Mike, your message to TIPS is very timely. I too am a member of PRIMR and am currently preparing to take the CIP exam. I serve as chair of our IRB and we are currently revising our procedures to streamline them. Everything you said in your message is valid, and the links you provided are immensely helpful. Thank you! Carol
On Thu, Sep 6, 2012 at 3:18 AM, Mike Wiliams <[email protected]> wrote: > 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<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<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<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 > > > -- Carol DeVolder, Ph.D. Professor of Psychology St. Ambrose University 518 West Locust Street Davenport, Iowa 52803 563-333-6482 --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13090.68da6e6e5325aa33287ff385b70df5d5&n=T&l=tips&o=20241 or send a blank email to leave-20241-13090.68da6e6e5325aa33287ff385b70df...@fsulist.frostburg.edu
