Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along (...) with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

This paper presents the behavioral interview model that we developed to formalize our hiring practices when we, most recently, needed to hire a new clinical ethicist to join our staff at the Center for Ethics at Washington Hospital Center.

Curbside ethics consultations occur when an ethics consultant provides guidance to a party who seeks assistance over ethical concerns in a case, without the consultant involving other stakeholders, conducting his or her own comprehensive review of the case, or writing a chart note. Some have argued that curbside consultation is problematic because the consultant, in focusing on a single narrative offered by the party seeking advice, necessarily fails to account for the full range of moral perspectives. Their concern is that (...) any guidance offered by the ethics consultant will privilege and empower one party’s viewpoint over—and to the exclusion of—other stakeholders. This could lead to serious harms, such as the ethicist being reduced to a means to an end for a clinician seeking to achieve his or her own preferred outcome, the ethicist denying the broader array of stakeholders input in the process, or the ethicist providing wrongheaded or biased advice, posing dangers to the ethical quality of decision-making. Although these concerns are important and must be addressed, we suggest that they are manageable. This paper proposes using conflict coaching, a practice developed within the discipline of conflict management, to mitigate the risks posed by curbside consultation, and thereby create new “spaces” for moral discourse in the care of patients. Thinking of curbside consultations as an opportunity for “clinical ethics conflict coaching” can more fully integrate ethics committee members into the daily ethics of patient care and reduce the frequency of ethically harmful outcomes. (shrink)

The role of clinical ethics consultant in hospitals was created about 30 years ago. Since that time, two very different models for clinical ethics consultation, and who should perform it, have arisen: clinician ethicists and nonclinician ethicists, or bioethicists. Neither model provides everything that hospitals might need, and both include perspectives that are not ideal for hospital practice. It’s time for a new model, one designed specifically to meet the needs of hospital patients, one we might call the hospital model (...) of clinical ethics (HMCE). (shrink)

As the field of clinical bioethics has moved from its pioneers, who turned their attention to ethics problems in clinical medicine and clinical and animal research, to today’s ubiquity of university degrees and fellowships in bioethics, there has been a steady drumbeat to professionalize the field. The problem has been that the necessary next steps—to specify the skills, knowledge, and personal and professional attributes of a clinical bioethicist, and to have a method to train and evaluate mastery of these standards—are (...) lacking.Ordinarily, the path to professionalism in medicine starts with the intellectual pioneers. Then come those who develop early experience in clinical settings. Then comes the specification of the skills, knowledge, and personal and professional attributes needed to perform the activities of the new specialty or subspecialty. And only then, after a method to train and evaluate levels of mastery from novice to advanced practitioner has been developed, comes credible credentialing and certification/licensing.Unfortunately, the field of clinical bioethics has skipped these steps. Rather, a credential, that is, the Healthcare Ethics Consultant (HEC) certification, was created by a small group within the bioethics professional association, the American Society of Bioethics and Humanities (ASBH), without community agreement or necessary input. Further, the testing of processes to train HECs and to evaluate their levels of mastery of competencies was prematurely forwarded as sufficient evidence of competence in clinical ethics. That is, the credential, offered by the ASBH for a fee, upon passing an exam based on how many hours one has been involved in clinical consultation, about which there is no field agreement on how such consultations ought to be conducted and for which only controversial standards have been set, is being touted as evidence of competence in clinical bioethics. In their article, “Competencies and Milestones for Bioethics Trainees,” Sawyer and colleagues identify the central weakness of these claims to professionalization and provide the field the first substantive assessment tool and method to train and evaluate competencies. The tool these authors present is the real next step forward for true professionalization of the field of clinical bioethics. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is (...) also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically (...) permissible to involve persons in research who are too decisionally impaired to provide their own consent.It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections. (shrink)

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically (...) permissible to involve persons in research who are too decisionally impaired to provide their own consent.It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections. (shrink)

Ethics rounds in clinical ethics have already taken hold in multiple venues. There are “sit-down rounds,” which usually consist of a bioethicist setting a specific, prescheduled time aside for residents and/or others to bring a case or two for discussion with the bioethicist. Another kind of rounds that occurs on an ad hoc or infrequent basis is to have either a staff or outside bioethicist give hospital-wide and/or departmental “grand rounds.” Grand rounds is a traditional educational format in medicine and (...) adding bioethics to the topics covered in grand rounds is an important means of elevating ethical awareness within a department or throughout a healthcare organization. Newer is the rounding practice of adding a bioethicist to other established rounding processes, such as case management and utilization review rounds. All of these kinds of ethics rounds are important opportunities to elevate the level of moral discourse within a healthcare setting and are becoming part and parcel of any full-service hospital bioethics program. (shrink)

A commentary on “Must We Be Courageous?,” by Ann Hamric, John Arras, and Margaret Mohrmann, in the May-June 2015 issue.

Excellence in the care of hospital patients, particularly those in an intensive care unit, reflects esprit de corps among the care team. Esprit de corps depends on a delicate balance; each clinician must preserve a sense of personal responsibility for “my” patient and yet participate in the collaborative work essential to the care of “our” patient. A harmful imbalance occurs when a physician demands total control of the decision-making process, especially concerning end-of-life treatment options. Although emotional factors may push a (...) physician to claim decision-making exclusivity, compounded by a legal framework that overemphasizes individual responsibility, esprit de corps can be preserved through timely communication among clinicians and a recognition that optimal care for “my” patient requires effective team practice. (shrink)

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. “Immersion” refers to a high-intensity clinical ethics experience in a (...) busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients’ charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations.Specific to this pilot, because participants’ evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics. (shrink)

Communication and Conflict Management Training for Clinical Bioethics Committees Content Type Journal Article Pages 341-349 DOI 10.1007/s10730-009-9116-7 Authors Lauren M. Edelstein, Johns Hopkins Medicine’s Howard County General Hospital 5755 Cedar Lane Columbia MD 21044 USA Evan G. DeRenzo, Washington Hospital Center Center for Ethics 110 Irving St Washington, D.C. NW 20010 USA Elizabeth Waetzig, Change Matrix Inc. 485 Maylin St. Pasadena CA 91105 USA Craig Zelizer, Georgetown University Department of Government 3240 Prospect St. Washington, D.C. NW 20057 USA (...) Nneka O. Mokwunye, Washington Hospital Center Center for Ethics 110 Irving St Washington, D.C. NW 20010 USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 4. (shrink)

Scholars and professional organizations in bioethics describe various approaches to “quality assessment” in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes “quality” in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent (...) evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, in this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction. (shrink)

Organizational ethics programs often are created to address tensions in organizational values that have been identified through repeated clinical ethics consultation requests. Clinical ethicists possess some core competencies that are suitable for the leadership of high-quality organizational ethics programs, but they may need to develop new skills to build these programs, such as familiarity with healthcare delivery science, healthcare financing, and quality improvement methodology. To this end, we suggest that clinical ethicists build organizational ethics programs incrementally and via quality improvement (...) projects undertaken in collaboration with senior clinical leaders. Organizational ethics programs often differ from clinical ethics programs in their membership and processes, and likely will require ethicists to forge new partnerships with a wide array of organizational leaders. With attention to the ways that organizational ethics programs differ from clinical ethics programs, and investment in quality improvement methodology and formal institutional needs assessments, clinical ethics leaders can position an organizational ethics program to advocate effectively for visible and compelling alignment of leadership decision making with the values of the organization. (shrink)

This paper presents the behavioral interview model that we developed to formalize our hiring practices when we, most recently, needed to hire a new clinical ethicist to join our staff at the Center for Ethics at Washington Hospital Center.

Curbside ethics consultations occur when an ethics consultant provides guidance to a party who seeks assistance over ethical concerns in a case, without the consultant involving other stakeholders, conducting his or her own comprehensive review of the case, or writing a chart note. Some have argued that curbside consultation is problematic because the consultant, in focusing on a single narrative offered by the party seeking advice, necessarily fails to account for the full range of moral perspectives. Their concern is that (...) any guidance offered by the ethics consultant will privilege and empower one party’s viewpoint over—and to the exclusion of—other stakeholders. This could lead to serious harms, such as the ethicist being reduced to a means to an end for a clinician seeking to achieve his or her own preferred outcome, the ethicist denying the broader array of stakeholders input in the process, or the ethicist providing wrongheaded or biased advice, posing dangers to the ethical quality of decision-making. Although these concerns are important and must be addressed, we suggest that they are manageable. This paper proposes using conflict coaching, a practice developed within the discipline of conflict management, to mitigate the risks posed by curbside consultation, and thereby create new spaces for moral discourse in the care of patients. Thinking of curbside consultations as an opportunity for clinical ethics conflict coaching can more fully integrate ethics committee members into the daily ethics of patient care and reduce the frequency of ethically harmful outcomes. (shrink)

This is a sequel to the author's The Language and Logic of the Bible: The Earlier Middle Ages. The period of the reformation saw immense changes of approach to the study of the Bible, which in turn brought huge consequences. This book, seeking to show the direction of endeavour of such study in the last medieval centuries, examines the theory of exegesis, practical interpretation, popular Bible study and preaching, and looks especially at the areas of logic and language in which (...) the scholars of the period had considerable expertise. The condemnation of the scholastics has tended to sink with them a proper recognition of what they achieved. In looking forward to the reformation, Dr Evans demonstrates a greater continuity of attitude than has often been allowed and describes how the enquiries of later medieval scholars opened out into the explorations of the sixteenth century made by Protestant and Roman Catholic thinkers alike. (shrink)

This article gives two arguments for believing that our society is unknowingly guilty of serious, large-scale wrongdoing. First is an inductive argument: most other societies, in history and in the world today, have been unknowingly guilty of serious wrongdoing, so ours probably is too. Second is a disjunctive argument: there are a large number of distinct ways in which our practices could turn out to be horribly wrong, so even if no particular hypothesized moral mistake strikes us as very likely, (...) the disjunction of all such mistakes should receive significant credence. The article then discusses what our society should do in light of the likelihood that we are doing something seriously wrong: we should regard intellectual progress, of the sort that will allow us to find and correct our moral mistakes as soon as possible, as an urgent moral priority rather than as a mere luxury; and we should also consider it important to save resources and cultivate flexibility, so that when the time comes to change our policies we will be able to do so quickly and smoothly. (shrink)

_ Source: _Page Count 24 Moral theories which include a preference-fulfillment aspect should not restrict their concern to some subset of people’s preferences such as “now-for-now” preferences. Instead, preferences with all contents—e.g. ones which are external, diachronic, or even modal—should be taken into account. I offer a conceptualization of preferences and preference fulfillment which allows us to understand odd species of preferences, and I give a series of examples showing what it would mean to fulfill such preferences and why we (...) ought to do so. (shrink)

Without needing to commit to any specific claims about what states of affairs have most agent-neutral value, we can nevertheless predict that states of affairs which are relatively valuable are also relatively likely to occur—on the grounds that, all else equal, at least some other agents are likely to recognize the value of those states of affairs, pursue them because they are valuable, and successfully bring them about as a consequence of that pursuit. This gives us a way to promote (...) value as such, rather than promoting it under some more tendentious description. We can predict that actions which help other people—or our own future selves—to recognize valuable states of affairs, actions which motivate them to pursue whatever states of affairs they believe to be valuable, or actions which help them succeed at their pursuits will, all else equal, have positive consequences. So we have a pro tanto reason to take such actions, and the subjective justification of that reason is independent of other moral claims. (shrink)

This article presents a rule-utilitarian theory which lies much closer to the social contract tradition than most other forms of consequentialism do: calculated-rates rule preference utilitarianism. Being preference-utilitarian allows the theory to be grounded in instrumental rationality and the equality of agents, as opposed to teleological assumptions about impartial goodness. The calculated-rates approach, judging rules’ consequences by what would happen if they were accepted by whatever number of people is realistic rather than by what would happen if they were accepted (...) universally or by exactly 90% of the population, allows it to select rules based not just on their ability to give good advice to their followers but also on their ability to attract followers in the first place. The result is a theory that, although fully utilitarian and not at all pluralistic or intuitionist, nevertheless offers a principled justification for giving some weight to seemingly non-utilitarian considerations: Lockean natural rights, Kantian respect for autonomy, and Scanlonian distributive justice. (shrink)

This article proposes ‘Recursive Consequentialism’: the moral theory which gives agents whatever advice will produce good consequences by being given. It can be thought of as a version of Donald Regan's ‘Cooperative Utilitarianism’ to which two additional elements have been added: allowing people with differing conceptions of ‘good consequences’, e.g., a Utilitarian and a non-Utilitarian, to cooperate with one another, and taking into account the full consequences of accepting, not just complying with, moral guidance. The theory is motivated by a (...) series of game-theoretic examples in which adherence to alternative Consequentialist moral theories produces bad consequences. (shrink)

`For I do not seek to understand so that I may believe; but I believe so that I may understand. For I believe this also, that unless I believe, I shall not understand.' Does God exist? Can we know anything about God's nature? Have we any reason to think that the Christian religion is true? What is truth, anyway? Do human beings have freedom of choice? Can they have such freedom in a world created by God? These questions, and others, (...) were ones which Anselm of Canterbury took very seriously. He was utterly convinced of the truth of the Christian religion, but he was also determined to try to make sense of his Christian faith. Recognizing that the Christian God is incomprehensible, he also believed that Christianity is not simply something to be swallowed with mouth open and eyes shut. For Anselm, the doctrines of Christianity are an invitation to question, to think, and to learn. Anselm is studied today because his rigour of thought and clarity of writing place him among the greatest of theologians and philosophers. This translation provides readers with their first opportunity to read all of his most important works within the covers of a single volume. ABOUT THE SERIES: For over 100 years Oxford World's Classics has made available the widest range of literature from around the globe. Each affordable volume reflects Oxford's commitment to scholarship, providing the most accurate text plus a wealth of other valuable features, including expert introductions by leading authorities, helpful notes to clarify the text, up-to-date bibliographies for further study, and much more. (shrink)

This paper forms an introduction to this issue, the contents of which arose directly or indirectly from a conference in May 2001 on Corruption of scientific integrity? — The commercialisation of academic science. The introduction, in recent decades, of business culture and values into universities and research institutions is incompatible with the openness which scientific and all academic pursuit traditionally require. It has given rise to a web of problems over intellectual property and conflict of interest which has even led (...) to corporate sponsors’ suppressing unfavourable results of clinical trials, to the detriment of patients’ health. Although there are those who see the norms of science developing to recognise the importance of instrumental science aiming at specific goals and of knowledge judged by its value in a context of application, none justifies the covert manipulation of results by vested interest. Public awareness of these problems is growing and creating a climate of opinion where they may be addressed. We suggest a way forward by the introduction of nationally and internationally-accepted guidelines for industrial collaboration which contain proper protections of the core purposes of universities and of the independence of their research. Some codes suggested for this purpose are discussed. We note that some universities are moving to adopt such codes of conduct, but argue the need for strong support from the government through its funding bodies. (shrink)