45 found
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  1.  50
    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.  16
    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.  26
    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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  4.  23
    Can RESEARCH and CARE Be Ethically Integrated?Emily A. Largent, Steven Joffe & Franklin G. Miller - 2011 - Hastings Center Report 41 (4):37-46.
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  5.  55
    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.  11
    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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  7.  21
    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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  8.  20
    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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  9.  40
    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.
    As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations.
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  10. 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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  11.  42
    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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  12.  18
    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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  13.  15
    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 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 sophisticated (...)
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  14.  15
    Rethink "Affirmative Agreement," but Abandon "Assent".Steven Joffe - 2003 - American Journal of Bioethics 3 (4):9 – 11.
  15.  39
    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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  16.  18
    A Prescription for Ethical Learning.Emily A. Largent, Franklin G. Miller & Steven Joffe - 2013 - Hastings Center Report 43 (s1):28-29.
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  17.  17
    A Prescription for Ethical Learning.Emily A. Largent, Franklin G. Miller & Steven Joffe - 2013 - Hastings Center Report 43 (s1):S28-S29.
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  18. 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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  19.  9
    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.
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  20.  3
    Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
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  21.  9
    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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  22.  17
    The Challenge of Research on Ethics Education.Jennifer C. Kesselheim & Steven Joffe - 2008 - American Journal of Bioethics 8 (4):12 – 13.
  23.  5
    Equipoise and Randomization.Steven Joffe & R. Truog - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 245--60.
  24.  4
    Deliberation and the Life Cycle of Informed Consent.Steven Joffe & Jennifer W. Mack - 2014 - Hastings Center Report 44 (1):33-35.
  25.  27
    Altruistic Discourse and Therapeutic Misconception in Research Informed Consent.Steven Joffe - 2006 - American Journal of Bioethics 6 (5):53-54.
  26.  35
    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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  27.  37
    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.
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  28.  33
    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.
    Under the Physician Payment Sunshine Act (PPSA), payments to physicians from pharmaceutical, biologics, and medical device manufacturers will be disclosed on a national, publicly available website. To inform the development of the federal website, we evaluated 21 existing state and industry disclosure websites. The presentation formats and language used suggest that industry websites are aimed at patient audiences whereas state websites are structured to transmit data to researchers and guide compliance officers. These findings raise questions about the intended audience and (...)
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  29.  8
    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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  30.  37
    Child and Parent Understanding of Clinical Trials: The Semi-Structured Comprehension Interview.Erin Talati Paquette, Julie Najita, Debra Morley & Steven Joffe - 2015 - Ajob Empirical Bioethics 6 (2):23-32.
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  31.  31
    Evidence, Errors, and Ethics.Franklin G. Miller, Steven Joffe & Aaron S. Kesselheim - 2014 - Perspectives in Biology and Medicine 57 (3):299-307.
    Novel therapeutics enter human testing after they show promise in animal and in vitro studies. They then begin a life cycle that extends from early phase trials without control groups, to randomized trials, to approval by regulatory authorities, to coverage by payers, to use in clinical practice. At each stage, scientific evidence is critical to determining whether to progress to the next step in this life cycle. Each of these decisions also implicitly involves issues of value and ethical norms based (...)
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  32.  28
    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.
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  33.  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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  34.  19
    Mapping the Moral Terrain of Clinical Research.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (2):30-42.
  35.  12
    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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  36.  6
    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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  37.  8
    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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  38.  6
    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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  39.  7
    The Sex Kitten of Bioethics? Research Ethics Comes of Age Reply.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (5):7-7.
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  40.  5
    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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  41.  2
    Case Study: Informed Consent From the Doctor?Steven Joffe & Christian Simon - 2004 - Hastings Center Report 34 (4):12.
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  42.  3
    Informed Consent From the Doctor?Steven Joffe & Christian Simon - 2004 - Hastings Center Report 34 (4):12.
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  43. 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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  44. 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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  45. The Health Care Cost Monitor.Franklin G. Miller & Steven Joffe - 2011 - Hastings Center Report 41 (5):5-6.
     
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