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Course Summary
The purpose
of the course is to provide the Washington University community with an
introductory course in the conduct of human subjects research.
Course Information
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Cost: |
$150.00 (Included in cost: 2
course textbooks, handout materials, sample regulatory binder,
coffee, and lunch) |
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Days: |
Every Tuesday for 3 consecutive
weeks |
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2009 Fall Session: |
October 13, 20, & 27
The 2009 Fall Session registration is closed. Please contact Sara Baalman at 314-747-5568
to be placed on a waitlist for the 2010 Spring Session. |
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Location: |
Danforth University Center, Danforth Campus, Room 234 |
No refunds
or credits. Transfers will be accepted. If you'd like to
transfer your registration to someone else, please contact
Sara Baalman at
baalmans@wusm.wustl.edu or 314-747-5568. Please DO NOT register again.
Please
note: Payment must be received 2 weeks prior to the first session for which
you are registered. If payment is not received within this time frame,
you will be dropped from enrollment. If you are having problems
sending payment, please contact
Sara Baalman at
baalmans@wusm.wustl.edu or 314-747-5568
.
Course Outline
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I. An Introduction to Human Subject
Research
Objective: Explore the history of research ethics and
emerging ethical considerations as new fields emerge. Learn what
lead to the formation of current regulations governing human subject
research, their implications, and how research is governed.
- The Clinical Research Coordinator
- Clinical Practice vs. Research: Differences
- A History of Ethics
- General Overview of Research at Washington University
- HIPAA and Research
- Living with HIPAA: Case Studies at Washington University
- Federal Regulations
- The Regulatory Binder (PI vs. Sponsor Initiated Studies
- Submitting to the Human Research Protection Office
- IRBs
II. Good Clinical Practice
Objective: Provide an overview of the research process from
study origination through data collection and analysis.
- Protocols, Case Report Forms and Study Phases
- Regulations and Good Clinical Practice
- An Overview of Research and Study Roles
- Preparing for a Study - Developing a Study Budget
- Working with Subjects: Recruitment, Retention and
Advertising
III. Institutional and Investigator
Responsibilities
Objective: Explain responsibilities from study initiation
through closure.
- Informed Consent
- How to Consent Participants
- Data Monitoring
- Adverse Events and Safety Monitoring, and OHRP and the HRPO
Guidelines
- SAE Examples
- Audits
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Course Registration
Registration is closed. Please contact Sara Baalman at
314-747-5568 or
baalmans@wusm.wustl.edu to be placed on a waitlist for the 2010 Spring
Session.
Developed by:
Necessary Elements Steering and Oversight Committees
Initiated through cooperative efforts by:
Center for Applied Research Sciences (CARS)
Human Research Protection Office (HRPO)
Office of the Vice Chancellor for Research
and
Siteman Cancer Center
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