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Point/Counterpoint: Using Deception, Study Finds Clinics Violate Disabilities Act; Should Clinics Be Protected?

Point: Physicians do not deserve IRB protections like vulnerable patients

by: Sei Lee

The recent article by Lagu and colleagues entitled, “Access to Subspecialty Care for Patients with MobilityImpairment” in Annals of Internal Medicine found that when subspecialty practices in 4 US cities were contacted about a patient who was obese and hemiparetic, 22% stated they could not accommodate this disabled patient. As disturbing as this finding was, I was even more surprised to hear that the authors were required by their Institutional Review Board to shred identifying information as soon as research was completed. Thus, when they were contacted by the attorney general in one city and asked to identify which practices were discriminating against disabled patients, they informed the AG that at the instruction of the IRB, they had destroyed the information.

First, I am not an ethicist and therefore may be ignoring important considerations. However, it seems that research ethics appropriately centers on the vulnerable patient. Often, those who are sick and requiring medical attention may not feel that they can refuse an invitation to participate in research and are thus appropriately considered vulnerable. They need protections to ensure that powerful physicians and healthcare systems fully account for their interests when conducting research which may put them at additional risk.

In this case, it seems to me that the vulnerable population that we should be protecting are the disabled patients. Although physicians and subspecialty practices may be the research subjects here, they are not vulnerable and should not receive the same level of protections as vulnerable research subjects. Maybe the answer is not to call this research, but some other form of standardized inquiry. A colleague remarked that this seems more like investigative reporting than research, and that may be a more apt model. In this work as well as investigative reporting, the objects of inquiry are the powerful who have the resources to defend themselves if necessary. They do not need additional protections from the research protections infrastructure that has been built up to protect the vulnerable.

Counterpoint: Researchers Should Avoid Being an Arm of the Law

By: Anna Chodos, MD

The study mentioned by Dr. Lee above is unusual in two ways with regard to possible ethical violations. First, the practices that were called to request an appointment for a hypothetical patient did not go through an informed consent process because the investigators chose a “deceptive technique” to get at their research question. (In this way, as Dr. Lee points out, it seems like investigative journalism). The IRB required them to send a letter to the practices they included in their study to let them know that they had been included after the fact (and according to the lead author, Dr. Lagu, during an oral presentation of her paper, this resulted in some unfavorable responses from those practices). Second, they were required to destroy the data after the analysis to protect the subjects who subsequently could be linked to the violation of a federal law. The publication of the study led one city to call the investigators to ask for the practices’ identifying information so they could take legal action and then, when they discovered it did not exist, to consider conducting the same study themselves to get the information they wanted.

It strikes me as ethically sound that the IRB asked the investigators to destroy the information. The research question was to determine if these subspecialty practices were accessible to patients with disabilities; finding that they were not is effectively finding them in violation of the law. The main research question is equivalent to, “How often are subspecialty practices breaking the ADA and denying their services to patients with disabilities?”, and that could be seen as a legal question. These are medical researchers who are, presumably, interested foremost in the health implications of their question, though likely also interested in influencing the enforcement of this important law. But, they are neither enforcers nor defenders of the law in our society and it is not their role to aid such activity through their research in a specific way. By keeping the information with identifiers in a cabinet somewhere they would legally endanger the research subjects, ie. the subspecialty practices, beyond what these practices were already doing to endanger themselves. Again, I see it as far beyond the intention of research to directly aid enforcement of a law.

Fundamentally, I think health researchers must be careful not to consider themselves on the side of the law or not. Health researchers should be seeking to improve the health, not legal standing, of people and society. We hope laws related to public health will protect and promote health. But, as far as I can tell the law is not perfect, its enforcement is not perfect, and many laws are far from being in the right or wrong in any morally sound way. Were researchers to use their powerful tool of human observation and analysis—that has (mostly) gained the trust of people and society—with the aim of enforcing laws, they would have no credibility as objective scientists with loftier goals.

I think you can still be concerned about the ethics of this research on other counts, though. They truly may not have conducted their research at acceptable risk (to society or the subjects) for two reasons. First, the practices were not consented. The reason for this is clear because the information they would have obtained had they consented people would have been terribly inaccurate and practically useless. So the IRB evidently decided that a post-enrollment letter explaining the study was acceptable in order to answer this important question. Second, just by publishing their design, they gave anyone who wishes to enforce this law the roadmap to do it. Just have an intern with a spare half hour call all the OB/GYN practices in your city (of which they know a whopping 44% were inaccessible in this national sample). So did they effectively protect these subspecialties from being held accountable? Probably not. If these practices get fined huge amounts and close up shop, they may be able to serve no one at all. Is that fair? Frankly, it’s not my place to say.


Mike Steinman said…
I'm with Dr. Chodos on this one. This sort of research serves a valuable role in identifying disparities and other problems with our health care system - with the ultimate goal that the findings will spur improvement. If physicians or institutions fear sanction from sharing sensitive information, the long-term harms of chilling research will well exceed the short-term gains.
Dan Matlock said…
Are buildings with ramps and lifts human subjects?

IRBs protect humans not buildings or practics. Even if the names of the practices had been disclosed, no humans would have been harmed (those doctors would have surely found jobs elsewhere - they're specialists for Pete's sake).

The IRB at this instution was overly deferent to the practices.

By this reationale, we should stop all public reporting of quality measures at a hospital because we risk...I don't know...closing a bad hospital...?

I hate to say it...but I'm with Sei!!
ken covinsky said…
Thanks Sei and Anna for this great discussion! It is a really interesting issue, with lots of merit to both positions.

I wonder if the problem reflects the difficulty with defining research as any activity that produces generalizable knowledge--a definition that may seem to broad. From that perspective, the subjects (those who owned these practices) could be viewed as having had the right to decline participation.

But to say that this study should not have been done seems like the wrong result. It was important to discover that practices were violating the Americans with Disabilties Act. And this study will probably have tangible impacts on improving health access for disabled patients.

It seems wrong to say that health professionals should not engage in public interest "research" that challenges the profession. Even though this was published in the Annals, this seems to me much more akin to investigative journalism than research. Maybe we need to develop reasonable ways of defining when health professionals are engaging in journalism rather than research.
Paula Span said…
It is indeed akin to investigative reporting, except that journalists actually want to identify institutions that discriminate. Like health researchers, they are not prosecutors or regulators. Unlike health researchers, apparently, they are glad when prosecutors or regulators can use their work to hold lawbreakers accountable. That's how reporters win Pulitzers.

In this case, the researchers weren't taking advantage of privileged or confidential information that accrued to them as health care professionals. There was no release of "sensitive information." Any citizen with a phone could have called to ask about access to these facilities for people with disabilities.

So yes, the design was "deceptive" in that the callers didn't say, "Hello, I don't actually have a disabled patient to refer, I just want to know if you're violating the ADA." But providers of service, from medical care to auto repair, have no expectation of privacy when they make their services available to (or advertise to) the public.

Shredding the results? That creates the impression that the IRB values its protocols over the public interest.

Paula Span
Columbia University Graduate School of Journalism
amcr said…
This seems like mystery shopping- which is an accepted and well documented research method in the literature....

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