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Stephanie R. Morain [21]Stephanie Morain [8]
  1.  32
    Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?Andrew Garland, Stephanie Morain & Jeremy Sugarman - 2022 - American Journal of Bioethics 23 (8):22-32.
    Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...)
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  2.  30
    Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care.Stephanie R. Morain & Emily A. Largent - 2022 - American Journal of Bioethics 23 (8):10-21.
    Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged (...)
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  3.  50
    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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  4.  49
    Ethical allocation of future COVID-19 vaccines.Rohit Gupta & Stephanie R. Morain - 2021 - Journal of Medical Ethics 47 (3):137-141.
    The COVID-19 pandemic will likely recede only through development and distribution of an effective vaccine. Although there are many unknowns surrounding COVID-19 vaccine development, vaccine demand will likely outstrip early supply, making prospective planning for vaccine allocation critical for ensuring the ethical distribution of COVID-19 vaccines. Here, we propose three central goals for COVID-19 vaccination campaigns: to reduce morbidity and mortality, to minimise additional economic and societal burdens related to the pandemic and to narrow unjust health inequalities. We evaluate five (...)
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  5.  22
    Ethics and Collateral Findings in Pragmatic Clinical Trials.Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra J. H. Mathews & Jeremy Sugarman - 2020 - American Journal of Bioethics 20 (1):6-18.
    Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...)
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  6.  31
    Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials.Stephanie R. Morain, Stephanie A. Kraft, Benjamin S. Wilfond, Amy Mcguire, Neal W. Dickert, Andrew Garland & Jeremy Sugarman - 2022 - Hastings Center Report 52 (3):9-17.
    Hastings Center Report, Volume 52, Issue 3, Page 9-17, May–June 2022.
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  7.  29
    Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?Stephanie R. Morain & Emily A. Largent - 2021 - Hastings Center Report 51 (2):22-32.
    Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients' and the public's attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what (...)
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  8.  47
    Learning Is Not Enough: Earning Institutional Trustworthiness Through Knowledge Translation.Stephanie R. Morain, Nancy E. Kass & Ruth R. Faden - 2018 - American Journal of Bioethics 18 (4):31-34.
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  9.  36
    Alternative consent models for comparative effectiveness studies: Views of patients from two institutions.Nancy Kass, Ruth Faden, Rachel E. Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner & James Pitcavage - 2016 - AJOB Empirical Bioethics 7 (2):92-105.
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  10.  31
    From preferences to policies? Considerations when incorporating empirical ethics findings into research policymaking.Emily A. Largent & Stephanie R. Morain - 2020 - Journal of Medical Ethics 46 (6):378-379.
    Interest in the use of medical data for health research is increasing. Yet, as Elizabeth Ford and colleagues rightly note, there are open questions about the suitability of existing ethical and regulatory oversight frameworks for these research approaches. In their feature article, ‘Should free text data in electronic medical records be shared for research? A citizen’s jury study in the United Kingdom’, Ford et al report the results of a deliberative engagement study in which 18 members of the public were (...)
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  11.  19
    Researching the future: scenarios to explore the future of human genome editing.Cynthia Selin, Lauren Lambert, Stephanie Morain, John P. Nelson, Dorit Barlevy, Mahmud Farooque, Haley Manley & Christopher T. Scott - 2023 - BMC Medical Ethics 24 (1):1-12.
    Background Forward-looking, democratically oriented governance is needed to ensure that human genome editing serves rather than undercuts public values. Scientific, policy, and ethics communities have recognized this necessity but have demonstrated limited understanding of how to fulfill it. The field of bioethics has long attempted to grapple with the unintended consequences of emerging technologies, but too often such foresight has lacked adequate scientific grounding, overemphasized regulation to the exclusion of examining underlying values, and failed to adequately engage the public. Methods (...)
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  12.  19
    Ostriches and Obligations: Ethical Challenges Facing Research on Usual Care.Stephanie R. Morain - 2019 - Hastings Center Report 49 (4):28-30.
    In recent years, a robust body of scholarship has emerged that examines ethical challenges facing the learning health organization model. In “Bystander Ethics and Good Samaritanism,” James Sabin and colleagues make a valuable addition to this scholarship, identifying and exploring the important question of what researchers' obligations are to patients receiving “usual care” if “that care is seen as suboptimal.” The central issue that Sabin et al. faced was whether it would be acceptable for researchers to identify patients with untreated (...)
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  13.  20
    State Experiences Implementing Youth Sports Concussion Laws: Challenges, Successes, and Lessons for Evaluating Impact.Kerri McGowan Lowrey & Stephanie R. Morain - 2014 - Journal of Law, Medicine and Ethics 42 (3):290-296.
    Over the past decade, a flurry of media stories devoted to sports-related concussions have drawn attention to the previously “silent epidemic” of traumatic brain injury in athletes. From 2001 to 2009, the annual number of sports-related TBI emergency department visits in individuals age 19 and under climbed from 153,375 to 248,414, an increase of increase of 62 percent. Multiple head injuries place youth athletes at risk for serious health conditions, including cerebral swelling, brain herniation, and even death — postconcussive conditions (...)
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  14.  28
    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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  15.  50
    Who calls the shots? The ethics of adolescentself-consent for HPV vaccination.Suchi Agrawal & Stephanie R. Morain - 2018 - Journal of Medical Ethics 44 (8):531-535.
    While the human papillomavirus vaccine is medically indicated to reduce the risk of genital warts and certain types of cancer, rates of HPV vaccination repeatedly fall short of public health goals. Individual-level factors contributing to low vaccination rates are well documented. However, system-level barriers, particularly the need for parental consent, have been less explored. To date, there is no legal or ethical consensus in the USA regarding whether adolescents might permissibly self-consent to the HPV vaccine. Consequently, there is considerable variability (...)
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  16.  23
    Getting into Their Heads: When the Investigator is also the Treating Physician.Stephanie R. Morain, Emily A. Largent & Anna Wexler - 2021 - American Journal of Bioethics Neuroscience 12 (1):68-70.
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  17.  11
    Emergency-Only Hemodialysis Policies: Ethical Critique and Avenues for Reform.Richa Lavingia, Rajeev Raghavan & Stephanie R. Morain - 2020 - Journal of Law, Medicine and Ethics 48 (3):527-534.
    An estimated 6,500 undocumented immigrants in the United States have been diagnosed with end-stage renal disease. These individuals are ineligible for the federal insurance program that covers dialysis and/or transplantation for citizens, and consequently are subject to local or state policies regarding the provision of healthcare. In 76% of states, undocumented immigrants are ineligible to receive scheduled outpatient dialysis treatments, and typically receive dialysis only when presenting to the emergency center with severe life-threatening symptoms. ‘Emergency-only hemodialysis’ is associated with higher (...)
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  18.  54
    Latch On or Back Off? Public Health, Choice, and the Ethics of Breast-Feeding Promotion Campaigns.Anne Barnhill & Stephanie R. Morain - 2015 - International Journal of Feminist Approaches to Bioethics 8 (2):139-171.
    Breastfeeding and human milk are the normative standards for infant feeding and nutrition. Given the documented short- and long-term medical and neurodevelopment advantages of breastfeeding, infant nutrition should be considered a public health issue and not only a lifestyle choice.In a letter sent out to 2600 hospitals across the country they [Public Citizen] demand that healthcare facilities “immediately discontinue the distribution of commercial infant formula manufacturer discharge bags,” claiming it undermines women’s success at breastfeeding. What they failed to explain is (...)
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  19.  19
    Evaluating the Legitimacy of Contemporary Legal Strategies for Obesity.Stephanie Morain - 2015 - Kennedy Institute of Ethics Journal 25 (4):369-393.
    In recent years, various obesity-related policy strategies have fostered rigorous debate in both the academic and popular literature: should a city restrict soda size to reduce obesity rates? Should low-income individuals receiving government food assistance through the Supplemental Nutritional Assistance Program be prohibited from using such funds to purchase soda or other “junk foods?” Should schools undertake screening and surveillance of student body mass index? These strategies pose a central challenge for public health regulation: what is the role of government (...)
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  20.  16
    Whom to Engage in Patient‐Engaged Research? Reflection on Selection.Stephanie R. Morain - 2018 - Hastings Center Report 48 (5):35-36.
    Engaging patients in research has come to be viewed as a vital component of high‐quality research, and funders now regard engaging patients and other stakeholders as a core criterion for funding decisions. In response, numerous empirical and conceptual papers have emerged to guide the process of engagement. However, as Emily Largent and colleagues rightly note, the inquiry of whom to engage has received less attention. While several teams have suggested that the selection of patients for engagement is an important consideration, (...)
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  21.  24
    Tobacco 21 Laws: Withdrawing Short-Term Freedom to Enable Long-Term Autonomy.Stephanie R. Morain - 2016 - American Journal of Bioethics 16 (7):26-28.
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  22.  19
    Response to Open Peer Commentaries on “Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?”.Andrew Garland, Stephanie Morain & Jeremy Sugarman - 2023 - American Journal of Bioethics 23 (10):1-3.
    We very much appreciate the helpful and generous commentaries in response to “Do Clinicians have a Duty to Participate in Pragmatic Clinical Trials?” (Garland, Morain, and Sugarman 2023). In that a...
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  23.  19
    Challenges in the Ethics and Implementation of Learning Health Care Systems.Matthew Crane, Stephanie Morain, Nancy Kass, Ruth Faden & Robert M. Califf - 2023 - American Journal of Bioethics 23 (8):1-4.
    Pragmatic clinical trials (PCTs) serve an important function in the modern research landscape: studying interventions in an environment that reflects real-world conditions, rather than the relative...
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  24.  41
    Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.Nancy Kass, Ruth Faden, Stephanie Morain, Kristina Hallez, Rebecca Stametz, Amanda Milo & Deserae Clarke - 2022 - Journal of Comparative Effectiveness Research 11 (5).
    Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical (...)
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  25.  37
    Grounding Medical Education in Health Equity: The Time is Now.Folasade C. Lapite, Stephanie R. Morain & Faith E. Fletcher - 2021 - American Journal of Bioethics 21 (9):23-25.
    Berger and Miller raise important considerations regarding the ongoing relevance and use of cultural competency in medical education. In particular, the authors critique the United States’ L...
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  26. 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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  27.  18
    Learning Health System — Moving from Ethical Frameworks to Practical Implementation.Stephanie R. Morain, Mary A. Majumder & Amy L. McGuire - 2019 - Journal of Law, Medicine and Ethics 47 (3):454-458.
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  28.  18
    Response to Open Peer Commentaries on “Ethics and Collateral Findings in Pragmatic Clinical Trials”.Stephanie Morain, Debra Mathews, Juli Murphy Bollinger & Jeremy Sugarman - 2020 - American Journal of Bioethics 20 (1):W9-W11.
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  29.  27
    When are primary care physicians untruthful with patients? A qualitative study.Stephanie R. Morain, Lisa I. Iezzoni, Michelle M. Mello, Elyse R. Park, Joshua P. Metlay, Gabrielle Horner & Eric G. Campbell - 2017 - AJOB Empirical Bioethics 8 (1):32-39.
    Background: Notwithstanding near-universal agreement on the theoretical importance of truthfulness, empirical research has documented gaps between ethical norms and physician behaviors. Although prior research has explored situations in which physicians may not be truthful with patients, it has focused on contexts within specialty practice. In this article, we report on a qualitative study of truthfulness in primary care. Methods: We conducted a qualitative study during December 2014–March 2015 involving both focus groups and in-depth, semistructured interviews with 32 primary care physicians (...)
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