Introduction to Clinical Research:

Children’s Hospital Los Angeles Research Program

University of Southern California

Keck School of Medicine

Children’s Hospital Los Angeles

Course Syllabus

Spring Semester 2014

I. COURSE INFORMATION

Course Directors:

Danica Liberman, MD, MPH ()

Vincent Wang, MD, MHA ()

Course Instructors:

Danica Liberman, MD, MPH ()

Vincent Wang, MD, MHA ()

Marsha Elkhunovich, MD ()

Leighanne Johnson, MS ()

Course Location:

Children’s Hospital Los Angeles

Anderson Pavilion

Emergency Department Conference Room: G439

4650 Sunset Blvd

Los Angeles, CA 90027

(323) 361-2109

Course Overview:

This is a course for students who are interested in medicine and clinical research. It is designed to provide both an introduction to the fundamentals of clinical research and direct exposure to clinical medicine and clinical research projects in the emergency department. Throughout the course, students will receive didactic sessions on research methodology and ethics, hands on experience in data collection and enrolling patients in clinical trials, and direct observational experience in the Emergency Department at Children’s Hospital Los Angeles. Students will have an opportunity to work closely with CHLA faculty, and through their work in the emergency department, will be contributing to the advancement of the field of pediatric emergency medicine.

Course size will be limited to 18 students for the semester. Students interested in this course must complete a brief application in the event there are more than 18 students interested in the course.

Course Objectives:

Upon completing the course, the student will be able to:

  1. Successfully recruit patients for enrollment in clinical research trials
  2. Collect and organize data for clinical research trials
  3. Understand and participate in the team concept of delivering health care
  4. Describe different research study designs and research tools, and understand their advantages and disadvantages
  5. Participate more effectively and comfortably as a research assistant
  6. Define and understand the concept of informed consent
  7. Describe the history and current standards of human subject protection
  8. Be familiar with some of the different career pathways for clinician researchers
  9. Understand the concepts of basic epidemiology
  10. Effectively review and interpret the literature on various health topics

Prerequisites:

  1. Students must be at least 19 years old. Preference will be given to juniors, seniors, and post-baccalaureate students.
  2. Students must have completed the course “Preparation for the Clinical Experience” prior to enrolling in this course.
  3. Students must complete the following online education modules:
  4. CITI training: 3 modules, refer to instructions uploaded to Blackboard for more information
  5. Good Clinical Practice (GCP)
  6. Basic Human Subjects—Biomedical
  7. Basic Human Subjects—Social/Behavioral
  8. HIPAA certification
  9. No later than January 10th, and prior to the first session on January 17th, 2014, students must complete and submit to the CHLA ED Administrative Assistant, Yvette Resendiz (), the following forms: (all forms can be found on the blackboard site under registration & certification forms)
  10. Student Self-Transportation Form (page 5)
  11. Waiver, Release and Indemnity Agreement Form
  1. CITI training certificates
  2. HIPAA certification
  3. Academic Affairs Student Observer Forms
  4. Observer-Applicant Forms
  5. Medical Observer Health Clearance Form
  6. Official Immunization and TB record

Didactic Sessions: Formal didactic sessions will consist of five structured lectures, held at regular, predetermined intervals throughout the term. Each didactic session will also provide students time to ask questions about, and reflect on their time spent working in the emergency department. All sessions will be held on Fridays from 3pm to 5 or 6pm. The location of the sessions will be at CHLA as delineated below. Students will be required to complete a related make-up assignment for any missed didactic session.

Clinical Time: During the course of the semester, each student will be expected to spend a total of 84 hours, or approximately 14six-hour shifts, in the Emergency Department at CHLA recruiting patients for research studies and observing clinical care. Students electing to take the course for 2 units rather than the recommended 4 units, are expected to complete 42 hours in the Emergency Department at CHLA, and are required to attend all didactic sessions and complete all assignments and tests.

Preferred weekday shifts run from 4pm to midnight. Preferred weekend shifts are 8am to 4pm or 4pm to MN. Students must schedule their shifts in a way that minimizes student overlap in the ED. Morning and daytime shifts are allowed if afternoon/evening and weekend shifts have been filled. Students will be responsible for arranging their own transportation to and from CHLA. Public transportation is available via the Metro. Parking passes at the hospital will be provided for those students with access to private cars.Please contact Joyce Williams () for more information on parking at CHLA.

One student volunteer will be designated as a course scheduler and tasked with creating and maintaining the shift schedule for all enrolled students. In exchange for this additional work, the course scheduler will have a reduction in his/her shift load by one shift, and will be required to complete 76 hours in the Emergency Department at CHLA, or approximately 13 six-hour shifts.

Any missed shifts must be made up. Course instructors and the course scheduler should be given 24 hours advanced notice about missed shifts. It is the student’s responsibility to schedule a make-up shift with the course scheduler. Absences from the didactic sessions must be cleared by the course instructors in advance, and a make-up assignment will be required of the student.

Reading Materials and Assignments: Articles and online resource materials have been selected on topics related to didactic sessions, clinical research, and the medical field as listed below.Readings should be reviewed prior to their associated session. More readings will likely be added as the course progresses at the discretion of the course instructors. All additions and modifications will be announced through Blackboard with ample time for completion.

Online Research Assignments:You will be required to complete fouronline research assignments that are based on the prompts listed in the course schedule. The purpose of these assignments is to prepare you to think critically about challenges in healthcare and to familiarize you with literature search tools such as PubMed, WebOfKnowledge, etc. On the weeks that you have research assignments, complete a literature search on the assigned topic. While you will not have to turn in this literature search, you will use the results for the online assignment.

Response to these topics should be one-page single spaced, with two references from peer reviewed journals. You do not need to post the actual referenced article, however, please provide enough information that a student or instructor could locate your reference for further information or review. You must post these on Blackboard in the discussion section by 11:59PM on the due date. In addition, you are required to respond to twoof your classmates with constructive feedback (not just “good job” or “I disagree”, but something that shows you read what they have to say, and you are responding with additional questions for consideration or a proposed research topic for them in the future).

Consenting Practical:You will be required to do one consenting practical on 1/31. During class, you will be presented with one of the studies and must do a “mock consent” in front of your classmates and instructors. You will be graded on your introduction to the family, explanation of the study, and overall consenting competency. To prepare for this, please review the mock consents and study information on Blackboard.

Final Reflection Paper:Your final reflection paper is a way for you to express how your experiences doing research in the Emergency Department have made you a better candidate for further education (medical school, PhD programs, PA school, nursing school, etc). Please respond to the topic with a one to two page single spaced paper, and please send this directly to the course instructors by the date provided below. You may submit this together with your final exam.

Please complete the following by January 10th!

  • CITI Training (Good Clinical Practice, Basic Human Subjects Biomedical, Basic Human Subjects Social-Behavioral): refer to instructions uploaded onto Blackboard
  • HIPAA Certification
  • Student Self-Transportation Form
  • Waiver, Release and Indemnity Agreement Form
  • Official Immunization and TB test record
  • Academic Affairs Student Observer Forms
  • Observer-Applicant Forms
  • Medical Observer Health Clearance Form

Course Schedule & Assignments

Topics / Readings / Assignment
Didactic Session #1: 1/17/2014
3pm-5pmCHLA ED Conference Room
Part A: Orientation & Course Introduction
  1. Overview of course expectations and requirements
  2. Access, clearance, identification, certification
  3. Tour of the ED and introduction to staff
  4. Introduction to the practice of clinical medicine
  5. Working in the Emergency Department
  6. Introduction to clinical research projects ongoing in the ED
Part B: Informed Consent Introduction & Workshop
  1. Discussion of the definition and meaning of informed consent
  2. Introduction to the laws governing patient and study participant protection
/ USC, “Is Your Project Human Subjects Research? A Guide for Investigators.” here and uploaded onto Blackboard) / All required paperwork and forms completed. CHLA ID obtained prior to first session. Contact Yvette Resendiz with questions.
Didactic Session #2: 1/31/2014
3pm-6pmCHLA ED Conference Room
Part A: Informed Consent Practical
Part B: Professionalism and Bioethics
a.Professionalism in medicine
b.Ethics and human subjects research
c.Review of informed consent / Brandt, Allan M. Racism and Research: The Case of the Tuskegee Syphilis Study. Ethical Issues in Medicine, 5th ed. pp 547-57. (uploaded onto Blackboard in two separate parts)
Faison, Amanda. The Miracle of Molly. 5280 The Denver Magazine. August 2005. here and uploaded onto Blackboard) / Review all ED studies and online mock consents
Due: Informed Consent Practical in class (9/13)
Online research assignment #1, Due 2/14/2014:Scenario: You are a Pediatrician, seeing children in an emergency medicine situation. You realize that many parents bring their children to the ED with viral infections such as colds, the flu, coughs, and ear infections. While these types of illnesses do not typically require antibiotics, parents are expecting you to prescribe their children medications when leaving the ED. How do you explain to the parents the issue of antibiotic overuse, and the potential problems associated with this misuse?
Look through multiple pediatric peer reviewed journals and research the topic “Antibiotic overuse in children.”
Post your response with TWO peer review journals cited on the Blackboard website. In addition, respond to TWO of your classmates’ online posts with feedback. / Responses due on 2/14 by 11:59PM
Didactic Session #3: 2/21/2014
3pm-5pm CHLA ED, Conference Room
Topic: Study Design
  1. Introduction to clinical research
  2. Clinical study design
  3. Research instruments

ONLINE MIDTERM—Available on Blackboard 2/21
Due 2/26 at 5PM / Submit by 5pm on 2/26 to course instructors and division administrative assistant



Online research assignment #2, Due 3/7/2014: Identify the issues in society today with exposing young children to violence. This could be through the media, video games, cartoons, television, magazines, or through peer and familial experiences. In addition, identify what types of implications these exposures could have on children’s mental health status in the future. Furthermore, you may add what current events have been related to children’s mental health status and exposure to violence. Please read through peer reviewed literature based on this topic, and suggest further research ideas on how to identify these issues, and how healthcare practitioners can help to address this problem going forward.
Look through multiple pediatric peer reviewed journals and research the topic “Violence in the media and its implications for children.”
Post your response with TWO peer review journals cited on the Blackboard website. In addition, respond to TWO of your classmates’ online posts with feedback. / Response due on 3/7 by 11:59PM
Online research assignment #3, Due 3/21/2014:Obesity in the United States is a growing issue. Many people have hypothesized ways to combat the obesity epidemic. One opinion is that imposing high tax on fast food and other unhealthy foods will help decrease the number of obese children in the U.S. Write about whether or not you agree with this type of intervention. Or if you believe there is a better, more evidence-based approach to solving the obesity epidemic, please elaborate.
Look through multiple pediatric peer reviewed journals and research the topic “Obesity in U.S. Children.”
Post your response with TWO peer review journals cited on the Blackboard website. In addition, respond to TWO of your classmates’ online posts with feedback. / Response due on 3/21 by 11:59PM
Didactic Session #4: 3/28/2014
3pm-5pmCHLA ED Conference Room
Part A:Epidemiology
Part B: Journal Club / Aschengrau A, Seage GR. The Approach and Evolution of Epidemiology. Essentials of Epidemiology in Public Health, 2nd ed. 2008. pp 15-21.(uploaded onto Blackboard)
California Emergency Response Team. Investigation of an Escherichia coli O157:H7 OutbreakAssociated with Dole Pre-Packaged Spinach. March 21,2007.(uploaded onto Blackboard)
Nightline Ebola Outbreak in Uganda YouTube Video (we will view this in class)
Zorc, Joseph, et. al. Scheduled Follow-up After a Pediatric Emergency Department Visit for Asthma: a Randomized Trial. Pediatrics, 2003:111;495.(uploaded onto Blackboard) / Discussion on assigned readings
Didactic Session #5 3pm-5pm: 4/11/2014 CHLA, Holden Family Conference Room
Topic: Panel Discussion
  1. The clinician scientist
  2. Additional training beyond an MD
  3. Course evaluation and debriefing

Online research assignment #4, Due 4/18/2014:As you continue your journey into the medical field, you will witness many disparities in healthcare. In the future, how do you plan to address these disparities? Pick a disparity that is of particular interest to you and create a brief plan of how you would attempt to eliminate this disparity.
Look through multiple pediatric peer reviewed journals and research the topic “Healthcare disparities.”
Post your response with TWO peer review journals cited on the Blackboard website. In addition, respond to TWO of your classmates’ online posts with feedback. / Response due on 4/18 by 11:59PM
ONLINE FINAL—Available on Blackboard 4/25
Due 4/30 at 5PM / Submit Online Final Exam by 5PM on4/30 to course instructors and division administrative assistant



Final Reflection Paper:Scenario: You are interviewing for medical/physician assistant/nursing/graduate school and are being compared to your peers. You all have extracurricular activities, high GPA’s, and strong academic letters of recommendation. The admissions committee asks you what sets you apart from the group, and how your research experience puts you above the other students.
Send a response to the admissions committee on how your clinical observations and research experiences this semester have helped make you the best fit for their program. / Response due on 4/30 by 5PM
Send directly to course instructorsand division administrative assistant, may send together with final exam.



Research Presentations by Advanced MEDS-490 Students
(Attendance Required!)
5/9/2014 3PM-5PM, CHLA ED CONFERENCE ROOM

Grading Scale:

Attendance/Performance in the ED and lectures—50%

Consenting Practical – 5%

Online Assignments—20 %

Midterm – 10%

Final Assignment (Reflection Paper) – 5%

Final – 10%

Grades will be given on a standard letter grade scale. Course instructors must be notified greater than 24 hours in advance about any conflicts students may have with their assigned shifts or scheduled didactic sessions. All missed shifts must be made up before the end of the semester, and make up shifts must be coordinated with the course instructors. An alternative assignment will be required of the student if he/she misses a didactic session.

Exam Dates and Times:The midterm examination will be a take home exam, open book and open note. It will be posted on Blackboard by 5pm on February 21, 2014 and must be submitted online to the course instructors ( and ) and Division Administrative Assistant () by 5pm on February 2, 2014. The final examination will also be a take home exam, open book and open note. It will be posted on Blackboard by 5pm on April 25, 2014, and must be submitted online to the course instructors ( ) and Division Administrative Assistant () by 5pm on April 30, 2014. Exams must be completed independently.The Final Reflection Paper is also due by 5pm on April 30, 2014 and may be submitted collectively with the final exam.

Statement for Students with Disabilities:

Any student requesting academic accommodations based on a disability is required to register with Disability Services and Programs (DSP) each semester. A letter of verification for approved accommodations can be obtained from DSP. DSP is located in STU 301 and is open 8:30 a.m.5:00 p.m., Monday through Friday. The phone number for DSP is (213) 740-0776. Please be sure the letter is delivered to the course instructors as early in the semester as possible.

Statement on Academic Integrity:

USC seeks to maintain an optimal learning environment. General principles of academic honesty include the concept of respect for the intellectual property of others, the expectation that individual work will be submitted unless otherwise allowed by an instructor, and the obligations both to protect ones own academic work from misuse by others as well as to avoid using another’s work as one’s own. All students are expected to understand and abide by these principles. Scampus, the Student Guidebook, contains the Student Conduct Code in Section 11.00, while the recommended sanctions are located in Appendix A: Students will be referred to the Office of Student Judicial Affairs and Community Standards for further review, should there be any suspicion of academic dishonesty. The Review process can be found at:

Plagiarism (copying or modifying someone else’s work and presenting it as your own) and other forms of cheating will not be tolerated. Please ask the instructor if you have questions about proper behavior.

II. HOLIDAYS

Martin Luther King’s Birthday: January 20, 2014

Presidents’ Day: February 20, 2014

Spring Recess: March 17-22, 2014