民眾健康加值—醫療安全暨品質討論會

張耀懋

由民眾觀點談醫療同意書簽署

哈佛大學法學院訪問學者　哈佛大學公共衛生學院研究員台大衛政所博士班 東吳法研所碩士 波士頓大學法學碩士 中國醫藥大學醫管碩士 北醫大、中醫大助教授 民生報醫藥新聞組長 聯合報資深撰述委員 醫藥新聞組長

1.金鼎獎（民 81)

2.第八屆吳舜文新聞獎（民 82)3.金鼎獎（民 82) ) 4.第九屆吳舜文新聞獎（民 83)5.聯合報系守望東台灣報導文學佳作獎（民 86)6.第八屆傑出新聞人員獎（民 87)7.金鼎獎（民 88）8.曾虛白新聞獎（民 88)9.曾虛白新聞獎（民 89，民 90)10.曾虛白新聞獎（民 90)11.社會光明面報導獎 ( 民 92)12.卓越新聞獎評論獎入圍（民 93)13.卓越新聞評論獎入圍 ( 民 94)14.國科會千里馬計畫獎助學人 ( 民 94)15.社會光明面新聞報導佳作獎 ( 民 95)16.2006-2007美國傅爾布萊特 (Fulbright)獎助學人17 思恆獎18.社會光明面新聞報導獎 ( 民 98)19.卓越新聞專題報導獎 ( 民 98)20.吳舜文即時新聞報導獎（民 98）

Patient Rights

Quality of Care

Information/TransparencyDoctor-Patient Relationship

Informed Consent

醫師權益？ 病患權利 ?

1.更多管道2.方便取得

各國同意書

告知同意書

• 淺顯 易懂• 盡量不要有專有名詞• 不要中英夾雜• 科學證據

• 2659 adult emergency room patients were assessed using Test of Functional Health Literacy (FHL)

• 1006 (42%) were unable to understand directions for taking medication on an empty stomach.

• 691 (26%) could not determine when the next appointment was scheduled after looking at a standard appointment slip.

• Inadequate or marginal FHL those age > or = 60 years was ~82%,

• This was significantly higher (P < .001) than in younger patients

Williams, M. V., et al. JAMA 1995: 274(21)

Over-view of Informed Consent

• No exculpatory language– “By agreeing to this use, you should understand

that you will give up all claim to personal benefit from commercial or other use of these substances.”

– “Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.”

– “I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items. “

– “I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.“

Over-view of Informed Consent

• No Exculpatory Language– “By consenting to participate, you authorize the use

of your bodily fluids and tissue samples for the research described above. “

– “By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.”

– “This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research.”

– “This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.”

開脫式的文字無助於責任開脫 ，只有增加醫病間的緊 張。

• 範圍：目的、方法、預期利益及潛在風險；及任意退出自由 (）

• 態度：避免因醫病間之權威關係而「不得不」同意

• 父母與家屬的同意：病患為無行為能力人時，應取得其法定代理人同意；病患為未成年人，但只要具備意思能力，也應一併取得其本人同意

• 改編自赫爾辛基宣言通則

影片 vs. 圖片