Patient InformationInformed Consent for all patients - iPLEDGE 2025

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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.
Its also important to remember the 4 Cs of consent: clear, continuous, conscious, coercion-free: Clear: Communication, both verbal and nonverbal, with a partner is crucial.
Only enrolled and activated prescribers can prescribe isotretinoin, and only enrolled and activated pharmacies can dispense isotretinoin. In order to receive isotretinoin, all patients must be enrolled in the iPLEDGE REMS and agree to follow the requirements.
For consent to treatment to be considered valid, it must be an informed consent. The patient must have been given an adequate explanation about the nature of the proposed investigation or treatment and its anticipated outcome as well as the significant risks involved and alternatives available.
Informed consent is a cornerstone of medicine, ensuring ethical treatment decisions and patient-centered care. Patients have the right to make informed and voluntary treatment decisions. Informed consent is more than merely a signature on a document; it is a communication process between the clinician and the patient.
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Basic Elements of Informed Consent Purpose of the Research. Description of the Research. Risks. Benefits. Alternatives to Participation.
If you are male, or you are a woman who cant get pregnant, you are required by iPledge to do the following. Talk to Your Healthcare Provider. Read and Sign Patient Information/Informed Consent. See Your Healthcare Provider Every Month. Pick up Your Prescription Within a 30-Day Window. Do Not Donate Your Blood.

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