https://www.alllaw.com/articles/nolo/medical-malpractice/release-consent-forms-preclude-suing.html A consent form is a pre-printed legal formwith 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.
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
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
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.
Consent Form Templates https://irb.ucsf.edu/consent-and-assent-form-templates#consent-templates
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
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
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
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
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
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
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.
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.
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 commonrisks 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.
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.
Informed Consent Liability & Lawsuits: 3 Ways to Get Sued https://jacksonllp.com/informedconsent-lawsuits/
裁判の例など
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/
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
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）
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
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.
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/