The Changing Moral Focus of Newborn Screening: An Ethical Analysis by the President's Council on Bioethics
The President's Council on Bioethics
The Council’s white paper perceptively surveys and lucidly describes a complex problem. The white paper skillfully analyzes the problem by recruiting the approaches that have become standard in bioethical thought. Those approaches include a tight focus on the rights of the patient or research subject and a potent preference for using informed consent and the IRB system to protect those rights. These standard approaches provide one significant way to think about bioethics generally and newborn screening particularly. Standard approaches have dominated bioethics, not least because it is a movement more than a discipline, a regulatory regime more than a field of inquiry, and even a creed more than a question. But might a less conventional approach not only offer insights into newborn screening but also deepen and refresh a discourse in which dogmatism has always been a danger? Let us try the experiment.
Screening calls on scarce social and scarce personal resources. So what if we ask how good stewards of such resources should think about such calls? The white paper impressively canvasses the costs and benefits of newborn screening and rightly says that screening is wrong if its costs (economic, social, and personal) exceed its benefits. But even if its benefits exceed its costs, screening would still be a poor investment if other investments are more rewarding. For example, HHS reports that the United States “ranks 27th among industrialized countries” in infant mortality and that “disparities remain among racial and ethnic groups in many measures of maternal and child health.” Dollars spent changing these figures seem likelier to help children and families than dollars spent screening for rare illnesses.1
When the state makes screening policy, it not only allocates its own resources; it also shapes the way parents employ their resources (of time, energy, money, and medical services). Bioethical doctrine demands informed consent to screening, but to learn enough to make wise choices parents must devote resources—attention, energy, and medical-consultation opportunities—to that education. If newborn screening were all new parents had to think about, imposing that education on them could make sense. But of course new parents have more on their minds. And they should. When I asked a family-practice physician where newborn screening fell in his list of educational priorities for new parents, he tried to be tactful. He struggles to teach parents to bring babies in for attention when they have a fever, not to give babies water, to put babies to sleep on their back, and much else that is not obvious but saves lives.2
Telling parents to spend resources learning about newborn screening looks even less prudent given the sobering but ever-mounting evidence that informed consent cannot achieve the goal set for it—equipping people to reason their way to well-founded and well-considered medical decisions. Legions of able and earnest researchers have for decades labored nobly to make informed consent work, but even after the most arduous education patients regularly retain only a fraction of what they need to make a sound decision.3 This should not be surprising. Teaching is hard. Learning is hard.
So once again we are brought back to stewardship: People can only learn so much; governments can only teach so much. Both need to allocate their educational efforts wisely. (As Alfred North Whitehead put it, “Operations of thought are like cavalry charges in a battle—they are strictly limited in number, they require fresh horses, and must only be made at decisive moments.”) The Council’s white paper confirms that informed consent for screening is if anything less effective than informed consent generally.
If stewardship is our standard, we must also evaluate another feature of bioethical wisdom—IRB review. The IRB system is an experiment in censorship on a remarkable scale, but is the system justifiable? While the system’s proponents recite scandals, serious attempts to show systematically that the IRB system does more good than harm are hard to find. Yet a distressingly strong case can be made that the IRB system is an improvident steward of the resources it commands—that it is structured to make capricious and unwise decisions; that it delays, damages, and stops research that could save lives and relieve suffering; that it institutionalizes an impoverished ethics; that it imposes orthodoxy where there should be freedom; that it corrodes the values the First Amendment protects; that it flouts the most essential principles of due process; that it is a lawless enterprise that evades democratic accountability. These possibilities may seem startling, but more startling is that so potent an institution has never been held to the standards of justification we expect of any exercise of the state’s coercive power.
The stewardship approach leads us to one more question: If newborn screening is needed, how should it be instituted? The issue is not whether parents may exempt children from screening. It is whether the rule should be that children are screened unless their parents opt out or that children are not screened unless their parents opt in. This is a critical question because a large literature tells us that even when people care about a decision (like contributing to retirement accounts), they frequently leave themselves wherever default rules put them.
So which default rule should govern newborn screening? That depends on two things. First, which rule would best reflect parents’ preferences? That is, which rule is likeliest to leave parents where they want to be? The Council’s white paper persuasively answers that question. Given a choice in surveys and in real life, parents almost all choose screening. So if conserving scarce social and personal resources is our goal, an opt-out system is plainly better. And if promoting parents’ autonomy is our goal, an opt-out system is plainly better.
The second question about defaults is, which rule would best promote broader social interests? The arguments for screening are that it protects newborns and their families and that it promotes valuable research. Assuming that these arguments are reasonable, the opt-out rule again is preferable. One more social interest points in that direction: an opt-out rule attributes to parents a willingness to assist in medical research when they can do so at vanishingly small risk. An opt-out rule assumes that parents recognize that they and their children benefit from generations of participation in research and can repay their debt by participating in research that will help families yet to come. An opt-out rule thus stands in the long American tradition Tocqueville described: “The free institutions which the inhabitants of the United States possess, and the political rights of which they make so much use, remind every citizen, and in a thousand ways, that he lives in society. They every instant impress upon his mind the notion that it is the duty as well as the interest of men to make themselves useful to their fellow creatures; and as he sees no particular ground of animosity to them, since he is never either their master or their slave, his heart readily leans to the side of kindness.”
The Council’s mandate is to explore fundamental issues in bioethics. The Council’s white paper does so by carefully and insightfully applying the principles of bioethics that have become canonical. This brief statement is a case study intended to ask—in the most allusive and possibly elusive way—whether the time has come to re-evaluate those principles, to identify their limits, and to supplement them with a richer range of ethical wisdom.
1. For helpful reflections on this likelihood, see Mary Ann Baily and Thomas H. Murray, “Ethics, Evidence, and Cost in Newborn Screening,” Hastings Center Report 38 (2008): 23-31.
2.See Robert C. Langan, “Discharge Procedures for Healthy Newborns,” American Family Physician 73 (2006): 849-852.
3. Carl E. Schneider, “After Autonomy,” Wake Forest Law Review 41 (2006): 411-444.