Jeremy Garrett

Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear. As this paper will explore, much of this confusion is definitional or conceptual in nature. The extent of a researcher’s obligation to return secondary and other research findings is often limited by reference to terms and concepts like “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” “actionability,” and “desirability.” These terms are used in different ways by different writers to describe obligations in different sorts of cases. Underneath this definitional confusion is a general notion, supported by much of the literature, that findings only need to be disclosed when they surpass certain presumably objective or measureable thresholds, such as medical importance or scientific reproducibility. The problem is that there is significant variability in the way that these terms and concepts are used in the literature and, as such, in defining the scope of an obligation to return findings that surpasses the relevant thresholds. The goal of this paper is to analyze the definitional muddle underlying the debate about returning genetic research findings, with the hope of answering a few questions. First, what is the range of definitions being used in this debate? Based on an extensive literature review, Part 1 will lay out a range of articulated definitions for each relevant term, with the goal of categorizing them into a handful of distinct types. Part 2 explains the definitional redundancy and confusion in the current literature, and, drawing from the terminological patterns identified in Part 1, outlines more cohesive building blocks to inform the development of future disclosure frameworks.Our minimum goal in articulating these conceptual building blocks is to promote clearer articulations of, and distinctions between, future disclosure frameworks. More ambitiously, we suggest which definitions and conceptualizations we consider most appropriate to use in future disclosure frameworks. Here, we seek to balance benefits to participants through the disclosure of important information with the minimization of undue burdens on individual researchers and the research enterprise more generally. Our analysis builds upon the central philosophical distinction between concepts and conceptions. The basic idea is that the “concept” of X refers to the general (and relatively uncontroversial) structure/shape of X, while various “conceptions” of X are more particular, filled out, and controversial elaborations of the concept. In other words, “concepts” of X will be formal representations of X, while “conceptions” of X will be substantive interpretations of the key elements and relationships operating within that formal framework. (Implicit in this distinction is an important point about the nature of disagreement – namely, that in order for two or more parties to “disagree” about X as opposed to simply talk past one another, there must be at least enough shared agreement about X to know that the parties are referring to the same thing. A concept of X provides this point of common agreement, while competing conceptions of X mark the areas where disagreement arises.) In this paper, we will employ this distinction in a fundamental way to clarify exactly where the primary disagreements arise in the debate over disclosing genetic research findings. We propose that, underlying all the seeming confusion and disagreement, there are three central and widely agreed upon concepts at work in this debate—validity, value, and volition. The first two concepts concern the nature of the information itself. An obligation to disclose only exists when findings are valid and have value but there are competing conceptions of how to determine or define validity and valuableness. The third concept—volition—pertains not to the information but rather to the person to whom it will be disclosed. Does that person want or not want the information, and what is the best way of determining this? Here, too, competing conceptions arise. Our key point, though, is that almost all of the ethical disagreement arises because of competing conceptions of these three concepts. Understanding and appreciating this key point can help to refocus the substantive debate by providing some common ground to start from in determining how best to interpret these shared concepts. This refocusing can, ideally, produce more productive debate and facilitate some progress in resolving it.

In this issue of the Hastings Center Report, Amulya Mandava, Joseph Millum, and Benjamin E. Berkman revisit an old conundrum—whether to disclose incidental findings of misattributed parentage—in light of new developments in genomic sequencing that will make that conundrum both more complex and more common. While the authors’ defense of nondisclosure as the appropriate default action in genomic research aligns with prior thinking and practice, their exploration of philosophical foundations is refreshingly rigorous and developed. The final product of their analysis—an applied taxonomy of the types of harms and benefits that can result from disclosure of misattributed parentage—is an important contribution to the literature on this subject and worthy of serious consideration by genomic researchers and bioethicists alike. Despite these virtues, I am struck by the authors’ deference to the traditional assumption that disclosure ethics can be adequately understood and appreciated within a purely consequentialist framework.

abstract It is generally assumed that the link between utilitarianism and vegetarianism is relatively straightforward. However, a familiar objection to utility‐based vegetarianism maintains that, given the massive scale of animal agribusiness, any given person is causally impotent in reducing the overall number of animals raised for food and, thus, in reducing the unfathomably high quantity of disutility engendered thereby. Utilitarians have frequently responded to this objection in two ways: first, by appealing to expected utility and economic thresholds, and, secondly, by appealing to publicity effects. In this paper, I will offer some reasons for thinking that, however far these responses go in the direction of ethical vegetarianism, both leave an important normative gap between the dietary prescription they are capable of underwriting and a ‘minimally‐genuine’ vegetarian obligation. What is needed to close this gap is a utility‐based reason that (1) generates an ethical prescription for minimally‐genuine vegetarianism and (2) circumvents the causal impotence objection. As I see it, there is a straightforward and auspicious reason that can perform both of the required tasks — namely, an appeal to the well‐documented welfare‐reducing effects of eating animal products upon human health. For, if causal impotence is to work as a global objection to utility‐based vegetarianism (rather than as a more local objection to certain reasons supporting that position), then it must operate as a general thesis about the incapacity for any given individual to bring about more utility solely through her own abstention from consuming animal products. However, for almost any given individual, the decision to maintain a vegetarian diet is causally potent in at least diminishing the expected disutility for herself of poorer health and a shorter life span associated with the consumption of animal products. Thus, it follows that (1) there are plausible, if not conclusive, utilitarian grounds for minimally‐genuine vegetarianism and (2) the causal impotence objection fails as a general criticism of utility‐based vegetarianism.

In 1970, President Richard Nixon expressed his unambiguous support for interracial marriage; as for same-sex marriage, he exclaimed, "I can't go that far—that's the year 2000" . Nixon's prescient remark, made shortly after the Supreme Court's 1967 decision in Loving v. Virginia to overturn anti-miscegenation laws, expresses at once hesitancy for, yet resigned acceptance of, the inevitable expansion of civil marriage to include more and more kinds of loving partnerships. Nearly forty years later, Nixon's uncanny prediction appears close to being realized. At the very least, many have gone where he claimed to be unable to go, adding their voices to a growing movement seeking state recognition of same-sex unions as a matter of equality, rights, and justice. And, indeed, a strong case might be made on such grounds, were the state justified in sponsoring an institution of civil marriage in the first place