Informed Consent Maria Lorentzon Tzu-Chuan Liao Bryan Keane

What is Informed Consent? Informed consent is a legal procedure to ensure that a patient and physician know all of the risks and costs involved in a treatment. (Cherry, Kendra) An Informed consent is a written document that contains elements that includes informing the client of: the nature of the treatment possible alternative treatments potential risks and benefits of the treatment.

What is Informed Consent continued For informed consent to be valid, the patient must be compliant and the consent should be given voluntarily. Once an informed consent form is signed, its important that patient knows they aren’t legally bound to participate in the study or treatment. (Patrick McNamara, 2009) Video of History of Informed Consent: d

Elements of Full Informed Consent 1. The nature of the Decision/Procedure 2. Reasonable alternative to the proposed intervention 3. Relevant risks, benefits, and uncertainties related to each alternative procedure

Elements of Informed Consent Continued 4. Assessment of patients understanding 5. The acceptance of the intervention by the patient This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case laws in all 50 states. Video of Informed Consent to Medical Treatment: Medical Malpractice

Types of Consent Expressed Consent: Oral or Written Needed for most investigation or treatment with risks attached e.g. Consent for operation Implied Consent: Non-written consent when patient co-operates with a particular action e.g. Physical Examination

Surrogate Decision Making If the patient can’t make a medical decision and is determined to be incapacitated/ incompetent to make a health care decision than a Surrogate decision maker must be appointed or speak for them. If there is no Surrogate decision maker than the physicians are expected to act in the best interest of the patient until one is appointed.

Questions to ask before signing Possible Risks and Benefits What are my possible short/ long -term benefits? What are my short/long - term risks, such as side effects? What other options do people with my condition have? How do the possible risks and benefits of this trial/treatment compare with those options?

Questions Continued Personal Issues How could being in the study affect my daily life? Can I talk to other people in the study/or who have had the same treatment?

Questions Continued Participation and Care What kinds of therapies, procedures and /or tests will I have during the trial? Will they hurt, and if so, how long? How do the tests in the study compare with those I would have outside of the trial? Will I be able to take my regular medications while in the clinical trial? Where will I have my medical care? Will I have to be hospitalized? If so, how often and for how long? Who will be in charge of my care? What type of follow-up care is part of the study?

Questions Continued Cost Issues Will I have to pay for any part of the trial such as tests or the study drug? If so, what will the charges likely be? What is my health insurance likely to cover? Who can help answer any questions from my insurance company or health plan? Will there be many travel or child care costs that I need to consider while I am in the trial?

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