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Topic: Informed consent

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	Device Advice - Informed Consent (Site not responding. Last check: 2007-10-07)
		Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study.
		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 legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
		These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible.
	www.fda.gov /cdrh/devadvice/ide/informed_consent.shtml (1866 words)

	Informed consent - Wikipedia, the free encyclopedia
		Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action.
		A person below the age of consent may agree to sex, know all the consequences, but their consent is deemed invalid as they are deemed (regardless of the reality) to be a child unaware of the issues and thus incapable of being informed consent.
		The doctrine of informed consent relates to professional negligence and establishes a breach of the duty of care owed to the patient (see duty of care, breach of the duty, and causation in English law).
	en.wikipedia.org /wiki/Informed_consent (1676 words)

	IRB Information Sheets Page 5 - Updated 9/98
		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.
		Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding.
		The informed consent documentation requirements [21 CFR 50.27] permit the use of either a written consent document that embodies the elements of informed consent or a "short form" stating that the elements of informed consent have been presented orally to the subject.
	www.fda.gov /oc/ohrt/irbs/informedconsent.html (4474 words)

	ACS :: Informed Consent
		Informed consent is the process or action that takes place as you learn about and consider a treatment before you agree to it.
		Informed consent for a clinical trial is usually required to be more detailed and thorough than consent for a standard medical procedure or treatment.
		Informed consent for a clinical trial or investigational procedure (where new treatments are compared to the current standard treatment) usually includes more information than the consent for any standard treatment.
	www.cancer.org /docroot/eto/content/eto_1_2x_informed_consent.asp (4062 words)

	Medical Informed Consent
		Informed consent is the legal embodiment of the concept that each individual has the right to make decisions affecting his or her well-being.
		Informed consent law developed from the intentional tort of battery, which protects the individual from an unwanted physical touching of the body by one having neither express nor implied consent of the person touched nor a privilege to do so.
		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.
	www.piercelaw.edu /risk/vol2/winter/merz.htm (12546 words)

	eMedicine - Informed Consent : Article by Matthew L Howard, MD, JD (Site not responding. Last check: 2007-10-07)
		Instead, modern informed consent law states that, once a physician-patient relationship exists, a physician has a duty to provide to his or her patient the information needed for the person to make a rational decision whether to undergo surgery or any other treatment or to refuse treatment altogether.
		The responsibility for informed consent remains with the physician, even though physicians may delegate the duty of educating patients to auxiliary staff, and the auxiliary staff presents the informed consent document to the patient for signature.
		An informed consent is a consent that results from an understanding by the patient of the risks and adverse effects of the proposed treatment.
	www.emedicine.com /ent/topic181.htm (3301 words)

	Informed Consent
		Informed consent is a process in which the researcher fully informs the subject about the research (its purpose, scope, risk/benefit, and other characteristics), and the subject is given an opportunity to consider whether or not to participate without undue influence or coercion.
		Although the consent of a family member is not required if the subject can and does give consent, obtaining informed consent from both the subject and the involved family member may avoid any future dispute about the propriety of the research and the validity of the subject's own consent.
		When informed consent is not documented in writing, the subject must nevertheless be fully informed about the research and must truly consent to it.
	www.uwgb.edu /irb/UWGBinformed_consent.htm (2850 words)

	Informed Consent Process (Site not responding. Last check: 2007-10-07)
		The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires.
		The witness must sign and date the consent form attesting that the requirements for informed consent have been satisfied; that consent is voluntary and freely given by the subject, guardian, or surrogate, without any element of force, fraud, deceit, duress, coercion, or undue influence.
		The consent form (or research record) should document the method used for communication with the potential subject and the specific means by which the potential subject communicated agreement to participate in the study.
	www.rgs.uci.edu /ora/rp/hrpp/informedconsentprocess.htm (2018 words)

	YNHH Risk Management Handbook-Informed Consent
		Many physicians feel that informed consent is merely a formality necessary to obtain the patient's signature on a form in order to allow a specific procedure or treatment to be performed on the patient.
		Rather, informed consent should be thought of as a communication process through which a patient, with the advice and support of his or her physician, makes decisions concerning the treatment he or she will receive.
		Informed consent may be given by adult patients with capacity, the parent or legal guardian of a minor, emancipated minors under specific circumstances or a court or patient designated surrogate of a patient without capacity.
	info.med.yale.edu /caim/risk/handbook/rmh_informed_consent.html (1215 words)

	Medical Informed Consent
		Informed consent is the legal embodiment of the concept that each individual has the right to make decisions affecting his or her well-being.
		Informed consent law developed from the intentional tort of battery, which protects the individual from an unwanted physical touching of the body by one having neither express nor implied consent of the person touched nor a privilege to do so.
		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.
	www.fplc.edu /risk/vol2/winter/merz.htm (12546 words)

	Informed Consent and "Material Risks"
		Informed consent is a legal doctrine in America that is defined in all 50 states as a consent to treatment (for example, a consent to an operation) obtained after adequate disclosure.
		Louisiana Uniform Consent Law of 1975 Louisiana attempted to solve the problem of informed consent in 1975 with the passage of La. R.S. This law states that consent shall be presumed to be valid and effective, in the absence of proof that execution of the consent was induced by misrepresentation of material facts, if
		Informed consent under this older version of informed consent is valid as an oral consent as well as a written consent.
	www.intrepidresources.com /html/informed_consent.html (931 words)

	/humansubjects/guidance/ documents
		The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand.
		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.
		Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity.
	www.hhs.gov /ohrp/humansubjects/guidance/ictips.htm (914 words)

	Informed Consent and Medical Research
		Informed Consent is derived from the principle of Autonomy.
		Consent by the patient must be "specific as to the proposed intervention." For example, if a pregnant woman signs consent for a Caesarian section, the physician has no right to go ahead and perform a tubal ligation while she is in surgery.
		Consent by the patient must also be fully informed-that is, the patient must be told the details of the procedure, the risk factors, the likelihood of success, and so on (Hebert, 1996).
	www.uky.edu /~cperring/ic.htm (3405 words)

	IRB Informed Consent
		Broadly, the informed consent document communicates to the prospective research subject the purpose, procedures, risks and benefits of the study, the subject’s rights in participating in the research, and the freedom to decline to participate without jeopardy.
		If oral consent is necessary due to limited literacy or language comprehension, the subject or his/her legal representative will be asked to sign a consent form stating that the basic consent form elements have been orally presented.
		Consent documents become part of the IRB file of a project and as such, are subject to Federal Audit.
	www.xu.edu /IRB/infconsent.htm (1670 words)

	NOCIRC - Informed consent
		Informed consent is a legal doctrine that has been developed by the courts over a number of years.
		The Informed Consent Doctrine requires that medical doctors provide a patient with all relevant information about a proposed procedure or treatment prior to obtaining the consent of the patient to carry out the procedure or treatment.
		Informed consent usually also protects the doctor from financial liability (with exceptions) provided that the procedure is properly executed according to the prevailing standard of care and without negligence.
	www.nocirc.org /consent (722 words)

	Informed Consent
		Consent for research involving clinical procedures should be discussed during prior visits to the clinic, not on the day of the procedure.
		For example, a single project may require a consent form for the guardian or parent of a child, a consent form for the competent adult subject, and a simplified assent form for the 8- to 18-year-old or for the adult who is not competent to give consent alone.
		"Informed Consent" is not an acceptable title because it obscures the fact that informed consent is a process, not the document itself, and implies a completeness that the form may not have.
	www.cuw.edu /Academics/irb/informed_consent.html (4004 words)

	Draft of Proposed Legislation Concerning Informed Consent and Medical Accountability
		Persons signing consent papers for non-emergency procedures shall be in an unaltered state of consciousness, shall not be in labor or in postpartum euphoria, and shall not be on mind- or emotion-altering drugs.
		Women facing mastectomy shall be informed in writing of the current statistics concerning the 30% disagreement rate among pathologists as to whether a pathology slide is cancerous; she shall be offered a second pathologist's opinion; and she shall be given her pathology glass slide to take home and keep.
		Parents consenting to circumcision shall be informed in writing that the surgery is done without the child's consent, permanently removes erogenous tissue, is painful during and after the surgery, is typically done without anesthesia, and may be objected to by the child, so that he may try to restore his foreskin as an adult.
	www.informedconsent.org /draft.html (2795 words)

	Informed Consent
		Informed consent exists only when there is full disclose of known relevant information and known risk presented to the patient in a manner that they can understand.
		No area of informed consent is more important than that of medical research and the involvement of human subjects.
		Informed consent is an essential requirement for the well-being of any modern health care system in the 21st century.
	www.burtonreport.com /InfForensic/InformedConsent.html (1904 words)

	Ethics Committee Briefing Paper on Informed Consent
		It is understood that the degree and breadth of informed consent required will depend on the nature of the project and may be affected by requirements of other codes, laws, and ethics of the country or community in which the research is pursued.
		Further, it is understood that the informed consent process is dynamic and continuous; the process should be initiated in the project design and continue through implementation by way of dialogue and negotiation with those studied.
		Informed consent, for the purposes of this code, does not necessarily imply or require a particular written or signed form.
	www.aaanet.org /committees/ethics/bp5.htm (897 words)

	Informed Consent Issues
		In the case of a minor, the written, informed consent of the parent or guardian is required.
		Oral consent shall be documented in the patient’s record, along with details of the information verbally explained to the parent or guardian about the proposed treatment.
		Verbal consent shall be valid for a period of 10 days, during which time informed consent shall be obtained in writing.
	dhfs.wisconsin.gov /clientrights/InformdConsent.htm (360 words)

	Informed Consent
		Assuring informed consent for research participants is a very important practical and ethical imperative.
		An informed consent checklist of issues identified in the regulations is available to help you review your own work.
		Informed consent must be obtained prospectively (that is, before you collect the data) in most circumstances.
	sophia.smith.edu /~jdrisko/consent.htm (398 words)

	Bioethics: Informed Consent
		In these jurisdictions, the parties cannot introduce expert testimony on the adequacy of informed consent; instead, the matter is left up to the jury (or the judge, if the case is being tried without a jury) to decide, based on their own experiences and attitudes.
		Another answer might be for the physician to inform the patient that the physician is going to provide information about mainstream approaches, but that some other physicians might recommend other, non-mainstream approaches, and that if the patient wishes, she can contact these other physicians.
		The duty to obtain the patient's informed consent to proceed with a less experienced physician is related to the duty to refer a patient to a more expert professional.
	www.thedoctorwillseeyounow.com /articles/bioethics/consent_3 (1971 words)

	ACS :: What is informed consent?
		Informed consent is a process that starts with a discussion of the risks and benefits of your treatment with your health care team.
		The term "informed consent" is a legal standard meaning a person has been told enough about the risks and benefits of a treatment or procedure to make an informed decision.
		Consent forms are often lengthy and riddled with medical terms, so it’s important to ask questions about your treatment and the form itself.
	www.cancer.org /docroot/NWS/content/NWS_1_1x_What_is_informed_consent_.asp (688 words)

	Counseling, Informed Choice, Informed Consent, and the Rights of the Client
		Informed consent is the communication between client and provider that confirms that the client has made an informed and voluntary choice to use or receive a medical method or procedure.
		Informed consent can only be obtained after the client has been given information about the nature of the medical procedure, its associated risks and benefits, and other alternatives.
		Informed and voluntary client consent is especially important before a medical procedure that has a permanent or long-acting effect or that requires the skills of a trained provider.
	www.engenderhealth.org /wh/fp/iwhat.html (569 words)

	Consent and Informed Consent
		No Consent is not failure of informed consent - Wuerz v.
		Thomas, 611 P.2d 902 (Cal. 1980) - This case involves the failure to warn the patient of the risks of not consenting to a diagnostic test.
		Consent as a fiduciary duty - Moore v.
	biotech.law.lsu.edu /cases/consent/index.htm (762 words)

	A Guide to Understanding Informed Consent - National Cancer Institute
		The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant.
		It is designed to begin the informed consent process, which consists of conversations between you and the research team.
		The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.
	www.cancer.gov /clinicaltrials/AGuidetoUnderstandingInformedConsent/Page2 (754 words)

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