I will be out of the office from Monday, August 19th through Wednesday, September 4, 2002.  I will return your email on Thursday, Sept 5th.

If you have a grant related question, please contact Anne Chisholm at 4-0627 or Sue Tower at 4-0525.  Thanks!
Diane

>>> "xxxxxx@HRINET.ORG" 08/17/02 21:14 >>>

It's no wonder  we have so many lawyers.

Indemnification is supposed to hold one party harmless from  liabiltiy
for someone else's use of the first party's product, service or work.
(Great Scott!  That sounded like a lawyer!).  There are implied
indemnifications all over the place.  Every time we get in a car, we
exercise one for the motor company.  If we drive recklessly, crash the
car, and damage someone's priceless dog house (sans dog), the doghouse
owner could not go back to the auto maker and sue for damages.  However,
if the cause of the accident was due to a design defect in the car that
causes an unrecoverable  mechanical failure, the owner of the car could
sue the manufacturer.

Same deal with research.  We do the cutting edge research and find all
kinds of new things which are picked up by industry and government.
 Their application of our research is out of our hands, and we should
hold no liability for it (indemnification).  However, if we are
negligent in our science which causes harm to be inflicted upon someone,
then we should rightly be held liable, especially if we make certain
statements concerning the veracity of the research.  This is probably
the strongest justification for publicly publishing the research results
and methodologies in juried journals and getting collaborating research
results from other independent  sources.

Of course, this also makes patenting and copywriting much more
difficult.  Another lawyer problem...

Greg Schmidt

Aylin A. Regulski wrote:

> We also need indemnification for Sponsor's use of the results for
> PI-initiated studies.  Usually it is not a big issue, but about a year
> ago
> we dealt with a sponsor that had huge problems with it (though they
> hadn't
> in prior PI-initiated agreements we had with them).
>
> There were big delays on 2 PI-initiated projects we had with them and we
> conferred with our central legal dept who advised us to hang tight as we
> should expect to be covered for this.  Since the projects were
> PI-initiated, sponsor was not so concerned about the delays.  After
> lengthy
> delays in which Sponsor was so amazingly unresponsive that we finally had
> to prepare a project timeline and get one of the PI's involved, there was
> some more detailed communication.
>
> We had asked Sponsor why they did not want to indemnify for their use of
> the results and could they think of a sitution where it would not be fair
> to them.  They stated that perhaps we would publish the results and
> sponsor
> would reference the publication, exposing sponsor to liability.  However,
> if we publish, sponsor is not using the results, we are--Sponsor is just
> referencing our use.  Nonetheless, we stated we could also make an
> exception for NU's publication of results that Sponsor references.
> After
> much last minute discussions, Sponsor finally agreed to include the
> language (without the exception).
>
> Perhaps it would be helpful to determine sponsor's concerns so they
> coud be
> addressed?
>
> Aylin
>
>
>
> At 09:35 AM 8/14/02 -0400, you wrote:
>
>> Stick with your position. You have the right instincts on this one.
>> If the
>> company is objecting to this indemnification if could very well be
>> due to the
>> fact they are concerned there is real potential for exposure. You
>> have no
>> control over the use to which the company will pur the results of the
>> project.
>> They could very well interpret the data in ways you feel are
>> incorrect or
>> inappropriate. They could use the data in ways you do not intend. In any
>> event,
>> the bottom line is that if you don't have control over a situation,
>> then those
>> that do bear responsibility should be the indemnifying party.
>>
>> Steve
>>
>>
>> "Jessica K. Moraski" wrote:
>>
>> > Good Morning All,
>> >
>> > We are currently negotiating a clinical trial agreement  and seem
>> to have
>> > hit an impasse. It is our standard requirement that companies
>> indemnify our
>> > organization for "Use of Study Results".  Specifically the company
>> shall
>> > defend, indemnify and hold harmless our Institution, Principal
>> Investigator
>> > etc. from any and all liabilities, claims etc. resulting from The
>> Company's
>> > use of the study results.  (we do include the standard provisions
>> that the
>> > study is in accordance to protocol, there is no negligence on our
>> part,
>> > etc.)
>> >
>> > The Company has asked us what our concern is, and we gave the
>> example we
>> > study 200 women who take this drug.  There are no adverse effects.
>> The
>> > drug goes to market, or the Company uses the results in a publication
>> > stating our results.   Then when the population takes the drug
>> something
>> > awful happens and those who have taken the drug, not only sue the
>> company
>> > but those involved in the clinical trial.
>> >
>> > In the instance of the agreement we are negotiating the Company has
>> > indicated they no longer will indemnify for "use of results".  (We
>> have
>> > past agreements where they do.)   They tell me other universities and
>> > medical centers have agreed to forgo "use of results".  They feel
>> that the
>> > phrase is too broad and if we can write language that will cover
>> just the
>> > above example they would consider it.
>> >
>> > My questions:
>> >
>> > 1)   Do others feel "use of results" is as important as we have in the
>> > past. Have there been agreements in clinical trials in which use of
>> results
>> > are not required?  (In our case it can be a deal breaker)
>> > 2)  Are there other examples of potential problems which I am
>> overlooking
>> > if we do not obtain such indemnification?
>> >
>> > Thanks in advance.
>> >
>> > ****************************
>> > Jessica Moraski, CRA
>> > Grant Administrator
>> > Health Research, Inc.
>> > One University Place
>> > Rensselaer, NY  12144
>> > (518) 431-1265
>> > (518) 431-1234 (FAX)
>> > xxxxxx@health.state.ny.us
>> >
>> > ======================================================================
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>> >  subscription information and a web-searchable archive, are available
>> >  via our web site at http://www.hrinet.org (click on "Listserv Lists")
>> > ======================================================================
>>
>> --
>> Stephen Erickson, Director
>> Research Compliance and Intellectual Property Management
>> Boston College, McGuinn Hall 221
>> Chestnut Hill, MA 02467
>> Telephone: 617-552-3345
>> Fax to my computer:  413-895-8328
>>
>>
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>>  subscription information and a web-searchable archive, are available
>>  via our web site at http://www.hrinet.org (click on "Listserv Lists")
>> ======================================================================
>
>
>
> **********************************************************
> Aylin A. Regulski  M.S., J.D.
> Research Administrator/ Clinical Trials and Industry
> Office of Research and Sponsored Programs
> Northwestern University
> Abbott Hall, Room 506
> 710 N. Lake Shore Drive
> Chicago, IL  60611-3078
> Phone: 312-503-7905
> Fax: 312-503-2234
> Click here to visit our webpage:  http://nuinfo.nwu.edu/orsp/
>
>
> ======================================================================
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> subscription information and a web-searchable archive, are available
> via our web site at http://www.hrinet.org (click on "Listserv Lists")
> ======================================================================
>

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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
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