Title:
Informed Consent
Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Medical Communications,Project Management,Quality Assurance/Quality Control,Regulatory Affairs
Overview:
This innovative eLearning module uses a detailed case study and examples taken from actual consent forms to provide an in-depth analysis of the key concepts of the informed consent process. Topics covered include the identification of situations that require consent, the proper methods of gaining consent, and the writing of consent forms and related documents for studies with different characteristics. The module also addresses unique situations that do not require consent, alternative methods of communicating consent information to different populations, and changes to informed consent under HIPAA.
Faculty
Drug Information Association has developed this eLearning program.
Estimated Time to Complete
It is estimated that this module will take, on average, 3.5 hours to complete.
Note that this is an estimated time. Different people will learn at different rates, and explore resources and examples at different lengths.
Learning Objectives:
Upon completion of this course, you should be able to:
- Define informed consent and identify the key overall characteristics of the process
- Identify situations that would require informed consent, and exceptions to consent
- Explain the proper methods of communicating with and gaining consent from various populations of potential study subjects
- Identify common problems with completed consent forms
- Write a complete and appropriate consent form
- Determine which consent form components are necessary based on the characteristics of the study and potential study subjects
- Analyze completed consent forms for comprehensiveness, appropriateness, and accuracy
- Describe the difference between short and long consent forms, and explain when each is appropriate
- Summarize changes to informed consent under HIPAA
Target Audience:
This module will benefit qualified physicians, pharmacists, physician assistants, nurse practitioners, research scientists, and clinical research professionals. In addition, those attending DIA training courses may find this module beneficial as a supplemental source of information, especially for Regulatory courses.
Event Code:
05702
Contact Information:
Linda Belmont at DIA
Tel +1-215-293-5818
Email linda.belmont@diahome.org
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