52 found
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  1. Reframing Consent for Clinical Research: A Function-Based Approach.Scott Y. H. Kim, David Wendler, Kevin P. Weinfurt, Robert Silbergleit, Rebecca D. Pentz, Franklin G. Miller, Bernard Lo, Steven Joffe, Christine Grady, Sara F. Goldkind, Nir Eyal & Neal W. Dickert - 2017 - American Journal of Bioethics 17 (12):3-11.
    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 (...)
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  2.  42
    When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?Stephanie R. Morain, Steven Joffe & Emily A. Largent - 2019 - American Journal of Bioethics 19 (4):11-18.
    Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...)
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  3.  22
    Ethical Responsibilities for Companies That Process Personal Data.Matthew S. McCoy, Anita L. Allen, Katharina Kopp, Michelle M. Mello, D. J. Patil, Pilar Ossorio, Steven Joffe & Ezekiel J. Emanuel - 2023 - American Journal of Bioethics 23 (11):11-23.
    It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data (...)
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  4.  50
    Can RESEARCH and CARE Be Ethically Integrated?Emily A. Largent, Steven Joffe & Franklin G. Miller - 2011 - Hastings Center Report 41 (4):37-46.
    Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.
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  5.  78
    Bench to bedside: Mapping the moral terrain of clinical research.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (2):30-42.
    : Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.
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  6.  45
    Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making.Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Emily Rosenthal, Steven Joffe, Mildred K. Cho, Benjamin Wilfond & Sandra Soo-Jin Lee - 2015 - American Journal of Bioethics 15 (9):4-17.
    We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...)
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  7.  31
    Mapping the Moral Terrain of Clinical Research.Steven Joffe & Franklin G. Miller - 2012 - Hastings Center Report 38 (2):30-42.
    Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor‐patient relationship.
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  8.  37
    Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?Franklin G. Miller, Michelle M. Mello & Steven Joffe - 2008 - Journal of Law, Medicine and Ethics 36 (2):271-279.
    The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...)
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  9.  49
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton, Laurence B. McCullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf & For the Clinical Sequencing Exploratory Research Group - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or (...)
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  10.  46
    Allocating scarce life-saving resources: the proper role of age.Govind Persad & Steven Joffe - 2021 - Journal of Medical Ethics 47 (12):836-838.
    The COVID-19 pandemic has forced clinicians, policy-makers and the public to wrestle with stark choices about who should receive potentially life-saving interventions such as ventilators, ICU beds and dialysis machines if demand overwhelms capacity. Many allocation schemes face the question of whether to consider age. We offer two underdiscussed arguments for prioritising younger patients in allocation policies, which are grounded in prudence and fairness rather than purely in maximising benefits: prioritising one’s younger self for lifesaving treatments is prudent from an (...)
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  11.  44
    Justifying Clinical Nudges.Moti Gorin, Steven Joffe, Neal Dickert & Scott Halpern - 2017 - Hastings Center Report 47 (2):32-38.
    The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...)
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  12.  30
    Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (6):3-11.
    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...)
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  13.  69
    The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations.Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon-Ho Yu & Paul S. Appelbaum - 2014 - Journal of Law, Medicine and Ethics 42 (3):344-355.
    Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...)
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  14.  50
    IRB practices and policies regarding the secondary research use of biospecimens.Aaron J. Goldenberg, Karen J. Maschke, Steven Joffe, Jeffrey R. Botkin, Erin Rothwell, Thomas H. Murray, Rebecca Anderson, Nicole Deming, Beth F. Rosenthal & Suzanne M. Rivera - 2015 - BMC Medical Ethics 16 (1):32.
    As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.
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  15.  26
    Rethink "affirmative agreement," but abandon "assent".Steven Joffe - 2003 - American Journal of Bioethics 3 (4):9 – 11.
  16.  58
    Phase 1 oncology trials and informed consent.Franklin G. Miller & Steven Joffe - 2013 - Journal of Medical Ethics 39 (12):761-764.
    Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...)
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  17.  35
    A Prescription for Ethical Learning.Emily A. Largent, Franklin G. Miller & Steven Joffe - 2013 - Hastings Center Report 43 (s1):28-29.
    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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  18.  34
    A Prescription for Ethical Learning.Emily A. Largent, Franklin G. Miller & Steven Joffe - 2013 - Hastings Center Report 43 (s1):28-29.
    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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  19. Clinical research: Should patients pay to play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  20.  47
    The Ethics of Infection Challenges in Primates.Anne Barnhill, Steven Joffe & Franklin G. Miller - 2016 - Hastings Center Report 46 (4):20-26.
    In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates (NHPs) sparked hope that successful treatments and vaccines may soon become available. Yet these studies pose a stark ethical quandary. On the one hand, they represent an important step in developing novel therapies and vaccines for Ebola and the Marburg virus, with the potential to save thousands of human lives and to protect whole communities from devastation; on the other hand, they intentionally expose (...)
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  21.  56
    Evaluating the therapeutic misconception.Franklin G. Miller & Steven Joffe - 2006 - Kennedy Institute of Ethics Journal 16 (4):353-366.
    : The "therapeutic misconception," described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic (...)
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  22.  23
    Response to Open Peer Commentaries: When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?Stephanie R. Morain, Steven Joffe & Emily A. Largent - 2019 - American Journal of Bioethics 19 (5):W3-W4.
    Volume 19, Issue 5, May 2019, Page W3-W4.
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  23.  21
    Prescription Requirements and Patient Autonomy: Considering an Over‐the‐Counter Default.Madison Kilbride, Steven Joffe & Holly Fernandez Lynch - 2020 - Hastings Center Report 50 (6):15-26.
    When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle to exercise their autonomy in using a drug (...)
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  24.  11
    Response to Open Peer Commentaries on “Ethical Responsibilities for Companies That Process Personal Data”.Matthew S. McCoy, Ezekiel J. Emanuel & Steven Joffe - 2024 - American Journal of Bioethics 24 (3):1-5.
    We’re grateful for the thoughtful and incisive commentaries on our article, “Ethical Responsibilities for Companies that Process Personal Data” (McCoy et al. 2023). In the article, we propose the E...
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  25.  18
    Equipoise and randomization.Steven Joffe & R. Truog - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 245--60.
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  26. Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
    The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
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  27.  18
    The benefit sharing vision of H3Africa.Bege Dauda & Steven Joffe - 2018 - Developing World Bioethics 18 (2):165-170.
    One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host communities may deem (...)
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  28.  35
    Altruistic Discourse and Therapeutic Misconception in Research Informed Consent.Steven Joffe - 2006 - American Journal of Bioethics 6 (5):53-54.
  29.  14
    Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
    Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. (...)
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  30.  21
    Studying Effects of Medical Treatments: Randomized Clinical Trials and the Alternatives.Susan S. Ellenberg & Steven Joffe - 2017 - Journal of Law, Medicine and Ethics 45 (3):375-381.
    The random]ized clinical trial is widely accepted as the optimal approach to evaluating the safety and efficacy of medical treatments. Resistance to randomized treatment assignment arises regularly, most commonly in situations where the disease is life-threatening and treatments are either unavailable or unsatisfactory. Historical control designs, in which all participants receive the experimental treatment with results compared to a prior cohort, are advocated by some as more ethical in such circumstances; however, such studies are often highly biased in favor of (...)
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  31.  31
    The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on “Patient Perspectives on the Learning Health System”.Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Steven Joffe, Mildred K. Cho, Benjamin Wilfond & Sandra Soo-Jin Lee - 2016 - American Journal of Bioethics 16 (2):7-9.
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  32.  37
    The challenge of research on ethics education.Jennifer C. Kesselheim & Steven Joffe - 2008 - American Journal of Bioethics 8 (4):12 – 13.
  33.  61
    Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care.Ashley Kraybill, Laura M. Dember, Steven Joffe, Jason Karlawish, Susan S. Ellenberg, Vanessa Madden & Scott D. Halpern - 2016 - AJOB Empirical Bioethics 7 (2):106-115.
  34.  16
    Are hybrid umbilical cord blood banks really the best of both worlds?Gregory M. T. Guilcher, Conrad V. Fernandez & Steven Joffe - 2015 - Journal of Medical Ethics 41 (3):272-275.
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  35.  15
    Enhancing social value considerations in prioritising publicly funded biomedical research: the vital role of peer review.Katherine W. Saylor & Steven Joffe - 2024 - Journal of Medical Ethics 50 (4):253-257.
    The main goal of publicly funded biomedical research is to generate social value through the creation and application of knowledge that can improve the well-being of current and future people. Prioritising research with the greatest potential social value is crucial for good stewardship of limited public resources and ensuring ethical involvement of research participants. At the National Institutes of Health (NIH), peer reviewers hold the expertise and responsibility for social value assessment and resulting prioritisation at the project level. However, previous (...)
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  36.  16
    Deliberation and the Life Cycle of Informed Consent.Steven Joffe & Jennifer W. Mack - 2014 - Hastings Center Report 44 (1):33-35.
    In “Mindsets, Informed Consent and Research,” Lynn Jansen opens a promising new window onto consent for early‐phase cancer trials. She hypothesizes that patients who have agreed to take part in these trials, most of whom have incurable cancers, adopt different cognitive orientations or mindsets during the predecisional “deliberative” phase than they do during the postdecisional “implementation” phase. The different objectives that individuals hold during these phases—choosing among courses of action during the former, implementing the chosen action during the latter—lead to (...)
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  37.  30
    Trials Infrastructure as Good Old-Fashioned Health System Strengthening.Avram Denburg, Carlos Rodriguez Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (7):3-5.
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  38. A prescription for ethical learning.A. Largent Emily, G. Miller Franklin & Steven Joffe - 2013 - In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell.
     
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  39.  42
    A Systematic Review of State and Manufacturer Physician Payment Disclosure Websites: Implications for Implementation of the Sunshine Act.Alison R. Hwong, Noor Qaragholi, Daniel Carpenter, Steven Joffe, Eric G. Campbell & Lisa Soleymani Lehmann - 2014 - Journal of Law, Medicine and Ethics 42 (2):208-219.
    Public disclosure of industry payments to physicians is one way to address financial conflicts of interest in medicine. As part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act requires pharmaceutical, medical device, and biologics manufacturers who have at least one product reimbursed by Medicare or Medicaid to disclose payments to physicians and teaching hospitals on a public website starting in 2014. The physician payment data will contain individual physician names, monetary values, and specific products connected (...)
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  40.  12
    Case Study: Informed Consent from the Doctor?Steven Joffe & Christian Simon - 2004 - Hastings Center Report 34 (4):12.
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  41.  15
    Informed consent from the doctor?Steven Joffe & Christian Simon - 2004 - Hastings Center Report 34 (4):12.
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  42.  23
    Public Dialogue and the Boundaries of Moral Community.Steven Joffe - 2003 - Journal of Clinical Ethics 14 (1-2):101-108.
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  43.  58
    Steven Joffe and Franklin G. Miller reply.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (5):7-7.
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  44.  29
    Steven Joffe and Franklin G. Miller reply.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (5):7-7.
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  45.  29
    Ethics knowledge of recent paediatric residency graduates: the role of residency ethics curricula.Jennifer C. Kesselheim, Julie Najita, Debra Morley, Elizabeth Bair & Steven Joffe - 2016 - Journal of Medical Ethics 42 (12):809-814.
    ObjectiveTo evaluate the relationship between recently trained paediatricians' ethics knowledge and exposure to a formal ethics or professionalism curriculum during residency.MethodsWe conducted a cross-sectional survey of recently trained paediatricians which included a validated 23-item instrument called the Test of Residents' Ethics Knowledge for Pediatrics. The sample included paediatricians who completed medical school in 2006–2008, whose primary specialty was paediatrics or a paediatric subspecialty, and who completed paediatric residency training in 2010–2011. This sample was stratified based on residency programme variables: presence (...)
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  46.  46
    Knowledge of Pediatric Ethics: Results of a Survey of Pediatric Ethics Consultants.Jennifer C. Kesselheim, Nita Bhatia, Angel Cronin, Eric Kodish & Steven Joffe - 2015 - AJOB Empirical Bioethics 6 (4):19-30.
    Background: Ethics consultants (ECs) are increasingly expected to possess core knowledge and skills. Few data address whether ECs actually possess recommended core knowledge. We aimed to measure pediatric ECs’ understanding of ethical principles, identify knowledge gaps, and explore associations between experience/training and knowledge in pediatric ethics consultations. Methods: We identified the 2 ECs most knowledgeable in pediatric ethics from each of 45 freestanding children's hospitals and an equal number of general teaching hospitals in the United States. This yielded a sample (...)
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  47.  56
    Dana-Farber cancer institute ethics Rounds: Life-threatening illness and the desire to adopt.Margaret Olivia Little, Walter V. Moczynski, Paul G. Richardson & Steven Joffe - 2005 - Kennedy Institute of Ethics Journal 15 (4):385-393.
    : Originally presented during Ethic Rounds at the Dana-Farber Cancer Institute, this commentary on the case of a patient treated for life-threatening cancer explores the responsibilities of health care providers when addressing the patient's desire to adopt a child.
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  48. Science, Ethics, and Politics: The Case of Avastin.Franklin G. Miller & Steven Joffe - 2011 - Hastings Center Report 41 (5):5-5.
     
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  49. The Health Care Cost Monitor.Franklin G. Miller & Steven Joffe - 2011 - Hastings Center Report 41 (5):5-6.
     
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  50. Institutional Oversight of Faculty‐Industry Consulting Relationships in U.S. Medical Schools: A Delphi Study.Stephanie R. Morain, Steven Joffe, Eric G. Campbell & Michelle M. Mello - 2015 - Journal of Law, Medicine and Ethics 43 (2):383-396.
    The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but (...)
     
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