A slightly different twist to the "patient pay" question.

Recently, our IRB has see a large number of clinical trials/investigational
drug studies that are attempting to limit the companies liability for
study-related injuries. The consents have included variations on the
following clause:

If you sustain a bodily injury that is caused by the study drug, you will
be reimbursed by the sponsor of the study for reasonable physician fees and
medical expenses necessary for the treatment of the injury that are not
covered by you rmedical or hospital insurance coverage, provided that the
injury is nt due to a negligent or wrongful act or omission of any person
employed by the sponsor. The study doctor and his staff are not employed by
the sponsor. No other compensation of any type will be provided by the
sponsor.

Our IRB is of the view that, since in Canada the insurance costs would be
covered from an employer's insurance and/or the provincial (state) medical
health insurance, that this clause is unacceptable, that it places the
burden of study related injury on the subject's insurer, the taxpayer and
the subject. The IRB has taken the view that these costs (indeed all costs
related to the study, including the medical check-ups etc) must be covered
by the budget of the study and that the subject needs to retain the right
to go after the company for all costs associated with study related
injuries.

A bit long winded, but I need to know how other IRBs handle these clauses.

Michael Owen
Director
Research Services
210 Kirk Hall
University of Saskatchewan
Saskatoon, Saskatchewan
S7N 0W0

306-966-8575 (tel)
306-966-8597 (fax)
xxxxxx@sask.usask.ca (e-mail)