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At the Dana-Farber Cancer Institute in Boston, human subjects protection is treated as a quality assurance issue. The institute takes steps to ensure that protections are extended throughout protocols through data monitoring and auditing and is working to improve informed consent through a validated questionnaire.
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A proposal to create a new category of Food and Drug Administration (FDA) licensure for drugs used by the Department of Defense (DoD) against nuclear, biological, and chemical threats has caused a stir in human research circles.
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Its no secret that the process of obtaining informed consent for research involving human subjects is never easy. The process is even more complicated, however, when the proposed study participant is a newborn.
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The public is increasingly concerned about the integrity and ethical conduct of research. Now with the release of draft guidance Financial Relationship and Interests in Research Involving Human Subjects: Guidance for Human Subject protection, published on March 31, the discussion will take on greater urgency and importance.
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IRBs now have a new legal worry the recent emergence of lawsuits aimed squarely at individual IRB members, rather than just at the institution or the IRB as a whole.
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A 50-year-old man with end-stage heart failure is referred to your medical center for evaluation to receive a heart transplant. He is in reasonably good health, considering his condition, but has only entered a smoking cessation program two months ago. His previous attempts to quit smoking all have been unsuccessful. Is this patient an appropriate candidate for organ transplantation?
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As controversies over fetal tissue research, cloning, and stem cells grab the headlines, other applications of genetic research are quietly making their way into clinical practice. But many health care providers arent ready for them.
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Following Congressional scrutiny of their business practices, hospital group purchasing organizations (GPOs) are moving to adopt new standards governing how they collect fees, contract with vendors, and manage potential conflicts of interest.
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