Wednesday, January 02, 2008

An Idiotic Review Board? AKA The Office for Human Research Protections

Another view on this post "Why was this QI Project Shut Down":

It is possible to adhere to institutional "process" so blindly and so obstinately, ignoring common sense (which may not be all that common) as to impair medical progress.

It has been also said that "process" is no substitute for smart people, but tries to be, based upon beliefs in management theories (a.k.a. "management mysticism") and simplistic, mechanistic views about how the world really works. Unfortunately, any theory, rule, or process taken too far or adhered to too rigidly can have major downsides.

The case below is such an example of this, where process trumps common sense, cleverness trumps wisdom:


A Lifesaving Checklist
By ATUL GAWANDE
New York Times,
Dec. 30, 2007

In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

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.

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.


For the love of god ... perhaps only a bureaucrat is capable of such idiotic thinking? Most if not all of the items on the checklist could be read in any introductory text on medicine or The Washington Manual. They were reminders of the obvious, not experimental protocols.

The overly litigious and predatory nature of U.S. healthcare also affected the thinking of the Office for Human Research Protections, I'm sure, and this idiocy is perhaps another example of the pernicious effects of the litigiousness. Predatory lawyers and bumbling bureacrats are not among my list of primary actors for creation of sound medical policy.


... Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the [checklist] endeavor itself is treated as the danger.

If the government’s ruling were applied more widely, whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease; the military’s program to track the care of wounded soldiers; the Five Million Lives campaign, by the nonprofit Institute for Healthcare Improvement, to reduce avoidable complications in 3,700 hospitals nationwide.

... Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to.

Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston and a New Yorker staff writer, is the author of “Better."


The "process fanatic" will be the death of good medicine, including those who believe that all of medicine can be deterministically modeled and cybernetic miracles worked with EHR's.

Speaking of religion, and considering the above report came out just after Christmas, the following humorous but meaningful piece comes to mind. Ironically, both the NYT story and the piece below were sent to me by different parties independently at around the same time:


IRB Global Observational Study of Behavior in Children review

Dr. K Kringle
Adjunct Professor of Child Psychology
Far Northern University

Dear Dr. Kringle (Ph.D, M.D., D.O.? Please verify your credentials):

At the regularly scheduled December 24 meeting, the IRB reviewed your protocol, "A Global Observational Study of Behavior in Children" While we believe it has many good features, it could not be approved as submitted. If you choose to revise your study, please address the following IRB concerns:

1. You propose to study "children of all ages." Please provide an exact lower and upper age limit, as well as the precise number of subjects. Provide a statistically valid power calculation to justify this large of a study.

2. Your only inclusion criterion is "belief in Santa Claus." Please provide a copy of the screening questionnaire that determines such a belief. Provide a Waiver of Authorization under MPAA in order to record these beliefs prior to enrollment in your study. The Board recommends that you obtain a Certificate of Confidentiality as beliefs are sensitive and personal information.

3. You propose to "know when they are sleeping and know when they are awake." How will this be done? Will children undergo video monitoring in their beds? Will they have sleep EEGs? You list 100 elves as research assistants. Are any of them sleep physiologists? Please provide credentials of elves.

4. Your primary outcome measure is to "know when they've been bad or good." What standard is being used to determine "goodness"? Do children have to be good all year or just most of the time? Please specify required duration and provide the instrumentation, with appropriate consent forms, that will be used for operationally defining "goodness."

5. You propose to conduct your research by entering the subjects' homes through the chimney. Have you considered the liability potential, i.e., damage to the roof, carpeting, etc., that this will cause? Moreover, children are likely to be startled by your appearance late at night. Please revise your protocol to conduct your home visits between 9 am and 5 pm Monday through Friday with at least one parent being present and all risks and benefits carefully described.

6. You state that compensation for participation will be "sugarplums, candy, and toys" for the good little girls and boys. This may not be appropriate for the children with obesity, dental cavities, and hyperactivity. Also, your proposal to leave a lump of coal in the stockings of the bad children will be unfairly stigmatizing to them individually and as a group. In general, the Board suggests a small token of appreciation for all participants. Perhaps a $5 Toys-R-Us gift card would be more appropriate in order to avoid potential coercion.

7. The database of good and bad children will be kept "on a scroll at the North Pole." Please describe the location of the scroll and the security provisions you have in place to protect the data Is the scroll kept in a locked cabinet in a locked room? Who has access to the scroll? Are there backup copies of the scroll and how often are they compared to the original?

8. You mention the participation of "eight tiny reindeer" in your protocol. Please provide the Board with documentation of Institutional Animal Care and Use Committee approval.

9. Please provide the Human Subjects Protection training dates for Mrs. Claus and the elves.

10. As this study involves prospective data collection and is more than minimal risk without prospect of direct benefit to the subjects, informed consent signed by both parents will be required. Please have the consent form translated into every language spoken by children and ensure that assent forms are signed by all.

Please submit 25 copies of your revised protocol to the IRB. The IRB will be on Holiday Season schedule for the next two weeks. If approved, you will be able to conduct your study sometime in the spring, if all items are appropriately addressed.

Sincerely,
E. Scrooge, MD

Chair, Institutional Review Board

Copyright 2006, David R. Karp


-- SS

10 comments:

Daniel said...

SS,

I'm curious about this comment:

"The overly litigious and predatory nature of U.S. healthcare also affected the thinking of the Office for Human Research Protections, I'm confident, and this idiocy is perhaps another example of the pernicious effects of the litigiousnous."

I wonder what the basis is for this supposition, especially given that, to the best of my knowledge, there is not much of an active plaintiff's bar regarding regulatory violations for IRB procedures. While I certainly agree that the IRB decision was unwise, I can't see any way this connects to predatory litigiousness.

Moreover, I would also add that the raison d'etre for the IRB system was hardly lawyers run amok. The history of human subjects research in the U.S. does not lend itself to the argument that less, rather than more oversight is needed. To be sure, many, including myself, are less than thrilled with the current system, though the reasons for my cynicism have much less to do with over-active enforcement and much more to do with structural weaknesses in the IRB system.

(Again, none of this is intended as any defense of this particular decision)

--Daniel Goldberg
www.medhumanities.org

MedInformaticsMD said...

Dear Mr. Goldberg,

I refer to this quote from the NYT article:

"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 believe the Office for Human Research Protections might have been affected by what such exposure might do, beyond correcting the sloppy medicine.

-- SS

Daniel said...

SS,

I'm still not understanding your argument. First, if physician-investigators, in the course of conducting a clinical trial, behave in negligent ways (i.e., by failing to follow basic infection-prevention procedures, which, given the studies on nosocomial and MRSA infections cannot be said to be of minimal probability), I fail to see why they should not bear the consequences of that negligence.

Second, the quotation provided merely suggests grounds for a private cause of action sounding in tort that has absolutely nothing to do with OHRP, seeing as how they would have no reason to act as a party to the litigation.

Thus, even if the doctors referred to for some reason ought not justly fear administrative sanction or litigation as a result of failing to observe the most basic infection control procedures, there is simply no connection between this behavior and OHRP. OHRP is neither an aggrieved party in any negligence action, nor are they, obviously, a defendant.

OHRP could of course choose to request that OIG or even DOJ (if it believes the bad conduct could be criminal) take enforcement action against the bad actors, but that's garden variety regulatory action that has nothing to do, so far as I can tell, with predatory litigiousness.

In short, I still fail to see any basis for the claim that OHRP was somehow influenced by an atmosphere of "predatory litigiousness" surrounding clinical research.

Finally, to the best of my knowledge, private litigation in tort over against physicians conducting clinical research itself is quite rare. Tort liability for health professionals tends to come out of the clinical care paradigm, not the clinical research paradigm. Cases to the contrary are usually quite famous, i.e., the Jesse Gelsinger case.

--Daniel

Roy M. Poses MD said...

Scot, you may want to reconsider your title, and perhaps the last satiric quote.
As far as I can tell, the problem here was NOT with the local IRB. The local IRB apparently approved the study. See the letter written by the OHRP to Johns Hopkins in July (http://www.hhs.gov/ohrp/detrm_letrs/YR07/jul07d.pdf which refers to various details of the application the investigators made to the IRB for approval. The decision to shut this project down appears solely the responsibility of the OHRP.

MedInformaticsMD said...

Yes, and my title meant to call the OHRP a type of "IRB." I have clarified that.

MedInformaticsMD said...

Daniel wrote:

"I'm still not understanding your argument. First, if physician-investigators, in the course of conducting a clinical trial, behave in negligent ways (i.e., by failing to follow basic infection-prevention procedures, which, given the studies on nosocomial and MRSA infections cannot be said to be of minimal probability), I fail to see why they should not bear the consequences of that negligence."

You're thinking too linearly.

Do you really think medical malpractice is a scientific, rational endeavor, and that bad patient outcomes are always presented as linearly related to what actually was done (or not done) by clinicians?

Daniel said...

SS,

Who said that I believe that "medical malpractice is a scientific, rational endeavor, and that bad patient outcomes are always presented as linearly related to what actually was done (or not done) by clinicians"?

I simply said that if "sloppy medicine" (in your words) was done, why should the actors be insulated from the consequences of that behavior?

But moreover, as an attorney with med-mal (defense) experience, I well understand the hidden costs of "predatory litigiousness." But I'm still failing to see the connection you adduced between such litigiousness and OHRP's behavior. The former would relate to a private action in tort to which OHRP would assuredly not be a party.

Look, I'm not trying to be any more annoying than I normally am, and I'm certainly not blind to the costs associated with tort litigation. But I cannot see any basis for the supposition that these factors somehow played a role in OHRP's decision on this point.

MedInformaticsMD said...

> I simply said that if "sloppy medicine" (in your words) was done, why should the actors be insulated from the consequences of that behavior?

They should not be insulated, of course.

However, patients who become septic may become septic for reasons having nothing to do with handwashing or other processes (e.g., from airborne or internal sources), but compliance or lack thereof may be raised as a causative factor to a jury, science be damned.

In an environment of litigation paranoia (and believe me, doctors are paranoid about being sued), I can envision OHRP officials acting in the manner they did.

Note: I don't agree with this line of thought, as it represents a somewhat perverse way of thinking on their part. However, there are reasons for such thinking beyond, say, deliberate malfeasance.

Daniel said...

SS,

Of course, I'm well aware of how difficult epidemiologic and medical causation is to prove. My experience with pharmaceutical litigation always came down to such issues: we know the plaintiff took the drug, we know the plaintiff got injured, the question is whether the drug actually caused the injury.

I guess I remain unclear on how litigation paranoia could affect OHRP's behavior in this manner insofar as they remain fairly insulated from tort litigation brought against investigators. OHRP possesses remedies, of course, but those remedies are regulatory in nature and have little to do with tort litigation per se.

In any case, thanks for explaining your position, and I think we can just agree to disagree on the motives for OHRP's (puzzling) decision.

MedInformaticsMD said...

I guess I remain unclear on how litigation paranoia could affect OHRP's behavior in this manner insofar as they remain fairly insulated from tort litigation brought against investigators.

I agree I doubt they were worried about litigation against themselves. Yet I've seen people make odd decisions because they were trying to be as "fair" as possible to all parties involved. That is the interpretation I'm taking.