47 found
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  1.  37
    Bioethics and the Moral Authority of Experience.Ryan H. Nelson, Bryanna Moore, Holly Fernandez Lynch, Miranda R. Waggoner & Jennifer Blumenthal-Barby - 2022 - American Journal of Bioethics 23 (1):12-24.
    While experience often affords important knowledge and insight that is difficult to garner through observation or testimony alone, it also has the potential to generate conflicts of interest and unrepresentative perspectives. We call this tension the paradox of experience. In this paper, we first outline appeals to experience made in debates about access to unproven medical products and disability bioethics, as examples of how experience claims arise in bioethics and some of the challenges raised by these claims. We then motivate (...)
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  2.  35
    Promoting Ethical Payment in Human Infection Challenge Studies.Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley & Emily A. Largent - 2021 - American Journal of Bioethics 21 (3):11-31.
    To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...
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  3.  38
    Journeying to Ixtlan: Ethics of Psychedelic Medicine and Research for Alzheimer’s Disease and Related Dementias.Andrew Peterson, Emily A. Largent, Holly Fernandez Lynch, Jason Karlawish & Dominic Sisti - 2023 - American Journal of Bioethics Neuroscience 14 (2):107-123.
    In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; (...)
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  4.  29
    Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?Holly Fernandez Lynch, Arthur Caplan, Patricia Furlong & Alison Bateman-House - 2021 - American Journal of Bioethics 21 (12):4-19.
    After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...
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  5.  36
    Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization.Jamie Webb, Lesha D. Shah & Holly Fernandez Lynch - 2020 - American Journal of Bioethics 20 (9):4-17.
    Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....
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  6.  98
    Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch & Barbara E. Bierer - 2017 - American Journal of Bioethics 17 (3):3-14.
    The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator (...)
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  7.  37
    The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement.Edward Jacobs, Brian D. Earp, Paul S. Appelbaum, Lori Bruce, Ksenia Cassidy, Yuria Celidwen, Katherine Cheung, Sean K. Clancy, Neşe Devenot, Jules Evans, Holly Fernandez Lynch, Phoebe Friesen, Albert Garcia Romeu, Neil Gehani, Molly Maloof, Olivia Marcus, Ole Martin Moen, Mayli Mertens, Sandeep M. Nayak, Tehseen Noorani, Kyle Patch, Sebastian Porsdam-Mann, Gokul Raj, Khaleel Rajwani, Keisha Ray, William Smith, Daniel Villiger, Neil Levy, Roger Crisp, Julian Savulescu, Ilina Singh & David B. Yaden - 2024 - American Journal of Bioethics 24 (7):6-12.
    Volume 24, Issue 7, July 2024, Page 6-12.
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  8.  36
    When clinical trials compete: prioritising study recruitment.Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2017 - Journal of Medical Ethics 43 (12):803-809.
    It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...)
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  9.  28
    Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways.Holly Fernandez Lynch & Alison Bateman-House - 2020 - Journal of Law, Medicine and Ethics 48 (2):365-372.
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  10.  23
    Opening Closed Doors: Promoting IRB Transparency.Holly Fernandez Lynch - 2018 - Journal of Law, Medicine and Ethics 46 (1):145-158.
    Institutional Review Boards have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater (...)
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  11.  14
    Diversity in IRB Membership: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers.Sydney Churchill, Emily A. Largent, Elizabeth Taggert & Holly Fernandez Lynch - 2022 - AJOB Empirical Bioethics 13 (4):237-250.
    Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered (...)
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  12.  29
    Institutional Review Board Use of Outside Experts: A National Survey.Kimberley Serpico, Vasiliki Rahimzadeh, Luke Gelinas, Lauren Hartsmith, Holly Fernandez Lynch & Emily E. Anderson - 2022 - AJOB Empirical Bioethics 13 (4):251-262.
    Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently (...)
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  13.  20
    Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence.Holly Fernandez Lynch, Leslie E. Wolf & Mark Barnes - 2019 - Journal of Law, Medicine and Ethics 47 (2):213-231.
    The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...)
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  14.  32
    Differential Payments to Research Participants in the Same Study: An Ethical Analysis.Govind Persad, Holly Fernandez Lynch & Emily Largent - 2019 - Journal of Medical Ethics 1:10.1136/medethics-2018-105140.
    Recognizing that offers of payment to research participants can serve various purposes—reimbursement, compensation, and incentive—helps uncover differences between participants that can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their pre-participation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible (...)
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  15.  30
    Regulating Research with Biospecimens under the Revised Common Rule.Holly Fernandez Lynch & Michelle N. Meyer - 2017 - Hastings Center Report 47 (3):3-4.
    Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of relief. (...)
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  16.  31
    Patient‐Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues.Emily A. Largent, Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch & I. Glenn Cohen - 2018 - IRB: Ethics & Human Research 40 (1):7-17.
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  17.  28
    Patient‐Engaged Research: Choosing the “Right” Patients to Avoid Pitfalls.Emily A. Largent, Holly Fernandez Lynch & Matthew S. McCoy - 2018 - Hastings Center Report 48 (5):26-34.
    To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they (...)
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  18.  12
    The right to withdraw from controlled human infection studies: Justifications and avoidance.Holly Fernandez Lynch - 2020 - Bioethics 34 (8):833-848.
    The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide support (...)
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  19.  21
    Evaluating the Quality of Research Ethics Review and Oversight: A Systematic Analysis of Quality Assessment Instruments.Holly Fernandez Lynch, Mohamed Abdirisak, Megan Bogia & Justin Clapp - 2020 - AJOB Empirical Bioethics 11 (4):208-222.
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  20.  42
    Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule.Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2016 - Hastings Center Report 46 (1):4-5.
    On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...)
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  21.  25
    How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs?Holly Fernandez Lynch & Holly A. Taylor - 2023 - AJOB Empirical Bioethics 14 (1):23-37.
    Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 (...)
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  22.  30
    No Easy Answers in Allocating Unapproved COVID-19 Drugs Outside Clinical Trials.Jaime Webb, Lesha Shah & Holly Fernandez Lynch - 2020 - American Journal of Bioethics 20 (9):W1-W4.
    Volume 20, Issue 9, September 2020, Page W1-W4.
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  23.  26
    Filthy Lucre or Fitting Offer? Understanding Worries About Payments to Research Participants.Holly Fernandez Lynch, Ezekiel J. Emanuel & Emily A. Largent - 2019 - American Journal of Bioethics 19 (9):1-4.
    Volume 19, Issue 9, September 2019, Page 1-4.
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  24.  37
    A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player Trust.I. Glenn Cohen, Holly Fernandez Lynch & Christopher R. Deubert - 2016 - Hastings Center Report 46 (S2):2-24.
    How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club's own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the player concerning those ailments. At the same time, club doctors have obligations (...)
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  25.  29
    Allocation of Opportunities to Participate in Clinical Trials during the Covid‐19 Pandemic and Other Public Health Emergencies.Kayte Spector-Bagdady, Holly Fernandez Lynch, Barbara E. Bierer, Luke Gelinas, Sara Chandros Hull, David Magnus, Michelle N. Meyer, Richard R. Sharp, Jeremy Sugarman, Benjamin S. Wilfond, Ruqaiijah Yearby & Seema Mohapatra - 2021 - Hastings Center Report 52 (1):51-58.
    Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.
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  26.  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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  27.  44
    Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.Rebecca H. Li, Mary C. Wacholtz, Mark Barnes, Liam Boggs, Susan Callery-D'Amico, Amy Davis, Alla Digilova, David Forster, Kate Heffernan, Maeve Luthin, Holly Fernandez Lynch, Lindsay McNair, Jennifer E. Miller, Jacquelyn Murphy, Luann Van Campen, Mark Wilenzick, Delia Wolf, Cris Woolston, Carmen Aldinger & Barbara E. Bierer - 2016 - Journal of Medical Ethics 42 (4):229-234.
    A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...)
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  28.  19
    Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants.Holly Fernandez Lynch - 2020 - Bioethics 34 (9):923-932.
    When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be “minimal.” Outside the research context, US tort law tolerates a more flexible “reasonable” risk (...)
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  29.  43
    On Scarcity and the Value of Clinical Trials.Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2018 - American Journal of Bioethics 18 (4):71-73.
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  30.  20
    Ethical evasion or happenstance and hubris?Holly Fernandez Lynch - 2012 - Hastings Center Report 42 (2):30-38.
  31.  31
    The rights and wrongs of intentional exposure research: contextualising the Guatemala STD inoculation study.Holly Fernandez Lynch - 2012 - Journal of Medical Ethics 38 (8):513-515.
    In its recent review of the US Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala from 1946 to 1948, the Presidential Commission for the Study of Bioethical Issues identified a number of egregious ethical violations, but failed to adequately address issues associated with the intentional exposure research design in particular. As a result, a common public misconception that the study was wrong because researchers purposefully infected their subjects has been left standing. In fact, human subjects have been (...)
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  32. Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.Govind Persad, Holly Fernandez Lynch & Patricia J. Zettler - 2021 - Pediatrics 2021:e2021054578.
    We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.
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  33.  49
    Institutions as an ethical locus of research prioritisation.Luke Gelinas, Holly Fernandez Lynch, Barbara Bierer & I. Glenn Cohen - 2017 - Journal of Medical Ethics 43 (12):816-818.
    Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in (...)
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  34.  36
    Nonexceptionalism, Research Risks, and Social Media: Response to Open Peer Commentaries on “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations”.Luke Gelinas, Robin Pierce, Sabune Winkler, Glenn Cohen, Holly Fernandez Lynch & Barbara E. Bierer - 2017 - American Journal of Bioethics 17 (5):1-3.
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  35.  13
    Devil in the Details: Physician Duties and Expanded Access.Holly Fernandez Lynch - 2023 - Journal of Law, Medicine and Ethics 51 (1):181-184.
    Vermeulen et al. suggest a moral duty exists for physicians to inform patients of “relevant opportunities” for Expanded Access. Such a duty is likely both too broad, leading to important practical challenges, and too narrow, without further steps to promote patient access. However, physicians should be expected to be aware of the EA pathway, disclose it to eligible patients, and support the pursuit of EA options reasonably likely to help.
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  36.  32
    Streamlining Review by Accepting Equivalence.Holly Fernandez Lynch & I. Glenn Cohen - 2014 - American Journal of Bioethics 14 (5):11-13.
  37.  46
    A Response to Commentaries.I. Glenn Cohen, Holly Fernandez Lynch & Christopher R. Deubert - 2016 - Hastings Center Report 46 (S2):45-48.
    Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsible for providing player care being chosen and subject to review and termination by a (...)
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  38.  18
    INTRODUCTION Health Law and Anti-Racism: Reckoning and Response.Michele Goodwin & Holly Fernandez Lynch - 2022 - Journal of Law, Medicine and Ethics 50 (1):10-14.
    Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco regulation, worker safety, and environmental racism; health care and research in the context of infant mortality, bias in medical applications of AI, and diverse inclusion in (...)
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  39.  35
    A Functional Approach to Assessing Consent for Biospecimen Research.Holly Fernandez Lynch - 2017 - American Journal of Bioethics 17 (12):20-23.
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  40.  23
    Adding Insult to Injury: Reluctance to Engage in Clinical Research with At-Risk Groups Further Disenfranchises These Populations.Holly Fernandez Lynch & Liza Dawson - 2009 - American Journal of Bioethics 9 (11):62-64.
  41.  3
    Big Mistake: Knowing and Doing Better in Patient Engagement.Holly Fernandez Lynch - 2023 - Hastings Center Report 53 (6):2-2.
    Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a trusted advisor, at least for some. Patient‐engaged bioethics doesn't mean taking the view that (...)
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  42.  42
    Mountains and Molehills When Using Social Media as a Research Support Tool.Holly Fernandez Lynch & Emily A. Largent - 2019 - American Journal of Bioethics 19 (6):64-66.
    Volume 19, Issue 6, June 2019, Page 64-66.
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  43. Michael Hauskeller is an associate pro.Holly Fernandez Lynch - forthcoming - Hastings Center Report.
     
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  44.  31
    Mutual Obligations in Research and Withholding Payment From Deceptive Participants.Holly Fernandez Lynch, Luke Gelinas & Emily A. Largent - 2018 - American Journal of Bioethics 18 (4):85-87.
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  45.  6
    Physicians often enter theprofessionofmedicinebe-causetheywish allydogood.Holly Fernandez Lynch - 2009 - In Vardit Ravitsky, Autumn Fiester & Arthur L. Caplan (eds.), The Penn Center Guide to Bioethics. Springer Publishing Company.
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  46.  27
    The Legality of Biometric Screening of Professional Athletes.Jessica L. Roberts, I. Glenn Cohen, Christopher R. Deubert & Holly Fernandez Lynch - 2017 - American Journal of Bioethics 17 (1):65-67.
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  47.  10
    Curbside Consults in Clinical Medicine: Empirical and Liability Challenges.Rachel L. Zacharias, Eric A. Feldman, Steven Joffe & Holly Fernandez Lynch - 2021 - Journal of Law, Medicine and Ethics 49 (4):599-610.
    In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota Supreme Court case, Warren v. Dinter, offers the opportunity to reassess whether the majority rule is truly serving the best interests of patients.
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