This web seminar presents the elements of the informed
consent document and the components of the process. Industry specific scenarios
are presented to reinforce important concepts, for example: Evaluating and
documenting capacity to consent, voluntariness, when a HIPAA authorization is
required, withdrawal of consent, and more. Discussions also include reported
poor regulatory performance regarding informed consent, and successful
solutions for practices that increase the protection of human subjects in clinical
research.
- Examine required content
of the Informed Consent Form (ICF): Are all stakeholders checking?
- Define the informed
consent process per regulations and best practices
- Clearly define who and
what determines if consent has been adequately executed
- Evaluate exceptions for
obtaining consent, and the role of the research site, Institutional Review
Board (IRB), and sponsor in the process
- Apply clear documentation
of the informed consent process, including withdrawal of consent
- Review elements that must
be included in an authorization for use and disclosure of protected health
information
- Compare and contrast HIPAA
authorization and the informed consent process
- Clinical Research
Coordinators
- Site Research Managers
- Clinical Research Monitors
- Sponsor Project Managers
- Investigators
The course will be led by one of the following
instructors:
Gary B. Freeman, M.S., C.C.R.A.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.