Barbara

We have had this happen in a couple of instances, each time the IRB did not
review it until it has a proper signature.  Once we found it before the
review began and called the Dept Chair.  The other time we didn't realize it
until after the review was started and we held it and notified the Dept.
Chair.  In once instance the chair withdrew the IRB application.  In the
other instance the Chair allowed it to go forward after his review and a
written warning was placed in the faculty members personnel file, in both
instances the Dean was notified.   One of the faculty members is no longer
at the school.

We felt that this was an extremely serious matter and the IRB was prepared
to act, if the School Chair or Dean did not.

If you can't trust an investigator to get the appropriate signatures prior
to the study being started, how can you trust them not to falsify the data
once the study begins?

I hope this helps.

Barbara J. LoDico, B.S., CIP
Executive Director, Human Subject Protections
University of Medicine & Dentistry of New Jersey
Human Subjects Protection Program Office
65 Bergen Street, Suite 507
Newark, NJ 07107-2000
P.O. Box 1709
xxxxxx@umdnj.edu
Phone: 973-972-1149
Fax: 973-972-1598
Beeper: 973-421-0670
voice message: 866-208-6365

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org]On Behalf
Of Mike McCallister
Sent: Thursday, November 13, 2003 10:06 AM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] Forged Signature on IRB Application

Off with their heads!  Off with their heads!

Spanky

At 08:37 AM 11/13/2003, you wrote:
>Hi Barbara,
>If this in in fact a forgery, that PI has done a dreadful thing in signing
her
>own permission slip! Regardless of the innocuos nature of the procedure she
is
>planning, it is still a major breach of the highest magnitude, and it
should
>never, ever happen.
>How do you know it is a forgery?
>If it is, she should under no circumstances be allowed to proceed, and if
you
>all overlook it, you are tacitly giving approval by failure to act.
>In this case I don't think the students' short term needs come first; a
model
>of ethical behavior is absolutely required, and the ends do not justify the
>means. Whatever follows from that is what the institution has to face up to
>and deal with, even if it is major unpleasantness.
>I don't think your office should even have to determine what to do; it
should
>come from the President's office.
>Roberta
>
>Barbara Gray wrote:
>
> > Compliance/IRB staffers out there, how would you deal with this
situation?
> >
> > We require department chairs to sign off on human subject applications.
> > A faculty member is in a rush to have an human subject protocol approved
> > (under expedited criteria) for a very innocuous procedure--virtually no
> > risk at all except it is a phyical measurement that does not fit within
> > exemption criteria.  (Note that the project involves students who will
> > be collecting the data as part of a class assignment.)  She indicates
> > she'll just sign for her chair, we indicate that she can't do that, and,
> > lo and behold, the signature page comes in a couple of days later with
> > the chair's signature forged.
> >
> > Would you take this to her chair?  Her dean?  The provost?  Would you
> > prohibit her from implementing the protocol (which will impact the
> > students in her class)?  Would you bar her from doing human subject
> > research for a period of time?  Is this "misconduct" that should be
> > referred for handling through ORI regs?  (note that we've made our
> > misconduct policy applicable to all research and scholarship, not just
> > that funded externally or by the Feds.)  Personally, I find the faculty
> > member's action offensive and unethical (if not downright illegal)--if
> > she will do this on an application, might she do the same someday on a
> > consent form??  But, in the big scheme of things, is this worth going to
> > the mat on?  After all, it's only falsification of an internal
> > signature, not scientific data....
> >
> > Thanks.
> >
> > --
> > ==================================================================
> > Barbara H. Gray, Director
> > Office of Research & Grants Administration
> > College of Charleston
> > 66 George Street
> > Charleston, SC  29424
> > Campus Location:  407-G Bell Bldg.
> > Office: 843.953.5673  Desk: 843.953.5885  Fax:  843.953.6577
> > e-mail:  xxxxxx@cofc.edu   URL: http://www.orga.cofc.edu/
> > ==================================================================
> >
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> >  via our web site at http://www.hrinet.org (click on "Listserv Lists")
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>
>
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Mike McCallister, Ph.D.
Office of Research and Sponsored Programs
University of Arkansas at Little Rock
2801 South University
Little Rock, AR  72204-1099

(o) 501-569-8474
(c) 501-590-5609
(f)  501-371-7614
http://www.ualr.edu/orsp/

Better blatant than latent.

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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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