Clinical Trials Administrator Archives – September 1, 2003

September 1, 2003

• Says who? Laws are murky when it comes to surrogate consent

  Researchers in California have a bit less to worry about when it comes to consent. As of Jan. 1, 2003, there is a specific law to cover who can provide surrogate consent for participation in medical research.

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• Policy on Surrogate Consent for Research — Excerpts

  Policy on Surrogate Consent for Research Excerpts

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• FDA says off-the-shelf should be on the record

  Too many research studies in this country are using experimental substances in human subjects without the oversight required by federal law and now can expect to undergo heavier scrutiny, say authorities with the U.S. Food and Drug Administration (FDA).

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• Budget pitfalls can lead to monetary shortfalls

  Before any clinical trial gets under way, the principal investigator and study coordinator must prepare the trial budget, ensuring not only that the investigators and staff have spending guidelines, but also that the site can support the work the trial will require.

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• News Brief

  Privacy requirements give researchers fits

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