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In March 2013, the Department of Health and Human Services (HHS) issued a final omnibus rule modifying various aspects of the Health Insurance Portability and Accountability Act (HIPAA) to implement provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH). These rules include a few notable changes that affect research programs, including provisions related to compound authorizations and authorizations for future research use and disclosure of protected health information (PHI).
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The federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered, according to a March 2013 report from the Presidential Commission for the Study of Bioethical Issues.
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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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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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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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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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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 Now with the release of draft guidance Financial Relationship and Interests in Research Involving Human Subjects: Guidance for Human Subject protection, published on March 31, the discussion will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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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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The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.
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The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the colleges IRBs.