Informed Consent



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9AM - 5PM CST (M-F)

Faculty: Erin Azuse, RN BSN


Successful Completion: Complete entire module, complete the exam with a passing score of 80% or better, and complete the evaluation form.


Estimated Time to Complete Activity: 60 minutes.


CEUs: HIPAA Exams is authorized by IACET to offer 0.1 CEUs for this program.  CEU Information


Free Certification of Completion available instantly for download or printing upon successful completion.


Informed consent is a fundamental part of health care. It is related to the patient's right to choose what happens to his/her body and have a say in medical treatment decisions. Those who work in the health care field need to have a solid understanding of what constitutes an informed consent, both legally and ethically.

Course includes a video and audio component with stand-alone exam


What is HIPAA and informed consent for therapy?

HIPAA is a U.S. legislation designed to safeguard the privacy and security of patients' medical and personal health information. It ensures that healthcare providers, including therapists, strictly handle clients' health data in ways that maintain confidentiality and integrity.

On the other hand, informed consent in therapy is a process that involves clear communication between a therapist and their client regarding the rights, responsibilities, and expectations of therapy. It serves to protect the client's autonomy and ensure they understand what the therapy involves before agreeing to it. Informed consent generally encompasses disclosing information about the therapeutic procedure, risks, benefits, and alternatives.

HIPAA informs part of the informed consent process in therapy in an important way. Since part of the informed consent process involves collecting, documenting, and using sensitive client information, HIPAA stipulates guidelines to ensure that all these processes are carried out responsibly and ethically. Part of HIPAA's requirements include providing the client information on how their health information may be used and their rights over it.

What are the HIPAA rules about informed and implied consent?

Under HIPAA, there's a distinction between informed consent and authorization. The HIPAA Privacy Rule allows covered entities to voluntarily obtain patient consent for the use and disclosure of protected health information for treatment, payment, and healthcare operations. This grants entities the freedom to devise a procedure that best suits their requirements.

In comparison, informed consent is typically required by the Common Rule and the FDA's human subjects regulations. This refers to a consent to participate in something as a whole, not merely a consent for the research use or disclosure of protected health information.

Implied consent typically refers to a situation where consent is not explicitly provided but is nonetheless inferred based on the individual's actions and the facts and circumstances of the situation. However, neither the texts of HIPAA nor the Common Rule intend to approve, permit, or recognize "implied consent" in lieu of either HIPAA's authorization or the Common Rule's informed consent.

Therefore, while some instances and scenarios might legally or ethically utilize implied consent, it doesn't appear to be a recognized concept under either HIPAA or the Common Rule's framework concerning the use, disclosure, or participation involving protected health information.

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Learning Objectives

  • Explain when an informed consent is needed
  • Identify what information must be provided to constitute an informed consent
  • Identify who can obtain an informed consent
  • Discuss cultural and literacy issues that may present
  • Review exceptions to obtaining an informed consent

Table of Contents

Commonly referred to as: The Basics of Informed Consent

Informed Consent

Table of Contents:

  • Informed Consent
  • Legal Notice
  • Purpose of Course
  • Objectives
  • What is Informed Consent?
  • When is Informed Consent Needed?
  • Who May Obtain an Informed Consent?
  • General Guidelines for Informed Consent
  • Important Elements of Informed Consent
  • Cultural and Literacy Considerations
  • Exceptions to Informed Consent
  • End of Course Exam


Course Content Example 1:

What is Informed Consent?


Informed Consent is an agreement by a patient to accept a proposed medical treatment after receiving adequate information to make that decision from a health care provider.


Often a form is signed by patient indicating this.

  • The form is merely a record of the informed consent. The informed consent itself refers to the dialogue

There are generally three approaches to determine what is considered "adequate information"

  • Reasonable physician standard
  • Reasonable patient standard
  • Subjective standard
  • State legislation will dictate which standard is required for the informed consent


Course Content Example 2:

When is Informed Consent Needed?


Patients have the ultimate right to be involved in their health care and help decide what health care treatment they want to receive. Therefore, every medical intervention requires a consent by the patient, after discussing the treatment with their healthcare provider.


In many cases, this can be done orally.


For more invasive procedures or those with more potential for risk, a written informed consent is needed

  • Examples are surgery, anesthesia, chemotherapy, and complex medical treatment


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