Re: legally liable


"Jerry Dallal" <gdallal@xxxxxxxxxxxxxxxxxxxx> wrote in message
news:7JidncgjHfvLzJHbnZ2dnUVZ_vTinZ2d@xxxxxxxxxxxxxx
Jerry Dallal wrote:
st0rmy@xxxxxxxxxxxxx wrote:
Hi, my name is Leila and I have a question:

1. As a researcher, is a researcher legally liable for any harm that
occurs to subjects participating in the research?

thanks You


You betcha.

According to the Common Rule 45 CFR 46, the investigator--not the
institution, not the IRB, not OHRP--is ultimately responsible for the
safety of participants.

http://tinyurl.com/2wnefe
http://tinyurl.com/2ugg8s

IANAL
I should have added...

That isn't to say that an injured participant can't sue everyone and
everything in sight. The point is that the investigator cannot disavow
responsibility because the study was approved by his/her institution. I
would guess that in the absence of wrongdoing most institutions would
support their investigators, but the investigator can't simply bow out.

In fact, I believe that as soon as any adverse or harmful effects are seen
the study or that aspect of the study is supposed to be terminated.

Likewise if the positive effects of a study are so obvious before the end of
the study the treatment (or whatever) to people should be concluded, on the
basis that any medical study can have harmful effects on a few people (even
where the majority effects are positive) so that this should not be risked
for even a few.

Nick


.

Relevant Pages

  • Re: legally liable
    ... As a researcher, is a researcher legally liable for any harm that ... occurs to subjects participating in the research? ... The point is that the investigator cannot disavow responsibility because the study was approved by his/her institution. ... I would guess that in the absence of wrongdoing most institutions would support their investigators, but the investigator can't simply bow out. ...
    (sci.stat.math)
  • Re: legally liable
    ... As a researcher, is a researcher legally liable for any harm that ... occurs to subjects participating in the research? ... According to the Common Rule 45 CFR 46, the investigator--not the institution, not the IRB, not OHRP--is ultimately responsible for the safety of participants. ...
    (sci.stat.math)