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

• 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

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.