Research Compliance

Latest Discussion Posts

  • Thank you for weighing in. This seems to be the general consensus, but I can't find anything recent to back it up, and our corporate counsel is questioning. Many people cite the Special Edition article (SE0822) released in 2008, which specifically references ...

  • The following, from the Walters-Lutz correspondence in 2004, is the only direct addressing of this. CMS has not put this letter on its website as it was a private ruling but it has been circulated enough and from the text you get the gist and the ...

  • Seeking help from those expert in Medicare billing for research: we are struggling to find a legal or regulatory basis for the notion that Medicare cannot be billed for clinical trial services when a sponsor has agreed to pay for those services in the ...

  • Yes, the group working on the Sec 1557 wants to include the discrimination language if they believe the research subject is not receiving it elsewhere such as registration. I also raised the point that not all research patient are receiving treatment ...

  • Hi, I haven't given this much thought- can you give more explanation as to what is being discussed? Are you thinking the research consent should state that the institution will not discriminate on the basis of the participant's age, sex, national origin ...

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