11 found
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  1.  40
    IRBs and the Protection-Inclusion Dilemma: Finding a Balance.Phoebe Friesen, Luke Gelinas, Aaron Kirby, David H. Strauss & Barbara E. Bierer - 2022 - American Journal of Bioethics 23 (6):75-88.
    Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...)
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  2.  26
    Returning Individual Research Results from Digital Phenotyping in Psychiatry.Francis X. Shen, Matthew L. Baum, Nicole Martinez-Martin, Adam S. Miner, Melissa Abraham, Catherine A. Brownstein, Nathan Cortez, Barbara J. Evans, Laura T. Germine, David C. Glahn, Christine Grady, Ingrid A. Holm, Elisa A. Hurley, Sara Kimble, Gabriel Lázaro-Muñoz, Kimberlyn Leary, Mason Marks, Patrick J. Monette, Jukka-Pekka Onnela, P. Pearl O’Rourke, Scott L. Rauch, Carmel Shachar, Srijan Sen, Ipsit Vahia, Jason L. Vassy, Justin T. Baker, Barbara E. Bierer & Benjamin C. Silverman - 2024 - American Journal of Bioethics 24 (2):69-90.
    Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...)
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  3.  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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  4.  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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  5.  14
    Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study.Walker Morrell, Luke Gelinas, Deborah Zarin & Barbara E. Bierer - 2023 - AJOB Empirical Bioethics 14 (2):99-110.
    Background Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.Methods We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and (...)
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  6.  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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  7.  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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  8.  22
    Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma.Phoebe Friesen, Luke Gelinas, Aaron Kirby, David H. Strauss & Barbara E. Bierer - 2023 - American Journal of Bioethics 23 (9):1-8.
    We are grateful to everyone who took the time to offer such insightful comments with regard to the protection–inclusion dilemma in research oversight. Nearly all respondents agreed that this dilemm...
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  9.  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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  10.  28
    Universal Funder Responsibilities That Advance Social Value.Barbara E. Bierer, David H. Strauss, Sarah A. White & Deborah A. Zarin - 2018 - American Journal of Bioethics 18 (11):30-32.
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  11.  1
    A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19.Cristina Huebner Torres, Sylvia Baedorf Kassis, Sadath Sayeed, Barbara E. Bierer & Karen M. Emmons - 2024 - Journal of Law, Medicine and Ethics 52 (1):41-44.
    With disparate rates of morbidity and mortality among minoritized communities, COVID-19 illuminated the need for equity-informed practices in public health. Pacia et al posit FQHCs as entities that addressed inequity when others failed. This commentary further situates how FQHCs address the public health crisis of institutional racism and related health inequities every day and presents a FQHC-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with FQHCs.
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