Ellen Roche story
Aug 23, 2001 15:11 PDT
[Forwarding from Sterling Stoudenmire]
you ask about what does this case imply?
I respond that the Ellen Roche/ Dr. Alkis Togias type problem points to
system which relies on ethics committees and MDs as a cause of this kind of
problem. They are not trained researchers, and should not be held
accountable to be either researchers or scientists, especially when they
are the ones who are going to profit by doing the research.
This case is a clear, undisputable reason to open up all literature, no
matter how scientific, no matter the ip issues, to all persons (general
public), and to mandate that anyone engaged in any kind of experiment that
could affect their health, be given both a complete printed package
[appropriately underlined] of all of the prior research and someone to
explain it all to them... before they be allowed to sign consent forms.
Otherwise, they are signing "victum to be" consent forms on blind
faith.. in which case, there is little reason for the consent, just do it.
Also, before a consent form is signed, it should be passed to an
attorney-CPA-scientist team (who do not represent any connection to anyone
in the research, the producer of the materials or procedures to be tested,
or the government) representing the person to be experimented on.
The cost of that representation should be made an obligatory part of the
preconsent process and no one should be allowed to sign such a form until a
personal attorney-CPA-scientist-librarian independant audit team have
passed favorably on it. Ethics Committees are not acceptable, and are
usually formed merely to protect the hospital and physician teams and to
tacitly comply with the law. I would call this team, the preconsent
independent audit team.
No one, hospital, physician, manufacturer, government or passerby should be
exempt from unlimited liability should they procede without the victum
first having a clear understanding of the known or suspected risks.