Failure of Handling Informed Consent
Over the years of the study, Dr. Isaacs and I identified multiple serious design and management lapses by the personnel assigned from the various supervisory institutions. However, of all shortcomings we found so unfortunate in the conduct of this project, the mishandling by Dr. Chabot of patient informed consent - a crucial component of any federally supervised clinical trial, the mechanism in place to insure protection of clinical trial candidates - would ultimately be the most egregious. The strong evidence that Dr. Chabot did not properly obtain the required signed consent forms in three study patients would also help us prove, amidst a flurry of constant denials that reached right up to the office of the NIH Director, that the study had not been properly run and that patients’ lives had been put at risk.
All clinical trials involving human subjects, certainly all those funded by the Federal government, require that each prospective patient who agrees to participate sign a consent form acknowledging in writing their wish to be part of the study. As carefully outlined on the official NCI website, these documents must describe the purpose of the project, possible dangers of treatment, potential benefits, options and responsibilities. And, they must be signed:
Sec. 50. 27 Documentation of Informed Consent
(a)…informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of the consent. A copy shall be given to the person signing the form.
In the case of our particular project, the written protocol for the study clearly required that each prospective candidate must sign a consent form as part of the entry process, as stated within sections 3 and 4:
3.8 Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent for the chosen regimen. The patient must understand the alternatives, potential benefits, side-effects, risks, and discomforts.
4.4 Registration: To register the patient, fax or deliver the completed Eligibility Criteria Form and signed Informed Consent to the Cancer Center Protocol Office, located on MHB 6N-435…
4.5 Required Forms:
Eligibility Criteria Form
Informed Consent
In accordance with the above written regulations, the Columbia team devised a lengthy document for this specific purpose. Though for the first 20 months of the study we were given veto power over entry of trial candidates, from the onset Dr. Chabot was solely responsible for performing informed consent and obtaining the signed consent documents. The forms would then be kept in the appropriate patient files at Columbia, not in our charts. We were told that no patient would be officially considered as admitted – as the written protocol instructed - or even sent to us for treatment as part of the trial unless all the completed documents were in hand at Dr. Chabot’s office.
That all seemed simple enough. However, we first became suspicious that all was not well with Dr. Chabot’s processing of informed consent early on in the study. In July 2002 he sent us a patient as appropriately vetted and approved for entry into the nutrition arm of the study. Shortly after her initial consultation with Dr. Isaacs, the patient quit the nutritional therapy, and soon died. Some time later Michelle Gabay, Dr. Chabot’s physician’s assistant, called our office to inform us, to our surprise, that the patient had never signed the consent form and had now been disqualified by Dr. Chabot from the study – after we had already begun the treatment process! Apparently, during her initial meeting with Dr. Chabot, the patient asked if she could take the form home to “think about it,” before signing and mailing the document back to Dr. Chabot. For reasons we do not understand, Dr. Chabot, we were told, agreed to this arrangement, then sent the patient to us as if she had been properly consented - in complete violation of the written protocol requirements. Dr. Chabot’s decision subsequently to exclude the patient doesn’t make right his handling of consent in this case.
We assumed at that time that this episode, as strange as it seemed, represented an isolated incident, so we didn’t make much of it. Some time later, in the summer of 2003, since I wasn’t on staff at Columbia, the administrators there required that I sign a subcontract agreement with the University beginning each fiscal year, defining my specific responsibilities for the clinical trial. When Dr. Isaacs and I read the document, we realized that we were now required to keep copies of the signed consent forms for each patient in our own patient charts, in addition to the originals which would remain in Dr. Chabot’s office files. In order to comply with this regulation, Dr. Isaacs immediately asked Dr. Chabot’s staff for copies of the consent forms of all patients entered to that point into the nutritional arm.
Despite repeated requests made over a period of several months, the relevant documents did not appear. Finally, in some frustration, in October 2003 Dr. Isaacs went in person to the Columbia Cancer Center to copy the forms. While reviewing the records, she noticed that in the case of two patients (#9 and #16 by our identifiers), considered as properly admitted into the study, the charts lacked the required, signed papers. I want to emphasize that these two differ from the one that had previously been excluded. Both of these, neither of whom had followed the prescribed regimen for any length of time, had died by the summer of 2003.
Dr. Chabot’s staff could not locate the forms but assured us some time later that the documents might be in a second set of charts kept in a different office, but this proved not to be the case. In response to our request for an explanation, eventually Dr. Chabot’s assistant, Carolyn DeRosa herself went through the charts of Patients #9 and #16. Nearly a year after we first discovered the apparent protocol violation, in an August 19, 2004 e-mail to us, she reported what she had uncovered:
Linda/Michelle:
As noted previously, there are no consents in the charts for patients 9 and 16 seen on 2-7-03 and 2-10-03. There is however, a note by JC (John Chabot) in the chart that the patient 16 was given the consent form at the time of the office visit.
She confirmed the forms were missing, but said nothing about either patient having been consented in any way, or that either signed the required forms. She only reported Dr. Chabot’s odd note that Patient #16 “was given the consent form at the time of the office visit.”
After we tried for some eighteen months to learn what had happened to the consent forms, on February 4, 2005 I e-mailed Dr. Chabot about the issue:
We have been trying to get copies of the consent form for (patient #9 and patient #16) for quite some time now, and both Michelle and Cara say that the other person has them. Some intervention here would be appreciated since by the contract requirements, we are expected to keep copies in our charts. The subcontract with Columbia we signed says that we must keep them for all patients on the study.
On February 8, 2005, Dr. Chabot replied:
Last week Michelle went through all the charts to confirm data accuracy. It is loaded into the system now.
Though we assumed Michelle’s review of patient charts include a search for the missing consent forms, we still received no answer as to their status.
As the weeks passed with no explanation forthcoming from Dr. Chabot, I began to suspect these two patients, who never followed the prescribed regimen, had not signed the required forms. At a June 29, 2005 group meeting of study personnel held at Columbia – the last we would attend - we briefly discussed the missing forms, but Dr. Chabot still had no idea what had happened to them. Nonetheless, these two patients were still being counted as “Gonzalez failures” in the tabulation of the interim data, despite the absent forms and the total non-compliance. To me, their inclusion as properly vetted and properly treated made no sense.
On July 26, 2005, I again e-mailed Dr. Chabot about the missing papers:
The terms of the subcontract require that we have a copy of the consent form that the patient signs. Linda went to Cara’s office and copied most of them nearly 2 years ago, but there were two that were not available when she came…She has intermittently tried to get these from either Cara or Michelle ever since. Each said to check with the other, or would say that the consent form must be in a chart that was in another location, or something. Given that both of these patients did not follow through with their protocols, we would like to know if they even signed the consent forms. So we would appreciate either receiving a copy of these consent forms or getting an answer as to whether these patients are data points on this trial.
In his reply the following day, Dr. Chabot wrote:
I will F/U (follow up) with Cara and Jane Lyons on these issues. Thx for the heads-up.
Despite the assurances, Dr. Chabot did not provide us with an answer as to what had happened.
I finally received the minutes of the June 20, 2005 meeting on Sunday, September 11, 2005, the day before the September 12 session. In response to what I perceived as the many errors in the document, I subsequently e-mailed the various trial personnel, raising once again the issue of the missing forms:
There are a number of very serious errors in the minutes. Under point 2, you have a question about how many patients are in the enzyme arm. So do we. For quite some time now, we have been trying to get copies of the consent forms of two of the patients on the enzyme arm (#16 and #9), most recently in an e-mail to Dr. Chabot dated July 27, 2005. We still have not received these, and so we will now bring up the same question we brought up to him at that time. If the patients have consent forms, we want a copy, as the subcontract we were required to sign requires that we keep them. If the patients do not have consent forms, we would like to know if they are included in the clinical trial.
Our questions were ignored. Frankly, by this point I felt Dr. Chabot was stonewalling me, perhaps hoping I would forget about the issue and go on to some other problem. On October 19, 2005, I e-mailed Dr. Chabot yet again, hoping to get an answer about the fate of the forms:
We are still waiting for an answer about the consent forms for (patient #16 and patient #9). Do they exist, or don’t they? If they exist, we would like a copy as is required by the subcontract we signed. If they don’t exist, we would like to know if the patients are included as data points in the study. We continue to request them because, although your office was entrusted with the job of getting consent forms, as a part of the subcontracts we were required to sign, I am obligated to maintain copies of these consent forms. Linda started trying to get these consent forms in the summer of 2003. She finally came over and photocopied the bulk of them in October of 2003, but has been trying ever since to obtain copies of (#9) and (#16)‘s forms. We have repeatedly requested copies, or an indication of their status, since we were instructed to treat these patients as if they had met the criteria, including filling out consent forms.
Finally, in an e-mail sent October 26, Dr. Chabot confirmed the documents did not exist for either patient:
The consent forms have not been identified. Both patients were accrued at times when Michelle was away and a research nurse from the cancer center was covering this clinical trial. The IRB was notified of this problem, in writing quite a long time ago and I have no further instructions…
I don’t know why Dr. Chabot hadn’t shared this information with us months earlier. And despite his explanation, I still didn’t know if he considered the two patients properly qualified “Gonzalez treatment failures.” (I later learned he did). I was also somewhat surprised that a substitute nurse had been assigned any part of the intake process, particularly that of informed consent, since I had been repeatedly told Dr. Chabot and only Dr. Chabot would be responsible for interviewing study candidates.
My many written complaints about the June 2005 minutes – which I didn’t receive until September 2005 - would not be addressed until the March 20, 2006 group meeting, According to the notes of the session, Dr. Chabot described the fate of the mysterious missing consent forms.
1. Number of subjects in the enzyme arm and missing consent forms:
The Columbia staff investigated this issue. Two consent forms from
subjects entered in the enzyme arm are missing. Their follow up
into this issue revealed that there are notes in both subjects’
medical charts indicating that they were consented and in at least
one of these cases, it is recalled that the patient requested to
take the form with them and planned to return it. It appears that
both these patients “walked off” with their forms. The
IRB was informed of this and as both charts note that subjects were
consented, the IRB left it up to the investigators to decide about
inclusion of this data. The investigators conducted the statistical
analyses both with and without these two subjects and there is no
effect on the statistical conclusions.
I was surprised, when I first read this paragraph, to learn that Dr. Chabot now claimed the medical records of the two patients in question contained written verification that both had been “consented,” though in each case the forms were not in the chart. Not once during the 2.5 years we tried to elicit some response from Dr. Chabot’s office regarding the missing consent forms for the two subjects #9 and #16 did he or his staff ever state or imply or write in any communication to us that these two patients had been consented in any way. If this were the case, why hadn’t we been told?
I also have no idea what Dr. Chabot means when he states “there are notes in both subjects’ medical charts indicating that they were consented.” Does that mean they were orally consented, then handed the forms which they then didn’t sign? Do his words mean to imply or infer that the patients signed the forms, but that one is missing, and in the other case the patient walked off with the signed form? Or that both patients walked off with their signed forms? None of it makes any sense.
In his February 8, 2005 e-mail, written eighteen months after we first learned of the problem, Dr. Chabot did report, as noted above, that a staff member “went through all the charts to confirm data accuracy,” so by his own statement we know that charts were carefully reviewed at some time. Yet never once prior to the official minutes of the March 20, 2006 meeting had he or anyone else implied that the records indicated the patients had been “consented” in any way, or that such a claim had been written in the chart.
We have never seen the actual notations allegedly made in the charts of subjects #9 and #16 documenting the alleged “consent” that occurred. However, the August 19, 2004 e-mail sent to us by Dr. Chabot’s assistant, Carolyn DeRosa, contradicts Dr. Chabot’s claim made at the March 20, 2005 meeting:
Linda/Michelle:
As noted previously, there are no consents in the charts for patients 9 and 16 seen on 2-7-03 and 2-10-03. There is however, a note by JC (John Chabot) in the chart that the patient 16 was given the consent form at the time of the office visit.
So according to Dr. Chabot’s own assistant who reviewed the chart at our request Dr. Chabot’s notation in the chart of subject #16 only states the patient “was given the consent form” and nowhere claims the patient had been consented in any way, orally or otherwise. Certainly it does not imply that patient ever signed the form. Furthermore Ms. DeRosa’s own review of the charts in response to our queries says nothing about a notation in the chart of subject #9 regarding the consent form. One can only assume, since she had searched the charts precisely to look for information on the consent that might or might not have been completed, if a notation actually existed for subject #9 she would have told us, as she did in the case of subject #16. I do not believe that the two patients #9 and #16 ever signed the forms, and no evidence exists to the contrary.
Again, the written protocol, as quoted before, required a “signed Informed Consent” be delivered to the Columbia Cancer Center protocol office:
4.4 Registration: To register the patient, fax or deliver the completed Eligibility Criteria Form and signed Informed Consent to the Cancer Center Protocol Office, located on MHB 6N-435…
4.5 Required Forms:
Eligibility Criteria Form
Informed Consent
NCI regulations also required that a copy of the consent form be given to the patient, but that the original must remain in the chart:
Sect. 50. 27 Documentation of Informed Consent
(a)…informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of the consent. A copy shall be given to the person signing the form.
The rules couldn’t have been simpler. If the forms weren’t signed, as I believe to have been the case, Dr. Chabot violated the written protocol, as well as NCI and Federal regulations. Even if we assume for the sake of hypothetical argument the documents had been signed and misplaced, or that in one case, #16, the patient walked off with the signed forms, or that both walked off with the signed forms, Dr. Chabot still violated the written protocol, NCI and Federal regulations. Nowhere anywhere does any NCI rule permit investigators to let patients approved for a Federally supervised study “walk off” with the original copy of the consent form, signed or unsigned, ever.
Despite his vague answers, according to the minutes of the March 20, 2006 meeting, Dr. Chabot reported that the Columbia IRB seemed quite satisfied with his explanation. Not only did the IRB seem unconcerned about the issue, but according to Dr. Chabot they would allow him to qualify or disqualify these two patients at his discretion from the final tabulation of the data – though, to repeat myself, neither followed the prescribed regimen.
At every academic medical center in this country, an Institutional Review Board (IRB) helps oversee the safety of patients as well as the ethical management of all scientific investigations conducted at the institution. No clinical trial can begin without IRB consent, regardless of any approval that might already have been granted from any other group, such as the NCI or FDA. The IRB can also stop a study already up and running, if they suspect even minor infractions of the written protocol. So it was not insignificant for Dr. Chabot to claim the IRB had given him a free pass on the missing consent forms, even permitting him to decide if these two patients would be included during the final tabulation of the data.
Assuming the minutes to be accurate, I was astounded that the Columbia IRB could be so blasé over such a significant oversight, and that Dr. Chabot believed the problem had gone away. Proper informed consent has become a major issue in academic circles, to the point even the UN’s World Health Organization has weighed in on the matter. The National Cancer Institute requires that all candidates sign an informed consent document before admission to any clinical trial under its jurisdiction and that a copy be kept in the patient chart. This rule is not optional nor can it be ignored or disregarded at the whim of any IRB. And a verbal discussion about the issue, even if documented in the chart, does not substitute for evidence of a signed form. Ironically, the Columbia IRB regulations for clinical trials at the institution resemble those of the NCI, and the section in our written protocol describing the need for signed consent comes right from the computerized master template for Columbia oncology clinical trials. And it’s helpful to keep in mind that this particular circus started when our subcontract with Columbia mandated we keep copies of the signed consent in each patient’s chart!
I am surprised that both Dr. Smith and Dr. White, the NCI representatives at the March 2006 meeting, did not challenge Dr. Chabot’s reasoning or his odd claim of IRB blessing, which amounts to disregard of Federal regulations. These NCI personnel, based on what the minutes report, apparently accepted Dr. Chabot’s answers as perfectly acceptable and reasonable, though the failure to obtain signed informed consent represented a violation of the written protocol for this study, the regulations of the Columbia IRB and the rules of their own Federal institution.
The evolving epic of the missing consent forms ultimately took an even more bizarre twist, as the study wound down. Along with a brief April 22, 2006 letter to me in which he defended his handling of the study throughout, Dr. Chabot sent us a chart listing all patients ultimately qualified for the study in both arms, and their stage. After Dr. Chabot’s years of stonewalling, after his insisting patients #9 and 16 would be counted as appropriate “Gonzalez patients” though neither followed the prescribed regimen and both lacked signed consent, neither appeared on this document.
In our clinical trial, involving major lifestyle modification,
screening potential candidates should have been an intensive and
meticulously detailed process, involving in-depth assessment of
the patients’ ability to eat and care for themselves, an evaluation
of their home and social environment, their willingness to follow
through with the prescribed regimen, their mental and cognitive
state, etc. Obtaining informed consent, in comparison, is quite
a simple affair. You hand the form to the patient, tell him or her
what it means, and they either sign it or they don’t. Then
you put the form in the chart, or if the patient refuses to sign,
send him or her packing. If Dr. Chabot could not effectively manage
this rather basic, straightforward and absolutely critical step
in the entry process properly, why should we assume he more competently
handled its more difficult aspects?
Copyright © Nicholas J. Gonzalez, M.D.
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Linda L. Isaacs, MD
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