Informed consent forms reflect Ethical and Religious Directives of the Catholic Church.
A recent report by Kate Howard of the Kentucky Center for Investigative Reporting on the withdrawal of federal funding for a University of Louisville research study conducted at Frazier Rehabilitation Hospital shines a bright light on how research –specifically research involving human subjects – is performed at the University of Louisville and in its partner institutions. The specific research protocol in question, directed by UofL faculty member, Dr. Susan Harkema, was intended to examine if adding the muscle relaxer Baclofen to a regimen of physical therapy on a treadmill improves or worsens function in patients who are partially paralyzed as a result of spinal cord injury. The study holds out what is in my opinion an insufficiently proven hope of a possible increase in ability to stand or ambulate. Many aspects of the study were criticized by both federal authorities and by the university’s own investigation. I believe those criticisms to be valid but will not address them in this article. In my own professional opinion, the study as designed and conducted had very little chance of producing meaningful data in any event.
Informed consent – The ethical core of human subject research.
Human subject research must be reviewed and approved by the University of Louisville’s research Institutional Review Board (IRB) using a rigorous national set of requirements and guidelines designed to put the interests of the research subject first. These rules comprise a ‘Federal Policy for the Protection of Human Subjects’ and collectively are called the ‘Common Rule‘. Violation of the Common Rule can result not only in grant support being withdrawn as it was here in Louisville, but in prohibition of future human subject research. To put things in perspective, this would be the equivalent of a death-sentence penalty from the NCAA. By contract, KentuckyOne has agreed to use the UofL IRB to supervise research performed in its facilities, including in University of Louisville Hospital.
Problems with informed consent.
The IRB’s own recent internal investigation revealed that that some Baclofen study participants signed the wrong consent forms. Specifically, this had to do with whether or not the research subject was aware that they would be personally responsible to pay for the (expensive) experimental physical therapy that is at the center of the research protocol. Initially some subjects were surprised to get very large bills for their participation on top of the unreimbursed travel and housing expenses required for the several-month study. The consent form had been changed by the IRB to make it clear that there were financial implications to participation.
I too was concerned about the informed consent forms used, but for a very different and profoundly more significant reason. In my opinion, full informed consent was not being given. Additionally, the template consent form required by the University of Louisville’s IRB had been altered to conform to the religious tenants of the Roman Catholic Church – changes which I and others had been promised would not occur. If these alterations to the standard informed consent form template were made without the documented express permission of the IRB, this would constitute a major violation of research protocol and ethics. If my University’s IRB did in fact approve the changes, my earlier concerns have been realized and I am ashamed for it. Let me explain. Continue reading “Termination of Baclofen Study at UofL Discloses Influence of Catholic Health Initiatives on University Research.”
The matter of compensation to UofL President James Ramsey that tipped public opinion of the University in a more critical direction is back in the news. Both Chris Otts of WDRB and Andrew Wolfson of the Courier-Journal reported yesterday on the release by the University of Louisville Foundation of its Form 990 Federal Tax Return for 2014. The University knew it would not be pretty and began to prepare the way with letters to supporters and posts to various social media. Pretty it was not– except for Dr. Ramsey and his senior supportive staff. Numbers taken directly from the compensation pages of the return listed President Ramsey’s salary from the Foundation alone as $2,428,886 with additional benefits of $362,500. His compensation included tax “gross-ups” to make up for any personal income tax he would have to pay. A great deal if you can get it, but not offered to most faculty or staff!
Even before the ink hit the page, Foundation Chairman and former UofL Trustee Chairman Robert Hughes broadcast an email to the UofL world at large highly critical of Mr. Otts. He accused Mr. Otts him of missing the point, vastly overstating Dr. Ramsey’s salary, having an agenda, and misleading the public with fairy tales. (I am accused of much of the same by the University’s internet trolls.) In my experience, Mr. Otts and Mr. Wolfson are both knowledgeable and careful reporters. If they have an agenda, it is in providing accurate and relevant information to their public. Continue reading “More Fireworks Over Executive Salaries at UofL.”
A Former UofL Lobbyist’s Perspective.
A few months ago, someone anonymously sent me preliminary news reports about the University of Louisville’s engagement with politically conservative donors over the establishment of a new University Center. A fair amount has been written since about the UofL’s willingness, if not eagerness, to accept a grant from the John H. Schnatter Family to fund a new John. H. Schnatter Center for Free Enterprise within, but effectively independent of the School of Business. Insider Louisville and the Kentucky Center for Investigative Reporting have followed the matter closely. The grant itself is contingent on the University’s also accepting a grant from and sharing controlling interest with the Charles Koch Foundation. Most community concern stems from attached strings that restrict the academic viewpoints that can be addressed by the funding, and which give inordinate and inappropriate academic control to outside political and business interests. Read the Grant Contract yourself (6MB). As I lifetime member of the Academy, it made me shudder— and I am not alone. Alas, I do not think the University felt it was in a position to say no. Even as a non-University person, would you have agreed to all the provisions in this contract? If so, tell us why in your own name in the comments section. What parts of the contract do you believe are inappropriate? I don’t have enough room to do so here. Continue reading “Why UofL Can’t Say No to the Kochs or Papa John.”
In Reporter Michael McKay’s account of the UofL Board meeting earlier this month when progress towards the University’s 2020 Plan was summarized, and when the post-fraud “Audit” was formally presented; President James Ramsey commented on the University’s failure to earn a National Cancer Institute (NCI) designation for its James Graham Brown Cancer Center. Dr. Ramsey stated that it was unlikely that UofL would receive an NCI designation because the UK program is so close. (The Markey Cancer Center at the University of Kentucky was designated as an NCI Comprehensive Cancer Center in 2013.) Dr. Ramsey is said to have implied that UofL had been in talks for some sort of “partnership” with UK before that institution went on its way alone. These comments sound more to me like excuses than explanations. I found nothing in the NCI application documents that would indicate that distance from another center would be a factor. Indeed, depth of collaborations with other research and clinical centers is highly desirable if not essential.
Continue reading “Why Is There Only One NCI Cancer Center in Louisville?”