DoD consent clause Terry A. May 27 Oct 1994 20:15 EST

 Celia Walker presents an interesting problem for consideration.  The
clause does not appear to me to be unreasonable, depending upon what the
intent actually is.  It would appear that the intent is to provide health
care to the subject, at no cost to the subject, for problems directly
resulting from the protocol.  For most drug & device trials sponsored by
companies, they will agree to this in various ways.  I assume that DOD is
not willing to do this.  Am I correct on that point?

 If so, then the organization responsible to conduct the trial would
assume responsibility.  The actual nature of the protocol is not provided
so it is impossible to assess whether or not it is an in-patient trial nor
the risk involved.  DOD may be assuming that the BAA will result in
submissions by medical centers / facilities that could decide to agree to
the care at no charge, because they also would presumably be gaining some
benefit by providing a new option for health care.

 I certainly would want the option to edit the consent language to make
it clearer to understand - the local IRB has ultimate responsibility and I
doubt that an outside agency can mandate specific language.  I do not know
if or where this requirement is mandated by DOD, but I would first check 32
CFR 219 - Protection of Human Subjects (DOD) (219.116 General requirements
for informed consent).  The common rule published 06/18/91 did not contain
anything like that language.  I believe the FAR & DOD implementing
regulations are also not different.  Therefore, I would guess there is no
regulatory basis for the requirement.  If there is, I too would be
interested in the citation.

 I would like to hear more about CO's limited liability clause, because
I assume that University liability is covered by the state for all
sponsored projects, this being no exception.  In this situation, we are
talking about medical insurance for this project, I assume.

 Finially, I see no reason why the insurance could not be charged to
the project if approved by the agency.  A-21 J.21.a - says that "Costs of
insurance required or approved, and maintained pursuant to the sponsored
agreement, are allowable".  I know that professional liability insurance is
a problem with DHHS but more in the context of an inclusion in the indirect
cost pool.  There, it is an allocation problem.

 Good Luck -

Terry A. May, Ph.D.                       Voice:    602-523-6788
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