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  • Full May 2004 Issue in PDF

  • Experimental devices and clinical trials

    A report in the March 25 Philadelphia Inquirer regarding the use of experimental treatment on an infant in connection with a heart repair highlights a series of issues related to both the use of devices not approved by the Food and Drug Administration (FDA) and, in turn, their use on minors, including infants.
  • Informed consent process at center of another suit

    In March, members of the Havasupai Indian Tribe of northwestern Arizona filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers. The lawsuit claims that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors consent.
  • Data monitoring can affect risk management 

    Christopher Gallen, MD, PhD, vice president and chief of operations for clinical research and development at Wyeth in Collegeville, PA, highlights some strategies developed at Wyeth that are designed to help improve the clinical trials process and manage risk.
  • Risk management making its way into clinical trials

    Developing and adhering to a solid risk management strategy is an important foundation for preparing for the possibility of clinical trial problems, including those pertaining to patient safety, regulatory issues, and civil suits, experts say.
  • Given rules and regs, is emergency department research even possible?

    Surveys of emergency department (ED) patients indicate most patients present there in moderate to severe pain. But ED physicians have a difficult time knowing which medications will work best for their patients because research specifically targeted to emergency conditions is lacking.
  • Facility makes patients partners in safety efforts

    In its recent initiative to minimize medical errors, William Beaumont Hospital in Royal Oak, MI, has made its patients Partners in Safety. Thats the name of the new program, which was launched in 2002.
  • Medication errors targeted in new JCAHO survey process

    In light of so many providers having difficulty meeting the standard of care for medication administration, the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, is taking action.
  • New infection control standard proposed by JCAHO

    The Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, has proposed a new infection control standard. As part of emergency management activities, organizations should prepare to respond to epidemics or infections likely to require expanded care capabilities over an extended period of time.
  • Using creativity in patient education

    In a recent interview with Patient Education Management, Laura Gebers, BSN, RN, BC discussed her job, her philosophy on patient education, the challenges she has met, and the skills she has developed that help her do her job well.