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MEDLIB-L  October 2001, Week 1

MEDLIB-L October 2001, Week 1

Subject:

Responses: Post Hopkins-Tragedy - Lengthy Post

From:

Lilian Hoffecker <[log in to unmask]>

Reply-To:

[log in to unmask]

Date:

Wed, 3 Oct 2001 15:39:53 -0600

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (107 lines)

Dear Medlibbers,

Thanks very much for your responses.  Several of you pointed out that a
similar request was posted a few weeks back.  I'm new to the list and I
thank all of you for your patience.  Nonetheless, there seems to be
significant interest (maybe renewed interest?) in this topic so here is what
I have so far including links to previous posts which can be accessed via
the archives:

- Hopkins librarians posted a message on September 7th outlining their plans
http://listserv.acsu.buffalo.edu/cgi-bin/wa?A2=ind0109a&L=medlib-l&F=&S=&P=9
625

- The summary of responses to a similar question is found here
http://listserv.acsu.buffalo.edu/cgi-bin/wa?A2=ind0108e&L=medlib-l&F=&S=&P=3
874

-Excerpts from other responses:
        * I serve on our IRB.  Also, all investigators are required to show
proof of having done a literature search (ie., what databases, how far back,
etc.).  They are advised to contact me for assistance, but this is not
always done.  As most of our major drug studies are multicenter, this is not
always feasible anyhow.  We are a small hospital and most of the studies
done would not be severely affected by such a requirement anyhow.

        *... here's my opinion. I have been asked to work directly with IRB
(stuff), but refused, because it is not what librarians are trained to do.
Indirect assistance is fine, because you don't necessarily need to know what
the research is for. The issue is liability. It is to easy to get caught up
in the problems that may arise as a result of the research being conducted.
It is to easy to get caught up in the problems that may arise as a result of
the research being conducted. I make sure that I am only given generic info
to aid in any lit searches needed. You don't want to know any personal info
about a patient that will connect them to the help you are giving. The best
thing to do is give Doctors a range of sources to choose from and let them
decide on the info they need. For whatever they need it for. I only want to
know what I need to know to do my job.

        * I simply visited with the chair of our IRB and he agreed to
include me from
now on.

        * I have been a member of our IRB for about 4 years.  My role on our
IRB includes acting as the non-scientific member of the committee,making
sure language is understandable for patients, searching for additional
information to clarify the research as well as check references
and information.  Along with the rest of the members, I review proposals for
merit, ask for clarifications and recommend changes when needed.

        * Following the Hopkins events, I initiated a conversation with our
QA manager.  She was enthusiastic at involving me in the Root Cause Analysis
process, and almost immediately gave me list of research topics to start
working through, covering the last 4 years (!). She also asked that I
document such searches (quantity only, not topics!) in my quarterly/annual
reports.
However, there has been no formalization of the role by describing/including
it in Policies, etc.  We intend to take this up with our risk management
consultants when they visit in December; I am going to suggest to my boss
that it be incorporated into my job description.Given how complex and time
consuming these searches are, I may also ask for a raise!
        I certainly hope that this will continue to be a topic for MEDLIB-L;
as a OPL I can use the advice.  I am eager to see what Hopkins' comes up
with on their promised guidelines for literature searches.
        ...some of my questions to our consultants will be regarding how
much documentation do I
need to keep in the Library on the searches I have done?  The search
history?  copies of all texts/articles supplied?  lists of sources that had
no useful results? will I be cross-examined on my search techniques?  I'm
hoping some of your other respondants have already addressed these
questions!

        * Here's what MLA is doing:
9.  TASKFORCE TO PROMOTE THE IMPORTANCE OF EXPERT SEARCHING
As a result of the situation at Johns Hopkins in which a research subject
lost her life, Carol Jenkins, as MLA President, will appoint a Taskforce to
Promote the Importance of Expert Searching.  The charge will be to recommend
action(s), including Best Practice Guidelines that promote excellence in
expert searching in biomedicine and  research

        *In response to the Hopkins publicity, our Library Director asked
for a meeting with the head  of Research Development and the IRB
coordinator. The head of the Library Reference dept also attended.
Some suggestions voiced at the meeting were:
1. The library request form for mediated searches could add the question -
is research involving human subjects a factor?
2. The library could put in place a protocol to ensure that such searches
are handled consistently and effectively.
3. The The IRB office could sponsor a seminar on how to do an effective
literature search.
4. In it's CE module for investgators, the IRB could include information on
the library's search services.
        At this point there was no decision to REQUIRE an independent search
done by the library, but there was general agreement that, in cases
involving potentially significant risk to humans, where there was no FDA or
NIH oversight, this would be helpful. The research and IRB staff will be
discussing these options. We hope we will hear back from them at a later
date.
__________________________________


Lilian Hoffecker
Denison Library
University of Colorado Health Sciences Center
4200 E. 9th Avenue, A003
Denver, CO 80262-0003
303-315-1229 tel, 303-315-0932 fax

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March 2003, Week 5
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December 2002, Week 5
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April 2001, Week 1
March 2001, Week 5
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January 2001, Week 5
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January 2001, Week 1
December 2000, Week 5
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January 2000, Week 1
December 1999, Week 5
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December 1998, Week 5
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April 1998, Week 5
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April 1998, Week 1
March 1998, Week 5
March 1998, Week 4
March 1998, Week 3
March 1998, Week 2
March 1998, Week 1
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February 1998, Week 3
February 1998, Week 2
February 1998, Week 1
January 1998, Week 5
January 1998, Week 4
January 1998, Week 3
January 1998, Week 2
January 1998, Week 1
December 1997, Week 5
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December 1997, Week 3
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January 1997, Week 5
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December 1996, Week 5
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December 1995, Week 5
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December 1994, Week 5
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April 1994, Week 1
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