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This module is designed to provide an informative overview of the key concepts of informed consent that will benefit qualified physicians, pharmacists, physician assistants, nurse practitioners, research scientists, and clinical research professionals.

It is also designed to provide a detailed explanation of all the components of a complete and appropriate consent form, as well as guidance for the creation and appropriate wording of these components.

Featured topics

  • Identification of situations that require consent
  • Proper methods of gaining consent
  • Writing consent forms and related documents for studies with different characteristics

Who should attend?

  • Physicians
  • Pharmacists
  • Physician assistants
  • Nurse practitioners
  • Research scientists
  • Clinical research professionals
  • Professionals attending DIA training courses who seek supplemental information for use in other courses, such as those dealing with regulations

Learning objectives

Participants who complete this course 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

The module takes an average of 3.5 hours to complete.

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