I agree, Alexander.  This may also to some extent be a question of
what one is "required to do" legally vs. "should do" ethically.

The FDA is clear that data from withdrawn participants is to be
included in data analysis.

www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0576-gdl.pdf

From p. 4 of this document:

"FDA recognizes that a subject may withdraw from a study; however, the
withdrawal does not extend to the data already obtained during the
time the subject was enrolled. FDA’s longstanding policy has been that
all data collected up to the point of withdrawal must be maintained in
the database and included in subsequent analyses, as appropriate."

I'm involved quite a bit with reviewing clinical drug trials within
our local IRB and the consent forms are clear that data is maintained
after withdrawal from the study.

Darrell Spurlock, Jr. PhD, RN
Director of Research
Graduate Medical Education
Assistant Professor, MCCN
Mount Carmel Health System
793 West State St., 3rd Floor - MSB
Columbus, OH 43222
Phone:  614-234-5414
Fax:  614-234-2772
xxxxxx@mchs.com
xxxxxx@mccn.edu

On Fri, May 14, 2010 at 13:08, Schoen, Alexander <xxxxxx@winthrop.org> wrote:
>
> yes, they do, but if the consent form states, in advance, that the data will not be removed, then the investigator can retain it.  Those consent forms contain lots of embedded language.
>
>
> -----------------------------------------
>
> Alexander Schoen
>
> Director, Office of Sponsored Programs
>
> Winthrop-University Hospital
>
> 222 Station Plaza North, Suite 510
>
> Mineola, NY  11501
>
> Phone: (516) 663-4931
>
> Fax:     (516) 663-9718
>
> xxxxxx@winthrop.org
>
> www.winthrop.org
>
> P Please consider the environment before printing this email
>
>

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