Guidelines

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
• Explore the completed MSR projects list from preceding classes
• Through discussions with fellow students and advisers for any medical interest group you join
• Through conversations with fellow students and advisers 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

All projects must have a clear research question. Quantitative and/or qualitative data will be collected, analyzed, and reported. The specific elements that must be addressed for each project include:

1. Is the research question clearly stated and relevant?
2. Can the student explain why the problem selected is important in the context of other research that has been carried out? Has the relevant literature been cited correctly?
3. Are there specific and appropriate methods that will be carried out to address the question?
4. Is the Experimental Design section detailed enough to portray a clear understanding of the methods? Does the student state the planned outcomes and how the outcomes will be interpreted with regard to the research question? If questionnaires are being used, are example questions attached?
5. How will the data be gathered and analyzed? Are appropriate statistical tests described that will apply to determining the confidence with which any conclusions are reached?
6. Is the timeline for the project realistic?
7. Is the research setting appropriate? Are techniques established and/or equipment available? Has a preliminary analysis been done to estimate the number of subjects required for significance in the results? Is the adviser oversight appropriate?

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 Page:

• Title of Project
• Name and contact information of author
• Name and contact information of adviser

Specific Research Question/Hypothesis/Specific Aims and Goals: (500 words or less)

The first sentence of this section should state your research question. Most research questions cannot be completely addressed 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 on some aspect of the broader research question. This section will typically include 3-5 additional sentences that introduce the topic and the significance of work in this area, followed by a succinct summary of your plans and how this work will addresses some specific aspect of the overall research question.

If you are doing quantitative research (most clinical and basic research studies) you should include testable hypotheses and/or specific aims that will be addressed. In other projects, qualitative research (which typically does not have a testable hypothesis) may best address your question. In some projects, a mixture 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)

Try to address the following questions in the body of this section:

• 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: (1,000 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? (Identify statistical tests you anticipate you’ll use)
• What barriers do you or your adviser 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.)? Why these subjects?
• How will you determine the number of participants needed to make your study significant?

Statement of Student Responsibilities:

You may have assistance from your adviser, laboratory technicians or other staff people associated with your adviser, other medical and/or graduate students or residents in data collection and/or analysis. You may be working with another medical student who is working on their MSR project in collaboration with you. Acknowledge everyone’s expected roles, and state what you expect to have direct 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 Adviser Responsibilities:

State the expected contribution from the adviser. Make sure that any specific parts of the project that can only be done by the adviser are noted.

References:

Typically 4-10 references

When your proposal is complete, please submit the following forms

Student Proposal Submission Form
(Submission of a document from your e-mail address can serve in place of a physical signature on the document)

— Adviser Proposal Review Form
(Submission of a document from your adviser’s email address can serve in place of a physical signature on the document)

Note

If you are conducting your research at another institution, your adviser from the other institution will be your primary adviser. In addition, you should select an internal adviser to help deal with any complications that might arise from working at another site.  Both advisers should review your proposal and complete an adviser form.

Submission and approval of the MSR Proposal ensures that the project meets the goals of the Medical Student Research requirement. The ability to plan research is an important part of the development of your skills.

• Clinical Research – An institutional resource for various programs supporting patient research at Penn State College of Medicine and Penn State Health Milton S. Hershey Medical Center
• Core Facilities and research resources – All facilities and services offered through the College of Medicine that might help you with your project.
• Research Concierge – Helps Penn State College of Medicine investigators strengthen grant writing skills, form collaborative teams and develop complex research proposals.
• Research Support – The landing page for the central research administration, support and compliance offices of the College of Medicine.

Adequate statistical analysis is an essential part of most research projects, and usually required of all human subjects research. If your adviser 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.

It is the responsibility of research adviser 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 adviser 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 adviser, however, student participation provides a valuable learning experience.

The Adviser Proposal Review Form must be completed and signed by the Research Adviser, 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. You can find more information about the awards here. The due date for applications is the first week of April, and awards are announced in the first week of May.

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 adviser for evaluation, and then are reviewed by the Medical Student Research Committee. The MSR Committee has no control over the research adviser review, which can delay MSR Committee review; Medical Student Research Committee review generally takes four to six 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.

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 already been published, and you are the first author, that manuscript or reprint is your Final MSR Report. If you are not the first author on the manuscript or publication, or if you share the first authorship with another (or several) individuals, you must also submit a summary of your specific role in the project, data collection, research, preparation of the manuscript, etc. This summary is typically 0.5 – 2 pages long.

Your Final Report must be submitted with an MSR Final Report Submission Form.

Please submit both forms online (preferred) or via email to msr@pennstatehealth.psu.edu.

Submissions with an incomplete form will be returned to the student without review.

Your final report should be formatted like a manuscript for submission to a journal in the field of your research. Depending on the journal, it may have all or most of these elements.

• Abstract
• Introduction (containing a statement of the problem and background information)
• Specific Aims/Objectives
• Methods/Subjects
• Results
• Conclusion(s)
• Discussion
• References

Examples of approved reports can be found under Year I Resources in the MSR section in Canvas.

Deadlines for each class can be found at this link.

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 College of Medicine and Penn State Health 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 adviser 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

You can view the detailed IRB website on the Infonet (on-campus logged-in users only).

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 College of Medicine IRB.  To receive Penn State College of Medicine IRB approval, please submit the following documents in a single email to the Human Subjects Protection Office at HSPO@pennstatehealth.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 IRB approval before initiating any work with human subjects or data.

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).
   • 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
   • Download the IT Account Request Form (PDF, internal) to request permission to use Powerchart
   • If you need assistance filling out the IT Account Request Form, contact the program administrator.
   • Complete the IT Account Request Form as follows:
     • Page 1
       Section 1: Check “New user”
       Section 2: Check “Connected/Powerchart” and “DocFinity/Intraviewer”
       Section 3: Complete personal information
     • Page 2 – Delete
     • Page 3
       Section C: for Department, enter “HIS;” for Group, enter “MRVIEW”
       Section D: select “Research Staff” from the drop-down menu.
     • Print out the form and complete Section 4
     • Sign and Date as applicant
     • Have your Research Supervisor sign and date as “authorized Signature”
   • Submit Pages 1 and 3 of the IT Account Request Form to Account Management using ONE of the following methods:
     • Scan and email to acctmgmt@pennstatehealth.psu.edu (after all signatures are complete)
     • Fax to 717-531-0261
     • Deliver to drop box in the George T. Harrell Library
     • Interoffice mail to Account Management, mail code HS80
   • When you are informed that your application has been processed, take your Training Verification Form to the library to retrieve your information packet.

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, 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)

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 College of Medicine Global Health Center.

To discuss specific issues regarding MSRs abroad, please contact The Global Health Center:

Email:  globalhealthcenter@psu.edu
Phone: 717-531-8187

Students must contact the Penn State College of Medicine 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: khay@psu.edu