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Health Law and Policy

Informed consent

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Full-Text Articles in Law

The Hydra, Carl E. Schneider Jul 2010

The Hydra, Carl E. Schneider

Articles

Almost nobody favors long consent forms for prospective research subjects. Almost everybody thinks they interfere with informed consent's purpose-good decisions. Nevertheless, almost everybody believes consent forms have long been getting longer. Years ago, Paul Appelbaum lamented the "tendency to cram ever more information into consent forms." Weeks ago, Ilene Albala and her colleagues (one of them Appelbaum) reported in IRE: Ethics & Human Research that the length of one institutional review board's forms "increased roughly linearly by an average of 1.5 pages per decade. In the 1970s, the average consent form was less than one page long and often only …


Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk Jan 2008

Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk

Articles

We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the …


After Autonomy, Carl E. Schneider Apr 2006

After Autonomy, Carl E. Schneider

Articles

Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …


Gang Aft Agley, Carl E. Schneider Jan 2001

Gang Aft Agley, Carl E. Schneider

Articles

In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …


The Best-Laid Plans, Carl E. Schneider Jul 2000

The Best-Laid Plans, Carl E. Schneider

Articles

It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …


From Consumer Choice To Consumer Welfare, Carl E. Schneider Nov 1995

From Consumer Choice To Consumer Welfare, Carl E. Schneider

Articles

In trying to understand the I SUPPORT study, it may be useful to think of contemporary bioethics reform in terms of the principles of consumer protection. The central tendency of that reform (particularly in my own field-the law) has been to employ the model of consumer choice. That model sets as its purpose to allow consumers to choose the kinds of products they prefer. It seeks to accomplish that purpose primarily by supplying consumers the information they need to make choices and by insisting that they are given what they chose. Thus, for example, merchants may be required to reveal …