77 found
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  1.  14
    Examining Provisions Related to Consent in the Revised Common Rule.Jeremy Sugarman - 2017 - American Journal of Bioethics 17 (7):22-26.
    The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance consent for research. While some of the particular provisions in this regard will be easy to apply and promise to help meet this (...)
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  2.  43
    The Limitations of "Vulnerability" as a Protection for Human Research Participants.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):44 – 49.
    Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...)
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  3.  10
    Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, Saibou Maiga, Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabeth Higgs, Christopher Plowe, Jeremy Sugarman & David Wendler - 2004 - Hastings Center Report 34 (3):17.
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  4.  21
    Evaluating Community Engagement in Global Health Research: The Need for Metrics.Kathleen M. MacQueen, Anant Bhan, Janet Frohlich, Jessica Holzer & Jeremy Sugarman - 2015 - BMC Medical Ethics 16 (1):1-9.
    BackgroundCommunity engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.DiscussionWe describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work (...)
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  5.  22
    Dealing With the Long-Term Social Implications of Research.Jeremy Sugarman, Dale E. Hammerschmidt, Christine Grady, Lisa Eckenwiler, Carol Levine & Alan Fleischman - 2011 - American Journal of Bioethics 11 (5):5-9.
    Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...)
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  6.  28
    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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  7.  11
    What Patients Say About Medical Research.Jeremy Sugarman, Nancy E. Kass, Steven N. Goodman, Patricia Perentesis, Praveen Fernandes & Ruth R. Faden - forthcoming - IRB: Ethics & Human Research.
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  8.  40
    Trust: The Fragile Foundation of Contemporary Biomedical Research.Nancy E. Kass, Jeremy Sugarman, Ruth Faden & Monica Schoch-Spana - 1996 - Hastings Center Report 26 (5):25-29.
  9.  41
    Ethics in Human Subjects Research: Do Incentives Matter?Ruth W. Grant & Jeremy Sugarman - 2004 - Journal of Medicine and Philosophy 29 (6):717 – 738.
    There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But there are some instances (...)
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  10.  8
    Empirical Research on Informed Consent: An Annotated Bibliography.Jeremy Sugarman, Douglas C. McCrory, Donald Powell, Alex Krasny, Betsy Adams, Eric Ball & Cynthia Cassell - 1999 - Hastings Center Report 29 (1):1-42.
  11.  14
    The Future of Empirical Research in Bioethics.Jeremy Sugarman - 2004 - Journal of Law, Medicine and Ethics 32 (2):226-231.
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  12.  38
    Medical and Nursing Students' Television Viewing Habits: Potential Implications for Bioethics.Matthew J. Czarny, Ruth R. Faden, Marie T. Nolan, Edwin Bodensiek & Jeremy Sugarman - 2008 - American Journal of Bioethics 8 (12):1 – 8.
    Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in (...)
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  13.  23
    Patients' Views Concerning Research on Medical Practices: Implications for Consent.Kevin P. Weinfurt, Juli M. Bollinger, Kathleen M. Brelsford, Travis J. Crayton, Rachel J. Topazian, Nancy E. Kass, Laura M. Beskow & Jeremy Sugarman - 2016 - Ajob Empirical Bioethics 7 (2):76-91.
  14.  11
    Categorizing Empirical Research in Bioethics: Why Count the Ways?Jeremy Sugarman, Nancy Kass & Ruth Faden - 2009 - American Journal of Bioethics 9 (6-7):66-67.
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  15.  20
    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 - 2016 - 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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  16.  5
    The Future of Empirical Research in Bioethics.Jeremy Sugarman - 2004 - Journal of Law, Medicine and Ethics 32 (2):226-231.
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  17.  23
    Response to Open Peer Commentaries on “Medical and Nursing Students' Television Viewing Habits: Potential Implications for Bioethics”.Matthew Czarny, Ruth Faden, Marie Nolan, Edwin Bodensiek & Jeremy Sugarman - 2008 - American Journal of Bioethics 8 (12):1-1.
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  18. Beyond Consent: Seeking Justice in Research.Jeffrey P. Kahn, Anna C. Mastroianni & Jeremy Sugarman (eds.) - 1998 - Oup Usa.
    Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.
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  19.  17
    The Task Force Responds.Baruch Brody, Nancy Dubler, Jeff Blustein, Arthur Caplan, Jeffrey P. Kahn, Nancy Kass, Bernard Lo, Jonathan Moreno, Jeremy Sugarman & Laurie Zoloth - 2002 - Hastings Center Report 32 (3):22-23.
  20.  5
    Reflections on Governance Models for the Clinical Translation of Stem Cells.Jeremy Sugarman - 2010 - Journal of Law, Medicine and Ethics 38 (2):251-256.
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  21.  7
    Special Supplement: Empirical Research on Informed Consent: An Annotated Bibliography.Jeremy Sugarman, Douglas C. McCrory, Donald Powell, Alex Krasny, Betsy Adams, Eric Ball & Cynthia Cassell - 1999 - Hastings Center Report 29 (1):S1.
  22.  5
    Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.Jeremy Sugarman, Li Lin, Jared M. Baeten, Thesla Palanee-Phillips, Elizabeth R. Brown, Flavia Matovu Kiweewa, Nyaradzo M. Mgodi, Gonasagrie Nair, Samantha Siva, Damon M. Seils & Kevin P. Weinfurt - 2019 - Ajob Empirical Bioethics 10 (2):79-87.
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  23.  11
    Developing Ethics Guidance for HIV Prevention Research: The HIV Prevention Trials Network Approach.Stuart Rennie & Jeremy Sugarman - 2010 - Journal of Medical Ethics 36 (12):810-815.
    More than 25 years into the HIV epidemic, in excess of 2 million new infections continue to occur each year. HIV prevention research is crucial for groups at heightened risk for HIV, but the design and conduct of HIV prevention research with vulnerable populations worldwide raises considerable ethical challenges. The HIV Prevention Trials Network (HPTN) is a global collaborative network that conducts clinical and behavioural studies on non-vaccine interventions to reduce the transmission of HIV. In 2003, the HPTN developed ethical (...)
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  24.  15
    Reflections on Governance Models for the Clinical Translation of Stem Cells.Jeremy Sugarman - 2010 - Journal of Law, Medicine and Ethics 38 (2):251-256.
    Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation — such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable — which suggest areas where gathering data may facilitate more appropriate oversight. In addition, (...)
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  25.  14
    An Intervention to Improve Cancer Patients' Understanding of Early-Phase Clinical Trials.Nancy E. Kass, Jeremy Sugarman, Amy M. Medley, Linda A. Fogarty, Holly A. Taylor, Christopher K. Daugherty, Mark R. Emerson, Steven N. Goodman, Fay J. Hlubocky & Herbert I. Hurwitz - 2009 - IRB: Ethics & Human Research 31 (3):1.
    Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its purpose. Intervention (...)
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  26.  13
    Community Consultation: Not the Problem - an Important Part of the Solution.Neal W. Dickert & Jeremy Sugarman - 2006 - American Journal of Bioethics 6 (3):26 – 28.
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  27.  24
    Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials.Jeremy Sugarman, Damon M. Seils, J. Kemp Watson-Ormond & Kevin P. Weinfurt - 2016 - Ajob Empirical Bioethics 7 (1):17-23.
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  28.  26
    A Response to Commentators on “The Limitations of 'Vulnerability' as a Protection for Human Research Participants”.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):W32-W32.
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  29.  7
    Observations of Respect and Dignity in the Intensive Care Unit.Joseph Carrese, Lindsay Forbes, Emily Branyon, Hanan Aboumatar, Gail Geller, Mary Catherine Beach & Jeremy Sugarman - 2015 - Narrative Inquiry in Bioethics 5 (1A):43A-53A.
  30.  47
    Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP.Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee & Mitchell Warren - 2013 - Developing World Bioethics 13 (2):87-94.
    The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...)
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  31.  15
    Policy Recommendations for Addressing Privacy Challenges Associated with Cell-Based Research and Interventions.Ubaka Ogbogu, Sarah Burningham, Adam Ollenberger, Kathryn Calder, Li Du, Khaled El Emam, Robyn Hyde-Lay, Rosario Isasi, Yann Joly, Ian Kerr, Bradley Malin, Michael McDonald, Steven Penney, Gayle Piat, Denis-Claude Roy, Jeremy Sugarman, Suzanne Vercauteren, Griet Verhenneman, Lori West & Timothy Caulfield - 2014 - BMC Medical Ethics 15 (1):7.
    The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what (...)
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  32.  27
    Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials.Jeremy Sugarman - 2004 - Science and Engineering Ethics 10 (1):29-35.
    There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data (...)
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  33.  17
    Empirical Research on Informed Consent with the Cognitively Impaired.Gavin W. Hougham, Greg A. Sachs, Deborah Danner, Jim Mintz, Marian Patterson, Laura W. Roberts, Laura A. Siminoff, Jeremy Sugarman, Peter J. Whitehouse & Donna Wirshing - 2003 - IRB: Ethics & Human Research 25 (5):s26 - 32.
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  34.  18
    Are Research Subjects Adequately Protected? A Review and Discussion of Studies Conducted by the Advisory Committee on Human Radiation Experiments.Jeremy Sugarman & Nancy E. Kass - 1996 - Kennedy Institute of Ethics Journal 6 (3):271-282.
    : In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...)
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  35.  14
    Ethical Oversight of Multinational Collaborative Research: Lessons From Africa for Building Capacity and for Policy.Jeremy Sugarman - 2007 - Research Ethics 3 (3):84-86.
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  36.  26
    Taking a Hard Look at Advocacy in ResearchWhen Science Offers Salvation: Patient Advocacy and Research Ethics. [REVIEW]Jeremy Sugarman & Rebecca Dresser - 2001 - Hastings Center Report 31 (6):47.
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  37.  13
    Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators.Kevin P. Weinfurt, Joëlle Y. Friedman, Michaela A. Dinan, Jennifer S. Allsbrook, Mark A. Hall, Jatinder K. Dhillon & Jeremy Sugarman - 2006 - Journal of Law, Medicine and Ethics 34 (3):581-591.
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  38.  34
    Informed Consent, Shared Decision-Making, and Complementary and Alternative Medicine.Jeremy Sugarman - 2003 - Journal of Law, Medicine and Ethics 31 (2):247-250.
  39.  14
    Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators.Kevin P. Weinfurt, Joëlle Y. Friedman, Michaela A. Dinan, Jennifer S. Allsbrook, Mark A. Hall, Jatinder K. Dhillon & Jeremy Sugarman - 2006 - Journal of Law, Medicine and Ethics 34 (3):581-591.
    Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general (...)
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  40.  5
    Questions Concerning the Clinical Translation of Cell-Based Interventions Under an Innovation Pathway.Jeremy Sugarman - 2012 - Journal of Law, Medicine and Ethics 40 (4):945-950.
    Stem cell-based innovation is one pathway to clinical translation that stands in contrast to clinical research and medical treatment. After reviewing recently issued guidelines for responsible innovation, this article examines the potential benefits and harms of using this pathway as well as practical barriers and conceptual concerns regarding it.
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  41.  2
    Questions Concerning the Clinical Translation of Cell-Based Interventions Under an Innovation Pathway.Jeremy Sugarman - 2012 - Journal of Law, Medicine and Ethics 40 (4):945-950.
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  42.  8
    Ethical Considerations in the Manufacture, Sale, and Distribution of Genome Editing Technologies.Jeremy Sugarman, Supriya Shivakumar, Martha Rook, Jeanne F. Loring, Christoph Rehmann-Sutter, Jochen Taupitz, Jutta Reinhard-Rupp & Steven Hildemann - 2018 - American Journal of Bioethics 18 (8):3-6.
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  43.  15
    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 Recent Issues 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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  44.  15
    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 Recent Issues 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 (...)
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  45.  14
    Implementing Post-Trial Access Plans for HIV Prevention Research.Amy Paul, Maria W. Merritt & Jeremy Sugarman - 2018 - Journal of Medical Ethics 44 (5):354-358.
    Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV (...)
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  46.  22
    Informed Consent, Shared Decision-Making, and Complementary and Alternative Medicine.Jeremy Sugarman - 2003 - Journal of Law, Medicine and Ethics 31 (2):247-250.
  47.  16
    Talking About FutilityWrong Medicine. [REVIEW]Jeremy Sugarman, Lawrence J. Schneiderman & Nancy S. Jecker - 1996 - Hastings Center Report 26 (3):41.
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  48.  9
    Editors' Introduction to the Special Section on Ethics, Policy, and Autologous Cellular Therapies.Jeremy Sugarman & Tamra Lysaght - 2018 - Perspectives in Biology and Medicine 61 (1):1-6.
    Bioethical, legal, and professional discussions concerning human stem cell science have moved away from the contentious, and possibly irreconcilable, debates about human embryos to other sources of pluripotent stem cells. While there is an array of ethical and legal issues associated with all types of pluripotent stem cells, in recent years complex issues have arisen with regard to the premature use of somatic or "adult" stem cells. Of particular concern is the global emergence of an industry selling products and services (...)
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  49.  10
    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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  50. Back to the Rough Ground: Working in International HIV Prevention as Ethical Debates Continue.Kathleen M. MacQueen & Jeremy Sugarman - 2003 - IRB: Ethics & Human Research 25 (2):11-13.
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