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Benjamin S. Wilfond [94]Benjamin Wilfond [9]
  1.  64
    Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research.Stephanie A. Kraft, Mildred K. Cho, Katherine Gillespie, Meghan Halley, Nina Varsava, Kelly E. Ormond, Harold S. Luft, Benjamin S. Wilfond & Sandra Soo-Jin Lee - 2018 - American Journal of Bioethics 18 (4):3-20.
    With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...)
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  2.  48
    Broad Consent for Research With Biological Samples: Workshop Conclusions.Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Hank Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond & David Wendler - 2015 - American Journal of Bioethics 15 (9):34-42.
    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...)
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  3.  62
    Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...)
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  4.  19
    The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...)
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  5.  34
    Disclosing Individual Genetic Results to Research Participants.Vardit Ravitsky & Benjamin S. Wilfond - 2006 - American Journal of Bioethics 6 (6):8 – 17.
    Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...)
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  6.  8
    The Relational Potential Standard: Rethinking the Ethical Justification for Life‐Sustaining Treatment for Children with Profound Cognitive Disabilities.Aaron Wightman, Jennifer Kett, Georgina Campelia & Benjamin S. Wilfond - 2019 - Hastings Center Report 49 (3):18-25.
    Caregivers should usually accede to parents’ requests for life-sustaining treatment. For such decision-making, the best interests standard is too limited. John Arras’s “relational potential standard,” con-joined to a contemporary care ethics framework, provides a better guide.
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  7.  31
    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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  8.  31
    Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.Susan M. Wolf, Rebecca Branum, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2015 - Journal of Law, Medicine and Ethics 43 (3):440-463.
    Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.
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  9.  9
    Justifying Investigator/Clinician Consent When The Physician-Patient Relationship Can Support Better Research Decision-Making.Benjamin S. Wilfond & Kathryn M. Porter - 2019 - American Journal of Bioethics 19 (4):26-28.
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  10.  5
    A Pragmatic Trial of Suicide Risk Assessment and Ambulance Transport Decision Making Among Emergency Medical Services Providers: Implications for Patient Consent.Liza-Marie Johnson, Jennifer Zabrowski & Benjamin S. Wilfond - 2019 - American Journal of Bioethics 19 (10):97-98.
    Volume 19, Issue 10, October 2019, Page 97-98.
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  11.  20
    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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  12.  21
    A Conceptual Model for the Translation of Bioethics Research and Scholarship.Debra J. H. Mathews, D. Micah Hester, Jeffrey Kahn, Amy McGuire, Ross McKinney, Keith Meador, Sean Philpott-Jones, Stuart Youngner & Benjamin S. Wilfond - 2016 - Hastings Center Report 46 (5):34-39.
    While the bioethics literature demonstrates that the field has spent substantial time and thought over the last four decades on the goals, methods, and desired outcomes for service and training in bioethics, there has been less progress defining the nature and goals of bioethics research and scholarship. This gap makes it difficult both to describe the breadth and depth of these areas of bioethics and, importantly, to gauge their success. However, the gap also presents us with an opportunity to define (...)
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  13.  13
    The Limitations of “Boilerplate” Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel.Benjamin S. Wilfond, Jennifer Zabrowski & Liza M. Johnson - 2019 - American Journal of Bioethics 19 (4):81-82.
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  14.  23
    Trustworthiness in Untrustworthy Times: Response to Open Peer Commentaries on Beyond Consent.Stephanie A. Kraft, Mildred K. Cho, Katherine Gillespie, Nina Varsava, Kelly E. Ormond, Benjamin S. Wilfond & Sandra Soo-Jin Lee - 2018 - American Journal of Bioethics 18 (5):W6-W8.
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  15.  10
    Should Research Participants Be Notified About Results of Currently Unknown but Potential Significance?Liza-Marie Johnson, Jennifer Zabrowski & Benjamin S. Wilfond - 2019 - American Journal of Bioethics 19 (4):73-74.
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  16.  40
    Patients' Views on Identifiability of Samples and Informed Consent for Genetic Research.Sara Chandros Hull, Richard Sharp, Jeffrey Botkin, Mark Brown, Mark Hughes, Jeremy Sugarman, Debra Schwinn, Pamela Sankar, Dragana Bolcic-Jankovic, Brian Clarridge & Benjamin Wilfond - 2008 - American Journal of Bioethics 8 (10):62-70.
    It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know (...)
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  17.  6
    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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  18.  8
    Consent Forms and the Therapeutic Misconception.Nancy M. P. King, Gail E. Henderson, Larry R. Churchill, Arlene M. Davis, Sara Chandros Hull, Daniel K. Nelson, P. Christy Parham-Vetter, Barbra Bluestone Rothschild, Michele M. Easter & Benjamin S. Wilfond - 2005 - IRB: Ethics & Human Research 27 (1):1-7.
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  19.  10
    Quality Improvement Ethics: Lessons From the SUPPORT Study.Benjamin S. Wilfond - 2013 - American Journal of Bioethics 13 (12):14-19.
    The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. The current regulatory framework and the concept of foreseeable research risks is insufficient to advance the debate about the ethics of randomization of standard clinical interventions. This article uses (...)
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  20.  5
    Click Here to Complete This Survey: Online Research, Adolescents, and Parental Consent.Liza-Marie Johnson, Devan M. Duenas & Benjamin S. Wilfond - 2020 - American Journal of Bioethics 20 (10):82-83.
    Volume 20, Issue 10, October 2020, Page 82-83.
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  21.  13
    Precluding Consent by Clinicians Who Are Both the Attending and the Investigator: An Outdated Shibboleth?Anita Shah, Kathryn Porter, Sandra Juul & Benjamin S. Wilfond - 2015 - American Journal of Bioethics 15 (4):80-82.
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  22.  4
    Conflicts of Interest and Recommendations for Clinical Treatments That Benefit Researchers.Benjamin S. Wilfond, Devan M. Duenas & Liza-Marie Johnson - 2020 - American Journal of Bioethics 20 (10):90-91.
    Volume 20, Issue 10, October 2020, Page 90-91.
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  23.  3
    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):8-8.
    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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  24.  5
    Ethical Drug Development for Rare Childhood Diseases: When There Are Limited But Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?Liza-Marie Johnson, Devan M. Duenas & Benjamin S. Wilfond - 2020 - American Journal of Bioethics 20 (4):111-113.
    Volume 20, Issue 4, May 2020, Page 111-113.
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  25.  6
    Relationships Help Make Life Worth Living.Aaron Wightman, Benjamin S. Wilfond, Douglas Diekema, Erin Paquette & Seema Shah - 2020 - Journal of Medical Ethics 46 (1):22-23.
    Decisions regarding life-sustaining medical treatments for young children with profound disabilities can be extremely challenging for families and clinicians. In this study, Brick and colleagues1 surveyed adult residents of the UK about their attitudes regarding withdrawal of treatment using a series of vignettes of infants with varying levels of intellectual and physical disability, based on real and hypothetical cases.1 This is an interesting study on an important topic. We first highlight the limitations of using these survey data to inform public (...)
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  26.  3
    Greater Than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.Benjamin S. Wilfond, Devan M. Duenas & Liza-Marie Johnson - 2020 - American Journal of Bioethics 20 (4):102-103.
    Volume 20, Issue 4, May 2020, Page 102-103.
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  27.  25
    Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.Sandra Soo-Jin Lee, Maureen Kelley, Mildred K. Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond & David Magnus - 2016 - Ajob Empirical Bioethics 7 (2):125-134.
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  28.  3
    Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be Risky.Larry R. Churchill, Daniel K. Nelson, Gail E. Henderson, Nancy M. P. King, Arlene M. Davis, Erin Leahey & Benjamin S. Wilfond - 2003 - IRB: Ethics & Human Research 25 (3):1.
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  29.  22
    Incidental Findings in Pediatric Research.Benjamin S. Wilfond & Katherine J. Carpenter - 2008 - Journal of Law, Medicine and Ethics 36 (2):332-340.
    The approach to incidental research fndings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental fndings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information should be disclosed to the adolescent frst, while particularly serious information should frst be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where (...)
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  30.  19
    Understanding as an Ethical Aspiration in an Era of Digital Technology-Based Communication: An Analysis of Informed Consent Functions.Stephanie A. Kraft, Nanibaa’ A. Garrison & Benjamin S. Wilfond - 2019 - American Journal of Bioethics 19 (5):34-36.
    Volume 19, Issue 5, May 2019, Page 34-36.
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  31.  19
    Lethal Language, Lethal Decisions.Tracy K. Koogler, Benjamin S. Wilfond & Lainie Friedman Ross - 2003 - Hastings Center Report 33 (2):37-41.
  32.  16
    Incidental Findings in Pediatric Research.Benjamin S. Wilfond & Katherine J. Carpenter - 2008 - Journal of Law, Medicine and Ethics 36 (2):332-340.
    Incidental research findings, as defined in this symposium’s consensus paper, are unexpected findings discovered in the course of research but “beyond the aims of the study.” These include findings generated by research methodology, such as imaging or genetic analysis, findings related to clinical screening for inclusion or exclusion, or direct observations of physical abnormalities or behavior. Decisions about managing incidental research findings involve important ethical considerations regarding a researcher’s obligations to provide care, minimize harms, and respect research participants’ wishes. When (...)
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  33.  6
    Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study.Stephanie A. Kraft, Kathryn M. Porter, Devan M. Duenas, Claudia Guerra, Galen Joseph, Sandra Soo-Jin Lee, Kelly J. Shipman, Jake Allen, Donna Eubanks, Tia L. Kauffman, Nangel M. Lindberg, Katherine Anderson, Jamilyn M. Zepp, Marian J. Gilmore, Kathleen F. Mittendorf, Elizabeth Shuster, Kristin R. Muessig, Briana Arnold, Katrina A. B. Goddard & Benjamin S. Wilfond - 2021 - AJOB Empirical Bioethics 12 (1):1-11.
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  34.  24
    Adolescent Research Participants' Descriptions of Medical Research.Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler - 2016 - Ajob Empirical Bioethics 7 (1):1-7.
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  35.  6
    Reimagining the Goal of Informed Consent to Help Patients Make Decisions About Research.Benjamin S. Wilfond & Kathryn M. Porter - 2020 - American Journal of Bioethics 20 (5):22-23.
    Volume 20, Issue 5, June 2020, Page 22-23.
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  36.  24
    Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants.Susan M. Wolf, Emily Scholtes, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2018 - Journal of Law, Medicine and Ethics 46 (1):87-109.
    Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...)
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  37.  32
    Navigating Growth Attenuation in Children with Profound Disabilities.Benjamin S. Wilfond, Paul Steven Miller, Carolyn Korfiatis, Douglas S. Diekema, Denise M. Dudzinski, Sara Goering & The Seattle Growth Attenuation and Ethics Working Group - 2010 - Hastings Center Report 40 (6):27-40.
  38.  1
    Supporting Investigators in Challenging Cases: Unease in the Face of an Ethically Appropriate Action.Liza-Marie Johnson, Devan M. Duenas & Benjamin S. Wilfond - 2021 - American Journal of Bioethics 21 (4):98-99.
    As medicine and science advance, new ethical questions emerge. Over time, deliberation and analysis result in a somewhat settled approach to a problem. Often the settled approach is based on group...
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  39.  12
    Points to Consider: The Research Ethics Consultation Service and the IRB.Laura M. Beskow, Christine Grady, Ana S. Iltis, John Z. Sadler & Benjamin S. Wilfond - 2009 - IRB: Ethics & Human Research 31 (6):1.
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  40.  4
    Breaking the Sounds of Silence: Respecting People With Disabilities and Reproductive Decision Making.Benjamin S. Wilfond - 2017 - American Journal of Bioethics 17 (1):37-39.
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  41.  13
    Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (2):13-15.
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  42.  8
    Ethical Implications of Social Media in Health Care Research.Holly A. Taylor, Ellen Kuwana & Benjamin S. Wilfond - 2014 - American Journal of Bioethics 14 (10):58-59.
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  43.  25
    On the Proliferation of Bioethics Sub-Disciplines: Do We Really Need "Genethics" and "Neuroethics"?Benjamin S. Wilfond & Vardit Ravitsky - 2005 - American Journal of Bioethics 5 (2):20 – 21.
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  44.  15
    Navigating Growth Attenuation in Children with Profound Disabilities.Benjamin S. Wilfond, Paul Steven Miller, Carolyn Korfiatis, Douglas S. Diekema, Denise M. Dudzinski & Sara Goering - 2010 - Hastings Center Report 40 (6):27-40.
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  45.  13
    Genetic Research Involving Human Biological Materials: A Need to Tailor Current Consent Forms.Sara Chandros Hull, Holly Gooding, Alison P. Klein, Esther Warshauer-Baker, Susan Metosky & Benjamin S. Wilfond - 2004 - IRB: Ethics & Human Research 26 (3):1.
  46.  8
    Cancer Genetic Susceptibility Testing: Ethical and Policy Implications for Future Research and Clinical Practice.Benjamin S. Wilfond, Karen H. Rothenberg, Elizabeth J. Thomson & Caryn Lerman - 1997 - Journal of Law, Medicine and Ethics 25 (4):243-251.
    Genetic testing for cancer susceptibility is an application of biotechnology that has the potential both to improve the psychosocial and physical wellbeing of the population and to cause significant psychosocia1 and physical harms. In spite of the uncertain value of genetic testing, it has captured the interest of biotechnology companies, researchers, health care providers, and the public. As more tests become feasible, pressure may increase to make the tests available and reimbursable. Both the benefits and harms of these tests lie (...)
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  47.  20
    A Trial to Test a Novel Approach to Diabetes Prevention.Holly A. Taylor, Christian Morales & Benjamin S. Wilfond - 2017 - American Journal of Bioethics 17 (10):74-75.
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  48.  3
    Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions.Kathryn M. Porter, Anne Stevens & Benjamin S. Wilfond - 2020 - American Journal of Bioethics 20 (4):116-118.
    Volume 20, Issue 4, May 2020, Page 116-118.
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  49.  19
    Genotype-Driven Recruitment in Population-Based Biomedical Research.Holly A. Taylor, Christian Morales & Benjamin S. Wilfond - 2017 - American Journal of Bioethics 17 (4):58-59.
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  50.  14
    Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources.Benjamin S. Wilfond, Christian Morales & Holly A. Taylor - 2017 - American Journal of Bioethics 17 (10):66-67.
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