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>A patient of mine called me today to report that someone from
>Stanford had asked her to come in to be evaluated for pallidotomy.
>She was very upset , thinking that I had given her number to them.
>If anyone fromthe Stanford program reads this ,I want you to
>know that I do not agree with this mechanism of recruiting patints.
>This is not appropriate and possibly unethical. I feel patients
>need to be evaluated by a neurologist who works with an experienced
>surgeon. Patient lists should not be perused for possible candidates.
>I would like to hear from others on the list about this issue.
 
I could not find anything in the 1993 GCP (Good Clinical
Practices) regulations specifically addressing recruitment
of subjects.  I attended a conference last year, and one of
the topics was "Recruitment and Retention" for clinical
trials.  It lists one avenue of identifying potential subjects
is to review the hospital database for patients with
specific diseases and to review hospital admitting reports.
It also notes that with these two techniques, contact with
the patient should only be by an MD, I assume for
confidentiality reasons.  So, if the Stanford people were
trying to recruit subjects for a clinical trial, it may be
acceptable to contact potential subjects who may have an
interest in the research directly.  They may also have obtained her
phone number from a list of a local Parkinson's chapter.  It
is not uncommon for a group to give out names and addresses
to a hospital research team studying the disease of interest for
that organization.  I myself have received information regarding
several trials for PD, and I do not have PD.  I belong to a local PD
chapter, because my grandfather has PD.
 
I do agree that it sounds like this could have been handled
better by the people at Stanford.  But I also know from
experience that even when you give a person information,
they do not always comprehend and interpret what was actually
said.  I think this is especially true regarding research, because
many people do not understand how a research study works.
This patient can refused to be in the study, which it sounds like
she did.  Another person may have been very interested in
participating, and happy to receive the call.  That's what
informed consent is for!
 
Wendy Rogers
Clinical Research Coordinator
Indiana University Medical Center
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