Informed Consent: Comprehensive Concepts and Components eLearning Module
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This comprehensive module provides the key concepts of informed consent. It reviews the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes information on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.
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Credit Information
ACPE = 3.5
IACET = .4
IACET = .4
Description
Learning Objectives
After completing this activity, you should be better 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
- 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