Did I Violate Federal Regulations Today? (I Hope So)

By  |  January 16, 2008 | 

The patient safety and quality movements are precious and fragile. Just as IOM reports I and II spawned these modern, life-saving revolutions, the Federal shutdown of the Hopkins/Michigan checklist program may help extinguish them. After all, Tipping Points can tip both ways.

I laid out the issues in this prior post. Those of you who know me know that I am anything but a rabble-rouser – I have the affliction of seeing both sides of every issue. But, as someone who cares about the lives of patients, this one gets me PISSED. Apparently, many of you feel the same way – particular thanks to Paul Levy, Charlie Baker, Maggie Mahar, Jim Sabin, AHA Prez Rich Umbdenstock, and of course Atul Gawande. After many of you wrote, blogged, and otherwise bellowed, “I’m Mad As Hell And I’m Not Gonna Take This Anymore,” the Office for Health Research Protection issued an Orwellian statement today; I’ll quote the highlights:

… some readers have contacted the [OHRP] concerning… the [Gawande] op-ed. While some expressed concern that OHRP has prohibited hospitals in Michigan and elsewhere from implementing a program intervention consisting of a checklist and other measures to prevent certain hospital-acquired infections, OHRP has taken no such action. On the contrary, if any hospital or intensive care unit decides to implement the use of checklists or other measures only for the reason that they believe those measures will improve the quality of care provided, they may do so without consideration of the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46)… 

Then comes some bureaucracy-speak, punctuated by a “note that the [Gawande] op-ed also inaccurately characterized certain facts of the case involving the Michigan hospitals and how the regulations apply.” The OHRP never enumerates these alleged inaccuracies, instead segueing to this chilling statement:

As stated above, the regulations do not apply when institutions are only implementing practices to improve the quality of care.  At the same time, if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections are important to protect the rights and welfare of human research subjects… [emphasis added] 

Can OHRP define “research activities” – which, we are now given to understand, will always require IRB approval and the consent of every patient and provider – when used in this context? Will somebody tell Don Berwick to pull the plug on his 5 Million Lives campaign? (IHI is doing “research examining the effectiveness of interventions to improve the quality of care,” aren’t they?) How about the CDC and CMS’s Surgical Care Improvement Project? The WHO’s patient safety initiative? And every healthcare consortium that collects data, analyzes it, and disseminates it in an effort to support quality improvement? If these aren’t research activities, why not: Does it hinge on whether I have a hypothesis? Or that I intend to send the results to JAMA? Or the fact that I’m not 100% sure that my intervention will work?

In fact, there is no real distinction. It seems to me that we’ll need to change the rapid PDSA (Plan-Do-Study-Act) cycle so central to Quality Improvement into the P-GIRBA-CEPAP-D-S-A cycle. As in “Get IRB Approval” and “Consent Every Patient and Provider.” Just might slow us down a tad.

OK, I’ve been reasonable enough. It’s time to open my window and shout:


My mother will be very disappointed. And she was so very proud.

Let me reiterate: OHRP does important work, and local and regional IRBs are critical to protecting patients from potential harm. But we’re talking about checklists here. CHECKLISTS!

I urge you to keep those cards and letters coming. The following people really need to know how you feel about the impact of this ludicrous ruling on the lives of real patients:

I know that writing takes a bit of time, but just pretend that you’re submitting an incident report to your hospital after having identified an unsafe practice or condition that might kill people if it isn’t fixed.

Because that’s exactly what you’ll be doing.


  1. bev M.D. January 16, 2008 at 1:47 pm - Reply

    Excellent post , Bob. As I indicated in my latest comment on your last post, the only person who has responded to my letters so far is the AHRQ, whose letter I reproduced in the comment section to that post.

    The part of the OHRP’s latest statement which you put in bold says it all – THEY DON’T GET IT. As you pointed out, it is an integral component of quality improvement to “examine the effectiveness of interventions to improve the quality of care” – or how else would you know whether to continue the intervention, for cripe’s sake!??

    As one who is retired and has time to delve into their regulatory arcana, I do not even believe they are applying their own regulations correctly. Hopkins IRB(which, by the way, did review the research; it’s just the Michigan IRB’s did not) felt the research was exempt from requiring informed consent under the OHRP’s regulation 45 CFR 46.101(b)(4), copied below:

    (b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

    (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

    The OHRP claimed the data was not “existing” because it was a prospective study, therefore the exemption did not apply. I pointed out to them that if Hopkins had performed it as a retrospective study, then the exemption would apply – an entirely artificial distinction.

    Also, in their “clarification” to which you linked above, they cite 45 CFR 46.116(d), which says:

    d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

    (1) The research involves no more than minimal risk to the subjects;

    (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

    (3) The research could not practicably be carried out without the waiver or alteration; and

    (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

    Methinks the Hopkins project definitely meets criterion #1, minimal risk to the subjects, don’t you?

    It is clear OHRP is tangled in their own regulations and, caught, are taking the lawyerly approach rather than admitting they screwed up.

    I understand the AHA has written to Secretary Leavitt, but I agree we should still send our outrage to our elected representatives. Thanks for carrying the flag on this one.

  2. WRS January 16, 2008 at 2:33 pm - Reply

    I doubt it.

    For being the thunderous clarion call of a ruling that threatens the dignity of patients at times when they are most vulnerable, I doubt that your mother would disappointed. I would surmise that she is immensely proud–and she should be. At least my mother would.

  3. bev M.D. January 17, 2008 at 12:51 am - Reply

    Response to my letter from Dr. Pritchard:

    “Dr. (bev, my last name redacted):

    Thank you for your email message and the copy of the letter you sent to
    Dr. Borror and Dr. Chesley related to Atul Gawande’s op-ed piece in the
    New York Times and the study initiated by Johns Hopkins University and
    the discussion of research concerning quality improvement activities.
    Yesterday our office released a response to that piece, which follows.
    I hope this information is helpful.


    Ivor Pritchard, Ph.D.

    Acting Director, Office for Human Research Protections”

    What followed was the same link to the OHRP website that Bob provided above.

  4. Bob Wachter January 18, 2008 at 8:41 am - Reply

    Wonderful posting by Avery Comarow today on his excellent blog, “Comarow on Quality.” Among many other things, Avery is the man behind the US News & World Report’s ranking of America’s Best Hospitals. I particularly like his pilot checklist analogy, which vividly illustrates the point so many of us are making. Check it out!

    And keep those cards and letters coming to OHRP, the HHS secretary, and Congress. Word on the street is that some major medical societies are going to begin making a fuss very soon. I think the message is starting to get through.

  5. chris johnson January 18, 2008 at 5:54 pm - Reply

    My question, which I also asked on Comarow’s blog is this: what person reported this activity to the feds, and why did he or she do so? I know this is privileged information, but I’ve got to wonder what the story is.

  6. Bob Wachter January 22, 2008 at 11:08 pm - Reply

    FYI, another important article on the checklist controversy and the OHRP decision by Jane Brody in today’s New York Times. The piece also cites my friend Sanjay Saint’s important work on preventing hospital-acquired urinary infections.

  7. mcb January 25, 2008 at 5:51 pm - Reply

    Frankly the OHRP’s ruling benefits those in quality who place less emphasis on an evidence based approach. I do think the evaluation of quality initiatives is research. And I do think it needs to be done; otherwise we will implement lots of interventions and initiatives that seem to make sense or were helpful in a preliminary trial but which in the long run don’t actually help (eg RRTs.) I completely agree with Gawande when he says (in his op-ed piece 12/30/07) that research on quality initiatives does not involve exposing patients to a potentially toxic drug or prodecedure. Since the worse that can happen when these is initiatives don’t work is that patient care continues the same as it is now, and we all agree that we don’t want that, I think there ought to be a different standard for this type of research.

    I also thought is was interesting that Mark Chassin, the new president of JCAHCO, said in an interview in the ACP Hospitalist that one of his concerns is how to identify proven quality approaches then disseminate them widely so that each hospital does not have to re-invent the wheel. He also feels that we need to focus on the approaches that actually improve outcomes. So hopefully us physicians, our medical societies, and other groups can work together to fix this.

  8. Bob Wachter January 29, 2008 at 1:18 am - Reply

    More pressure on the OHRP to do the right thing from yesterday’s (Jan 27, 2008) Sunday NY Times Editorial Page, with the apt title of “Pointy-Headed Regulation”:

    How’s this for a nonsensical regulatory position?

    The federal Office for Human Research Protections has ruled that it is perfectly fine for hospitals to use checklists to remind doctors and nurses to wash their hands and follow other sanitary procedures — provided the goal is to improve the quality of care given to patients. But if those hospitals want to analyze what impact the checklists might have in reducing infections, that counts as research and they must first seek approval from institutional review boards.

    These review boards were set up to protect patients from being harmed — by risky drugs or treatments — in the course of medical research. Seeking approval is a cumbersome process that could delay studies for months. Surely, as the nation’s health care system works to reform dysfunctional practices, this makes no sense. The rules intended to protect patients could instead slow organizational reforms that would benefit the patients.

    This bizarre outcome came to light when Johns Hopkins researchers coordinated a study of whether bloodstream infections acquired in intensive care units could be reduced if doctors and nurses followed common-sense procedures to wash their hands, wear sterile garb and wash a patient’s skin with antiseptic before inserting a catheter. The results in 67 cooperating hospitals in Michigan were astonishing. Infection rates dropped by two-thirds, and the procedures saved an estimated 1,500 lives and almost $200 million.

    Then an anonymous critic complained to federal regulators that the study had not been approved by an institutional review board and had failed to obtain the informed consent of human subjects. The Office for Human Research Protections, a unit of the federal Department of Health and Human Services, forced Johns Hopkins to suspend further research until review board approval was obtained. It stressed that hospitals were free to follow the procedures if the goal was to improve patient care, and they could even monitor their infection rates. But once a research component is added, federal laws and regulations require that human subjects be protected by review board oversight.

    The regulators apparently reasoned that there was at least a small chance that the procedures under study could backfire and increase the rate of infections, and a possibility that doctors and nurses might suffer adverse consequences if their performance or comments angered colleagues or employers.

    The Bush administration — which has eviscerated many regulations for no good reason — has ample justification this time to revise a regulation in the interests of health care reform. It needs to make evaluations of programs to improve the quality of health care easier, not harder. If it does not, Congress will need to step in with legislation to expedite such studies.

  9. Bob Wachter January 29, 2008 at 4:16 pm - Reply

    And another powerful piece in the January 28, 2008 issue of the widely read AMA News. The Department of Health and Human Services now says it is reconsidering the regs, and the AMA appears to be weighing in too. Progress, perhaps…

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About the Author:

Robert M. Wachter, MD is Professor and Interim Chairman of the Department of Medicine at the University of California, San Francisco, where he holds the Lynne and Marc Benioff Endowed Chair in Hospital Medicine. He is also Chief of the Division of Hospital Medicine. He has published 250 articles and 6 books in the fields of quality, safety, and health policy. He coined the term hospitalist” in a 1996 New England Journal of Medicine article and is past-president of the Society of Hospital Medicine. He is generally considered the academic leader of the hospitalist movement, the fastest growing specialty in the history of modern medicine. He is also a national leader in the fields of patient safety and healthcare quality. He is editor of AHRQ WebM&M, a case-based patient safety journal on the Web, and AHRQ Patient Safety Network, the leading federal patient safety portal. Together, the sites receive nearly one million unique visits each year. He received one of the 2004 John M. Eisenberg Awards, the nation’s top honor in patient safety and quality. He has been selected as one of the 50 most influential physician-executives in the U.S. by Modern Healthcare magazine for the past eight years, the only academic physician to achieve this distinction; in 2015 he was #1 on the list. He is a former chair of the American Board of Internal Medicine, and has served on the healthcare advisory boards of several companies, including Google. His 2015 book, The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age, was a New York Times science bestseller.


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