Is informed consent being censored?
I take some pride that I have not, until now, had to retract anything of factual substance that I have written in these pages despite the fact that I have always invited others to offer corrections or to point out misinterpretations. I freely admit to offering a healthy amount of speculation about matters that turned out otherwise. However, I always identify speculation as such and do so in the interest of bringing a variety of issues into the arena of public discussion. However, I must now retract my earlier article congratulating KentuckyOne Health and the Catholic Church for joining the 21st century with respect to their apparent changing views on justified contraception and termination of pregnancy. I was wrong.
Two months ago I wrote about how the University of Louisville and the Roman Catholic organizations that now manage University of Louisville Hospital and the James Graham Brown Cancer Center were grappling with a perfectly predictable conflict between medieval religious dogma and modern ethical medical science. In the article I brought to light the fact that the University of Louisville’s Institutional Review Board for Research has been discussing the removal or alteration of certain language from the approved informed consent documents used in clinical research studies at the University Medical Center. The specific language addresses the necessity of using effective contraception while taking experimental drugs, and the need to consider terminating an accidental pregnancy conceived during the study. Such studies often involve giving people powerful drugs or otherwise doing things that will harm a developing fetus. Because of the unknown (but very real) risk of a bad or unexpected outcome in research, clinical researchers are required to obtain fully informed consent from their experimental human subjects. Patients need to know what they are getting into and why. To be less than completely forthright, or to deviate from accepted medical and scientific standards of disclosure is to offer less-than-fully-informed consent to a person. Lack of informed consent is a grave omission in medical care, be it either in the experimental or standard clinical setting.
Truth, the whole truth, or something else?
In my opinion, the initial cocktail party information I had heard was both credible and terribly troubling. This is exactly the kind of issue that I had predicted would occur as I wrote about my opposition to the structure of the proposed merger and subsequent partnership between our secular state university and an assertively religious organization. Surely this was not true! My University would never give away any more of its academic prerogatives than it already had.
I called the UofL Institutional Review Board (IRB) office and was told that there had been no changes, and that the template language was still posted unmodified on the University’s website. The latter assertion was the truth. Relying on this, and on my belief that the University and its faculty would never agree to such a thing led me to write my congratulatory article. As it happens, I was indeed told the truth, but I was not told the whole truth. My entire premise was faulty. As more information became available to me, I realized that I had wandered inappropriately down the garden path. I must now apologize to my readers.
Unreturned calls and emails. Is the stone wall going up again?
Some perceptive readers of my first article might conclude that I still harbored some reservations about what was happening. To follow-up, I began attempts to contact IRB office staff and members, former colleagues, and other individuals within the University research enterprise who might have reliable information. The leadership of the IRB committee did not return my phone calls. Neither did most committee members. I was left to conclude that committee members had been told not to talk to me, or if unavoidable, not to discuss anything of substance. And so it was for the majority of my calls and emails, even when I was calling in my capacity as a faculty member. Despite this, I was able to communicate directly with several individuals who had direct knowledge and who all told the same coherent story. I now feel comfortable reporting further.
Which is worse– contraception or vampires?
My worst fears were confirmed, and then some. There is no question that efforts are being made to adapt the current required informed consent language that must be used by UofL faculty so that it is compatible with the ethical and religious directives of the Catholic Church. The people I have spoken with have no doubt where this initiative is coming from as it seeks to bring University research practices into line with Catholic religious dogma. To remain consistent and not be subject to criticisms of hypocrisy, the Church cannot allow the current language to stand for research activities in its facilities. Any initiative for change is certainly is not coming from the University or its faculty. I was told that it was made clear to the IRB Committee that no research using consent forms containing such language would be allowed at University Hospital or the Brown Cancer Center even though the University IRB had previously been delegated as the common ultimate authority on approval of research protocols. Because University faculty are under IRB jurisdiction for all research they do anywhere in the University, any censorship of consent language would effect research done in teaching clinics, private offices, laboratories, and even the new Woman’s program! Based on what I have been told and understand, the University would no longer be master of its own academic show.
I was told that I would find nothing committed to paper even though the matter had been in discussion for some time. I was told not to expect to find anything in the minutes of the committee, even though such requests or deviations from approved standards are required to be documented there. When I called the IRB office as a member of the faculty and asked for an opportunity to review the minutes of the committee meetings, I was told by a staff member that, “we were told not to show anything to anybody.” By then I was certain I was being stonewalled.
I was warned that I would have difficulty finding University employees or faculty willing to talk frankly with me because of concerns about their future careers. In my opinion, that is a rational concern. It is clear to me that the University and its partners are aware that they are dealing with a controversial and sensitive issue. In my opinion the University is hunkering down into the defensive position of non-disclosure that I have seen before.
Who is watching the store?
I am told that at least some IRB committee members have reservations about what is happening. In my opinion they should! A few individuals on the published committee membership list that I was able to catch on the phone claimed ignorance about what is going on or noted that they had not been to many recent meetings. To me that is an oversight problem in its own right (although it is also possible this comments were offered as an excuse not to be frank with me).
Tell me it ain’t so!
Other things trouble me even more. In my opinion, the University and its IRB are being too cooperative and ceding too much authority over the terms of clinical research occurring on University of Louisville and KentuckyOne Health premises. I was told by one individual that committee members have little knowledge about what happens after they approve a study. (Are informed consent forms being used universally at all?) I had always assumed that it was part of the IRB’s responsibility to monitor and confirm the compliance of their investigators following the approval of a research protocol. I am not confident that this is happening, but would like to be. This and other concerns might vanish if I or someone I trust were able to review the informed consent forms currently in use at University Hospital and the Brown Cancer Center, or for that matter, research done at Jewish Hospital these past few years when that institution came under the mandates of the Ethical and Religious Directives of the Catholic Church. The past would probably illuminate the future inasmuch as the same entity now controls the clinical operations at the two hospitals and the Cancer Center.
Whose interests come first?
Troublesome to me were reports of the kind of language being used in the discussion. It seems to me that the committee is attempting to justify or rationalize its willingness not to address the matter in a forthright way or to stand up decisively for traditional academic values. In my opinion a reasonable person might conclude that the University is rolling over on this one. More consideration seems to be given to not putting obstacles in front of researchers or perhaps to the flow of income from the University’s research enterprise than to the interests of patients recruited to these research studies. In my opinion this should not be a matter of passively accepting the inevitably of the politics involved or trying to find some lame work-around. One common diversional technique currently used to save face might be to label contraception for female human subjects as “treatment for menstrual cramps,” or some related exercise in sophistry. In my opinion that is, or would be, medical fraud. Endorsing the unreliable rhythm method of birth control is not going to cut it here! Additionally, it would be downright cruel to demand abstinence during what might be the most difficult time a loving couple might face together. How to deal with an unexpected pregnancy in which the fetus was exposed to peril, or which places the mother in danger is not a decision for a third party to control.
The University and its faculty should not accept a compromise of its research integrity simply because a specific external religious corporation wills it. Why not ask the faculty what they think? There does not seem to have been very much of that lately. As a member of the Executive Faculty, I have not received notice of a faculty meeting or other relevant information for a long time. Healthcare professionals and scientists subject to public accountability should be setting the standards in this area, not administrators or religious authorities. I do not think you will find a single faculty member willing to defend not telling a woman with a serious illness exactly why she is being asked to use effective contraception in order to participate in a clinical study, or telling a man exactly why he should use a condom to prevent pregnancy when he is taking drugs that can damage his sperm. Who among us on the faculty is willing to justify allowing someone else’s church to rewrite our academic and research standards? If you are out there, please make your case in the replies section below for all of us to see.
I may be wrong, but have a right to be reassured.
I am neither naive nor uninformed about the practices of clinical research and informed consent. I conducted and reviewed such studies myself. I was a national officer for a one of the largest nationwide clinical research organizations. I was offered a position (that I did not accept) as director of compliance of human subject research for one of the largest research organizations in the country. Shortly before I retired from the University of Louisville it was suggested me that I should serve as Chairperson of its IRB. I have been on the faculty of the University for 30 years. I also freely admit to being old-fashioned when it concerns the relationship of absolute trust that must exist between a patient and doctor, or human research subject and a clinical scientist. Call me a dinosaur if you must. Nonetheless, I believe I have earned the credentials to suggest that something seems to be very wrong here in Louisville. How could it have come to this?
What about other patients not in studies?
While I have focused here on informed consent in the research setting, the concepts and principles involved are equally important in conventional, non-experimental medical care where risk is also ubiquitous. Oversight of the informed consent process is considerably less rigorous in that everyday setting where the issues and consequences are essentially the same. Who can tell us what is happening on the regular wards of our city’s hospitals? Laxity of oversight or adherence to the highest standards in one area would be unsettling when there are so many other equally important areas of clinical research or practice. It would trouble me greatly if other patients were receiving censored or incomplete informed consent.
My personal dilemma.
Because I believe, or at least strongly suspect, that a violation of human subject protections may be occurring, how can I not report my concerns to the appropriate local and national oversight authorities such as the Office for Human Research Protection? Perhaps this article serves that purpose. Doing so is not my wish, but the University seems unwilling to accept or even acknowledge my concerns. I practically begged committee members to disabuse me of my understanding, but none was willing or able to do so. (That is what happens when the flow of information is shut down.) In any event, I am no longer the only person or entity who wants reassurance. The horse is already out of the barn as we say here in Kentucky. Others in the community are asking the same questions I have been asking, and they will be harder to ignore.
Free advice to the University of Louisville.
I have some advice for my University. You are free as an institution to take it or not, but my personal experience suggests you will not. If you have taken a position of which you are proud concerning what constitutes fully informed consent for the human beings you recruit into your clinical programs and your research, tell us about it. Allow us of the public to make our own decisions about the appropriateness of your actions and about our willingness to participate in and to support your enterprise. There are other clinical centers in Louisville with state-wide networks that provide both superb clinical care and access to world-class clinical research programs. If you are not proud of what you are doing, the obvious next question is why are you doing it! Do not act behind closed doors. History tells us that people and organizations get into more trouble when they attempt to cover up their activities than they do from anything they might actually have done. In my opinion, you are operating in something other than a spirit of openness and accountability, and that such a posture over the last few years has damaged your good academic and clinical reputation. Please help me to be able to recommend your institutions to others.
This current matter is serious business. It lies at the core of a traditionally sacred bond of trust between a physician and their patient. One compromises that relationship at great peril to both parties of the relationship. Moreover, I fear that any perception of stonewalling or providing incomplete information on your part will prove a tipping point for your ability to do any clinical research at all. More prestigious Universities than ours have lost their clinical research privileges for failure to adhere to accepted human subject protections and procedures.
Keep your promises.
When you proposed a merger with Catholic Health Initiatives two years ago, you promised us that nothing meaningful would change at University Hospital. You made similar promises when you proposed a partnership with KentuckyOne Health. Despite the presence of competent physicians in the negotiations who would have known better, you led us to believe that you could isolate all of the very real concerns about separation of church and state to a single floor of your hospital, or a rented room elsewhere. You have not. You can not! I have not yet met a physician, nurse or other legitimate health professional who would argue that the reproductive or end-of-life medical care needs of one of our patients can be segregated from the whole.
It’s never too late to do the right thing.
I predicted many months ago that I would be writing this very article, but I am not happy to be doing so. I do not personally believe the structure you have created to take care of the sick and to educate our students and health professionals is intellectually or academically honest. I ask here and now that the Governor and other individuals or entities to whom you gave assurances that all would be well, take a careful interim look at how you are proceeding. I believe that dismantling your current agreements is an option that should be on the table. How you deal with this current issue that is so central to the academic and clinical enterprise will reveal what we may expect from you in the future. I and others want to know who you serve and how you do so.
Oil and water?
I close this missive by paraphrasing Hemant Mehta:
“… mixing science [, medicine] and religion requires a distortion of one or the other.”
The partnership between the University of Louisville, KentuckyOne Health, and Catholic Health Initiatives should never have been allowed to proceed as proposed. Some of the predicted problems are occurring, and I am still waiting to see any of the promised financial or programatic benefits. This was not a marriage made in heaven.
Peter Hasselbacher, MD
Emeritus Professor of Medicine, UofL
August 2, 2013
[Edited 22 Aug 2013 to reflect that despite the fact that individual IRB members and others had little doubt of from where the request to change informed consent language was coming, I cannot say which specific person, office, institution, or corporation initiated the process. I am told there are some emails and paper circulating, but I do not yet have access to any documents, nor have I found individuals willing to go on the record. If someone out there can do so, I welcome any opportunity to clarify matters. I want only the truth to be told and the public given an opportunity to participate in any discussion. PH]