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Non-English speakers often are under-represented in clinical trials because of the language barrier and the lack of resources to provide clear and up-to-date translations of informed consent. This leads to questions of equity, an expert notes.
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Informed consent templates are useful when an IRB office starts a new process or when there are new employees or new investigators submitting applications, but an experienced office can improve IC review quality by weaning its staff off of templates, an expert suggests.
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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 Now with the release of draft guidance Financial Relationship and Interests in Research Involving Human Subjects: Guidance for Human Subject protection, published on March 31, the discussion will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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Its a call an IRB office dreads getting a patient with a complaint about a study or a researcher, or an anonymous caller alleging problems with a clinical trial.
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As genetics research yields more and more information about individuals predispositions to disease and illness, researchers are beginning to question whether study participants should have access to the genetic information obtained about them.
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While the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is clearly getting all the headlines and a great deal of attention in the research community, the recent Food and Drug Administration (FDA) Guidance for Industry on Electronic Records indicates it is not the only game in town.
