DoD consent clause Celia Walker 27 Oct 1994 12:15 EST

A faculty member recently responded to an Army Medical Command BAA with a
project involving human subjects.  The BAA stipulated that the following
clause MUST appear on the subject consent form.  Problem is, it conflicts with
the University's Limited Liability clause, which is state mandated.

"DoD clause:  You are authorized all necessary medical care for injury or
illness which is proximate result of your participation in this research.
Contractors must provide such medical care when conducting research on private
citizens.  Other than medical care that may be provided (and any other
remuneration specifically stated on this consent form), there is no other
compensation available for your participation in this research study, however,
you understand this is not a waiver or release of your legal rights."

1.  Have you faced this situation before?  If so, could you ASAP e-mail (to
the list so we can all learn) responses to the following:

2.  Can you cite chapter and verse of the DoD regulations mandating this
3.  If it did conflict with your institutional requirements, how did you
resolve the two?
4.  Do you know if DoD would allow the insurance premiums for a 3rd party
insurer as a direct cost to the project?  [Our Risk Management people estimate
a premium of $20,000, incidently, so that may not be viable....]
5.  Do you have experience with *other* sponsors (NIH?) and this situation,
and how did you resolve them?  A preliminary read from NIH to my predecessor
was that "premiums are not an allowable direct cost and should be included in
the fringe benefit or the indirect cost rate or something like that."

Thanks for the benefit of your collective centuries of experience and wisdom.

Celia S. Walker
Director, Office of Regulatory Compliance
Colorado State University         TEL:303/491-6355          (After Nov 4:
Ft. Collins, CO  80523            FAX:303/491-6147          (After Nov 4: