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Clinical Trials Administrator Archives – March 1, 2004

March 1, 2004

View Archives Issues

  • Trends in clinical research require updated policies on tissue banking

    Researchers and clinical trials managers may have noticed that the best practices standards in tissue banking have been evolving in recent years due to scientific advances, greater public scrutiny on human subject protection, and new privacy rules under the Health Insurance Portability and Accountability Act.
  • Blood substitute study raises consent questions

    In emergency medicine and critical care, clinical trials are difficult to conduct. The unpredictable and time-sensitive nature of these specialties means that controlled, randomized, clinical trials are difficult, sometimes impossible to design.
  • Research on the dead: Standards are required

    A cardiovascular surgeon develops an experimental intravascular blood oxygenation device that has the potential to eliminate the need for mechanical ventilation in severely injured patients. However, testing the device in human patients would be unethical because of the great risk of harm, and the still-unknown chance for benefit.
  • A few simple rules ensure data sharing compliance

    The National Institutes of Health (NIH) wants all research supported with NIH funds to be shared with other investigators and made available to the public, but how can this philosophy be reconciled with privacy laws and concerns?
  • News Briefs

    Smallpox vaccine draft guidance issued by FDA; New technology, lack of consent leads to lawsuit