Jessica Wilen Berg

The Family Covenant and Genetic Testing

The physician-patient relationship has changed over the last several decades, requiring a systematic reevaluation of the competing demands of patients, physicians, and families. In the era of genetic testing, using a model of patient care known as the family covenant may prove effective in accounting for these demands. The family covenant articulates the roles of the physician, patient, and the family prior to genetic testing, as the participants consensually define them. The initial agreement defines the boundaries of autonomy and benefit for all participating family members. The physician may then serve as a facilitator in the relationship, working with all parties in resolving potential conflicts regarding genetic information. The family covenant promotes a fuller discussion of the competing ethical claims that may come to bear after genetic test results are received.

Protecting Communities in Biomedical Research

Holloways article on race, emergency medicine and clinical trials for the blood substitute PolyHeme® (Northfield Laboratories, Inc., Evanston, IL) calls attention to problematic applications of “c...

Surrogate decision making in the internet age.

The computer revolution has had an enormous effect on all aspects of the practice of medicine, yet little thought has been given to the role of social media in identifying treatment choices for incompetent patients. We are currently living in the “Internet age” and many people have integrated social media into all aspects of their lives. As use becomes more prevalent, and as users age, social media are more likely to be viewed as a source of information regarding medical care preferences. This article explores the ethical and legal issues raised by the use of social media in surrogate decision making.

Making All the Children Above Average: Ethical and Regulatory Concerns for Pediatricians in Pediatric Enhancement Research

Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer. Growing interest in pediatric enhancements is likely to stimulate the conduct of enhancement research involving children. However, guidelines for the protection of human subjects were developed for investigations of therapeutic modalities. To date, virtually no attention has been paid to whether these rules would be appropriate for investigations to establish the safety and efficacy of technologies intended for enhancement rather than therapeutic uses and, if not, whether ethically acceptable rules could be designed. This article discusses whether the current guidelines for pediatric research provide appropriate protections for pediatric subjects in enhancement research and considers what additional protections might be necessary.

Ethical and Legal Issues in Enhancement Research on Human Subjects

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation.

Strange bedfellows? Reflections on bioethics' role in disaster response planning.

This essay considers the potential role of bioethics in disaster response planning and preparedness. Bioethicists can make substantial contributions, by ensuring that decision-making and distribution of resources during crises is carried out in a fair and just manner, as well as by examining the assumptions upon which disaster planning are based. Bioethicists should also be aware of potential pitfalls of overly-hasty engagement with this new field.

Risky Business: Evaluating Oocyte Donation

Andrea Gurmankin’s (2001) study on the amount and quality of risk information provided to potential oocyte donors is quite interesting and raises some compelling issues. I share her concern about the validity of the informed consent provided by donors, but I think the issue is worth further elucidation. Although the legal doctrine of informed consent to medical treatment is well established (Berg et al. 2001), the situation Gurmankin describes clearly points out some of its limitations. First, informed-consent disclosure obligations generally apply to physicians or other medical personnel. So the response of one receptionist that she was told not to disclose any information may be appropriate— if disclosure is going to be done, only someone who has the requisite knowledge and the ethical and legal obligation should do it. The result, that an individual might have become signiacantly involved in the process before getting any information is further evidence of the oddity of using an event model of informed consent (i.e., sign the consent just before undergoing the procedure), rather than a process model that promotes involvement at all stages (Berg et al. 2001). Second, informed consent to medical treatment is premised on a physician-patient relationship— that is, a relationship in which one of the parties (the physician) is focused on the well-being of the other (the patient). There is no physician-patient relationship to speak of with respect to the oocyte donor. In fact, we might do better to analogize this to informed consent for research participation. Although oocyte donation is not research, it shares more characteristics with research than with treatment. The potential beneats gained by the oocyte donor do not include direct therapeutic ones. While only some research studies have the potential for direct therapeutic beneat, all treatment endeavors do. Here, in exchange for undertaking signiacant potential risk, the oocyte donor may gain both direct and indirect nontherapeutic beneats. She is compensated (a direct nontherapeutic beneat) and may experience positive feelings of altruism (an indirect nontherapeutic beneat). The federal regulations governing the conduct of research, better known as the Common Rule, stress that consideration should be given to the balance of risks and beneats and also to whether the subjects in question are vulnerable to coercion and thus need additional safeguards (45 CFR 46.111[b]). Arguably, the population targeted by the programs assessed in Gurmankin’s study, college students, is vulnerable. College students often lack anancial resources. Compensation amounts such as those mentioned may be so high as to unduly inouence the decision to donate. In addition, and more controversially, college-age individuals (18–22 years old) might be thought of as less competent decision makers. Although college students should not be considered incompetent by any means, additional scrutiny around decision-making situations that involve high risk and no potential direct therapeutic beneat is warranted. Safeguards, particularly those focused on risk disclosure, may be appropriate. Alternatively, we might consider the obligations of the parties under contract law principles. The analogy here is to contract for services, rather than consent to medical treatment or research participation. This has interesting implications for both compensation and disclosure. Gurmankin notes that some authors have suggested compensating egg donors at rates equivalent to sperm donors, taking into account the additional time commitment. However, this ignores the signiacant potential risks of oocyte donation, compared to the nonexistent risks of sperm donation. It is customary within our society to compensate individuals for undertaking risk. For example, construction workers who work on skyscrapers are paid amounts that reoect the risks involved in their jobs. Likewise, higher compensation rates for oocyte donation are appropriate. But although in many situations higher compensation rates put contracting individuals on notice of potential risks, this is unlikely to be true here. Legal restrictions regarding fraud in contracts, which can apply where one party has pertinent information that should be shared with the other party, may be applicable. Nonetheless, we may need to create special legal disclosure obligations for programs (similar to the statutory informedconsent requirements for blood donation). Oocyte donation is undertaken for a variety of reasons. It is not clear that in all cases it need be altruistically motivated in order to be ethical—compensation may play a signiacant role. But accurate disclosure of risks is absolutely crucial. Gurmankin’s study raises serious concerns that this is not the case. Although I do not necessarily advocate the formal application of either research principles or contract law to oocyte donation, we might beneat from exploring the implications of applying different legal frameworks, rather than assuming that the law of informed consent to treatment will ax all ills.

You Say Person, I Say Property: Does It Really Matter What We Call an Embryo?

William P. Cheshire (2004) raises interesting questions about the labeling of embryos in the news media. Although I agree “concerned readers should take notice . . . [of ] prejudicial and disparaging language,” I disagree both with his statement of the problem and with his proposed solution. One cannot help but notice that Cheshire falls into the same trap of which he accuses journalists—he clearly has a skewed focus, and this colors his evaluation of the empirical data. He refers to embryos as a “category of humanity,” “vulnerable human life,” “human subjects,” and “nascent human life,” all terms that qualify under his framework as afarmatively upgrading the moral valuation of the human embryo. Contrary to what Cheshire implies, one might be just as disturbed by media reports of embryos framed in terms of “killing tiny human beings” as those framed in terms of “destruction of property”—neither represents a neutral or completely accurate description of the issue. I’d challenge Cheshire to demonstrate the “higher standard of truth and fairness” rather than simply to promote his own personal viewpoint regarding the status of embryos. While I and it ironic that Cheshire uses such language given his apparent distaste for the “skewed linguistic distribution,” it is emblematic of the larger concern he raises. Contrary to Cheshire’s claim, so-called “biased” language might be both inevitable and even appropriate when discussing embryo research. The journalistic stumbling that Cheshire describes as valuing or devaluing moral status is a product of the current confusion regarding the appropriate categorization of human embryos. These are not neutral issues, and almost all words will have positive or negative connotations. Even Cheshire recognizes that the articles that attempted to use neutral language “adopted a sterile tone unsuited” for the discussion. Without public consensus regarding the underlying issues, it is hard to see how any labeling will fail to be biased in one direction or another. At best we might hope for less inoammatory language. But this might miss the point altogether. Skewed language might be appropriate. News media is quite often biased. No one was surprised in the 2000 U.S. presidential election to and that the New York Times endorsed Al Gore, while the Cleveland Plain Dealer endorsed George W. Bush. In fact, it might be more instructional to use “biased” language in news reporting because such language makes clear the author’s biases. In fact, empirical studies show that people are extremely wary of news reporting and might expect different commentators to slant their presentations based upon their underlying goals (Newport and Saad 1998; Bennett, Rhine, and Flickinger 2001). It is not at all obvious that journalists are supposed to be neutral in public-policy debates, even if we think they could be. So what role should journalists and popular media play in this and other bioethics debates? Here I agree with Cheshire that sensationalist reporting does a disservice to the public. Early research results should be cautiously reported. Despite the amazing headlines over the past few years, we have seen little if anything in the way of treatment for diseases based upon embryonic stem cell research. But if journalists have an obligation to report accurate facts, scientists and ethicists (and other professionals involved in these areas) have an obligation to learn how to communicate through the media. It is surprising to me how little professionals understand about the time and space limits of news reporting. There are ways to package information so that it will be most useful to journalists who are trying to disseminate it—the onus to distill pertinent information should not be on only the news media. Finally, although words do matter, perhaps they do not matter as much as one might think. Changing the words used is not likely to determine the outcome of the human embryo research debate. As Cheshire notes, Stanford University’s attempt to shift the debate by changing the terminology was unsuccessful. In fact the words are useful in identifying the complexity of the underlying issues. They serve a purpose—highlighting the fundamental issues that embryo research raises regarding notions of both property and personhood. Although reporting on embryo research, stem cells, use of reproductive technology in general, and potential medical advances certainly leaves much to be desired, the problem is not with the language used. Truth and fairness in this context are not obvious. The real attention should be paid to why particular words are used and the underlying beliefs that drive the debate about embryo research. What does it mean to refer to an embryo as property? Or as a person? In recent years we have gone far beyond the simple and traditional meaning of property as a parcel of land. There are partial property rights, shared property rights, property rights in one’s physical body and in intellectual products. Property has become shorthand for recognizing individual interests in an entity, person shorthand

Response to open peer commentaries on "Surrogate decision making in the internet age".

I read with interest the commentaries in response to my article on surrogate decision making and social media. As I conclude in the piece, more research (and discussion) is needed to understand fully the appropriate role for social media in this context and I’m gratified by the responses here. I agree with Pope (2012)—there are certainly other ways in which social media may prove especially useful. Although my comments were focused narrowly, he rightly points out that there may be additional means by which social media can improve surrogate decision making. Likewise, Stark and Fins (2012) raise vital questions regarding the role of social media in the social construction of the self. There is clearly a great deal more work that can be done in this area and they provide a useful framework for thinking about these complex issues. Moore and Gallagher’s (2012) points are important, and are in line with my discussion of the different types of social media and their potential to be useful. I agree completely—the format of the online media does matter (the sentence they quote refers only to the fact that there is no reason to think that a paper format is necessarily better than an electronic one). Furthermore, context is crucially important for understanding any evidence—oral, paper, or electronic. Likewise, Siess and Moyer (2012), along with Tsai (2012), expand on the concern, which I note briefly, that social media can be difficult to access and interpret. “Proactive discussion among family members about their wishes in various specific medical situations” (Siess and Moyer 2012) definitely should be encouraged, although this does not preclude the use of social media either to reiterate those discussions or as a platform on which to engage in them. While I agree that patients “could be encouraged to speak with their physician about completing an advance directive privately” (Siess and Moore 2012), the reality is that despite years of efforts, advance directive completion rates remain fairly low. Social media use is far more prevalent. While Tsai (2012) claims that most users are youth, this discounts both the increasing use among the adult population and the aging population of users who grew up on social media. Al-

Embryo Donation: Ethical Issues

This chapter explores the novel ethical and legal questions resulting from the ability to cryopreserve embryos for future use. Individuals or couples may discard the embryos, donate the embryos to another couple for reproduction, donate the embryos to research, or freeze the embryos indefinitely. Occasionally, couples cannot agree and may face legal battles regarding embryo disposition or parentage. In other cases, clinic negligence results in embryo destruction, loss, mix-up, or misuse. We discuss these issues, as well as the growing concern over access to the technology, long-term storage, and the impact on future-born children, including commercialization and the creation of designer babies.