This is somewhat late. Non the less…Respectful Insolence has all the gory details:
The American government’s Office for Human Research Protections (OHRP) has forced some hospitals to halt a program that threatened to save thousands of lives (and millions of dollars) annually. Why? Because it was, allegedly, an unethical experiment, done without the approval of the patients. To the uninitiated, this might seem to be an interesting conflict between doctors who want to carry on doing dangerous experiments, and government officials who try to bind the doctors to the rules of a democratic society.
The government’s decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.
I’m afraid there’s more than a certain blinkered logic to it.
… A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.
Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
So, a government agency is being insanely stupid. Nothing new here. Only… it is the government’s job to make sure doctors do ask permission before doing experiments on patients. The moment this procedure is tagged as “a study”, government has room to enforce voluntary participation. The problem, as Orac and others are pointing out, is that the government fails to use common sense. Enforcement was not needed in this particular study, but could be needed in other studies. So, the complaint boils down to this: that the OHRP should have looked into the details, and should have used common sense to decide whether this particular instance requires enforcement. Obviously, the OHRP failed to do so. Now, should we surprised? Hmm… That’s a tough one. Aren’t governments worldwide famed for their use of common sense?
Well, there was an Op. Ed. at the New York Times, and the OHRP responded:
…(3) In response to a written complaint about this research, OHRP opened a compliance oversight evaluation with the Johns Hopkins University and the Michigan Health & Hospital Association, regarding allegations of non-compliance with HHS regulations for the protection of human subjects (45 CFR part 46, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The complainant alleged that the research was conducted without prior review and approval by an institutional review board and without the informed consent of the human subjects who participated.
(4) The determination letters issued by OHRP so far during its compliance oversight evaluation of the research in this case can be found at:
(5) OHRP is working closely with Johns Hopkins University and the Michigan Health & Hospital Association to resolve the outstanding issues expeditiously, as it does in all compliance oversight investigations.
Information about how OHRP conducts compliance oversight investigations can be found at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf.
Seriously, if anyone is surprised to find that government officials, large corporations and the like are usually lacking in sense, than one must be very young and inexperienced. We shouldn’t marvel at the immense stupidity of the OHRP’s decision. What should really make us scratch our heads in puzzlement is the nitwit patient complaining to the OHRP about infringement of his rights by the hospital. Ah, these evil doctors were conducting a study on his health without his written approval!
And this is indeed the main question here: what is the role of the OHRP? If it is to support citizen’s formal rights, then, at first glance, they seem to have gotten it right. As stupid as it may be, I should have the formal right to reject medical treatment. I have a right to tell doctors: “no, you are not doing this operation/test/study on me”. And I have that privilege, right? Well, I have that privilege as long as I am aware of the medical procedures. I can refrain from (or approve to) what I know of. I cannot refrain from what is opaque. In order to exercise my rights I need to be informed. And if it is the OHRP’s role to make sure I can exercise my rights, then they aught to make sure that the hospital informs me on what I need to know. What the OHRP is doing is just making sure that patients are informed, and can exercise their legal rights.
But this begs the question: what should patients be informed of? And in what circumstances? When should it be the hospital’s obligation to inform me on a specific procedure/study/whatever? Of course it’s a question of circumstances: when my doctor sends me off to surgery, he consults me. He tells me what it means, what are the chances, complications, etc.. This is not the case with emergency medical care. When I’m having a heart attack, no one is going to wake me up and force me to read and sign 30 pages of legal stuff before I get on the operating table. Suppose that a hospital wants to check a new life-saving procedure for use in heart attacks. They can never get approval by the patients, who are barely conscious (if at all). Should the hospital ask permission from the patients as to a change in it’s paperwork? What if they compare deaths in different departments? Should I, as a patient, be asked whether, in the case I die, I permit the hospital to incorporate me in their statistics? If anyone wants to answer this in the affirmative, she should ask herself if she really wants to read mountains of legal papers every time she take gets medical care. Luckily for us, this formal rights question is a new one. Had it been introduced decades ago, little medical development would have been possible. But, surely, some experiments must get approval. Some experiments are unethical. After all, the OHRP didn’t just appear out of mid air. It was called for because of some nasty past examples.
So, who should decide which procedures call for patient approval and which don’t? The only people who can decide this are the people who work the hospitals. Sure, there should be some agency like OHRP making sure that they do. And, yes, it should have some non professionals. But you really can’t tell what is imperative for patients to know and what isn’t unless you work the system. The people at Johns Hopkins University did the right thing: a patient does not need to know of every little bit of procedure that the hospital has, even when this procedure is a study or a test. And everything in the workings of the hospital is relevant to a patient’s life – even the procedure for hiring secretaries. The people who decide which experiments call for forced approval and which don’t can only be hospital authorities. The people at the OHRP who check on them must be doctors with a fair amount of experience.
A few months back, my wife got hospitalized. They gave her 20 papers to sign. She wasn’t feeling very well at the time (as might be expected from a patient). Those 20 papers were a harassment. It was way too much. Some were probably important, most were not. Someone at the hospital should have screened them. As it were, she just signed the whole bunch without reading them. Too much information is as bad as too little.
So the OHRP got it upside-down. Sure, formal rights are important. To help patients exercise their rights and be informed, what you should do is to make everything transparent and open to public inquiry. Make sure I can check which experiments are conducted, if I actively choose to check that. Put the list of experiments on the hospital’s wabpage. That way, there is absolutely no chance they will ever do something unethical. But do not actively ask me about every procedure going on in the hospital. In most cases, you do not need my active consent. It should usually be taken for granted. I came to the hospital, after all, and I can walk away. The right way to make me an informed patient is to make the information available. Do not force needless information on the uninitiated; and do not to wait for their approval, unless this is really an intrusive test. These tests you should have forced approval. Not the whole bunch of them.