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Dear members,
here some concern to be clarified:
1. Can any clinical investigator working for CRO act as a member of
IRB/IEC provided the IEC/IRB is not involved in any of the trial for
same CRO?
example: Dr.A is working for CRO M. there is one IEC/IRB named as
QQ . can doctor A become a member of QQ involved in trial meeting and
apporval of CRO X?
Note: kindly give your thought on the basis of current ethical and
regulatory guideline with reference if any.
thanks in advance
paresh mistry
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The following message was posted to: PharmPK
Paresh:
Most IRBs require their members to sign a confidentiality agreement
and there could be serious legal repercussions if anyone thought the
confidentiality agreement was violated. Obviously, IRB members review
sensitive documents such as investigator brochures that sponsors
would not want their competitors to view. Investigator brochures can
be very detailed and certainly could be very valuable if one had bad
intentions.
The safest thing would be to not join the IRB. Now if protocols from
this competing CRO were only a small part of the material review by
this IRB and the person considering joining the IRB did not have the
expertise (say they were in regulatory not a scientist) to either
deliberately or even inadvertently use this sensitive information it
might be permissible to join. It does however place some risk on the
IRB- most IRBs do not disclose their membership list to sponsors but
if the sponsor found out they might take their business elsewhere.
Sincerely,
Carol Collins
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Dear Paresh, regarding IRB participation,
The best advice I have heard is, "if you think there may be a
conflict of interest; there already is".
The only possible remedy is full disclosure. Please disclose the
situation to all involve immediately.
Regards,
Frank
Frank Bales, Ph.D.
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