I need some very fast help on institutional policy regarding compensation of
human subjects injured during participation in an approved research study (I
am meeting with the provost mid-day Friday to discuss this).  Here is our
situation:

We are a liberal arts institution.  One of our PE and Health professors
plans to study ways to prevent or lessen the incidence of a certain type of
knee injury in female high school soccer players.  The intervention is a
specially designed exercise program to strengthen the knee.  Our professor
is collaborating with researchers at the local medical school (we are not
affiliated in any legal way with the medical school).  Initial exams and
assessments will be conducted by the medical school researchers at the
medical school.  The exercise program will be run by our professor on our
campus.  Both IRB's have determined the project to be minimal risk and
qualified for expedited review under the "exercise by healthy volunteers"
criterion.

Because the study involves investigators from the two institutions and will
take place partially on each campus, we felt that both IRBs needed to review
the project.  (We are Single Project Assurance; they are Multiple, so they
cannot accept an IRB review done by an SPA institution).  We want only one
informed consent form for each participant and have worked to develop
language that is agreeable to both IRBs.

The only remaining problem has to do with language regarding compensation
for injuries.  The medical school would like us to include the following:

 "...in the event of injury directly arising out of participation in the
study, the College of Charleston and/or the [medical school name] will
provide reasonable medical care not otherwise covered by third party (health
insurance company) payments..."

We do not view this as an IRB issue, but rather as an institutional policy
issue.  The IRB's role at this point seems to be one of making sure the
investigator provides accurate information about institutional policy in the
consent form.  The College's legal counsel feels that this clause would
create a contract to provide medical care even if the injury was not a
result of our negligence.  Further, it does not clearly state how costs of
such care would be distributed between the two institutions (which the
medical school feels would be decided on a case-by-case basis after the fact
and depending on the injury, where it occurred, and what treatment was
necessary), nor does it provide any limit to coverage or address the issue
of responsibility or non-responsibility of the college for deductibles and
co-payments for third party insurance.  This seems to be inordinate exposure
for an institution of our type, especially in our litigious society, and we
have no pot of funds to cover this type of expense.  Unlike the medical
university, we cannot offer "free" medical care on our campus (we only have
a small student infirmary).  We do have liability insurance which covers
injury in the case of our negligence, but we do not have "contract insurance."

Please tell me how you would handle this type of project.  Do you have an
institutional policy that addresses payment for injury during research?  If
so, what is it?  If you offer care in non-negligent cases, where does the
money come from?  Are their limits on the amount you will pay?  Do you
require your subjects to have their own health insurance?  Do you tell your
subjects that no care is available through your institution?  What kinds of
problems do you see if the medical university says they will provide care
for injuries on their premises but we say that we will provide no
compensation or services for injuries sustained on our campus?  What impact
would this have on the research?

I will be most grateful for any help you can give so I can go to the Provost
with some good suggestions.

Barbara H. Gray                           Telephone:  803-953-5673
Director of Sponsored Programs            FAX:        803-953-1434
University of Charleston, SC              e-mail:     xxxxxx@cofc.edu
Charleston, South Carolina  29424