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Re: [IP] studies

Anne Geller <email @ redacted> wrote:

> As a diabetes nurse educator I worked for a year in Renal Transplant
> Research, and also was involved in clinical research for diabetes. Any
> clinical trial has a risk/benefit ratio. You need to see if you might
> from the new drug/treatment, or if it will be just altruistic, with you
> having no benefit. All studies must have a detailed informed consent which
> lets you know the benefits, risks, etc, as well as potential side effects.
> The investigator and/or trial coordinator must explain this to you in

For complete information on what is required, visit the Office of Human
Research Protection at http://ohrp.osophs.dhhs.gov/.

> All new meds must go through extensive clinical trials for FDA approval,
> well as for new indications for current meds.

The FDA is in the process of reviewing and probably streamlining these
procedures.  Look for an announcement in the next few months.

Jim Handsfield, who also serves on one of CDC's IRBs
email @ redacted

The opinions expressed are mine and do not necessarily represent those of my
wife who runs our house and makes more important decisions than I do.
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