Why Consent Is a Requirement for Ethical Research

by Jonathan J. Darrow

In a Petrie-Flom Center event last month, Dr. Alan Wertheimer raised the question of why consent is needed in ethical research.  Without commenting on his answer to the question (attendees were asked not to do so), I would like to offer two principal lenses through which an answer can be understood: one by analogy to contract, and one by analogy to tort.

First, informed consent is needed to ensure that there is a “meeting of the minds” between the researcher and the research subject.  The concept of a meeting of the minds will be familiar to all first-year law students who have taken a course on contracts, and relates to the need for each party to assent to the essential elements or terms of the contract.  See 17A Am. Jur. 2d Contracts § 30.  In lay terms, a meeting of the minds is needed in order to protect the reasonable expectations of each party.  Just as each party to a contract desires to know, in advance, what must be given and what can be expected to be received, so too must each party to a research subject agreement know what is expected of him or her and what benefits are likely to accrue.  (Because of information asymmetries, with the researcher normally knowing far more than the subject about the nature of the proposed relationship, consent need only be required of the subject).

Second, consent is needed to avoid what essentially amounts to misappropriation or conversion.  Without an understanding of what the researcher will gain from the research, the subject may feel that what was taken from him or her was wrongfully converted to the benefit of the researcher.  The feeling that one’s property has been converted to the benefit of someone else, without appropriate disclosure or compensation, seems to have been a primary motivation to bring suit in the famous case of Moore v. Regents, 793 P.2d 479 (Cal. 1990), where cells extracted from a patient became potentially valuable to the researcher. While the analogy of this second lens is to tort law, rather than contract, the underlying motivation is the same: to protect the reasonable expectations of the subject, and thereby allow the subject to make a choice that he or she is less likely to later regret.

The Use of Electronic Health Records Is Increasing Medicare Billing: Is It Also Increasing the Amount of Care Physicians Provide?

 By: Katie Booth

The New York Times recently reported that the switch to Electronic Health Records (“EHRs”) may be contributing to rising Medicare costs. The Times described two hospitals where the portion of patients billed at the highest reimbursement rate rose by over 40% when the hospitals adopted EHRs. The Times also reported that in hospitals that switched to EHRs between 2006 and 2010, Medicare payments rose 47%. Medicare payments for hospitals that did not adopt EHRs rose 32%.

There are several potential explanations for this increase in billing. One is that doctors are simply doing a better job electronically recording the same care they’ve always given, leading to higher Medicare billing. Another is that some doctors are abusing the EHR system by upcoding patients or copying and pasting examination histories, fraudulently increasing Medicare billing.

A third explanation is that EHR systems actually change the way doctors practice medicine. In the process of asking doctors for particular data points, EHR systems may remind doctors to look for particular symptoms or to provide particular treatments that doctors may not have considered otherwise. It is thus possible that EHRs have led to higher Medicare bills because they have increased the amount of time doctors spend diagnosing and treating patients.

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Commentary from OPTN/UNOS Kidney Transplantation Committee Chair, John Friedewald

Related to Nikola’s post below on the proposed revisions to the deceased donor kidney allocation policy, Al Roth has posted some interesting commentary from OPTN/UNOS Kidney Transplantation Committee Chair John Friedewald (in response to a query on a list serve):

“The current proposal for kidney allocation from the UNOS kidney committee is what it is not because it was the first thing we thought of, and “wow, it’s perfect” but rather it is the product of 8 years of trial and error, consensus building, and compromise.  To state that EOFI takes into account both equity and efficiency would seem to suggest that the current UNOS proposal does not.  How could this be?  We have tried over 50 different methods of allocation and simulated them (which has not happened yet with EOFI).  And with each simulation, we view the results and how the system affects all sorts of different groups (NOT just age, but blood type, ethnic groups, sensitized patients, the effects on organ shipping, the effects on real efficiency in the system (the actual logistics).  And we have seen that some methods of allocation can generate massive utility (or efficiency in your terminology).  We can get thousands of extra life years out of the current supply of organs.  But in each instance, we have made concessions in the name of equity.  The current proposal does not increase or decrease organs to any age group by more than 5% (compared to current).   This has been our compromise on equity.  What we see in utility/efficiency is an extra 8000+ years lived each year with the current supply of organs.  So the current policy has done a tremendous amount to balance equity and utility.  And we have left thousands of life years lived on the table in the name of equity.  Now you may argue that we have not done enough in that regard, but rest assured, we have given equity hundreds of hours of consideration.

Missouri District Court Dismisses Challenge to Contraception Mandate

By Nadia N. Sawicki

Litigation challenging the PPACA contraception mandate continues, and last week’s decision by the U.S. District Court for the Eastern District of Missouri in O’Brien v. HHS brings the total number of decisions on the merits to two (three cases – Nebraska v. Sebelius, Wheaton College v. Sebelius, and Belmont Abbey v. Sebelius – have already been dismissed for lack of standing).

Judge Carol Jackson’s opinion dismisses all the plaintiffs’ claims, but focuses primarily on the Religious Freedom and Restoration Act (RFRA) claim.   RFRA, which was passed by Congress in response to the Supreme Court’s 1990 decision in Employment Division v. Smith, applies a stricter standard of scrutiny to burdens on religious exercise than is constitutionally required under Smith.  A plaintiff who can demonstrate that his freedom of religious exercise is being substantially burdened by a law will prevail unless the government can prove that the law serves a compelling state interest using the least restrictive means possible.

With respect to O’Brien’s RFRA claim, the District Court concluded that requiring a corporate employer to cover contraception in its health insurance plan does not impose a substantial burden on the entity’s right to religious exercise.  Or rather, the entity’s hypothetical right to religious exercise – the District Court assumed for the sake of argument that a secular corporation can, in fact, “exercise” a religion.  The court concluded, however, that whatever burdens exist on the plaintiffs’ right of free exercise, those burdens are “too attenuated to state a claim for relief.”   Unlike other cases where plaintiffs have been able to demonstrate substantial burdens on religion, the PPACA contraception mandate would not prevent the plaintiffs in O’Brien from keeping the Sabbath, raising a family according to Scripture, eschewing contraception, or expressing an opinion to employees.  Rather, the mandate merely requires indirect financial support of a practice with which the plaintiffs disagree – no different, the court suggests, than paying a salary to an employee who, through her own free will, chooses to purchase an objectionable product.  While the court did not draw this connection directly, this reasoning is similar in kind to the reasoning used by courts in rejecting claims of conscientious objection by taxpayers.

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UNOS Proposes a New Kidney Allocation System

By Nikola Biller Andorno

The Kidney Transplantation Committee of the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has put forward a proposal that would substantially revise the existing national allocation system for kidneys from deceased donors. It would also dissolve alternate local kidney allocation systems, which were put in place to study various allocation methods, some of which have been incorporated into the new proposal.

The proposal contains a number of provisions. Whereas the current allocation system is focused on the time a patient has been on the waiting list for a kidney, the new proposal suggests a tiered system: The 20% of kidneys that are ranked highest with regard to the likely duration of functioning once transplanted will be matched with the 20% of candidate recipients who are expected to have the longest time to benefit from a transplant. The logic behind this suggestion – like many others driving health policy considerations these days – is an attempt to maximize utility. Although the attempt to extract the most benefit out of a precious, scarce resource is certainly in keeping with good stewardship, the proposal raises concerns about fairness: What about patients who have a lower life expectancy due to age, disability, coexisting conditions, or socioeconomic status? Will they be deprioritized, with an increased risk of either dying before they get a transplant or of receiving a transplant that may not last for long? This would mean a departure from current policy, which focuses on waiting time, and it would also diverge from policies for other organs, such as livers, in which urgency is of primary concern and very sick patients are prioritized. On the other hand, stratifying organs for transplantation is not entirely new: in an attempt to reduce the number of discarded organs, several European countries have established so-called ‘old-to-old’ programs, which match the kidneys of donors 65 years of age or older with recipients of a similar age.

At the same time, the OPTN/UNOS proposal aims to promote equality of opportunity for the remaining 80% of potential recipients, by calculating their waiting time from the onset of end-stage kidney failure rather than from the date when they were added to the waiting list and by correcting for biological factors such as uncommon blood type or high immune-system sensitivity.

The proposal can be expected to undergo careful scrutiny by the different stakeholders. There is a period for public comment running through December 14, 2012. Have a look at http://optn.transplant.hrsa.gov/news/newsDetail.asp?id=1579 and contribute to the debate.

A Question of Insurance Fraud?

By Scott Burris

No, I mean it: this is a question to Bill of Health readers who know about the law on this topic.

This week, a colleague handed me a palm card she’d been given at a subway station here in Philadelphia. “Cash for diabetic test strips” it read.  Comparing prices on the company’s website with prices on Wal-Mart’s pharmacy page, it looked like the test-strip buyer pays about 20 cents on the dollar for “pre-owned” test strips.

The palm card and the website both stipulate that the strips be unexpired and in their original, unopened, factory-sealed boxes.

So, one asks, are there enough people out there who buy more diabetic test strips than they need, and are willing to take an 80% loss to ensure they are used by someone else? That seems unlikely.

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Upcoming Event – Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, October 10, 2012
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA

Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.

Bill of Health Co-Editor I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.

Introducing Nikola Biller-Andorno

We’re pleased to introduce and welcome Nikola Biller-Adorno to our blogging community as an occasional contributor.

Nikola  directs the Institute of Biomedical Ethics at the University of Zurich, Switzerland. She has been deputy editor of the Journal of Medical Ethics, and is the immediate past-president of the International Association of Bioethics. Currently, she is spending a year at Harvard and the New England Journal of Medicine as a Commonwealth Fund/Careum Foundation sponsored Harkness Fellow, exploring ethical and policy issues of health care reform.

Some of Nikola’s representative works include:

Welcome, Nikola!

Innovative Approaches to Pharmaceutical Innovation: Alternative R&D Mechanisms

by Adriana Lee Benedict

Earlier this year, the World Health Organization’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) issued a report calling for, inter alia, increased support for innovative pharmaceutical R&D funding mechanisms.  Although lack of financing has posed a challenge to implementation of alternative approaches to R&D, the increasing pace of pharmaceutical innovation has certainly spurred significant innovation in this realm.  These approaches can be broadly categorized into “push” and “pull” incentive mechanisms.

“Pull” mechanisms–such as advance market commitments, prize funds, and expedited regulatory review—reward R&D outcomes by facilitating translation of innovation to marketable products.  Several “pull” mechanisms have yet to be tested.  For instance, pay-for-performance mechanisms, such as those contemplated by the proposed Health Impact Fund, would use government and donor financing pay for performance in lieu of normal profits gained from market exclusivity.  Other untested ideas include patent buy-outs, transferable IP rights and market exclusivity, reduction of patent length, and “optimal hedging to smooth public health expenditures”.

“Push” mechanisms, on the other hand, fund R&D at earlier stages. Patent pools, for instance, bring patents into a collectively owned and managed pool that can issue voluntary licenses to generic companies for product development. Other “push” mechanisms that have seen some success include targeted disease-specific funding, health innovation networks for the “Global South”, capacity-building and technology transfer initiatives, open-source and crowd-sourced R&D for neglected and rare diseases, and private-public product development partnerships.  “Push” mechanisms that have been proposed but not yet tested include taxes on patents; proportional, tiered or stage-specific partial prizes; and making undisclosed clinical trial data an international public good. Innovative financial proposals that de-link R&D investment from profits include linking donor funding to technology transfer commitments, cost sharing for clinical trials, for-profit investment partnerships, neglected disease and global health tax credits, and additional fees on patent applications (called “Green IP”).

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The Fallacy of Fearing “Industrialized” Medicine

By Patrick O’Leary

Looking back over last month’s health-related news, two articles published on The Atlantic’s website stand out to illustrate a tension that has received a great deal of focus in Medicare reform circles, and that seems to be a political sticking point for many otherwise promising cost-reduction strategies. In his September 10th article The Fallacy of Treating Health Care as an Industry, Professor Gunderman of Indiana University criticizes a recent Institute of Medicine (“IOM”) report suggesting that our medical system could be providing better care at lower cost if it could only learn a few lessons from other industries. Professor Gunderman’s critique invokes the specter of mechanical medicine: an “industrial assembly line approach to medicine” where the pursuit of efficient care utterly eclipses the human element, the “communication and relationships” that make the practice of medicine more than just an industry. Similar arguments can be and have been deployed against any resource-sensitive reform of medical practice, as the “death panels” debate from several years ago well illustrates.

While these kinds of human-relationship based critiques of efforts to make medical care more efficient may be relevant in the context of more extreme proposals of medical rationing, they are misguided as applied to recommendations like those made in the IOM report. Read More