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Consent

Health Law and Policy

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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 …


Testing Testing, Carl E. Schneider Jul 1997

Testing Testing, Carl E. Schneider

Articles

Last year, Congress passed the Ryan White Care Act Amendments of 1996. The amendments authorize ten million dollars for each fiscal year from 1996 through 2000 for counseling pregnant women on HIV disease, for "outreach efforts to pregnant women at high risk of HN who are not currently receiving prenatal care," and for voluntary testing for pregnant women. The amendments compromise a central question: whether prenatal and neonatal AIDS testing should be compelled. The compromise is complex. The director of the Centers for Disease Control and Prevention is instructed to establish a system for states to use to discover and …