To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...) potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant9s consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan9s argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many otherwise (...) perfectly ethical research studies. This last conclusion follows from appreciating a pervasive phenomenon that is known as the "therapeutic misconception." I argue that a prospective subject's consent to participate in research can be perfectly valid even if he or she does not comprehend the information that investigators are required to disclose. Furthermore, I explain that this alternative view does not in the least compromise the vital goal of ensuring the protection of subjects in research. (shrink)

The philosophical literature displays a lively debate on the conditions under which ignorance excuses. In this paper, I formulate and defend an answer to two questions that have not yet been discussed in the literature on exculpatory ignorance. First, which kinds of propositional attitudes that count as ignorance provide an excuse? I argue that we need to consider four options here: having a false belief, suspending judgement on a true proposition, being deeply ignorant of a truth, and having a true (...) belief that falls short of knowledge. Second, ignorance of which propositions counts as an excuse? I discuss four candidates: ignorance of one’s obligation, ignorance that one is able to meet that obligation, ignorance of how to meet that obligation, and lack of foresight regarding that obligation. I argue that we can give a satisfactory account of exculpatory ignorance only if we pay attention to these two neglected issues. (shrink)

This article offers an analysis of ignorance. After a couple of preliminary remarks, I endeavor to show that, contrary to what one might expect and to what nearly all philosophers assume, being ignorant is not equivalent to failing to know, at least not on one of the stronger senses of knowledge. Subsequently, I offer two definitions of ignorance and argue that one’s definition of ignorance crucially depends on one’s account of belief. Finally, I illustrate the relevance of my analysis by (...) paying attention to four philosophical problems in which ignorance plays a crucial role. (shrink)

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...) other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...) the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

We citizens of the 21st century live in a world where division of epistemic labour rules. Most of what we know we learned from the spoken or written word of others, and we depend in endless practical ways on the technological fruits of the dispersed knowledge of others—of which we often know almost nothing—in virtually every moment of our lives. Interest has been growing in recent years amongst philosophers, in the issues in epistemology raised by this fact. One issue concerns (...) the depth and extent of our epistemic dependence on testimony, as we may label this broad epistemic source: Do we have any knowledge at all that is free of epistemic dependence on what we have learned from others? A related question is whether our entitlement to believe what we have learned from others can be explained without invoking any epistemic principles special to testimony. These questions concern, as it were, the macro-epistemology of testimony. In the present discussion I shall focus instead on the micro foundations. Testimony, in our broad sense, can occur through an extensive range of types of spoken and written means of purportedly factual communication, including telephone calls, e-mails and personal letters, lectures and radio broadcasts, newspapers, textbooks and encyclopaedias, personal diaries, and public records of all kinds. But the central paradigm—what started the whole communication thing off—is surely that of face-to-face spoken encounter, when one person tells something to another, thereby intending and hoping to share her knowledge with her audience. I begin by describing the speech act of telling, identifying what takes place in a felicitous act of telling. From the nature of the speech act of telling, we see precisely how it is that knowledge is, when all goes as it should, acquired from teller by trusting hearer, in such an act, and in acts of testimony more broadly. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

This important new book develops a new concept of autonomy. The notion of autonomy has emerged as central to contemporary moral and political philosophy, particularly in the area of applied ethics. professor Dworkin examines the nature and value of autonomy and uses the concept to analyse various practical moral issues such as proxy consent in the medical context, paternalism, and entrapment by law enforcement officials.