Informed Consent HIPAA EL.doc 2025

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The document is an Informed Consent Form and HIPAA notice for counseling services provided by Erin Leyba, LCSW, PhD. It outlines the therapist's qualifications, confidentiality policies, emergency procedures, financial responsibilities, and client rights. The form emphasizes the importance of informed consent and privacy practices in therapy while detailing the client's options for payment and insurance coverage.
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Elements of Informed Consent Title of the Study. Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the students information first. Purpose of the Study. Subject Selection Criteria. Study Procedures. Potential Risks and Discomforts. Potential Benefits. Cost and Compensation.
What Is Informed Consent? There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.
Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patients role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patients preference,
Consent must be freely given, informed, specific, unambiguous, and verifiable.
Key components of informed consent include: Clear communication of information in simple, understandable language. Comprehensive disclosure of risks, benefits, and alternatives. Verification of the individuals decision-making capacity. Assurance of voluntariness without coercion. Proper documentation of the consent.

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Function The nature of the procedure or intervention. The risks and benefits of the procedure or intervention. Reasonable alternatives. The risks and benefits of alternatives. An assessment of the patients understanding of these elements [10][11]
4.3. What are the requirements for obtaining a valid consent? Four core criteria must be met: the patient giving consent must have capacity the consent must be freely given the consent must be sufficiently specific to the procedure or treatment proposed the consent must be informed.
The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subjects voluntary agreement

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