Clinical Research Track

Title of Track: Clinical Research Scholar Track

The Clinical Research Scholars Track is a longitudinal academic track designed for students interested in engaging in substantial clinical or translational research. The aim of this track is to help students develop a solid foundation in key skills such as protocol design, data analysis, and manuscript writing that would further their skills as medical students, residents, and future physician investigators. Students will be paired with mentors on a four-year project that will allow them to take the lead and gain experience as the principal researcher. Students will ultimately be expected to present this project during their ISP research day and/or a national conference, with an optional goal of preparing the project for manuscript publication. In addition, students will have the opportunity to obtain a certificate in Principles and Practices of Clinical Research through the NIH, and attend regular meetings with their mentors, journal clubs, and grand rounds given by esteemed pioneers across various fields of medicine.

Number of M1 students accepted into the track: 10 students per year

Educational Rationale

For the mentorship matching process, please see below.

  1. Demonstrate understanding of clinical research methods, statistical analysis, and findings by analyzing primary journals and conducting an independent capstone research project.
  1. Formulate strong research questions, hypotheses, and methods consistent with rigorous clinical research techniques.
  2. Collaborate with other members of a research team, physician and resident collaborators across various departments, and pharmaceutical representatives.
  3. Communicate effectively through oral presentations and manuscript drafting.
  4. Serve as leaders through the execution of an independent research project and as mentors to other medical students who are interested in clinical research.
  5. Obtain skills, mentorship, and network that will serve the career goal of becoming a physician-investigator

Curriculum Overview

M1

  • Application:
    • Students apply for the Clinical Research ScholarsT rack
  • Meeting with director and survey:
    • Students will meet 1:1 with the director to discuss potential interests, goals, and expectations for the track.
    • Students will then fill out a survey ranking their preferences for research topics and mentors.
    • If students do not receive a placement they are satisfied with, the director will work closely with student to find another mentor.
  • Initial mentor meeting:
    Students will meet with mentors to discuss the project.
  • IRB training:
    Students will complete the following Collaborative Institutional Training Initiative (CITI) training modules for IRB training =>
    • Human Research Group 1. Biomedical research investigators and key personnel
    • Human Research – HIPAA and Human Subjects
    • Good Clinical Practice Course
  • Summer research:
    Students apply for the Medstar or Mitchell summer research scholarship.
  • Summer following M1
  • Summer research: Students will be in their research project with funding from Medstar or Mitchell’s summer research scholarship. Other possible summer funding will also be considered.
  • NIH Course:
    Students will register for and complete the NIH Introduction to the Principles and Practice of Clinical Research online module. https://ocreco.od.nih.gov/courses/ippcr.html
  • The course is approximately 40 lectures, with lectures ranging between 15- 90 minutes. Students are expected to work on the course throughout the duration of their summer research.
  • The academic track it self will not require students to stay local during the summer following M1, but the ultimate decision will need to be made between the students and their mentors.

M2

  • Research meetings: Students will attend meetings approximately every two months with the mentor to formulate data and discuss progress
  • Grand Rounds

Grand rounds are quarterly talks that are created and scheduled specifically for this longitudinal track. These sessions are usually given by faculty who join this task as mentors or invited speakers. Ground round subjects will include updates on new clinical trials and groundbreaking research, research ethics, skills workshops, and research methods. Some sessions may also be in journal club format led by faculty.

• Annual Clinical Research Scholar Meeting
Students will attend an annual in-person meeting. Sessions will be hosted by the longitudinal track and will include pioneers within various fields of medicine, giving students an opportunity to ask questions and connect with leaders in research.

• IRB Board (optional)
Students will have the opportunity to sit in on IRB review sessions to gain an understanding of the review process and how to effectively evaluate proposals/protocols. Students may apply for IRB board positions as a student representative.

M3

Research meetings: Students will attend bimonthly meetings with a mentor to formulate data and discuss progress

Grand Rounds:
Students will attend quarterly scheduled talks with invited speakers about key topics such as new groundbreaking research, research methods, skills workshops, etc.

Annual Clinical Research Scholar Meeting: Students will attend an annual in-person meeting

IRB Board (optional)

M4

  • ISP Research Day/National Conference: Students will present their project findings during ISP and/or national conferences.
  • Manuscript preparation:

Students will prepare their project for manuscript publication if applicable.
Students will continue to attend the bi-monthly mentor meetings, quarterly talks, and in-person annual meetings.

Student Requirements

  • Completion and submission of the NIH Introduction to Principles and Practice of Clinical Research certificate
  • Students must maintain contact and meet regularly with their mentors. Mentors will be asked to fill out form to assess and verify student participation during the end of M4 year.
  • Students must submit annual reports that detail their progress with their project.
  • Students must present their findings in poster form at ISP research day and/or a national conference. An electronic copy of their poster must be uploaded during the second semester of M4 year.
  • Students must attend 80% of quarterly grand rounds (additional excused absences will be granted based on director discretion)
  • Students must attend annual meeting.

Capstone Project

The goal of the project is for medical students to gain experience with long-term research projects that will develop their skills in protocol design, data gathering, data interpretation/analysis, presentations, poster design, and manuscript writing. From start to finish, students will have ownership over their research projects over the course of the four years they are in medical school. During M1 year, the students will submit their proposal for director approval. Students will continue working on their project during their M2-M4 years. With mentor approval, the capstone project will culminate when students to present their posters during ISP research day and/or a national conference* during their M4 year at the latest. Students are allowed to present earlier if their projects progress at a faster pace. *Presentations at national conferences must comply with updated student absence policy.

*Presentations at national conferences must comply with updated student absence policy.

Leadership: Students will take the lead in their research projects. That will include coordinating across multiple departments and positions, managing communications with collaborating

labs/pharmaceutical representatives, and recruiting/leading other medical students if the project requires more assistance.

Once they are in their third year, medical students will be paired with an incoming M1. They will serve as research mentors/advisors for their mentees, and meet at least every 6 months.

Additionally, students may have the opportunity to join the IRB Committee as student representatives if they are interested. This activity is optional.

Mentorship:

Physicians with active research projects who are interested in medical student mentorship will be recruited into the program. During the first meeting, they will present on their project and student expectations for 10-15 minutes, after which interested students will send them their CVs and have a face-to-face interview. After the allotted time, students and physicians will each rank their mentor/student preferences and be matched. Students who do not match will be able to reach out to potential mentors who are willing to take on another student. After the initial meeting, students will meet regularly with their research mentors on a bimonthly basis to discuss progress on the project. They can also use this time for residency/specialty advice or other areas of support as the students progress through their medical school education. If either mentor or student expresses dissatisfaction with the partnership, the director will assist in helping the student find a new mentor.

Assessment:

Mentors will submit an annual report to certify that students have been meeting on a regular basis with them. They will also be able to note within their report whether they are satisfied with the progress of the student and of the project. At the same time, students will also submit their annual report that reflects upon their progress on the project and areas of improvement or concern. They will also be able to signal at that time their satisfaction with mentorship. Students and mentors who do not meet the basic satisfactory criteria will meet with the director to discuss issues of concern and areas of improvement. Attendance for the annual meeting and quarterly talks will also be recorded.

Core elements will be assessed on a survey that uses a satisfaction scale from 1-5 for each element. Questions for the students will assess mentorship availability, willingness to mentor, respect, and support in project development. Questions for the mentors will assess student responsiveness, quality of performance, areas of growth, and willingness to meet on a bimonthly schedule (or whatever is mutually decided upon between student and mentor). If either mentor or student drop below 3.5/5 average across all questions on the survey, the director will meet with both the mentor and student to discuss concerns and opportunities for improvement.

Faculty and Contact Information

Faculty Director Contact

Dr. Carlo Tornatore

Carlo.S.Tornatore@gunet.georgetown.edu