Newspaper article from our research archive:
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Advanced Orthopaedics of South Florida.(BIMO/NIDPOE/ORI/OHRP)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Lake Worth, FL, May 6 (CDRH)
An FDA inspection conducted Dec. 13-21 found "serious violations" of regulations regarding IDES, protection of human subjects and other regulations, according to FDA's warning letter.
The agency cited the company for failing to ensure proper monitoring of the investigation, obtain IRB review and approval, submit an IDE application to FDA, receive FDA approval of the IDE before beginning the investigation, and control devices under investigation.
The sponsor of research is required to obtain a new IDE if a significant risk device that is approved for one indication is intended to be used in a clinical study for a new indication. Clinical ...
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Informed consent without autonomy.(medical ethics)
Fordham Urban Law Journal;
November 1, 2002 ;
Sulmasy, Daniel P.;
787 words
......it among themselves, Mary signs the informed consent form, and they make plans for the...Directives for Catholic Health Care require informed consent, just as secular ethics and law do...about Catholic medical ethics and informed consent is really a non-question. However...
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Informed consent
Progress in Transplantation;
December 1, 2005 ;
Zink, Sheldon; Wertlieb, Stacey; Kimberly, Laura;
787 words
...In the last half century, informed consent has become a central tenet...coercion is still a problem. Informed consent is not limited to obtaining...paper provides an overview of informed consent, principles behind the process...
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letters.(on informed consent; stem cell research)
The Hastings Center Report;
July 1, 1999 ;
787 words
...Why Study Informed Consent? Madam: The annotated bibliography of 377 empirical research studies on informed consent ( Empirical Research on Informed Consent: An Annotated Bibliography, HCR, January-February 1999) is dismaying. The study of informed...
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The rebirth of informed consent: A cultural analysis of the informed...
Northwestern University Law Review;
April 1, 2001 ;
Ketler, Suzanne K;
787 words
......neatly with the legal doctrine of informed consent. They are concerned with how much...similar fashion, the legal doctrine of informed consent is concerned with how much and what...legal liability.4 The doctrine of informed consent, in essence, obliges physicians to...
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The doctrine of informed consent: To inform or not to inform?
St. John's Law Review;
July 1, 1997 ;
Walter, Paula;
787 words
......provided a statutory basis for a lack of informed consent claim, established standards for disclosure...which medical providers must obtain informed consent. Over the years, much scholarly effort...common law requirement of "consent" to "informed consent" occurred.3 Academic ...
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Empirical Research on Informed Consent.
The Hastings Center Report;
January 1, 1999 ;
Sugarman, Jeremy McCrory, Douglas C. Powell, Donald Krasny, Alex Adams, Betsy Ball, Eric Cassell, Cynthia;
787 words
......Annotated Bibliography Obtaining the informed consent of patients and subjects is now an...the need for obtaining meaningful informed consent. Moreover, strong popular reactions...agreement about the need to obtain informed consent, there is some uncertainty, about...
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Understanding of informed consent and surgeon liability by the public and...
Journal of Orthopaedic Surgery;
August 1, 2008 ;
Amarasekera, S S; Lander, R O;
787 words
......understanding of the fundamental concepts of informed consent by the public and patients. Methods...Results. The fundamental concepts of informed consent were not appreciated by most respondents...Understanding of medico-legal implications of informed consent (e.g. self-autonomy, ...
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Unwittingly de-humanizing patients; rehabilitating informed consent.
Global Virtue Ethics Review;
January 1, 2004 ;
Russell, Barbara J.;
787 words
......interactions in a healthcare setting, informed consent is the doctrine that incorporates...truth. In everyday practice, however, informed consent has become ethically impoverished...and silence. Examples of typical informed consent discussions are presented with recommendations...
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New NQF Publication Helps With Informed Consent.
PR Newswire;
September 15, 2005 ;
727 words
......Sept. 15 /PRNewswire/ -- Effective informed consent leads to safer healthcare. Informed consent is the process in which a doctor discusses...doctors do a better job of getting informed consent. While informed consent requirements...
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Informed Consent
Dynamic Chiropractic;
March 26, 2007 ;
Perle, Stephen M;
787 words
......past 100 years that the concept of informed consent has appeared in health care. For a...that for many of you reading this, informed consent was never discussed when you were...clinic were never given any kind of informed consent. So, when I first taught ethics at...
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Medical Informed Consent: General Considerations for Physicians
Mayo Clinic Proceedings;
March 1, 2008 ;
Paterick, Timothy J; Carson, Geoff V; Allen, Marjorie C; Paterick, Timothy E;
787 words
...Medical informed consent is essential to the physician...treatment, or both. Medical informed consent should be an exchange of ideas...physicians and patients take medical informed consent seriously, the patient-physician...
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Potential barriers to informed consent.
Journal of the Alabama Academy of Science;
July 1, 2004 ;
Ross, Jill Allard;
787 words
......every researcher knows that securing informed consent from patients and potential study...The three necessary elements for informed consent are: facts about the nature and risks...with successful achievement of truly informed consent. The purpose of this paper is to discuss...
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Transparency: informed consent in primary care.
The Hastings Center Report;
September 1, 1989 ;
Brody, Howard;
787 words
...While the patient's right to give informed consent to medical treatment is now well-established...that the theory and the practice of informed consent are out of joint in some crucial ways...have suggested that the concept of informed consent is virtually foreign to primary care...
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Informed consent: from the ambivalence of Arato to the thunder of Thor....
Issues in Law & Medicine;
December 22, 1994 ;
Arabian, Armand;
787 words
...The law of informed consent touches on some of the most fundamental...The goals of the doctrine of informed consent, the preservation of patient...beginning. The legal aspect of informed consent is limited by the very nature...
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Informed Consent for Regional Anesthesia: What Is Necessary?
Regional Anesthesia and Pain Medicine;
January 1, 2007 ;
Domino, Karen B;
787 words
......regional-anesthesia fellowship programs in obtaining informed consent for regional anesthesia. Brull et...infrequently disclosed in the process of informed consent. For instance, a minority of anesthesiologists...ethical and legal requirement for informed consent. Informed ...
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