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Re: Compliance Office Young, Katherine S 31 May 2012 03:32 EST

Same here, John.  Good call!

Sent from my Verizon Wireless Phone

-----Original message-----
From: Sharon Brown-Smith <xxxxxx@MTSU.EDU>
To: "xxxxxx@lists.healthresearch.org" <xxxxxx@lists.healthresearch.org>
Sent: Thu, May 31, 2012 02:09:41 GMT+00:00
Subject: Re: [RESADM-L] Compliance Office

John, thumbs up. I love your response!!!

Sharon Smith, MS, CRA
ORS
Office#: 615-898-5894
________________________________________
From: Research Administration List [xxxxxx@lists.healthresearch.org] on behalf of Baumann, John R [xxxxxx@IU.EDU]
Sent: Wednesday, May 30, 2012 9:02 PM
To: xxxxxx@lists.healthresearch.org
Subject: Re: [RESADM-L] Compliance Office

This is an interesting issue and I have to disagree with my colleague on this matter.  The topic has come up a number of times on different listserves, including IRB forum.  The issue usually comes up as – is it apppropriate for the compliance office(s) to report to vice president/provost/chancellor for research.  The agruement is that this represents a conflict of interest as it is the purpose of this office to enhance research efforts and, further, the sponsored program office reports to this office as well.

Well, I think that it is for a couple of reasons. If not the chief research officer, to whom should it report? What are the other choices? VP for Administration and Finance is frequently identified as an option. Or the President/Chancellor.  I do not believe that these are more appropriate than the VPR.

 *   Report to a finance office? Seems even more dangerous to report to an office whose bottom line is the bottom line and not academic/research integrity. This office is also frequently entirely unaware of the academic/research issues and expertise that must figure into any compliance operation.
 *   Report to CEO or President?  The responsibility of this office is so often externally focused and there is no way that the officials of this office can be sufficiently hands on.
 *   Provost?Again, does the chief academic officer really have the time for this? Will this campus officer really be accessible?
 *   Board of Directors/Trustees? They are mostly by definition mandated to be not be involved in such operational matters. And, they are certainly not available to anyone in the compliance office or to the research community.

Who other than the chief research officer has the experience, expertise, or contacts necessary to understand and assess the issues in a compliance matter? It is a truism that research involves risk and the IRBs and IACUCs, for instance, are designed and mandated to assess risk/benefit. Who other than the chief research officer is so qualified by experience, expertise and contacts to do so? In my opinion, no one.

As to the Enron example - I no longer remember all of the details and whether the Board of Directors was aware of the behavior of the top officials. But,the recent record has certainly shown that boards have not served as an effective safeguard or gatekeeper against improper behavior.  It seems that they have been at best unaware (an old expression: how do you deal with the Board? Like you treat mushrooms, in the dark and covered in s#@t). The record is probably that they have been a passive, if not active, part of the mis-behavior.

So, while I understand the concern regarding a compliance office reporting to the chief research officer, I see no practical, effective, or more ideal alternative.

Just my 2 cents.

John

John R. Baumann, Ph.D.
Executive Director, Human Research Protection Program
Office of Research Administration
Office of Vice President for Research
Indiana University
xxxxxx@iu.edu
812.856.7987 (IUB office)
317.278.7830 (IUPUI office)
816.695.7146 (cell)
http://researchadmin.iu.edu/cs-humsub.html

From: Gloria Greene <xxxxxx@UAH.EDU<mailto:xxxxxx@UAH.EDU>>
Reply-To: Research Administration Discussion List <xxxxxx@lists.healthresearch.org<mailto:xxxxxx@lists.healthresearch.org>>
Date: Wednesday, May 30, 2012 4:17 PM
To: "xxxxxx@lists.healthresearch.org<mailto:xxxxxx@lists.healthresearch.org>" <xxxxxx@lists.healthresearch.org<mailto:xxxxxx@lists.healthresearch.org>>
Subject: [RESADM-L] Compliance Office

The compliance functions and areas of responsibilities are growing faster than resources needed to perform them.  I believe this function should be separate and distinct.  I am looking for anything that will help make the case why a separate stand-along Office of Compliance is required.  Any comments, links to documents, etc., that you are willing to share will be very helpful.

Please reply to me directly, my email address is noted below.

Thank you all.

Gloria Greene, MA, CRA
Director
UAHuntsville, Office of Sponsored Programs
SRA-Alabama Chapter, Vice President-Elect
301 Sparkman Drive, VBRH E26
Huntsville, AL  35899
Voice: (256) 824-2657
Fax: (256) 824-6677
Email:xxxxxx@uah.edu<mailto:xxxxxx@uah.edu>

"The person who knows 'how' will always have a job. The person who knows 'why' will always be his boss."   -- Diane Ravitch

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Take Charge,Go GREEN!
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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.healthresearch.org (click on the "LISTSERV" link in the upper right corner)

A link directly to helpful tips: http://tinyurl.com/resadm-l-help ======================================================================

===============================================

======================================================================
 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.healthresearch.org (click on the
 "LISTSERV" link in the upper right corner)

 A link directly to helpful tips:  http://tinyurl.com/resadm-l-help
======================================================================