29 found
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  1.  14
    Demonstrating ‘respect for persons’ in clinical research: findings from qualitative interviews with diverse genomics research participants.Stephanie A. Kraft, Erin Rothwell, Seema K. Shah, Devan M. Duenas, Hannah Lewis, Kristin Muessig, Douglas J. Opel, Katrina A. B. Goddard & Benjamin S. Wilfond - 2021 - Journal of Medical Ethics 47 (12):e8-e8.
    The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...)
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  2.  30
    A narrative review of the empirical evidence on public attitudes on brain death and vital organ transplantation: the need for better data to inform policy.Seema K. Shah, Kenneth Kasper & Franklin G. Miller - 2015 - Journal of Medical Ethics 41 (4):291-296.
  3.  25
    Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not.Benjamin S. Wilfond, Seema K. Shah, Kathryn M. Porter & Stephanie A. Kraft - 2017 - American Journal of Bioethics 17 (7):53-55.
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  4.  15
    Reframing Recruitment: Evaluating Framing in Authorization for Research Contact Programs.Candace D. Speight, Charlie Gregor, Yi-An Ko, Stephanie A. Kraft, Andrea R. Mitchell, Nyiramugisha K. Niyibizi, Bradley G. Phillips, Kathryn M. Porter, Seema K. Shah, Jeremy Sugarman, Benjamin S. Wilfond & Neal W. Dickert - 2021 - AJOB Empirical Bioethics 12 (3):206-213.
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  5.  30
    Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic.Seema K. Shah, David Wendler & Marion Danis - 2015 - American Journal of Bioethics 15 (4):11-16.
    The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth (...)
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  6.  15
    Rethinking Brain Death as a Legal Fiction: Is the Terminology the Problem?.Seema K. Shah - 2018 - Hastings Center Report 48 (S4):49-52.
    Brain death, or the determination of death by neurological criteria, has been described as a legal fiction. Legal fictions are devices by which the law treats two analogous things (in this case, biological death and brain death) in the same way so that the law developed for one can also cover the other. Some scholars argue that brain death should be understood as a fiction for two reasons: the way brain death is determined does not actually satisfy legal criteria requiring (...)
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  7.  62
    What Does the Duty to Warn Require?Seema K. Shah, Sara Chandros Hull, Michael A. Spinner, Benjamin E. Berkman, Lauren A. Sanchez, Ruquyyah Abdul-Karim, Amy P. Hsu, Reginald Claypool & Steven M. Holland - 2013 - American Journal of Bioethics 13 (10):62 - 63.
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  8.  17
    Substantiating the Social Value Requirement for Research: An Introduction.Annette Rid & Seema K. Shah - 2017 - Bioethics 31 (2):72-76.
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  9.  12
    Bridging the Researcher-Participant Gap: A Research Agenda to Build Effective Research Relationships.Stephanie A. Kraft, Devan M. Duenas, Hannah Lewis & Seema K. Shah - 2020 - American Journal of Bioethics 20 (5):31-33.
    Volume 20, Issue 5, June 2020, Page 31-33.
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  10.  3
    An International Legal Review of the Relationship between Brain Death and Organ Transplantation.Seema K. Shah, Dale Gardiner, Hitoshi Arima & Kiarash Aramesh - 2018 - Journal of Clinical Ethics 29 (1):31-42.
    The “dead-donor rule” states that, in any case of vital organ donation, the potential donor should be determined to be dead before transplantation occurs. In many countries around the world, neurological criteria can be used to legally determine death (also referred to as brain death). Nevertheless, there is considerable controversy in the bioethics literature over whether brain death is the equivalent of biological death. This international legal review demonstrates that there is considerable variability in how different jurisdictions have evolved to (...)
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  11.  9
    Should Social Value Obligations be Local or Global?Rahul Nayak & Seema K. Shah - 2017 - Bioethics 31 (2):116-127.
    According to prominent bioethics scholars and international guidelines, researchers and sponsors have obligations to ensure that the products of their research are reasonably available to research participants and their communities. In other words, the claim is that research is unethical unless it has local social value. In this article, we argue that the existing conception of reasonable availability should be replaced with a social value obligation that extends to the global poor. To the extent the social value requirement has been (...)
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  12.  19
    When to start paediatric testing of the adult HIV cure research agenda?Seema K. Shah - 2017 - Journal of Medical Ethics 43 (2):82-86.
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  13.  30
    Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?Seema K. Shah - 2013 - Journal of Law, Medicine and Ethics 41 (2):397-410.
    The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.
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  14.  9
    Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?Seema K. Shah - 2013 - Journal of Law, Medicine and Ethics 41 (2):397-410.
    Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...)
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  15.  17
    Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics.Erin T. Paquette & Seema K. Shah - 2020 - Perspectives in Biology and Medicine 63 (2):327-345.
    A core tenet of research ethics is that risks assumed by research participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks in research, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net risk in research—or, in (...)
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  16.  15
    Ethics of controlled human infection studies: Past, present and future.Seema K. Shah & Annette Rid - 2020 - Bioethics 34 (8):745-748.
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  17.  13
    The role of community engagement in addressing bystander risks in research: The case of a Zika virus controlled human infection study.Seema K. Shah, Franklin Miller & Holly Fernandez Lynch - 2020 - Bioethics 34 (9):883-892.
    There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goals and approaches, agreement on which is ethically required or recommended for a particular context. We analyse the case (...)
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  18.  16
    Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions.Vina Vaswani, Abha Saxena, Seema K. Shah, Ricardo Palacios & Annette Rid - 2020 - Bioethics 34 (8):809-818.
    In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some CHIs (...)
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  19.  19
    Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favor of the Ethically Preferable Outcome.Seema K. Shah & Kathryn Porter - 2018 - American Journal of Bioethics 18 (4):93-94.
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  20. Fair allocation of scarce therapies for COVID-19.Govind Persad, Monica E. Peek & Seema K. Shah - 2021 - Clinical Infectious Diseases 18:ciab1039.
    The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (...)
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  21.  5
    Patient priorities for fulfilling the principle of respect in research: findings from a modified Delphi study.Stephanie A. Kraft, Devan M. Duenas & Seema K. Shah - 2023 - BMC Medical Ethics 24 (1):1-11.
    Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of agreement (...)
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  22.  11
    Reexamining the categorical exclusion of pediatric participants from controlled human infection trials.Sean C. Murphy, Devan M. Duenas, Thomas L. Richie & Seema K. Shah - 2020 - Bioethics 34 (8):785-796.
    ABSTRACT Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI studies span a wide spectrum of benefit and risk, and that some CHI studies may involve minimal (...)
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  23.  12
    Improving Care for Suicidal Patients While Protecting Human Subjects: Addressing Ethical Challenges in Mental Health Research Involving Emergency Medical Services Providers.Kathryn M. Porter, Seema K. Shah & Christopher R. DeCou - 2019 - American Journal of Bioethics 19 (10):99-101.
    Volume 19, Issue 10, October 2019, Page 99-101.
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  24.  17
    Advancing independent adolescent consent for participation in HIV prevention research.Seema K. Shah, Susannah M. Allison, Bill G. Kapogiannis, Roberta Black, Liza Dawson & Emily Erbelding - 2018 - Journal of Medical Ethics 44 (7):431-433.
    In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...)
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  25.  24
    How lethal injection reform constitutes impermissible research on prisoners.Seema K. Shah - manuscript
    This essay exposes how recent attempts at lethal injection reform have involved unethical and illegal research on prisoners. States are varying the doses and types of drugs used, developing methods designed for non-medical professionals to administer medical procedures, and gathering data or making provisions for the gathering of data to learn from executions gone wrong. When individual prisoners are executed under these conditions, states are conducting research on them. Conducting research or experimentation on prisoners in the process of reform is (...)
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  26.  8
    HIV Remission in Neonates: Ethical and Human Rights Considerations.Seema K. Shah & Benjamin S. Wilfond - 2015 - Perspectives in Biology and Medicine 58 (3):341-343.
    A published case report of an infant who inadvertently developed remission of HIV viral expression has prompted research to determine if this observation is reproducible and can offer a potentially novel clinical approach to inducing sustained viral remission of HIV.Typically HIV-infected mothers receive antiretroviral therapy before delivery and infants receive between one and three drugs at “low doses” for prevention. In the case report, the mother delivered before she could receive ART. The infant was placed on a three-drug approach with (...)
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  27.  14
    Optimizing Ethics Engagement in Research: Learning from the Ethical Complexities of Studying Opioid Use in Pregnancy.Seema K. Shah, Marielle Gross & Camille Nebeker - 2022 - Journal of Law, Medicine and Ethics 50 (2):339-347.
    Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.
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  28.  15
    The Role of Community Engagement in Novel HIV Research in Infants.Seema K. Shah & Benjamin S. Wilfond - 2015 - Perspectives in Biology and Medicine 58 (3):344-347.
    The proposed study would be a single-arm interventional trial in a community where HIV is endemic. The proposed observational design can provide confirmatory data for the initial clinical observation, data that would be necessary before considering whether a randomized controlled trial is appropriate. A previous ethical analysis has argued for conducting such a study in a country with limited resources and with higher HIV prevalence, and to recruit those with the highest risk of transmission. The primary rationale was to address (...)
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  29. Ethical and Legal Obligations for Research Involving Pregnant Persons in a Post- Dobbs Context.Richard M. Weinmeyer, Seema K. Shah & Michelle L. McGowan - 2023 - Journal of Law, Medicine and Ethics 51 (3):504-510.
    In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure (...)
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