Informed Consent Essay

1659 Words Apr 26th, 2013 7 Pages
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,
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The laws of the United States implies that “no informed consent document may say anything that asks- or seems to ask- you to give up your legal rights” (Applied Clinical Trials, 2003). A patient has many rights before any clinical trials begin. In order to begin, the patient also be told of every option and informed of what it the best choice, given a copy of the signed consent form, and any complications with treatments if they do occur.

United States Government Guidelines It is mandatory by the U.S. Office for Human Research Protections (OHRP) and the Code of Federal Regulations (CFR) that specific materials be given to the research participants before conducting the study. For the minimal risk procedures, information must be gathered and provided for any treatments or even compensation if the substantial injuries do occur and what they cover and where additional information is available if requested.
The minimal risks are considered if the “probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (U.S. Governmental Guidelines, 1996)
Even if a procedure has already begun, a patient has the rights to stop it entirely. The procedures are exclusively voluntary and may refuse “ to participate that will involve no

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