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Switch to: Citations
References in:
Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation [Book Review]
Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard
BMC Medical Ethics 19 (1):14 (2018)
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Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about their (...) |
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The clinical research enterprise is changing in fundamental ways. The bright line that separates research and clinical care is beginning to fade, as both “research” and “nonresearch” converge into and are embodied by the concept of the learning health care system. Here, data about care and operations are translated into practice improvement. VA has been a leader in this area, and based on its use of electronic health records and other inputs, has formed large databases and a data‐driven health care (...) |
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Much of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they (...) |
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Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) |
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We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) |
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Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) |
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Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...) |
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Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...) |
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Introduction: making the invisible visible -- The nobility of the material -- Research at war -- The guilded age of research -- The doctor as whistle-blower -- New rules for the laboratory -- Bedside ethics -- The doctor as stranger -- Life through death -- Commissioning ethics -- No one to trust -- New rules for the bedside -- Epilogue: The price of success. |
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