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Robert Klitzman [41]Robert L. Klitzman [9]
  1.  93
    Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.Amy L. McGuire, Mark P. Aulisio, F. Daniel Davis, Cheryl Erwin, Thomas D. Harter, Reshma Jagsi, Robert Klitzman, Robert Macauley, Eric Racine, Susan M. Wolf, Matthew Wynia & Paul Root Wolpe - 2020 - American Journal of Bioethics 20 (7):15-27.
    The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing p...
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  2.  66
    How IRBs view and make decisions about coercion and undue influence: Table 1.Robert Klitzman - 2013 - Journal of Medical Ethics 39 (4):224.
    Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining of ‘coercion’ (...)
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  3.  7
    The ethics police?: the struggle to make human research safe.Robert Klitzman - 2015 - New York: Oxford University Press.
    Protecting the people we experiment on --"Inside the black box" : becoming and being IRB members -- Weighing risks and benefits and undue inducement -- Defining research and how good it needs to be -- What to tell subjects : battles over consent forms -- From "nitpicky" to "user-friendly" : inter-IRB variations and their causes -- Federal agencies vs. local IRBs -- The roles of industry -- The local ecologies of institutions -- Trusting vs. policing researchers -- Bad behavior: research (...)
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  4.  68
    (1 other version)Addressing ethical challenges in HIV prevention research with people who inject drugs.Liza Dawson, Steffanie A. Strathdee, Alex John London, Kathryn E. Lancaster, Robert Klitzman, Irving Hoffman, Scott Rose & Jeremy Sugarman - 2018 - Journal of Medical Ethics 44 (3):149-158.
    Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...)
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  5.  53
    Us irbs confronting research in the developing world.Robert L. Klitzman - 2012 - Developing World Bioethics 12 (2):63-73.
    Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...)
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  6.  19
    Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations.Laurie J. Bauman, Claude Ann Mellins & Robert Klitzman - 2020 - Journal of Law, Medicine and Ethics 48 (1):188-201.
    Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...)
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  7.  48
    Models of Consent to Return of Incidental Findings in Genomic Research.Paul S. Appelbaum, Erik Parens, Cameron R. Waldman, Robert Klitzman, Abby Fyer, Josue Martinez, W. Nicholson Price & Wendy K. Chung - 2014 - Hastings Center Report 44 (4):22-32.
    Genomic research—including whole genome sequencing and whole exome sequencing—has a growing presence in contemporary biomedical investigation. The capacity of sequencing techniques to generate results that go beyond the primary aims of the research—historically referred to as “incidental findings”—has generated considerable discussion as to how this information should be handled—that is, whether incidental results should be returned, and if so, which ones.Federal regulations governing most human subjects research in the United States require the disclosure of “the procedures to be followed” in (...)
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  8.  31
    How local IRBs view central IRBs in the US.Robert Klitzman - 2011 - BMC Medical Ethics 12 (1):13.
    Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with (...)
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  9.  21
    Buying and selling human eggs: infertility providers’ ethical and other concerns regarding egg donor agencies.Robert Klitzman - 2016 - BMC Medical Ethics 17 (1):71.
    BackgroundEgg donor agencies are increasingly being used as part of IVF in the US, but are essentially unregulated, posing critical ethical and policy questions concerning how providers view and use them, and what the implications might be.MethodsThirty-seven in-depth interviews of approximately 1 h were conducted – with 27 IVF providers and 10 patients.ResultsClinicians vary in their views and interactions concerning egg donor agencies, ranging widely in whether and how often they use agencies. Agencies may offer egg recipients increased choices, but (...)
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  10.  21
    The Needs to Focus on Process and Precise Language in Ethical Determination of cDCD.Robert Klitzman & Ahmed N. Khan - 2023 - American Journal of Bioethics 23 (2):50-52.
    Nielsen Busch and Mjaaland (2023) raise important considerations, but confuse certain critical issues and overlook others, and questions emerge about how these decisions should be made in our socie...
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  11.  40
    Detecting, Preventing, and Responding to “Fraudsters” in Internet Research: Ethics and Tradeoffs.Jennifer E. F. Teitcher, Walter O. Bockting, José A. Bauermeister, Chris J. Hoefer, Michael H. Miner & Robert L. Klitzman - 2015 - Journal of Law, Medicine and Ethics 43 (1):116-133.
    Internet-based health research is increasing, and often offers financial incentives but fraudulent behavior by participants can result. Specifically, eligible or ineligible individuals may enter the study multiple times and receive undeserved financial compensation. We review past experiences and approaches to this problem and propose several new strategies. Researchers can detect and prevent Internet research fraud in four broad ways: through the questionnaire/instrument ; through participants' non-questionnaire data and seeking external validation through computer information,, and 4) through study design. These approaches (...)
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  12.  30
    What Does It Mean for a Case to be ‘Local’?: the Importance of Local Relevance and Resonance for Bioethics Education in the Asia-Pacific Region.Sara M. Bergstresser, Kulsoom Ghias, Stuart Lane, Wee-Ming Lau, Isabel S. S. Hwang, Olivia M. Y. Ngan, Robert L. Klitzman & Ho Keung Ng - 2020 - Asian Bioethics Review 12 (2):173-194.
    Contemporary bioethics education has been developed predominately within Euro-American contexts, and now, other global regions are increasingly joining the field, leading to a richer global understanding. Nevertheless, many standard bioethics curriculum materials retain a narrow geographic focus. The purpose of this article is to use local cases from the Asia-Pacific region as examples for exploring questions such as ‘what makes a case or example truly local, and why?’, ‘what topics have we found to be best explained through local cases or (...)
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  13.  14
    Needs to address clinicians’ moral distress in treating unvaccinated COVID-19 patients.Robert Klitzman - 2022 - BMC Medical Ethics 23 (1):1-9.
    BackgroundMoral dilemmas have arisen concerning whether physicians and other providers should treat patients who have declined COVID vaccination and are now sick with this disease. Several ethicists have argued that clinicians have obligations to treat such patients, yet providing care to these patients has distressed clinicians, who have at times declined to do so. Critical questions thus emerge regarding how best to proceed.Main bodyProviders face moral tensions: whether to place the benefits to an unvaccinated patient over their duties to protect (...)
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  14.  34
    Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.Charles W. Lidz, Ekaterina Pivovarova, Paul Appelbaum, Deborah F. Stiles, Alexandra Murray & Robert L. Klitzman - 2018 - AJOB Empirical Bioethics 9 (3):164-172.
    The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...)
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  15.  21
    Questions, complexities, and limitations in disclosing individual genetic results.Robert Klitzman - 2006 - American Journal of Bioethics 6 (6):34 – 36.
  16.  10
    Struggles in Defining and Addressing Requests for “Family Balancing”: Ethical Issues Faced by Providers and Patients.Robert Klitzman - 2016 - Journal of Law, Medicine and Ethics 44 (4):616-629.
    This study – the first to explore how infertility providers confront several critical dilemmas concerning sex selection of embryos for nonmedical, social reasons – highlights key challenges and questions. Clinicians struggle, for instance, with how to define “family balalancing”, when to offer it, and how to decide.
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  17.  41
    Views of the process and content of ethical reviews of hiv vaccine trials among members of us institutional review boards and south african research ethics committees.Robert Klitzman - 2007 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to be white (...)
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  18.  34
    Qualifying confidentiality: Historical and empirical issues and facts.Robert Klitzman - 2006 - American Journal of Bioethics 6 (2):26 – 27.
  19. Clinicians, patients and the brain.Robert Klitzman - 2005 - In Judy Illes (ed.), Neuroethics: Defining the Issues in Theory, Practice, and Policy. Oxford University Press.
     
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  20.  24
    Views and Experiences of IRBs concerning Research Integrity.Robert Klitzman - 2011 - Journal of Law, Medicine and Ethics 39 (3):513-528.
    Institutional Review Boards can play vital roles in observing, monitoring, and responding to research integrity issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to (...)
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  21.  15
    How Agencies Market Egg Donation on the Internet: A Qualitative Study.Jason Keehn, Eve Howell, Mark V. Sauer & Robert Klitzman - 2015 - Journal of Law, Medicine and Ethics 43 (3):610-618.
    We systematically examined the content of the websites of 46 agencies that buy and sell human eggs to understand how they market themselves to both donors and recipients. We found that these websites use marketing techniques that obscure the realities of egg donation, presenting egg donation as a mutually beneficial and fulfilling experience. Sites emphasize egg donors' emotional fulfillment and address recipients' anxieties by stressing the ability to find the perfect “fit” or “match”, suiting recipients’“preferences”/“desires”, and even designing/customizing a child. (...)
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  22.  23
    Views of Genetic Testing for Autism Among Autism Self-Advocates: A Qualitative Study.Robert Klitzman, Ekaterina Bezborodko, Wendy K. Chung & Paul S. Appelbaum - 2024 - AJOB Empirical Bioethics 15 (4):262-279.
    Background Autism self-advocates’ views regarding genetic tests for autism are important, but critical questions about their perspectives arise.Methods We interviewed 11 autism self-advocates, recruited through autism self-advocacy websites, for 1 h each.Results Interviewees viewed genetic testing and its potential pros and cons through the lens of their own indiviudal perceived challenges, needs and struggles, especially concerning stigma and discrimination, lack of accommodations and misunderstandings from society about autism, their particular needs for services, and being blamed by others and by themselves (...)
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  23.  45
    Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies.Patrina Sexton, Katrina Hui, Donna Hanrahan, Mark Barnes, Jeremy Sugarman, Alex John London & Robert Klitzman - 2014 - Developing World Bioethics 16 (1):4-14.
    Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can (...)
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  24.  20
    HIV and the Law: Integrating Law, Policy, and Social Epidemiology.Zita Lazzarini & Robert Klitzman - 2002 - Journal of Law, Medicine and Ethics 30 (4):533-547.
    In the foundational piece in this issue of the journal, “Integrating Law and Social Epidemiology,” Burris, Kawachi, and Sarat present a model for understanding the relationship between law and health. This article uses the case of a specific health condition, the human immunodeficiency virus infection, as an opportunity to flesh out this schema and to test how the model “fits” the world of the HIV pandemic. In applying the model to this communicable disease, we hope to illustrate the multitude of (...)
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  25.  47
    (1 other version)Bringing science and advocacy together to address health needs of people who inject drugs.Liza Dawson, Steffanie A. Strathdee, Alex John London, Kathryn E. Lancaster, Robert Klitzman, Irving Hoffman, Scott Rose & Jeremy Sugarman - 2018 - Journal of Medical Ethics 44 (3):165-166.
    In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as well (...)
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  26.  11
    Anti‐obesity Medications: Ethical, Policy, and Public Health Concerns.Robert Klitzman & Henry Greenberg - 2024 - Hastings Center Report 54 (3):6-10.
    New anti‐obesity medications (AOMs) have received widespread acclaim in medical journals and the media, but they also raise critical ethical, public health, and public policy concerns that have largely been ignored. AOMs are very costly, need to be taken by a patient in perpetuity (since significant rebound weight gain otherwise occurs), and threaten to shift resources and focus away from other crucial efforts at obesity treatment and prevention. Many people may feel less motivated to exercise or reduce their caloric consumption, (...)
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  27.  21
    Risk Reduction Policies to Reduce HIV in Prisons: Ethical and Legal Considerations and Needs for Integrated Approaches.Sayantanee Das, Sameer Ladha & Robert Klitzman - 2023 - Journal of Law, Medicine and Ethics 51 (2):366-381.
    The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.
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  28.  28
    Complications of culture in obtaining informed consent.Robert Klitzman - 2006 - American Journal of Bioethics 6 (1):20 – 21.
  29.  19
    Contexts, Anyone?: The Need for Contextualization in the Debate About the Moral Status of Embryos.Robert Klitzman & Joseph Siragusa - 2005 - American Journal of Bioethics 5 (6):56-58.
  30.  27
    The importance of social, cultural, and economic contexts, and empirical research in examining "undue inducement".Robert Klitzman - 2005 - American Journal of Bioethics 5 (5):19 – 21.
  31.  49
    How US institutional review boards decide when researchers need to translate studies.Robert Klitzman - 2014 - Journal of Medical Ethics 40 (3):193-197.
    Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards and research ethics committees’ about the need for researchers to translate consent forms and other study materials. Sixty US IRBs were contacted, and leaders from 34 and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and (...)
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  32.  15
    17 Coercion and undue influence in decisions to participate in psychiatric research.Paul S. Appelbaum, Charles W. Lidz & Robert Klitzman - 2011 - In Thomas W. Kallert, Juan E. Mezzich & John Monahan (eds.), Coercive treatment in psychiatry: clinical, legal and ethical aspects. Hoboken, NJ: Wiley-Blackwell. pp. 293.
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  33.  28
    The Authors Reply.Paul S. Appelbaum, Wendy Chung, Abby J. Fyer, Robert L. Klitzman, Josue Martinez, Erik Parens, W. Nicholson Price & Cameron Waldman - 2015 - Hastings Center Report 45 (1):4-4.
    Reply to a commentary by Felicitas Holzer and Ignacio Mastroleoon “Models of Consent to Return of Incidental Findings in Genomic Research.”.
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  34.  43
    Paul S. Appelbaum is Elizabeth K.Susan Gilbert, Joyce A. Griffin, Gregory E. Kaebnick, Robert Klitzman & Charles W. Lidz - forthcoming - Hastings Center Report.
  35.  19
    Additional implications of a national survey on ethics consultation in united states hospitals.Robert Klitzman - 2007 - American Journal of Bioethics 7 (2):47 – 48.
  36.  14
    Experiment on identical siblings separated at birth: ethical implications for researchers, universities, and archives today.Robert L. Klitzman & Adam M. Kelmenson - 2021 - Journal of Medical Ethics 47 (10):657-661.
    Several films, includingThree Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960’s through 1980’s, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the research (...)
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  37.  24
    How Artistic Representation Can Inform Current Debates About Chimeras.Robert Klitzman - 2021 - Journal of Medical Humanities 42 (3):337-343.
    Researchers have increasingly been creating chimeras – combinations of cells from two species – raising profound ethical, social and scientific controversies. Such research could lead to the creation of animals such as pigs that contain human organs for transplantation, yet public fears have emerged. Scientists have thus called for enhanced public education and discussion, but these efforts require comprehension of the nature of public concerns. While arguments have viewed chimeras as either “good” or “bad,” artists have long depicted chimeras in (...)
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  38.  17
    Needs to Prepare for “Post-COVID-19 Syndrome”.Robert L. Klitzman - 2020 - American Journal of Bioethics 20 (11):4-6.
    While attention has focused in many states and countries on the initial acute phase of the COVID-19 pandemic and on lowering rates of infection and deaths, evidence suggests that among many survivo...
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  39.  12
    Preparing for the Next Generation of Ethical Challenges Concerning Heritable Human Genome Editing.Robert Klitzman - 2021 - American Journal of Bioethics 21 (6):1-4.
    On September 5, 2020, the International Commission on the Clinical Use of Human Germline Genome Editing, established by the U.S. National Academy of Medicine, the National Academy of Science,...
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  40.  19
    Roles of genetics and blood type in clinical responses to COVID-19: ethical and policy concerns.Robert Klitzman - 2021 - Journal of Medical Ethics 47 (3):149-151.
    Recently, several genetic variants have been associated with increased or decreased risks of becoming infected and/or seriously ill with COVID-19—not only offering important potential medical benefits but also posing critical ethical questions. These genetic factors, some of which are associated with blood type, may account for variations in observed responses to COVID-19. Hence, assessments of these genetic differences and blood type could provide possible benefits in gauging patients’ risks of disease acquisition and prioritising allocation of interventions or vaccines, if supplies (...)
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  41.  70
    The reporting of irb review in journal articles presenting hiv research conducted in the developing world.Robert L. Klitzman, Kelly Kleinert, Hoda Rifai-Bashjawish & L. E. U. Shiung - 2011 - Developing World Bioethics 11 (3):161-169.
    Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...)
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  42.  19
    The Reporting of Irb Review in Journal Articles Presenting Hiv Research Conducted in the Developing World.Robert L. Klitzman, Kelly Kleinert, Hoda Rifai-Bashjawish & Cheng Shiung Leu - 2011 - Developing World Bioethics 11 (3):161-169.
    Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...)
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  43.  34
    “Will they be good enough parents?”: Ethical dilemmas, views, and decisions among assisted reproductive technology providers.Robert Klitzman - 2017 - AJOB Empirical Bioethics 8 (4):253-265.
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  44.  29
    Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.Alexandra Murray, Ekaterina Pivovarova, Robert Klitzman, Deborah F. Stiles, Paul Appelbaum & Charles W. Lidz - 2021 - AJOB Empirical Bioethics 12 (1):33-40.
    Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...)
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  45.  29
    HIV prevention research and COVID-19: putting ethics guidance to the test.Jeremy Sugarman, Steven Wakefield, Brandon Brown, Ernest Moseki, Robert Klitzman, Florencia Luna, Leah A. Schrumpf, Wairimu Chege & Stuart Rennie - 2021 - BMC Medical Ethics 22 (1):1-10.
    BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/aids pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key (...)
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