Informed Consent

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Informed Consent
By Rachel
Health Care Systems Administrations 202

April 21st 2013

Table of Contents
Various ways to gain informed consent…………………………….Page 3 Factors that play into gaining informed consent……………………Page 4 Clinical Research……………………………………………………Page 5 United States Government Guidelines………………...……………Page 6 Timing of Consent…………………………………………………..Page 7 Consequences……………………………………….......…………..Page 7 Conclusion ………………………………………………………….Page 8 References…………………………………………………………. Page 10

Various ways to gain informed consent
There are various different ways to gain informed consent such as written, orally, or even a waiver. Written consent is when the patient or guardian has carefully read the risks, side effects, and procedure and then signed the paper for consent to precede. It is suggested that the patient read over the materials carefully in order to fully understand the entire procedure so the patient should be given the time to think about every option they have and every risk that may come up. Oral consent is when the patient is given the risks, side effects and procedure verbally and then will have to sign a short form stating that they clearly understand everything they have been informed of. Oral consent is not typically used for planned out surgeries but more so in emergency situations that do not have the time for the paper to be consigned. There must always be a witness for the oral consent because there is not any visible proof for the hospital that the consent was given. A waiver is used to gain consent when “the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context. ((OHRP), 1998)” Before any procedure takes place, informed consent must be given. Factors that play into gaining informed consent

In order to go on with a procedure, the physician must gain informed consent. Many factors play into gaining the consent from a patient, including if it is an emergency situation, emotionally fragile patient, and especially if the patient is a child. If the patient is a child, “permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child” ((OHRP), 1998). For aging parents, a legal guardian may be appointed in order for the best option for the child to be made. In some cases “the courts might also appoint a guardian if it appears that an elderly person is unable to handle his or her financial affairs or healthcare” (Legal Guardians, 2013). In emergency situations there usually is not a lot of time for the physician to describe risks, procedures, and side effects. If the situation is life-threatening, the physician must act fast in order to save the life even without consent. Therefore, a patient cannot sue the health care provider if they presumed “that the patient would have chosen the care others would have chosen under similar circumstances” (U.S. Department of Human and Health Services, 2013). Emotionally fragile patients are more likely to refuse medical treatment, therefore “the doctor is allowed to be vague about all the details and potentially negative effects of a procedure or treatment” (Medical Malpractice, 2012). Physicians need to remain calm during emergency situations in order to make the best choices for the patient in regarding their health and well-being and avoiding any potential lawsuit that the future could possibly bring. Clinical Research

A document and a process must be provided before any procedure starts. The document provides an outline for the patient of what is going to take place. The document includes the purpose of the procedure, a schedule of the treatment, the main treatment method, risks that could be involved, as well as benefits. Usually the alternative...
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