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Topic: Consent

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Informed consent

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	Informed consent - Wikipedia, the free encyclopedia
		In most countries, people must give informed consent before the majority of medical operations are performed and doctors may be sued for assault or battery for not giving their patients a full awareness of the risks associated with such things as medical trials of new medications and operations.
		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consent needs to be formally given before sexual intercourse or other sexual activity, and whether this consent can be withdrawn at any time during the act, is an issue which is currently being discussed in the United States in regard to rape and sexual assault legislation.
		While children may be able to give consent, a more complex quesion applies in terms of informed consent: whether children are developmentally and otherwise able to give informed consent, in particular to an adult, bearing in mind power relationships, maturity, experience and mental development.
	en.wikipedia.org /wiki/Informed_consent (580 words)

	CATHOLIC ENCYCLOPEDIA: Consent (In Canon Law)
		Completeness of consent is gauged not so much by the preliminaries of transactions as by their ratification, which is the psychological development of incipient consent, and gives consistency to legal transactions.
		This consent must include the material object of the matrimonial contract, which material object is the mutual right of one party to the body of the other, a right that carries with it every prerogative vested therein by the laws of nature.
		In general, this consent is necessary in such matters as usually involve a serious obligation or the possibility of a notable damage, or in matters which simultaneously pertain to bishops and their chapters.
	www.newadvent.org /cathen/04283a.htm (1387 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 (1646 words)

	1976 AAP statement on informed consent
		Generalities concerning consent are difficult to define when the involved patients are infants or minors, who may be incompetent and are not legally empowered, without guardian consent, to make serious decisions regarding their bodies.
		The rule of thumb in applying for parental consent is the feasibility of obtaining such consent, weighed against the necessity of urgent treatment for the child.
		It is suggested that consent to research procedures should be obtained from all children over the age of 7 years (the earliest age the law considers that a child could form a specific intent).
	www.cirp.org /library/ethics/AAP/1976.html (1366 words)

	AORN Journal: Informed consent and perioperative nursing
		Consent may be implied from conduct or may be expressed, whether in writing or orally.
		This has been labeled in some places as "ghost surgery." Most courts consider this practice deceit, holding that when consenting, a patient is indicating a willingness to put his or her life in the hands of a known and trusted physician.
		Consent also should be obtained routinely for use of videotape equipment and cameras used in laparoscopic surgery.
	www.findarticles.com /p/articles/mi_m0FSL/is_n1_v63/ai_19088719 (1493 words)

	Consent and Assent - WVU IRB Guidelines - Chapter IV (Site not responding. Last check: 2007-10-21)
		Informed consent is a person’s documented, voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure.
		Subjects document their consent by signing the most recent copy of the consent form that has a signed and dated IRB approval stamp (please note the expiration date on the stamp).
		When potential research subjects are not competent to give legally valid informed consent, respect for a person's autonomy mandates that the investigator obtain their voluntary assent to participate, in addition to obtaining the informed consent of a parent, guardian, or other legally authorized representative.
	www.wvu.edu /~rc/IRB/irb_guid/chap_iv.htm (3913 words)

	Understanding Informed Consent (Site not responding. Last check: 2007-10-21)
		If a patient's consent is written, it should include the name of the health care professional who discussed the proposed treatment with the patient, the name of the health care provider who is to perform the procedure, and the date, time and location where the consent form was signed.
		Consent not given by a patient in writing or verbally, but understood from the circumstances surrounding the procedure or treatment at issue, is known as implied consent.
		Consent is also usually implied for necessary procedures a surgeon might perform in the course of a surgical procedure to which the patient did consent.
	behmlaw.lawoffice.com /CM/FSDP/PracticeCenter/Personal-Injury/Medical-Malpractice.asp?focus=topic&id=1 (894 words)

	Informed Consent and the Clinical Investigator
		The informed consent process is designed to give subjects all the information that they need to decide about participating in a study; to ensure that subjects understand the information; and to give subjects an opportunity to consider participation in the study (initially and ongoing).
		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.
		When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress.
	www.unmc.edu /irb/source_documents/informed.htm (2097 words)

	Informed Consent: Ethical Topic in Medicine (Site not responding. Last check: 2007-10-21)
		Informed consent is the process by which a fully informed patient can participate in choices about her health care.
		The most important goal of informed consent is that the patient have an opportunity to be an informed participant in his health care decisions.
		The patient's consent should only be "presumed", rather than obtained, in emergency situations when the patient is unconscious or incompetent and no surrogate decision maker is available.
	eduserv.hscer.washington.edu /bioethics/topics/consent.html (1230 words)

	NOCIRC - Informed consent
		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.
		The adult patient's power to consent is very broad and includes the power to consent to such extreme operations as sexual reassignment.
		At the present time, the legal problems notwithstanding, the medical practice is to obtain the written consent of a parent to the circumcision of a male child before a circumcision is carried out.
	www.nocirc.org /consent (722 words)

	Consent Condoms (Site not responding. Last check: 2007-10-21)
		Using a Consent Condom will reduce your sexual partner's anxiety and should lead to an improved stress free performance as well as giving you peace of mind that he will wear a condom.
		It is hoped that it can be seen and used as an important protective device for both parties by bringing mutual consent into the sexual arena and removing the element of misunderstanding.
		When the emotions are highly charged as in a sexual encounter the consent condom allows for a moment of clarity.
	www.menstuff.org /issues/byissue/consentcondoms.html (1283 words)

	Human Subjects in Non-Medical Research: Informed Consent (Site not responding. Last check: 2007-10-21)
		Modified consent procedures can be appropriate if either a) written signed consent could increase the potential risk to subjects or b) the research presents no more than minimal risk and the research could not practicably be carried out without the alteration.
		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.
		Consent forms must state that the decision whether or not to participate will not affect their treatment at the facility.
	humansubjects.stanford.edu /nonmedical/cons.html (1068 words)

	News - Consent/Assent: Non-English Speaking Subjects - National Jewish Medical and Research Center
		When the translated consent form is used with a subject, the person obtaining consent and the subject or their representative will then sign the non-English consent form.
		Where the informed consent is documented in accordance with federal regulations, the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent.
		Alternatively, federal regulations permit oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally.
	www.njc.org /news/irb/reporting/consent/non-english.aspx (600 words)

	Community Grievance Decision Digest - Informed Consent
		In the case of a minor, the informed consent of the parent or guardian is required.
		Informed consent for treatment from a patient’s parent or guardian may be temporarily obtained by telephone in accordance with s.
		The hospital should have gotten his consent on admission to share his billing information with his wife so that they could inform her, too, when the insurance funds were running out.
	www.dhfs.state.wi.us /clientrights/CGDD/ConsentInfmd.htm (1260 words)

	Presumed Consent Foundation - Solutions
		While the family would be advised of this information, their consent would not be required, and no one would be allowed to override the donation.
		Presumed Consent could be implemented quickly, easily, and relatively inexpensively by working within the framework of the existing Organ Donation system.
		Presumed Consent could have a dramatic impact on the number of organs available for transplant, significantly reducing the Waiting List and the number of deaths on the waiting list, as well as relieving the pain and suffering of thousands.
	www.presumedconsent.org /solutions.htm (442 words)

	Roger Clarke's 'e-Consent'
		Some are at a high level of abstraction, as in the (often tacit) consent that citizens give to governments to define and implement social policy, and to engage in acts of war.
		Consent is then declared by the person concerned, using a computing facility, which comprises a computer with requisite systems software and application software (process 2).
		This inverts the expression of consent, because the statement is entirely pre-determined by the organisation seeking the consent.
	www.anu.edu.au /people/Roger.Clarke/EC/eConsent.html (8109 words)

	Ethics - Consent (Site not responding. Last check: 2007-10-21)
		In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship.
		This will sometimes places their interests in opposition to the person who is seeking consent, a consideration which is of particular importance within research where the researcher needs to find people willing to participate as research subjects in order to proceed with their programme of investigation.
		A key principle underlying the notion of informed consent is respect for patient autonomy; it is for the patient, not the doctor, to determine what is in the patient's own best interests.
	www.prs-ltsn.leeds.ac.uk /ethics/documents/consent.html (1889 words)

	CONSENT TO MEDICAL TREATMENT
		An implied consent is one that may be inferred from actions of the patient, or other circumstances, even though specific words of consent are not used.
		As mentioned above, an implied consent is one that may be inferred from actions of the patient, or other circumstances, even though specific words of consent are not used.
		Each state’s statutes and precedents will prescribe what is to be considered adequate informed consent and what standards will be used to determine whether the burden of properly informing the patient in accordance with the law has been met.
	www.wramc.amedd.army.mil /departments/judge/Consent.htm (1223 words)

	Informed Consent.:.IRB.:.OPRS (Site not responding. Last check: 2007-10-21)
		Consent forms for research studies at Northwestern and affiliates must use the standard template to construct a clear, well-designed consent form.
		Informed consent is mandated by Federal policy (45 CFR 46 Section 116) and is also one of the fundamental principles of ethical conduct in the use of human subjects.
		Investigators should wait for final approval of the consent form before translating it into another language though it is important that the original IRB submission reference the intention to prepare a translated consent form.
	www.northwestern.edu /research/OPRS/irb/informedConsent (849 words)

	Presumed Consent (Site not responding. Last check: 2007-10-21)
		This occurs, for example, when a patient arrives at a hospital unconscious or without decision-making capacity, and in need of necessary treatment that cannot be delayed until (1) the patient regains consciousness or capacity, or (2) his or her parent, spouse, or other surrogate decision maker can be contacted to give informed consent.
		Consent might also be presumed if an unforeseen circumstance for which the patient has not given specific consent arises during consented to treatment or surgery.
		For example, a patient who has consented to antibiotic treatment, and who is then rendered unconscious by a severe allergic reaction to the antibiotic, could be placed on a ventilator to assist his or her breathing based on presumed consent.
	www.sclhsc.org /mission_vision_values/ethics/presumed_consent.asp (210 words)

	Informed Consent Process: Printer
		The consent form should serve as a written summary of the exact information that was presented to the prospective participants before their agreement to participate in the study.
		In all cases, the researcher must demonstrate respect for the rights of the participant within the proposed consent procedures that should be developmentally appropriate to the age and circumstances of the participant.
		Permission (informed consent in writing) is required for all children and minors who participate in research, along with the assent of the child or minor.
	www4.nau.edu /ovp/irb/icdprocess.htm (3719 words)

	News - Consent/Assent: Telephone Consent Guidance - National Jewish Medical and Research Center
		However, in some cases, it is acceptable to send by mail or facsimile a copy of the informed consent document to the legally authorized representative (LAR) and to conduct the consent interview by telephone when the legally authorized representative can read the consent as it is discussed.
		No intervention can begin until the consent document is received by the investigator unless a waiver or alteration of the consent process is requested and approved by the IRB.
		If telephone consent is to be used in a study, the investigator must state so in the IRB application and fully describe the process which will be used to obtain and document telephone informed consent.
	www.njc.org /news/irb/reporting/consent/telephone.aspx (330 words)

	AllRefer.com - informed consent (Medicine) - Encyclopedia
		informed consent, in medicine, a patient's written consent to a surgical or medical procedure or other course of treatment, given after the physician has told the patient all of the potential benefits, risks, and alternatives involved.
		Informed consent is also required for participation in clinical studies.
		The concept of informed consent is based on the principle that a physician has a duty to disclose to a patient information that allows the patient to make a reasonable decision regarding his or her own treatment.
	reference.allrefer.com /encyclopedia/I/informed.html (199 words)

	eMedicine - Consent : Article by Ernest L Yeh, MD (Site not responding. Last check: 2007-10-21)
		In these instances, normal consent standards are not followed because immediate treatment may be required even before an opportunity to obtain consent is available.
		For example, a patient who presents to the ED with an acute-onset headache and requires a workup for a possible subarachnoid hemorrhage does not automatically consent to a lumbar puncture simply because she or he is in the ED.
		If the patient is of sound mind and judgment and refuses to consent to the procedure, the physician cannot apply emergency consent and may not proceed.
	www.emedicine.com /emerg/topic740.htm (1684 words)

	JAMA -- Abstract: Improving the Process of Informed Consent in the Critically Ill, April 16, 2003, Davis et al. 289 ...
		JAMA -- Abstract: Improving the Process of Informed Consent in the Critically Ill, April 16, 2003, Davis et al.
		by the consenter of the procedure as determined by the responses
		and consent for them is often obtained by proxy.
	jama.ama-assn.org /cgi/content/abstract/289/15/1963 (339 words)

	Informed Consent (Site not responding. Last check: 2007-10-21)
		Two ethical principles underlying informed consent are that it is free from coercion and that the prospective research subject has time to contemplate whether or not to participate.
		Their implementation has exposed a fundamental problem associated with conducting research with subjects who cannot provide consent: There is a direct and irrevocable tension between the standards of protecting the rights of research subjects and the ability to investigate and improve the care rendered to future patients.
		The consent form does not necessarily need to be a multi-page document and using a shorter form may facilitate giving information to the patient.
	www.nhtsa.dot.gov /PEOPLE/INJURY/ems/ems-agenda/informed_consent.htm (939 words)

	Consent Decree Overview
		A consent decree is an agreement between involved parties submitted in writing to a court.
		The Consent Decree is intended to promote police integrity within the Department and prevent conduct that deprives individuals of their rights, privileges, or immunities protected by the Constitution of the United States.
		Compliance with the Consent Decree is the baseline for, and not the ultimate standard, by which the Department’s commitment to excellence will ultimately be measured.
	www.lapdonline.org /inside_lapd/cd/consent_decree.htm (763 words)

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