Guidelines

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 by clicking on the 'Exemptions' tab above.

Identifying an MSR project

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
• 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 msr@hmc.psu.edu

MSR Proposal Guidelines

For details on proposing a qualitative research project for your MSR, click here.

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
PLEASE NOTE THAT A CLEAR, TESTABLE HYPOTHESIS IS A REQUIRED ELEMENT.  Specific aims or objectives are NOT a hypothesis, they are a description of what you will do. A hypothesis describes a possible explanation of a phenomenon.
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

6. References
7. Statement of Student'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:

• A completed and signed MSR Proposal Submission Form

• A completed and signed Proposal Review by MSR Research Advisor Form

Proposals with both signed forms must be submitted to Ms. Elizabeth Hamen 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. Students should seek biostatistical support before submitting their MSR proposal, as follows:

  1. The student completes the Department of Public Health Sciences (PHS) consultation request form at http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm
  2. 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.
  3. 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.
  4. 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.
  5. Allen Kunselman, or his designee, will sign the MSR Approval Form and return to the statistical consultant.
  6. 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
  • Hypothesis
  • Introduction (containing a statement of the problem and background information)
  • Specific Aims/Objectives to test the hypothesis
  • Methods/Subjects
  • Results
  • Conclusion(s)
  • Discussion
  • References

 

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 msr@hmc.psu.edu.

Submissions with an incomplete form or those lacking all required signatures will be returned to the student without review.

MSR Final Report Submission Form


Deadlines

Exemption Requests

All Exemption Requests must be submitted by December 31 of the student's second 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. 

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: khay@psu.edu

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.pdf
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)
====

Human Subjects Research: What Is Required and Why"

Download the PowerPoint Presentation

 

Qualitative Research

College of Medicine Medical Student Research Qualitative Research Guidelines

 

Qualitative methods of research examine a variety of empirical (i.e. observable and measurable) events that capture both the everyday and extraordinary aspects of an individual’s life. Examples include but are not limited to: in-depth analysis of case studies or life stories, conduct and interpretation of single or group interviews, in-depth examination of artifacts, cultural texts and productions, and observational, analysis of historical events, interactional processes, and visual texts. Qualitative studies are usually more hypothesis generating (inductive) than hypothesis testing (deductive).

Medical students are welcome to propose high-quality qualitative research projects to fulfill their Medical Student Research requirement. As with all Medical Student Research projects, this project must be related to medicine or medical practice.

Qualitative research projects must include the following information:

· A clear statement of an appropriately focused Research Question (see example below)

· A description of the data collection methods, and a justification for the proposed approach. Examples of data collection methods include:

  • Focus groups
  • Individual interviews
  • Ethnographic methods

· A copy of your research plan, including interview guide (at least a first draft) or materials for data collection

· A description of the initial data analysis plan, and time line. This description should address issues such as criteria for reaching saturation, reliability and validity, triangulation (i.e., multiple reviewers) and member checking (as appropriate)
 

Sample Research Questions

An unfocused research question


This study answers the question:

Do boys and girls play differently?

A focused research question

This study will use participant observation to answer the question:

Are there gender differences in the types of playacting games engaged in by kindergarten students during free time?

 

Other Important Information

 Qualitative research projects typically incorporate an “analytic team”. MSR qualitative research projects should have a team of at least three members: the student, the advisor, and one other person.

 

As with all MSR projects, students are expected to work on individual projects. However, students working on different research questions from the same data set may serve on each other’s analytic team.

 

For a scholarly introduction to qualitative research, see:

 

Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice (2nd edition), Part B

Chapter 11.5. Qualitative Research

by Mita Giacomini and Deborah J. Cook


http://jamaevidence.com/content/3345935?searchTerm=qualitative+research#334593

 

 


 

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:

 



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”:

http://www.research.psu.edu/orp/areas/humans/policies/guide2.asp

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 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 msr@hmc.psu.edu 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.