Treatment of Subject Injury: Fair is Fair

By Suzanne M. Rivera, Ph.D.

Of all the protections provided in the Common Rule to safeguard the rights and welfare of research participants, there’s one glaring omission: treatment of study-related injuries.

Our current regulatory apparatus is silent on whether treatment of injuries incurred while participating in a study ought to be the responsibility of the sponsor, the researcher, or the test subjects.  The closest thing to guidance we are given on this topic in the Common Rule is a requirement that, if the study involves more than minimal risk, the informed consent document must provide, “an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.”

Note, the regulations do not state that plans must be made to provide treatment at no cost to the participants.  In fact, the regulations don’t say treatment needs to be made available at all.  Thus, it is possible to comply with the letter and spirit of the regulations by stating the following in an informed consent document, “There are no plans to provide treatment if you should be injured or become ill as a result of your participation in this study.”  Or even, “The costs of any treatment of an injury or illness resulting from your participation in this study will be your responsibility.” Read More

Conscientious Actions and Refusals

Great new Perspectives piece by Lisa Harris out in NEJM on the need to recognize that conscience can compel action, not only refusals to provide certain types of care (including abortion).  Elizabeth Sepper makes a similar argument in her forthcoming article in the Virginia Law Review.

First,  let me just say that I couldn’t agree more – it is essential to recognize both sides of the coin.  As I’ve argued elsewhere, both ought to be respected and protected, to a point, but the issues raised by conscientious refusal versus conscientious action are distinct in some important ways.  The primary problem with refusals is that they can burden patients by creating barriers to care, if not managed appropriately.  On the other hand, conscientious action would make care available to patients – and what could be wrong with that?

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California Surrogacy Bill Reacts to Lawyer Bad Acts

[posted on behalf of Judy Daar]

Mishaps in assisted reproductive technologies (ART) breed public outcries and legislative hand-wringing.  It is no wonder a 2011 San Diego-based ART debacle dubbed “an international baby-selling ring” caught the attention of the California legislature.  In a state where elected officials practically swear fealty to the mantra, “there ought to be a law,” the conviction and imprisonment of a prominent attorney who ran a gestational surrogacy agency gone awry was bound to garner lawmaker attention.  The resulting sausage, A.B. 1217, passed legislative muster last week and now awaits signature or veto by Governor Brown.

The story of A.B. 1217 is far more elaborate than the typical sequence of mishap to measure that often accompanies ART blunders.  In California alone, our codes are peppered with laws reacting to all manner of ART black eyes, including the egg-swapping scandal at the UCI Center for Reproductive Health in the mid-1990s, the luring of egg donors by big money pay outs and the criminal mishandling of trust funds supplied by intended parents in surrogacy arrangements. Overwhelmingly, these laws are dormant but their enactment expressed the public’s outrage when third parties manipulated and mishandle the birth of an assisted conception child.

A.B. 1217 is likewise designed to forestall a perceived evil – the selling of ART offspring, a noble enough cause. But the bill began its legislative life in February 2011 as a behemoth “kitchen sink” overhaul of ART law in the Golden State.  The 34-page bill regulated all manner of assisted reproduction, sometimes for the better (defining “infertility” for purposes of state mandated health insurance as “the desire to achieve pregnancy by means other than sexual intercourse” – thus, growing the coverage pot for single and same-sex parents), and sometimes for the worse (requiring anyone using ART to undergo a mental health consultation – implying that infertility itself is a psychological impairment and burdening couples who just need a little help reproducing using their own gametes with an intrusion not visited upon those able to reproduce naturally).

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Is the Self Defense Exception Consistent with the Belief that a Fetus is a Person?

In Glenn Cohen’s first post on this blog, he questioned whether Mitt Romney’s position on abortion was coherent with respect to the rape and incest exception, but did not question the self-defense exception itself.  He addressed the self-defense exception briefly: “Through the well-known doctrine of self-defense, the criminal law has long recognized that an individual may be justified in killing to protect his or her own life, or possibly health, and these exceptions merely reflect a similar view as to fetuses.”  He is correct to say that this is the established position, one that dates at least as far back as the Talmud.  But, assuming one believes that the fetus is a person entitled to the full panoply of rights, is the self-defense exception defensible?

Lethal self-defense is generally legally justified when used to protect your life.  This is even true in cases where the attacker is not morally culpable. Judith Jarvis Thompson, in her article entitled “Self Defense,” argues that this is true because they will “otherwise violate your rights that they not kill you.”  She then extends the rights of self-defense to third parties arguing that the rights are not personal (agent-relative).

Additionally, in the article “A Defense of Abortion,” Judith Jarvis Thompson argues forcefully against the position that abortion should be impermissible even when the mother’s life is at risk. This position is untenable from the perspective of the mother because “[i]t cannot seriously be said that . . . that she must sit passively by and wait for her death.”  In the abortion case, it follows that a third party (doctor) has the right to save the mother’s life as well.  I find this to be a convincing argument against the position that abortion should never be allowed.  But does it establish that every time the health of the mother is at risk she has the right to abort the fetus, killing a person?

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Sunder on Patents and Access to Drugs

By Frank Pasquale

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  “I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

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Greenpeace Out to Sea on GM Rice Issue

[posted on behalf of Art Caplan]

Greenpeace, perhaps best known for its battles at sea to protect whales and the oceans, has gotten itself involved in a huge controversy over genetically modified food.

The group is charging that unsuspecting children were put at risk in a “dangerous” study of genetically engineered rice in rural China. It’s a serious claim, because it is putting research seeking to put more nutrition into food at risk.

Genetically engineered rice has the potential to help solve a big nutritional problem—vitamin A deficiency.  A lack of vitamin A kills 670,000 kids under 5 every year and causes 250,000 to 500,000 to go blind. Half die within a year of losing their sight, according to the World Health Organization. I think Greenpeace is being ethically irresponsible and putting those lives at continued risk.

Read the rest over at NBCNews Vitals.

Art Caplan in The Lancet: Death by Refusal to be Turned

Our blogger Art Caplan has a fascinating new piece in The Lancet today about an elderly patient who refused to be turned in his hospital bed and died from the ensuing bed sores/infection.  Art’s conclusions emphasize both patient autonomy and preserving the ability of health care professionals to provide care in humane and safe conditions.  In the meantime, he asks a number of important questions about this patient’s decision:

Could Harold or any other patient deny care considered basic and standard? If he asked not to be turned could he also demand that the heat be turned off in his room? Could he refuse to let anyone touch him at all? Could a patient demand no elevation of his bed? No taking of vital signs? And without a clear policy about a request not to turn, were the hospital staff exposing themselves to a good deal of bureaucratic and regulatory grief when Harold died?

 and

Harold seems to have been well within his legal rights to refuse turning. But would a hospital or a nursing home be within their rights to refuse him admission if what he wants is well outside the standard of care? Should all health-care institutions have a policy on turning? Although such requests are rare, the turmoil they cause is enormous. Should “not turning” be offered as an option in circumstances akin to those governing the ending of dialysis, ventilator support, resuscitation, and chemotherapy? Should turning be a topic of discussion as part of writing an advanced directive? If so, what support ought to be given to health-care providers involved in a case where a competent patient insists on not being turned?

What do you think?

Upcoming Event – What Money Can’t Buy: The Moral Limits of Markets, 9/19/12

The Petrie-Flom Center will be co-sponsoring this lecture by Michael Sandel, the Anne T. and Robert M. Bass Professor of Government at Harvard University, on his recent book What Money Can’t Buy: The Moral Limits of Markets published earlier this year. A question and answer period with Prof. Sandel and a small reception will immediately follow his lecture.

Wednesday, September 19, 2012
5:00pm
2019 Milstein West Conference Center, Rooms A & B
Wasserstein Hall, Harvard Law School