同意書(consent form)の英文例文集とインフォームドコンセント(informed consent; IC)に纏わる話題　

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同意書とは

  1. https://www.alllaw.com/articles/nolo/medical-malpractice/release-consent-forms-preclude-suing.html　A consent form is a pre-printed legal form with some blank spaces for the health care provider to fill in information that is specific to the medical procedure that will be performed on the patient. The purpose of the form is to ensure that the patient gives his/her informed consent for the medical procedure before the procedure is performed. The health care provider will describe the medical procedure on the form and will also list a dozen or more potential complications of all levels of severity, up to and perhaps even including the risk of death, even for the most minor of surgeries.
  2. THE PARAMETERS OF INFORMED CONSENT Edward L Raab, MD JD　Trans Am Ophthalmol Soc. 2004 Dec; 102: 225–232. PMCID: PMC1280103 PMID: 15747761　The patient’s consent distinguishes permitted from unpermitted treatment.

 

インフォームドコンセントとは

  1. Can Lack of Patient Consent Mean Medical Malpractice? https://www.alllaw.com/articles/nolo/medical-malpractice/lack-consent-patient-injury-lawsuit.html　But consent requires more than the patient merely agreeing to the procedure; the patient must give informed consent.

同意書(consent form)の英語版例文集

  1. Consent Form Guidelines and Suggested Wording　https://irb.ucsf.edu/consent-form-guidelines-and-suggested-wording#Write-at-an-eighthgrade-reading-level-and-use-lay-language-vs-medical-terminology　Write the consent document at the most likely level of understanding of the subject population—in general, an eighth-grade reading level. Use everyday vocabulary and simple sentence structure throughout. Replace or define scientific or technical terms in lay language.
  2. Consent Form Templates　https://irb.ucsf.edu/consent-and-assent-form-templates#consent-templates
  3. Surgery Informed Consent Form https://www.jotform.com/form-templates/surgery-informed-consent-form I hereby authorize the named Doctor/Surgeon below, and the assistants and associates whom he/she may designate to perform upon me the surgical procedure indicated below: （中略）I have been informed and it was explained to me that unforeseen conditions may arise where there might be a need for immediate surgical operation or procedure that is not within this informed consent. In such instance, I authorize the above-named surgeon to perform such immediate operation as deemed necessary

同意撤回書　Withdrawal of Consent　例文

  1. Withdrawal of Consent I hereby withdraw consent for authorised researchers to use my health information and samples for unspecified research related to the Coronavirus in the future. I understand that ‥　https://www.health.qld.gov.au/__data/assets/pdf_file/0015/1000833/ACV19-Withdrawal-of-Consent-Adult.pdf
  2. By signing this form I am saying that I do not want to be in the　　　　　　　 Health Home program. Because I will no longer be in this ‥　https://www.health.ny.gov/forms/doh-5058.pdf

医師へのガイド

  1. A Practical Guide To Informed Consent For Surgeons　https://incisionindemnity.com/news-resources/article/informed-consent-for-surgeons/

インフォームドコンセント・同意書（英文）の実例

研究への参加

  1. INFORMED CONSENT FORM　Title of Study: Improving Mind/Body Health and Functioning with Integrative Exercise　https://osher.ucsf.edu/sites/osher.ucsf.edu/files/inline-files/VGX_consent_sample.pdf　Why is this study being done? The purpose of this study is to compare the effectiveness of Integrative Exercise classes to PTSD Recovery Classes, to determine which can best improve quality of life and reduce symptoms of post-traumatic stress disorder (PTSD).

手術を受ける場合

  1. Hartford Hospital 　Authorization for Surgery and/or Special Procedure/Treatment Open Heart Surgery　https://hartfordhospital.org/file%20library/hartford%20hospital%20forms/consent%20forms/577070.pdf　I hereby authorize Dr._____________________________ to perform the following surgery and/or special procedure/treatment:　（中略）I understand that residents, medical students, physician assistants and/or advanced practice registered nurses may also be in attendance, and/or assisting in the performance, and/or performing significant medical/surgical tasks within the above specified surgery and/or special procedure/treatment.

インフォームドコンセントの不備がもたらしうる重大な結果について

  1. Consent Process Often Executed Poorly, Creating Risks and Costs　https://www.reliasmedia.com/articles/143036-consent-process-often-executed-poorly-creating-risks-and-costs　The informed consent process still creates liability risks and unnecessary costs for healthcare organizations.
  2. SIX COMMON MISTAKES WITH INFORMED CONSENTS THAT LEAD TO MEDICAL MALPRACTICE by Cody StrateSep 22, 2020　https://accessefm.com/blog/six-common-mistakes-informed-consents-lead-medical-malpractice/　2. USING NON-STANDARD FORMS OR NON-STANDARD LANGUAGE Forms provided by the hospital, employer, or group practice have gone through robust review by both legal and compliance teams to ensure the forms properly protect the business entity, physician, and patient. All too often, physicians will take these standard forms and modify the language in some way, inadvertently creating malpractice risk. This simple mistake can also lead to a physician being fired, causing irreparable harm to their reputation. Changing a few words or sentences in a form is not worth ruining a career over.
  3. The 10 Biggest Legal Mistakes Physicians Make That Could Lead to Liability for Failure to Provide Informed Consent　https://seak.com/blog/uncategorized/10-biggest-legal-mistakes-physicians-make-lead-liability-failure-provide-informed-consent/　The best written form is tailored to the procedure, listing the common risks and complications, the more serious risks and complications, and the benefits. The form should also indicate that alternatives to the procedure were discussed, including the alternative of not having the procedure, and that the patient decided to proceed. Many medical associations provide sample forms for common procedures that incorporate the common risks, benefits, and alternatives, and websites for these associations can be great resources.
  4. Understanding Perry v. Shaw — Making Informed Consent Better by Carolyn Oill, Esq. Greines, Martin, Stein & Richland LLP　 She argued that her consent to the enlargement was not valid because she was medicated and about to go into surgery when she signed the form and that she relied on the surgeon’s oral promise that he would not perform the enlargement.
  5. Informed Consent Liability & Lawsuits: 3 Ways to Get Sued　https://jacksonllp.com/informedconsent-lawsuits/

裁判の例など

  1. Arch Plast Surg. 2016 Sep; 43(5): 402–410. Published online 2016 Sep 21. doi: 10.5999/aps.2016.43.5.402 PMCID: PMC5040841 PMID: 27689046 Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents　　https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5040841/
  2. 第3章 患者の視点に立ったインフォームド・コンセント　＜判例② 福岡地裁昭和61.3.28＞ ネフローゼ症候群により入院中の患者が一時外泊中に死亡した事案　＜判例③ 最高裁平成7.5.30＞ 医師が未熟児である新生児を黄疸の認められる状態で退院させたところ新生児が退院後核黄疸に罹患して脳性麻痺の後遺症が生じた事案　＜判例④ 高松高裁平成8.2.27＞ 髄膜腫の手術を受けて抗痙攣剤２種の処方を受けていた患者が、退院の際に処方された同薬剤の副作用によって中毒性表皮融解壊死症（ＴＥＮ）を発症して死亡した事案　＜判例⑤ 福岡地裁小倉支部昭和58.3.29＞ 虫垂炎のため虫垂摘出術を執刀したが周囲臓器癒着のため一部しか摘出できなかった症例で、再手術の必要性等について説明していなかったところ、１４年経過後に虫垂粘液囊種等が形成されて再手術を余儀なくされた事案

インフォームドコンセントに纏わる話題

  1. Informed consent for heart procedure: most patients overestimate benefits 28 Nov 2019　https://www.escardio.org/The-ESC/Press-Office/Press-releases/Informed-consent-for-heart-procedure-most-patients-overestimate-benefits
  2. Medical Malpractice: The Ins and Outs of Informed Consent Nurses who interfere with the process can land in legal trouble. William Duffy Publish Date: August 9, 2020　Outpatient Surgery　https://www.aorn.org/outpatient-surgery/articles/outpatient-surgery-magazine/2020/august/medical-malpractice-the-ins-and-outs-of-informed-consent

インフォームドコンセントに纏わる議論（論文）

  1. Does content of informed consent forms make surgeons vulnerable to lawsuits?　Asian Journal of Surgery Volume 43, Issue 3, March 2020, Pages 497-503  https://www.sciencedirect.com/science/article/pii/S1015958419307870
  2. Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims　JAMA Surg. 2017;152(6):e170544. Original Investigation June 21, 2017 　doi:10.1001/jamasurg.2017.0544　the most common specific informed consent allegations were failure to explain the risks and adverse effects of surgery followed by failure to explain alternative treatment options.
  3. Is informed consent in cardiac surgery and percutaneous coronary intervention achievable?　ANZ J Surg . 2007 Jul;77(7):530-4. doi: 10.1111/j.1445-2197.2007.04143.x. https://pubmed.ncbi.nlm.nih.gov/17610687/

その他

  1. 役立つテンプレート・素材集 インフォームド・コンセントに使えるテンプレート集  素材集 患者さん説明用臓器 アステラス
  2. Medscape Malpractice Report 2017　Medscape
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