Hello
In regard to IRBs, I thought it might be helpful to point out some
things that most investigators do not know about the process. I don't
claim I know everything but I recently went through IRB Chair training
that included attending the PRIMR conference (http://www.primr.org/) and
working with a consulting group named Huron
(http://www.huronconsultinggroup.com/researchdetails.aspx?articleId=1506).
Most investigators do not know that PRIMR even exists. It is also not
referred to in any of the documents like the one from the AAUP.
PRIMR is a professional society of IRB Chairs and administrators. All
the IRBs have a budget for training that usually means periodic
attendance at PRIMR and each year thousands of IRB staff attend. There
is also a system for accrediting IRB professionals. They convene
sessions in which the outline is the same: rationalize the intense
review of protocols by citing all the abuses of investigators and then
itemize all the additional ways research should be regulated to stop the
investigators from harming people. I attended a training session and
the course leaders asked how many people were in each major category
(Chairs, Vice-chairs, IRB members, investigators etc.) Approx 3 people
raised their hands admitting they were investigators. The conference
has a few sessions for investigators but these are usually just sessions
used to inform investigators about new regulations. There is one thing
that the Republicans have correct: If you have a set of laws or
regulations, you will create an industry that has an interest in
protecting and extending the regulations. That is what has happened,
thousands of people now have a vested interest in keeping and extending
the domain of IRBs. They make money from these reviews and they need
them to be a complicated as they can be. The ambiguity present in the
IRB regulations has fed this interest and PRIMR rationalizes all this
because PRIMR itself feeds off the regulations.
Now, enter Huron. The Huron system is a marvel of administrative
process. It has a worksheet for every decision and clear models for
every process. It even includes a model Thank You letter you might send
to people who consult to the committee. At Drexel, we are going to this
system and it will be worth far more than the price. Temple University
now uses these forms and you can see them here:
(http://www.temple.edu/research/regaffairs/irb/index.html). I just
completed a set for a study I will do with Temple. If you want to see
what we have to go through at Drexel now, check this page:
(http://www.research.drexel.edu/compliance/irb/medical_irb.aspx). It
represents the idiosyncratic, common sense and overly-complicated system
that most IRBs use. Using the current Drexel system, and many others,
represents hours of wasted preparation time. Imagine if Temple and
Drexel used the same forms. Imagine if all the IRBs used the Huron
system. The Huron system also keeps the IRBs grounded. Every decision
is mediated by a worksheet. IRBs don't fly unguided. Most of the poor
IRB decisions occur because the regulations are unclear and the IRBs
have no guidance or supervision. Since it is a system developed
external to the IRB, and represents the best interpretation of the
regulations, the Huron system implicitly supervises them.
Millions of wasted hours and considerable frustration would be saved if
every IRB was required to use the same forms and review process. Most
of the people writing the pronouncement papers like this one from the
AAUP have obviously never consulted their colleagues who work on the
IRB. There are many aspects of the IRB process that could actually be
changed for the better that are never proposed because the authors are
unaware of the IRB systems.
Mike Williams
Subject: Critique of Ethics Procedures
From: "Jim Clark"<[email protected]>
Date: Wed, 05 Sep 2012 06:20:14 -0500
X-Message-Number: 1
Hi
A strong critique of current research ethics practices from the AAUP, with many
implications for most psychology research if its recommendations were adopted
(i.e., much would be exempt from IRB approval).
http://www.aaup.org/NR/rdonlyres/3F016909-1388-43DE-872B-18D7F1C373AC/0/IRBREPORT29August2012.pdf
Perhaps there is some hope that the flawed current practices will be revised?
And should we be educating our students not only about the current regulations,
but also about their weaknesses?
Take care
Jim
James M. Clark
Professor of Psychology and Chair
[email protected]
Room 4L41A
204-786-9757
204-774-4134 Fax
Dept of Psychology, U of Winnipeg
515 Portage Ave, Winnipeg, MB
R3B 0R4 CANADA
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