• Determining when informed consent is necessary
• Comprehension guidelines
• Overview of elements of consent
• Writing the introduction and purpose statement
• Explaining procedures
• Explaining risks and benefits
• Explaining alternatives, cost, and compensation
• Explaining confidentiality and subject rights
• Storage of specimens
• Contact information, consent statements, and signatures
• Long form versus short form, and tips for administering consent
• Changes to informed consent under HIPAA

This module is designed for professionals involved in:

• Clinical research including research scientists, clinical research associates, study coordinators, clinical trial recruiters, principal investigators, and clinical study teams
• Regulatory affairs team members at both sponsor and study site

Upon completion of this module, learners should be able to:

• Define informed consent and identify the key characteristics of the process
• Identify situations that would require informed consent, and exceptions to consent
• Select the proper methods of communicating with and gaining consent from various populations of potential study subjects
• Determine the proper use of electronic consent, its benefits, and concerns with its use
• Recognize common problems with completed consent forms
• Evaluate a complete and appropriate consent form
• List 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
• Differentiate between short and long consent forms, and explain when each is appropriate
• Define informed consent requirements under HIPAA