students must contact the Penn State Hershey Human Subjects Protection Office (HSPO) at least 6 months before the planned trip, and submit their IRB protocol at least 3 months before departure to ensure that they will receive approval in time.
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.
General 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: email@example.com
Exemption Requests (only applies to graduating classes prior to 2018)
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 research project in the biomedical sciences culminating in an honors or senior thesis
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 firstname.lastname@example.org 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.