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| | Informed consent - Wikipedia, the free encyclopedia |
 | | The question of whether informed consent needs to be formally given before sexual intercourse or other sexual activity, and whether this consent can be withdrawn at any time during the act, is an issue which is currently being discussed in the United States in regard to rape and sexual assault legislation. | | | It may not be legally possible to give consent to certain activities in certain jurisdictions; see the Operation Spanner case for an example of this in the UK which involved sadomasochistic activities such as branding. | | | In cases of incompetent minors informed consent is usually required from the parent (rather then the 'best interests standard') although a parens patriae order may apply (allowing the court to dispense with parental consent in cases of refusal). |
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http://en.wikipedia.org/wiki/Informed_consent
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| | IRB Information Sheets Page 5 - Updated 9/98 |
| | The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. | | | No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. | | | The consent document may, at the option of the IRB, state that subjects' names are not routinely required to be divulged to FDA. |
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http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
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| | Medical Informed Consent |
| | Consent forms that recite that these risks are associated with the procedure have been upheld by the courts as satisfying the statutory requirement. | | | The informed consent law is still in a development stage, and despite an extensive literature on the subject, many questions remain unanswered, providing a fruitful area for research that can contribute to the policy of the law and its implementation in the courts, and to physician-patient communications and decision-making. | | | In this regard, the reported data is more detailed, giving the appellate court's rationale and decision on the informed consent claim, although in some cases the appellate court must also guess at the rationale for the jury's finding. |
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http://www.piercelaw.edu/risk/vol2/winter/merz.htm
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| | Legal Briefs, June 1998 -- Informed Consent |
| | Informed consent has become such a common healthcare procedure that, in some states, the courts have held or the legislature has determined that it is a part of the standard of care. | | | Discussing informed consent, the court said that because the doctor's conduct did not significantly increase the risk that the patient would contract HIV, the doctor's failure to disclose his HIV status was not material. | | | As stated at the opening of this article, informed consent was originally seen as necessary to obtain permission to apply force to someone's body. |
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http://www.aana.com/legal/legbrfs/1998/06lb98.asp
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| | /humansubjects/guidance/ documents |
| | Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. | | | The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. | | | The written presentation of information is used to document the basis for consent and for the subjects' future reference. |
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http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm
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| | Informed Consent |
| | The special requirements for obtaining legally valid informed consent for children to be the subjects of research are set out in 45 CFR 46.401 et seq. | | | This permission should be on agency letterhead, should make clear the administrator's authority to grant such permission, and should indicate that the Informed Consent forms to be used in the research meet with his or her approval. | | | A copy of the debriefing statement must be included after the informed consent document in the application. |
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http://www.uwgb.edu/irb/UWGBinformed_consent.htm
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| | eMedicine - Informed Consent : Article by Matthew L Howard, MD, JD |
| | Persuading a court that a consent issue should be judged under the rules of battery may be of critical importance in some jurisdictions because punitive damages may be available for one cause of action and not the other. | | | American law initially considered issues of informed consent under the mantle of battery, which considers that any offensive and unconsented touching of another renders a person liable for damages. | | | In states with limitations on noneconomic loss in medical malpractice cases, the ability to seek punitive damages through a battery cause of action may be the only mean to obtain legal assistance (because medical malpractice claims accrue smaller fees for the attorneys). |
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http://www.emedicine.com/ent/topic181.htm
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| | Informed Consent |
| | Informed consent is a civil right", more specifically a conceptual "patient right". | | | Informed consent represents the single most important issue in the delivery of health care. | | | Now that the unique immunity against legal suit provided by ERISA is in the slow process of being stripped away by the courts the health care "playing field" may, finally, become more level. |
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http://www.burtonreport.com/InfForensic/InformedConsent.html
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| | Ethics Committee Briefing Paper on Informed Consent |
| | Informed consent, for the purposes of this code, does not necessarily imply or require a particular written or signed form. | | | Researchers are responsible for identifying and complying with the various informed consent codes, laws and regulations affecting their projects. | | | Those granting the permission should be involved actively in determining the appropriate form of documenting consent. |
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http://www.aaanet.org/committees/ethics/bp5.htm
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| | Human Subjects in Medical Research: Informed Consent |
| | Consent forms must state that the decision whether or not to participate will not affect their treatment at the facility. | | | In these cases, it may be appropriate to present subjects with a written consent form without a signature line and ask them to indicate their consent orally. | | | If this is the case, subjects must be informed of these circumstances in advance. |
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http://humansubjects.stanford.edu/medical/consent.html
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| | Informed Consent and Medical Research |
| | The presenters outlined the history of informed consent and discussed the procedure that researchers must follow to obtain it legally and ethically. | | | Researchers should understand that a subject gives up no legal rights through this procedure and that a minor's informed consent must also be agreed to by a parent or guardian. | | | As is usually the case, some exceptions apply to the principle of informed consent. |
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http://www.uky.edu/~cperring/ic.htm
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| | GenomicsPopulation ResearchELSIInformed Consent Article |
| | Consent documents should affirm that participants' privacy will be protected, as well as provide details about security measures and any legal protections that are available (e.g., a Certificate of Confidentiality). | | | This Act applies when records are maintained by a federal agency in a "system of records," a term that means a group of records under the control of a federal agency from which information is retrieved by the name of the individual, identifying number, or some other identifying particular. | | | When research is subject to the Privacy Act, informed consent documents need to include the Privacy Act notification statement. |
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http://www.cdc.gov/genomics/info/reports/policy/consentarticle.htm
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| | Informed Consent, Parental Permission, and Assent in Pediatric Practice |
| | In rare cases of refractory disagreement, formal legal adjudication may be necessary. | | | In some cases in which the patient has no legal entitlement to authorize treatment, the physician may have a legal obligation in some jurisdictions to obtain parental permission or to notify parents in addition to obtaining the patient's consent. | | | The first draft of this document, prepared by William G. Bartholome, MD, was presented to the original American Academy of Pediatrics (AAP) Committee on Bioethics in 1985. |
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http://www.cirp.org/library/ethics/AAP
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| | UIUC Institutional Review Board: Informed Consent |
| | Witnesses are sometimes required to attest to the consent process and sign the consent document in cases where nonstandard consent procedures are used—contact the IRB Office for more information. | | | The consent statement should be presented in the first person (e.g., "I have read and understood...and I agree to participate...") at the end of the document. | | | Though not required by law, the researcher may also wish to sign the consent form or, in more than minimal risk projects, initial each page. |
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http://www.irb.uiuc.edu/ic/samples.asp
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| | Findlaw for the Public - |
| | The patient or the patient's legally authorized representative must be given a copy of the informed consent documents once they are signed and dated, and a copy should be placed in the patient's file. | | | In those states, such young adults may be able to provide consent without consulting with their parents. | | | FindLaw: Understanding Informed Consent: A Primer - Attorney, Attorneys, Lawyer, Lawyers, Law, Laws, Litigation, Lawsuit |
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http://public.findlaw.com/healthcare/life_events/le23_2primer.html
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| | INFORMED CONSENT |
| | Such act of doing something against the wish of a legal entity, constitute an abuse of power, trespass on their person, betrayal of thrust, and may be, turning the patient to "human guinea pig"; all that is contrary to established constitution and law. | | | But once I inform of the risks of the procedure, they then refuse. | | | If this is the case, documentation should confirm the and probably witnessed. |
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http://www-hsc.usc.edu/~mbernste/ethics.informed_consent.html
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| | Informed Consent |
| | Informed consent must be obtained prospectively (that is, before you collect the data) in most circumstances. | | | An informed consent checklist of issues identified in the regulations is available to help you review your own work. | | | Information about obtaining consent from non-English speakers is also provided. |
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http://sophia.smith.edu/~jdrisko/consent.htm
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| | Tips on Informed Consent |
| | For persons who are legally incapable of giving informed consent, psychologists nevertheless (1) provide an appropriate explanation, (2) seek the individual's assent, (3) consider such persons' preferences and best interests, and (4) obtain appropriate permission from a legally authorized person, if such substitute consent is permitted or required by law. | | | That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence. | | | A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled |
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http://www.socialpsychology.org/consent.htm
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| | Informed Consent |
| | In signing this form, you are stating that you have read this consent form and although it contains medical terms which you may not completely understand, you have had the opportunity to ask questions and had them answered to your satisfaction. | | | Take as much time as you wish to make a decision about signing this form. | | | You have also viewed the video and understand the questions presented on the other side of this form. |
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http://www.elliseye.com/informed_consent.html
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| | National Cancer Institute - A Guide to Understanding Informed Consent |
| | If you then decide to enter the trial, you give your official consent by signing the document. | | | You can keep a copy and use it as an information resource throughout the course of the trial. | | | You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment. |
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http://www.cancer.gov/clinicaltrials/AGuidetoUnderstandingInformedConsent/Page2
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| | Informed Consent and "Material Risks" |
| | However, written consent always is advised as oral consent is difficult to prove. | | | However, on June 19, 1989, the Louisiana Supreme Court ruled in the Hondroulis v. | | | The Louisiana Uniform Consent Law of 1975 was upheld by the Louisiana courts on many occasions. |
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http://www.intrepidresources.com/html/informed_consent.html
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| | AMA (Legal Issues) Informed Consent |
| | Earlier consent cases were based in the tort of battery, under which liability is imposed for unpermitted touching. | | | To protect yourself in litigation, in addition to carrying adequate liability insurance, it is important that the communications process itself be documented. | | | A well-designed, signed informed consent form may also be useful, but an overly broad or highly detailed form actually can work against you. |
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http://www.ama-assn.org/ama/pub/category/4608.html
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| | AMT / Risk Review -- A History of Informed Consent |
| | In the United States the concept of informed consent was not the subject of much legal action prior to the twentieth century. | | | This rights declaration included the right to safety, the right to be informed, the right to choose and the right to be heard. | | | Since those days, however, as social trends changed and mankind as a whole became more focused on human rights, the concept of consent became the subject of case law both within and outside of the United States. |
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http://www.cnahealthpro.com/amt/consent_history.html
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| | Informed Consent: The Subject's Right to Know |
| | Is this an "umbrella" consent form that will allow several procedures to be performed at the same time or successively? | | | The more information you have about the options available to you, the more confident you will be in the decisions made. | | | The more information you have about the options available to you, the more confident you will be in the decisions made." |
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http://www.ahrp.org/InformedConsent/InformedConsent.php
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| | OMIC - Informed Consent Documents |
| | Suggested Informed Consent Clauses for Documenting "Off-label" PRK | | | Chalazion: Consent Form for Incision and Drainage of Chalazion | | | Addendum to General Consent Form: Orbital and Plastic Surgery |
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http://www.omic.com/resources/risk_man/forms.cfm
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| | Informed Comment : 08/01/2004 - 08/31/2004 |
| | Should it be changed in any way?" And, he might also have been prepping AIPAC for the lobbying campaign scheduled for early in 2005, when Congress will have to be convinced to authorize military action, or at least covert special operations, against Iran. | | | AIPAC probably passed the directive over to Israel for the same reason--not to inform, but to seek input. | | | That is, AIPAC and Israel were helping write US policy toward Iran, just as they had played a key role in fomenting the Iraq war. |
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http://www.juancole.com/2004_08_01_juancole_archive.html
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| | Informed Consent in the Operating Room: Ethical Topic in Medicine |
| | In the case of minor patients, legal precedents determine when a minor can give legal consent, but do not address the issues of when a minor patient should be invited ethically to participate in the informed consent process. | | | Patients have the right to refuse information, but the request must originate from the patient and not the physician. | | | Principles involving the informed consent process require that the best available information about procedures and risks be provided to patients. |
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http://eduserv.hscer.washington.edu/bioethics/topics/infc.html
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| | Making a decision about your pregnancy: Overview |
| | It is illegal for a health care provider to perform any medical or surgical procedure without first obtaining the informed consent of the patient. | | | You must have a chance to ask questions and discuss your pregnancy decision before an abortion can be performed. | | | You may view the entire text of the law by clicking this link --> Click here!! |
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http://www.hss.state.ak.us/dph/wcfh/informedconsent
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| | Informed Consent Orientation |
| | This site provides information on the informed consent process and also a tool to help you create a consent document. | | | Module 3, Create a Consent Document, is one screen split in two. | | | The lower portion of the screen offers aids in constructing the document. |
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http://www.research.umn.edu/consent/orientation.html
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| | American College of Surgeons When You Need An Operation |
| | The principle of informed consent is endorsed by the American College of Surgeons, the largest organization of surgeons in the world with more than 54,000 members. | | | Remember, the operation is being performed on you, and you should seek any information that you need to improve your understanding. | | | No doctor can, or should, guarantee outcomes, because each operation is different, depending upon the individual condition and response of each patient. |
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http://www.facs.org/public_info/operation/consent.html
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