HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Saturday, June 30, 2012

Guest Blogger Professor Leslie P. Francis - Aftermath

Francis-LeslieBut not the aftermath everyone is talking about—that’s the aftermath of the Supreme Court’s ruling on ACA.  To the extraordinary outpouring of commentary, I really have just two things to say about the decision.  The first is enormous relief that most of the statute remains intact.  The second is unexpected admiration for the Chief Justice’s opinion, which is a marvelously-crafted reflection on federalism.  Whether one agrees or disagrees with its conclusions—especially the limited reading of the Commerce Clause—there is much to praise about the delicate balance struck between federal powers, state powers, and the role of the Court.  It’s a magisterial, coherent, deft reading of US federalism, setting out a likely vision for the years ahead.

Instead, this post is about the aftermath of the International Association of Bioethics meeting in Rotterdam.  IAB is the organization for bioethics around the world; it meets every two years, with impressive satellite meetings such as FAB (Feminist Approaches to Bioethics).  Any health law professor with interests in the intersection between law and bioethics should know about IAB.  This year’s meeting was the first back in the Netherlands since the Association’s founding meeting 22 years ago.  In addition to the satellite FAB meeting, satellite sessions also included a conference organized by the World Medical Association on possible revisions to the Declaration of Helsinki, a session organized to plan international collaboration for genetics and society research, a session on “nudges,” and a session on personalized health monitoring.   In considering revisions to the Declaration, especially touching on issues such as informed consent, the use of placebos, and biobanking, the WMA is conducting open discussions around the world; the next will be held in South Africa during the first week in December.  It is expected that a draft of planned revisions will be available for public comment in spring 2013—anyone interested in commenting on the draft should be sure to save a bit of time for that sometime in March or April.

This year’s IAB meeting, however, was far less interesting than the satellite sessions.  Surprising and disturbing to me at least (and judging from applause from the audience in one session to many others) was the IAB’s failure to structure a program with plenary sessions that addressed many of the most serious issues of ethics and health today:  risks of infectious disease spread and anti-microbial resistance, global inequalities in access to health care, or even questions of inequality and resource-limitation within more affluent economies.  Instead, plenary sessions involved such topics as moral enhancement and (unsurprisingly for a meeting in the Netherlands) a session on policy choices in legalized euthanasia—important issues, to be sure, but issues of affluence not constraint.   Yes, there was a session on global justice, but it featured only speakers from well-off countries:  one speaker from Canada (albeit born in Rhodesia and with a longstanding career in South Africa), and three based primarily in the United States.

To be a truly international bioethics association, the IAB could surely do better.  I left the meeting with a sense of irony that just as the United States may have taken a significant step towards justice in health care on its own behalf, the field of bioethics—surely quite relevant to the work of health lawyers—took a step backwards.

- Leslie P. Francis

June 30, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, June 29, 2012

Introducing the Second of the Four New Members of the HealthLawProf Regular Blogging Team - Professor Jennifer S. Bard

The Health Law Prof Blog is very proud to introduce the second of the four new members of our regular blogging team here at the HealthLaw Prof Blog, Professor Jennifer S. Bard. Here is her short bio:

Bard Jennifer S. Bard is the Associate Dean for Faculty Research and Development and the Alvin R. Allison Professor of Law at the Texas Tech University School of Law where she directs the health law program, the health law certificate and the JD/MD program. She is also an adjunct assistant professor in the department of Psychiatry at Texas Tech University School of Medicine.  She is a graduate of Yale Law School, started her career working for a Federal District Court Judge and since then has worked at Shearman & Sterling in New York as a mergers & acquisitions litigator, been an Assistant Attorney General in the Health Care Fraud and Whistleblower Unit of the Connecticut Attorney General’s Office and a professor at the University of Texas Medical Branch in Galveston.


June 29, 2012 | Permalink | Comments (0) | TrackBack (0)

Introducing the First of Four New Members of the Regular HealthLawProf Blogging Team - Professor Nicole Huberfeld

The Health Law Prof Blog is very proud to introduce the first of the four new members of our regular blogging team here at the HelathLaw Prof Blog, Professor Nicole Huberfeld. Here is her short bio:


Nicole Huberfeld is Professor of Law at the University of Kentucky College of Law and Bioethics Associate at the University of Kentucky College of Medicine. Nicole teaches structural constitutional law and a variety of healthcare law courses. Her scholarship focuses on the cross-section of constitutional law and federal healthcare programs with a particular interest in federalism and Spending Clause jurisprudence. Her latest article, Post-Reform Medicaid before the Court: Discordant Advocacy Reflects Conflicting Attitudes, is forthcoming in the Annals of Health Law. She also published Federalizing Medicaid in the University of Pennsylvania Journal of Constitutional Law in December and a book review of The Politics of Medicaid with the Journal of Legal Medicine in March. She was the recipient of the Duncan Teaching award, a nominee for the University of Kentucky Great Teacher Award, and a nominee for the ALI Young Scholars Medal. Previously, she was the Health Law Faculty Fellow at Seton Hall Law School. While at Seton Hall, she created and was Director of the Health Care Compliance Certification Program, which educates compliance officers of pharmaceutical and medical device companies in corporate and healthcare compliance. Prior to academic life, she practiced regulatory and transactional healthcare law in New York and New Jersey.


June 29, 2012 | Permalink | Comments (0) | TrackBack (0)

Teaching Constitutional Issues in the ACA Decision Part 1: A Look Behind the Curtain to Find some of Justice Kennedy's Words in an Unsigned Dissent

So now we know.  After years of debate, law suits filed all over the country, and dozens of federal opinions predicting how the Supreme Court would evaluate the terms of the Affordable Care Act the answer is that it was found Constitutional in its entirety.   I, along with every other health lawyer and professor in the country, have a lot to say about this opinion.  And my plan was to use this particular “first out of the gate” opportunity to post by discussing how we should be teaching it to our students.   It’s a wonderful teaching tool both in terms of Health Law and Constitutional Law.  If we needed any further examples that Constitutional Law is what the Supreme Court says it is, we have them now.    It also puts into perspective something law students often  find troubling: there can be many “right” answers to a question involving legal interpretation—and it’s not the lawyer who chooses among them, it’s the Judges.   But I have all summer to write about that.

What I’d like to comment on now is a different question—what happened to Justice Kennedy?  Sure, he has expressed his doubts in the past about the Commerce Clause but why couldn’t he be persuaded to join Justice Robert’s remarkable opinion which upheld the statute without giving Congress one inch of additional regulatory power?  We probably won’t have the whole story for many years.   But it’s possible to learn a lot about how to read a Supreme Court opinion, and how to read him in the future.    It’s actually remarkable how much Justice Kennedy was able to communicate, without having a single word attributed to him, and, in a bit of Supreme Court word archeology, see some strong evidence that although he signed the dissenting opinion, he may not have been completely comfortable with it.

Here's the argument:

As we all now know, ACA was found Constitutional because it had, in the opinion of five of the Justices,  enough in common with a “tax” to benefit from the deference the Court grants Congress in exercising its Spending Power.  

If that wasn't enough of a surprise, we also know that the opinion was written by Chief Justice Roberts--not Justice Kennedy who was thought to be the most likely to swing his vote towards the four Justices already quite likely to find a way to uphold it.  

Continue reading

June 29, 2012 | Permalink | Comments (0) | TrackBack (0)

Delving Deeper into the Medicaid Aspect of the Health Care Cases

In December, I stated that I thought the Court would be inclined to solidify the coercion doctrine but would be likely to uphold the Medicaid expansion.  I am still parsing the way in which the Court performed this legal novelty, because, as I noted yesterday, even though there were seven votes holding the Medicaid expansion to be coercive, five votes upheld Congress's power to create the expansion but basically severed the remedy for noncompliance, thus effectively upholding the expansion while also expanding the coercion cause of action.  Though I was surprised at which justices were willing to agree that Tenth Amendment limits exist on conditional spending (Breyer? Kagan?), I was not surprised that the Court expressed its federalism project through the vehicle of Medicaid's expansion.

Although this was the first time the Court has struck down federal spending legislation as coercive, the Court still has not given us a theory to understand how it will decide future coercion cases.  The Court refused to define coercion beyond assessing the Medicaid expansion as being "beyond the line" where "persuasion becomes coercion."  (p. 55)   We do have two points of clarification, though.  First, Florida's brief was clearly persuasive to the Chief Justice, because he bought the states' argument that too much money could be taken away if the states do not comply with the Medicaid expansion.  This clarifies an aspect of South Dakota v. Dole's coercion dicta, which could be read to mean either that Congress has offered too much money or that Congress threatened to take away too much money.  Here, the Court accepted that Congress can offer the money for the Medicaid expansion, but it took issue with the fact that the Medicaid Act gives HHS the power to take away all Medicaid funding.  So, Congress can offer a lot, it just can't threaten to take it all away.

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June 29, 2012 | Permalink | Comments (0) | TrackBack (0)

EPA Finding on Greenhouse Gases Upheld

This week a panel of the DC Court of Appeals upheld the EPA’s 2007 finding that Greenhouse Gas (GHG) emissions contribute to global warming and are a threat to public health. This finding, according to the Supreme Court in Massachusetts v. EPA, allows the EPA to regulate GHGs under the Clean Air Act.  The opinion in Coalition for Responsible Regulation v. EPA clears the way for the EPA to continue its approval processes to regulate GHG emissions from cars and large power plants. This not unexpected ruling could be appealed to the full Court of Appeals or the Supreme Court. A good summary is available here.    

The plaintiffs challenged the finding rather than any of the proposed rules since winning the case would stop the rulemaking in its tracks. Now the EPA is required to issue reasonable regulations. Plaintiffs can still challenge those rules. But keep in mind that even overturning those rules will not let them off the hook. Last year in American Electric Power v. Connecticut, the Supreme Court ruled that a lawsuit brought by several U.S. states claiming that GHG emitted by five power companies was a nuisance could not go forward, since the federal government has pre-empted common law by passing the Clean Air Act. A key part of the opinion, delivered by Justice Ginsberg, was a reminder that states can re-file their common law nuisance claim in the event that the EPA fails to act or fails to issue reasonable regulations.


June 29, 2012 | Permalink | Comments (0) | TrackBack (0)

Thursday, June 28, 2012

Big Victory for Purchase Mandates

It's difficult to exaggerate the extent to which the argument against purchase mandates came up short in today's decision. Not only did the Supreme Court uphold the individual mandate to purchase health care, but the majority's opinion casts no doubt on just about any other mandate that Congress might want to pass.

As I have observed before, Congress usually can impose purchase mandates by tying the mandates to voluntary economic activity. If Congress wants us to buy broccoli, for example, it can require grocers and restauranteurs to include broccoli with every sale (say with an exception if you show you bought broccoli earlier that day or week). What's different about the health care mandate is the infeasibility of tying it to another voluntary purchase, like the purchase of health care services. Health care coverage must be purchased before the need for health care arises.

The majority may have rejected the imposition of mandates on those who are not engaged in economic activity, but it did not reject the regulation of people already engaged in economic activity. Just as Congress can require us to buy seat belts with our cars or V-chips with our television sets, it can require us to buy other things when we enter the marketplace. The barrier to purchase mandates remains political, not constitutional.

[DO] [cross-posted at Concurring Opinons]

June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

Preliminary thoughts on today's decision splitting the proverbial baby

Also posted at Concurring Opinions:

Today, Chief Justice Roberts truly wore King Solomon’s crown.  He managed to split the issue with regard to both the “individual mandate” requiring all Americans to have health insurance coverage by 2014 as well as the expansion of Medicaid making all Americans up to 133% of the federal poverty level eligible for Medicaid coverage.  The Medicaid aspect of the decision is particularly confusing, given that one must count the votes twice to understand what has happened. 

First, seven of the justices (Roberts, Breyer, Kagan, with Roberts writing in the majority; Scalia, Kennedy, Thomas and Alito, with Scalia writing for the joint dissent) voted that the Medicaid expansion was unconstitutionally “coercive” under South Dakota v. Dole.  So, the first vote as to whether Congress has the power to require states to expand Medicaid was answered with a no; this is impermissibly coercive because the states have too much to lose if all of their Medicaid funds are at stake.  This is the first time the Court has ruled that federal spending legislation is impermissibly coercive.

But, the second question is whether that historic vote for impermissible coercion means the Medicaid expansion fails in its entirety.  Here, five justices voted to uphold the expansion but strike the remedy (removal of all Medicaid funding), rather than strike the expansion from the statute.  Justices Roberts, Breyer, Kagan, Ginsburg, and Sotomayor agreed that the proper response was to sever the Medicaid expansion so that if a state does not comply with the expansion of Medicaid eligibility, the state cannot lose all Medicaid funding.  Instead, it will only lose the funding attached to the expansion but will continue to receive existing Medicaid funding.  Justices Scalia, Kennedy, Thomas, and Alito would have invalidated the entire Medicaid expansion.  The ultimate result is that the Medicaid expansion was upheld, but states may opt out of it without jeopardizing all of their Medicaid funding under 42 U.S.C. 1396c. 

I was surprised by the number of votes in favor of impermissible coercion, but I also would be surprised if many, if any, states opt out; they will have great pressure from both physicians and hospitals to get their poorest residents into Medicaid.  Also, states that opt out of the Medicaid expansion would have to figure out how to fund the cost of the poorest uninsured, who often arrive in emergency departments with late-stage injuries and diseases and thus cost more to treat.  Of course, if a number of states opt out, then states that have fully-expanded Medicaid may see greater increases of their enrollment that ultimately could lead to political pressure to modify Medicaid eligibility in a different way (as we have seen at other points in Medicaid’s history).

It is hard to say what the future implications of the reaffirmed coercion doctrine will be.  The majority applied the coercion concept primarily through factual application rather than by expanding supporting theory (other than reiterating the “political accountability” notion from New York v. U.S).  Undoubtedly more challenges to spending legislation will follow, but this disposition does not tell us much more about coercion than we knew before 10:15 this morning.

More to come when I have time away from the reporters...  [NH]

June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

ACA Ruling: Koan of Coercion, Constitutional as a Tax, and More

A few points on the ACA ruling: 

1) Congrats to Jack Balkin for authoring "The Health-Care Mandate Is Clearly a Tax—-and Therefore Constitutional," back in May. From his lips to Justice Roberts's ears.

2) I would also like to congratulate "individuals exposed to asbestos from a mine in Libby, Montana," for keeping the Medicare coverage PPACA granted them. The joint dissent would have stripped that away, along with other parts of the Act they deem "minor provisions," in a blanket repeal of PPACA they would characterize as "caution" and "minimalism." I'm sure the tens of millions of Americans who will now enjoy insurance define "caution" quite differently. 

3) Another tip of the hat to Tim Jost, who has carefully and comprehensively blogged about key steps toward PPACA implementation, even with the "constitution in exile's" Sword of Damocles hanging over it. If you want to learn more about the "Premium Tax Credit Final Rule," essential health benefits, or minimum loss ratios, he's the go-to person.

4) A good rundown of “what the decision means for you” is here.

5) A koan on coercion, compliments of the Chief Justice:

The Federal Government does not have the power to order people to buy health insurance. Section 5000A would therefore be unconstitutional if read as a command. The Federal Government does have the power to impose atax on those without health insurance. Section 5000A is therefore constitutional, because it can reasonably be read as a tax.

n. 11: Of course, individuals do not have a lawful choice not to pay a tax due, and may sometimes face prosecution for failing to do so (although not for declining to make the shared responsibility payment, see 26 U. S. C. §5000A(g)(2)). But that does not show that the tax restricts the lawful choice whether to undertake or forgo the activity on which the taxis predicated. Those subject to the individual mandate may lawfully forgo health insurance and pay higher taxes, or buy health insurance and pay lower taxes. The only thing they may not lawfully do is not buy health insurance and not pay the resulting tax.

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June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

ACA Opinions



June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

News Flash: SCOTUSblog - Individual Mandate Constitutional

According to SCOTUSblog:

The Affordable Care Act, including its individual mandate that virtually all Americans buy health insurance, is constitutional. There were not five votes to uphold it on the ground that Congress could use its power to regulate commerce between the states to require everyone to buy health insurance. However, five Justices agreed that the penalty that someone must pay if he refuses to buy insurance is a kind of tax that Congress can impose using its taxing power. That is all that matters. Because the mandate survives, the Court did not need to decide what other parts of the statute were constitutional, except for a provision that required states to comply with new eligibility requirements for Medicaid or risk losing their funding. On that question, the Court held that the provision is constitutional as long as states would only lose new funds if they didn't comply with the new requirements, rather than all of their funding.


June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

"Dewey Defeats Truman"


June 28, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, June 27, 2012

Worth Reading This Week

Monday, June 25, 2012

SCOTUSblog is Live Blogging the Supreme Court Proceedings Thursday, June 27

To "watch" a blow by blow summary of the Supreme Court proceedings as they happen this Thursday, June 27, go to SCOTUSblog using this special link - The SOCTUSblog team will be live blogging all of this Thursday's events starting at 9 a.m.

On Monday, almost 100,000 participated in the live blogging event. This number is predicted to increase on Thursday as the ACA decision is very likely to be announced. Cross your fingers that the site does not crash!


June 25, 2012 | Permalink | Comments (0) | TrackBack (0)

Sunday, June 24, 2012

George Bush Laughs Last?

The post-mortems already have begun, and as usual, they overdetermine the surprising success of the constitutional challenge to the individual mandate to purchase health insurance. If the Supreme Court actually strikes the mandate down, observers will continue to claim that the critics framed the debate effectively, that the Solicitor General defended the mandate ineffectively, that Congress and the Obama Administration were too slow to perceive the threat, etc.

But all we really need to know is that George Bush, rather than Al Gore or John Kerry, nominated Sandra Day O'Connor's replacement to the Supreme Court. That difference in the Court's ideology explains far more than anything else. Indeed, as the Court's decision last week in Knox illustrated, the justices can readily draw on their philosophical biases without any help to reach their decisions. In that case, as the four moderate justices pointed out, the conservative wing of the Court announced a new principle about the first amendment rights of non-union members without hearing arguments on the particular matter. Contrary to the Court's standard rules, the majority simply decided to establish a new doctrine without giving the parties a chance to weigh in. There was no need for conservative law professors, television hosts, newspaper columnists or elected officials to beat the drums on behalf of management.

If the individual mandate goes down, its viability was determined not in the past couple of years but in 2006 when George Bush appointed Samuel Alito to the Supreme Court.

[DO] [cross-posted at Concurring Opinions]


June 24, 2012 | Permalink | Comments (0) | TrackBack (0)

Thursday, June 21, 2012

Court Will Examine Legality, Not Merits, of Health Care Reform

Professor Jennifer Bard of Texas Tech University School of Law makes the point in an Op Ed written for the Houston Chronicle that "[w]hatever the opinion Supreme Court decides about the constitutionality of the Affordable Care Act (ACA), one thing is certain: it will not be based on an assessment of the merits of a national health care system." She goes on to explain that the Supreme Court's ruling on ACA 

will be a ruling about whether there is explicit constitutional authority for the way Congress chose to fund a system to make health insurance affordable and accessible to all Americans. In other words, the decision is about how Congress chose to fund the system it set up, not the system itself.

There is no legal dispute, either in the written opinions of in any of the courts that have reviewed the bill so far, or among anyone else, that Congress has the power to spend the money it collects in any way it believes will promote the nation's best interests. Article 1, Section 8, Clause 1 of the U.S. Constitution gives a lawfully elected Congress the power to tax and spend the money collected in order to promote the "general welfare" of the country. Since then, the Supreme Court has interpreted this clause very broadly and granted Congress nearly unlimited discretion in deciding what does, and does not, promote the general welfare. The dispute here is about whether Congress acted within its authority in how it structured the finances of this law, not about the law's merits.

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June 21, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, June 20, 2012

Guest Blogger Leslie Francis: Of “Datapaloozas”: Their Delights—and Dangers

Francis-LeslieFor the last three Junes, HHS has sponsored “Datapaloozas”: summits (otherwise known as the “Health Data Initiative Forum I, II, and III”) designed to highlight the vast resources of health information possessed by the federal government (and elsewhere); to showcase the impressive knowledge to be gained from their use; and to stimulate the development of innovative consumer, community, and industry tools that capitalize on their capabilities.  These data summits have so grown in popularity that they are now held in the Washington, D.C., Convention Center.  Todd Park, the dynamic former chief technology officer of HHS and now White House chief technology officer, is the enthusiastic champion of these events.  “Data liberation” is the rallying call.

These events are moments of genuine excitement.  This year’s was keynoted by a speech from HHS Secretary Sebelius, highlighting the importance of innovation in health care.  Attended by over 1600 people, the Datapalooza starred “Rockstars” of health care innovation—and also featured the music of at least one more conventional rock star, Jon Bon Jovi.  Major sponsors of this year’s Datapalooza were the Robert Wood Johnson Foundation; the California HealthCare Foundation; the Department of HHS; the Institute of Medicine; esri, a commercial provider of geospatial technologies; Healthways, a commercial provider of well-being services; the Jewish Healthcare Foundation; and Feinstein Kean Healthcare, a communications firm serving the health care industry.  As this sponsor list indicates, the Datapalooza is of great public health, research, and commercial interest.

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June 20, 2012 | Permalink | Comments (0) | TrackBack (0)

Trusting PhRMA?

I might have been persuaded by Justice Stephen Breyer's dissent on behalf of drug company sales representatives in Christopher v. SmithKline until I got to his reliance on the ethics code of the Pharmaceutical Research and Manufacturers of America (PhRMA). [The majority rejected a claim by sales representatives (detailers) that they were entitled to overtime pay under the Fair Labor Standards Act because they were not really engaged in sales.]

As Breyer observed, the PhRMA ethics code "refers to detailers as 'delivering accurate, up-to-date information to healthcare professionals'" and "explains why a detailer should not (hence likely does not) see himself as seeking primarily to obtain a promise to prescribe a particular drug, as opposed to providing information so that the doctor will keep the drug in mind with an eye toward using it when appropriate" (emphasis added).

Perhaps Breyer is correct that drug company detailers see themselves as educators, rather than salespersons, in accordance with the PhRMA ethics code. But it's difficult to square that view with the reality of the detailers' compensation. As the majority pointed out, detailers receive substantial incentive pay (more than 30 percent of gross pay for one of the plaintiffs) that is based on sales volume of the detailers' assigned drugs in their sales territory. They are not given bonus pay based on the extent to which doctors in their sales territory are knowledgeable about their assigned drugs.

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June 20, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, June 15, 2012

Worth Reading This Week

Katherine Baicker & Amitabh Chandra, The Health Care Jobs Fallacy, NEJM

David Hyman et al, Does Tort Reform Affect Physician Supply? Evidence from Texas, SSRN 

Bradley Areheart, GINA, Privacy, and Antisubordination, SSRN/Georgia L.Rev.

Jack Balkin, From Off the Wall to On the Wall: How the Mandate Challenge Went Mainstream, The Atlantic



June 15, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, June 13, 2012

Guest Blogger Leslie Francis - Approving Research with Large Sets of Patient Data: the Puzzling Use of Paradigms from Contract Law

Francis-LeslieAs a long-term IRB member at my institution, I have observed many IRB members stumble over a perplexing word in the Federal Regulations governing research with human subjects: “practicably.”  According to the Regulations, one of the criteria for approving a waiver or alteration of informed consent is that the research could not be “practicably” carried out if IC were required. (45 C.F.R. § 46.116(c) (2012). “Impractical,” IRB members think the word should be, and that’s how my IRB anyway tends to understand it in discussing whether proposed research studies come within the purview of the rule.  But I’m a contracts professor, too—familiar with explaining to my students the difference between “impractical” and “impracticability” as a defense to contractual obligations. That keeping contractual obligations would be hard, or even very hard—very, very clearly damaging, expensive, and certainly not prudential or cost-effective—is not enough for the defense. To meet the standards for the impracticability defense, the party claiming it must show that circumstances have changed, in a manner that could not have been anticipated at the time the contract was made, and that the change goes to a fundamental assumption of the contract.

Here a typical kind of example for which IRBs are asked to consider waiver of informed consent.  A researcher wishes to engage in retrospective analysis of data collected in patient care, to ascertain the comparative (or cost) effectiveness of a particular form of patient management.  The research itself might be quite benign—for example, effect on patient outcome of time to the administration of an antimicrobial to a febrile infant presenting in an emergency department.   Patient records are readily available—and for some reason connected with the research question (e.g. interest in linking outpatient and inpatient data), the researcher needs to use data that have not been de-identified to HIPAA standards.  The data set needed for analysis may be quite large: hundreds, or even thousands of patient records. The patients themselves are not readily available: they may have moved, been lost to follow up, or even died. In any event, seeking informed consent from each of them would be very, very expensive and time-consuming—far more so than the benefits of the research seem likely to be.  And studies might be biased if certain sub-groups are more difficult to contact or more likely to refuse to allow information about them to be used. The researcher describes security and confidentiality protections for the data that, if followed, would be adequate; and there is little reason to think that people might have principled reasons for opposing the research.  So, the IRB reasons a waiver of IC is permissible for this research: it would not be practical for the researcher to obtain IC, and if an IC requirement were imposed, the research (which might after all yield important results) would not be carried out.


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June 13, 2012 | Permalink | Comments (0) | TrackBack (0)