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Synopsis: When RALES and EPHESUS are considered together, one clearly can recommend the use of an aldosterone receptor blocker for all very ill patients with congestive heart failure and significant LV dysfunction, whether or not related to acute myocardial infarction.
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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 Now with the release of draft guidance Financial Relationship and Interests in Research Involving Human Subjects: Guidance for Human Subject protection, published on March 31, the discussion will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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Rheumatoid arthritis should be recognized as a marker of increased risk for myocardial infarction.
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The FDA recently approved a new class of antiretroviral drug for treatment of patients with resistant HIV infections.
