Clinical Trials Administrator Archives – October 1, 2003
October 1, 2003
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Collecting extra tissue samples should be a no-go without consent
In recent years, it has become a common practice for sponsors of clinical trials to collect extra blood and tissue samples from subjects for genetic analysis and possible later use in future research projects. -
Are research subject advocates the future?
There is a new kid on the block, helping to oversee human subject protections at some institutions and providing some assistance to overtaxed IRBs: the research subject advocate (RSA). -
It’s what you say that could create liability
Federal laws governing research on human beings prohibit research institutions and sponsors from requiring subjects to sign documents that waive or appear to waive any of their legal rights. -
What to Say, What Not to Say
Examples of Exculpatory Language -
NIH creates roadmap for clinical research
The National Institutes of Health (NIH) in the early fall announced plans to transform the nations medical research enterprises and expedite turning research discoveries into practical improvements. -
Keep up with new regs, know existing ones
Sometimes there are just too many acronyms, but its important for research professionals to learn the regulatory power wielded by the big three: OHRP (Office for Human Research Protections), FDA (Food and Drug Administration), and NIH (National Institutes of Health).