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)

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)

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)

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)

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)

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast (...) majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry. (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)

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)

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)

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)

Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand which resulted in the suffering and death (...) of many women diagnosed with carcinoma in situ. (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)

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)

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 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.

‘Virtue signaling’ is the practice of using moral talk in order to enhance one’s moral reputation. Many find this kind of behavior irritating. However, some philosophers have gone further, arguing that virtue signaling actively undermines the proper functioning of public moral discourse and impedes moral progress. Against this view, I argue that widespread virtue signaling is not a social ill, and that it can actually serve as an invaluable instrument for moral change, especially in cases where moral argument alone does (...) not suffice. Specifically, virtue signaling can change the broader public’s social expectations, which can in turn motivate the adoption of new, positive social norms. I also argue that the reputation-seeking motives underlying virtue signaling impose important constraints on virtue signalers’ behavior, which serve to keep the worst excesses of virtue signaling in check. (shrink)

Character judgments play an important role in our everyday lives. However, decades of empirical research on trait attribution suggest that the cognitive processes that generate these judgments are prone to a number of biases and cognitive distortions. This gives rise to a skeptical worry about the epistemic foundations of everyday characterological beliefs that has deeply disturbing and alienating consequences. In this paper, I argue that this skeptical worry is misplaced: under the appropriate informational conditions, our everyday character-trait judgments are in (...) fact quite trustworthy. I then propose a mindreading-based model of the socio-cognitive processes underlying trait attribution that explains both why these judgments are initially unreliable, and how they eventually become more accurate. (shrink)

In recent years, there has been a heated debate about how to interpret findings that seem to show that humans rapidly and automatically calculate the visual perspectives of others. In the current study, we investigated the question of whether automatic interference effects found in the dot-perspective task (Samson, Apperly, Braithwaite, Andrews, & Bodley Scott, 2010) are the product of domain-specific perspective-taking processes or of domain-general “submentalizing” processes (Heyes, 2014). Previous attempts to address this question have done so by implementing inanimate (...) controls, such as arrows, as stimuli. The rationale for this is that submentalizing processes that respond to directionality should be engaged by such stimuli, whereas domain-specific perspective-taking mechanisms, if they exist, should not. These previous attempts have been limited, however, by the implied intentionality of the stimuli they have used (e.g. arrows), which may have invited participants to imbue them with perspectival agency. Drawing inspiration from “novel entity” paradigms from infant gaze-following research, we designed a version of the dot-perspective task that allowed us to precisely control whether a central stimulus was viewed as animate or inanimate. Across four experiments, we found no evidence that automatic “perspective-taking” effects in the dot-perspective task are modulated by beliefs about the animacy of the central stimulus. Our results also suggest that these effects may be due to the task-switching elements of the dot-perspective paradigm, rather than automatic directional orienting. Together, these results indicate that neither the perspective-taking nor the standard submentalizing interpretations of the dot-perspective task are fully correct. (shrink)

Phillips and colleagues convincingly argue that knowledge attribution is a faster, more automatic form of mindreading than belief attribution. However, they do not explain what it is about knowledge attribution that lends it this cognitive advantage. I suggest an explanation of the knowledge-attribution advantage that would also help to distinguish it from belief-based and minimalist alternatives.

The current industrial revolution is said to be driven by the digitization that exploits connected information across all aspects of manufacturing. Standards have been recognized as an important enabler. Ontology-based information standard may provide benefits not offered by current information standards. Although there have been ontologies developed in the industrial manufacturing domain, they have been fragmented and inconsistent, and little has received a standard status. With successes in developing coherent ontologies in the biological, biomedical, and financial domains, an effort called (...) Industrial Ontologies Foundry (IOF) has been formed to pursue the same goal for the industrial manufacturing domain. However, developing a coherent ontology covering the entire industrial manufacturing domain has been known to be a mountainous challenge because of the multidisciplinary nature of manufacturing. To manage the scope and expectations, the IOF community kicked-off its effort with a proof-of-concept (POC) project. This paper describes the developments within the project. It also provides a brief update on the IOF organizational set up. (shrink)

The question has long confounded philosophers and scientists, and it is this so-called explanatory gap between biological life and consciousness that Evan ...

It is time to bring the rich resources of these traditions into the contemporary debate about the nature of self. This volume is the first of its kind.

The experience of a reward appears to enhance memory for recent prior events, adaptively making that information more available to guide future decision-making. Here, we tested whether reward enhances memory for associative item-location information and also whether the effect of reward spreads to other categorically-related but unrewarded items. Participants earned either points (Experiment 1) or money (Experiment 2) through a time-estimation reward task, during which stimuli-location pairings around a 2D-ring were shown followed by either high-value or low-value rewards. All stimuli (...) were then tested for location memory or recognition (yes/no), immediately and after a 24-hour delay. Across both experiments (combined analysis), there was a robust improvement in location memory following high-value rewards, even though evidence supporting this effect was reliable in Experiment 2 but not in Experiment 1. The memory-enhancing effect of reward was observed on both the immediate and delayed location-memory tests. Reward-enhanced memory for both directly rewarded stimuli and categorically related stimuli that were not directly rewarded. No reliable effect of reward value on yes/no recognition-memory performance was observed in either experiment. We hypothesise that reward enhances the consolidation of recent experience and conceptually related memories to make these more available for future decisions. (shrink)