Results for 'research oversight'

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  1.  17
    Real‐Time Responsiveness for Ethics Oversight During Disaster Research.Lisa Eckenwiler, John Pringle, Renaud Boulanger & Matthew Hunt - 2015 - Bioethics 29 (9):653-661.
    Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster (...) and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)
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  2.  16
    Barriers to Effective Deliberation in Clinical Research Oversight.Danielle M. Wenner - 2016 - HEC Forum 28 (3):245-259.
    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because (...)
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  3.  43
    Four Paradigms of Clinical Research and Research Oversight.Ezekiel J. Emanuel & Christine Grady - 2007 - Cambridge Quarterly of Healthcare Ethics 16 (1):82-96.
    The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.
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  4. Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
    The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
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  5.  10
    Problems with Minimal-Risk Research Oversight: A Threat to Academic Freedom?Lisa M. Rasmussen - 2009 - IRB: Ethics & Human Research 31 (3):11.
    A subcommittee of the American Association of University Professors has published a report, “Research on Human Subjects: Academic Freedom and the Institutional Review Board” , which argues that institutional review board oversight may pose a threat to academic freedom, and that a different oversight model based on departmental review would both maintain subject protection and eliminate the threat. But the report does not demonstrate that IRBs pose a threat to academic freedom, and using departmental oversight may (...)
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  6.  63
    Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline - 2012 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is (...)
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  7.  71
    Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries.Brandon Brown, Janni Kinsler, Morenike O. Folayan, Karen Allen & Carlos F. Cáceres - 2014 - Journal of Bioethical Inquiry 11 (2):119-123.
    The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research (...)
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  8. Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research.Holly Taylor - 2007 - IRB: Ethics & Human Research 29 (5).
    A robust measure of whether local oversight of human subjects research is achieving the ethical goals of research oversight has never been developed. Assessing whether the local review process is achieving the ethical goals of research oversight will allow institutions to monitor their own human subjects protection programs and guide the investment of funds to improve performance. Without a measure of ethical quality, institutions, institutional review boards, regulators, and the public have no way of (...)
     
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  9.  35
    Scientific Forensics: How the Office of Research Integrity Can Assist Institutional Investigations of Research Misconduct During Oversight Review.John E. Dahlberg & Nancy M. Davidian - 2010 - Science and Engineering Ethics 16 (4):713-735.
    The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution’s analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of analytical (...)
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  10.  17
    Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.Carl H. Coleman, Chantal Ardiot, Séverine Blesson, Yves Bonnin, Francois Bompart, Pierre Colonna, Ames Dhai, Julius Ecuru, Andrew Edielu, Christian Hervé, François Hirsch, Bocar Kouyaté, Marie‐France Mamzer‐Bruneel, Dionko Maoundé, Eric Martinent, Honoré Ntsiba, Gérard Pelé, Gilles Quéva, Marie‐Christine Reinmund, Samba Cor Sarr, Abdoulaye Sepou, Antoine Tarral, Djetodjide Tetimian, Olaf Valverde, Simon Van Nieuwenhove & Nathalie Strub‐Wourgaft - 2015 - Developing World Bioethics 15 (3):241-247.
    Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, (...)
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  11.  71
    Oversight Framework Over Oocyte Procurement for Somatic Cell Nuclear Transfer: Comparative Analysis of the Hwang Woo Suk Case Under South Korean Bioethics Law and U.S. Guidelines for Human Embryonic Stem Cell Research.Mi-Kyung Kim - 2009 - Theoretical Medicine and Bioethics 30 (5):367-384.
    We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under (...)
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  12.  6
    Research Oversight Through New Lenses: The Consortium to Examine Clinical Research Ethics.Jeremy Sugarman, Lisa A. Eckenwiler & Ezekiel J. Emanuel - 2002 - IRB: Ethics & Human Research 25 (1):9-10.
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  13.  6
    Four Paradigms of Clinical Research and Research Oversight.Ezekiel J. Emanuel Christine Grady - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press.
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  14.  7
    The Case for Local Ethics Oversight in International Development Research.Logan Cochrane, Renaud F. Boulanger, Gussai H. Sheikheldin & Gloria Song - unknown
    This paper argues that international development research should be submitted to the oversight of research ethics committees from the countries where data will be collected. This includes research conducted by individuals who may fall outside the jurisdictions of most ethics guidelines or policies, such as individuals contracted by non-governmental organizations. The argument is grounded in an understanding of social justice that recognizes that not seeking local ethics approval can be an affront to the decolonization movement, and (...)
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  15.  9
    N-of-1 Precision Medicine and Research Oversight.Andrew Crouse, Mariko Nakano-Okuno, Matthew Might & Thomas May - 2019 - American Journal of Bioethics 19 (8):36-37.
    Volume 19, Issue 8, August 2019, Page 36-37.
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  16.  3
    Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
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  17.  2
    Evaluating Ethics Oversight During Assessment of Research Integrity.Alison Avenell, Mark Bolland & Andrew Grey - 2019 - Research Integrity and Peer Review 4 (1).
    We provide additional information relevant to our previous publication on the quality of reports of investigations of research integrity by academic institutions. Despite concerns being raised about ethical oversight of research published by a group of researchers, each of the four institutional investigations failed to determine and/or report whether ethics committee approval was obtained for the majority of publications assessed.
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  18.  18
    Companion Animal Studies: Slipping Through a Research Oversight Gap.Rebecca L. Walker & Jill A. Fisher - 2018 - American Journal of Bioethics 18 (10):62-63.
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  19.  35
    Unscrambling the Eggs: Cybrid Research Through an Embryonic Stem Cell Research Oversight Committee (ESCRO) Lens.Audrey Chapman & Anne L. Hiskes - 2008 - American Journal of Bioethics 8 (12):44 – 46.
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  20.  21
    Expanding Human Research Oversight.Ellen Holt - 2002 - Kennedy Institute of Ethics Journal 12 (2):215-224.
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  21.  11
    Stem Cell Research Oversight: Personal Reflections and Public Reasoning.Jason Scott Robert - 2013 - American Journal of Bioethics 13 (1):66-68.
  22.  1
    At Law: Research Oversight and Adults with Cognitive Impairment.Rebecca Dresser - 2003 - Hastings Center Report 33 (6):9.
  23.  78
    Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight.D. Buchanan, S. Sifunda, N. Naidoo, S. James & P. Reddy - 2008 - Public Health Ethics 1 (3):246-257.
    The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight (...)
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  24.  10
    Bioethics in the Oversight of Clinical Research: Institutional Review Boards and Data and Safety Monitoring Boards.Christine Grady - 2019 - Kennedy Institute of Ethics Journal 29 (1):33-49.
    In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of Health. (...)
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  25.  51
    Oversight of Research Involving the Dead.Mark R. Wicclair & Michael DeVita - 2004 - Kennedy Institute of Ethics Journal 14 (2):143-164.
    : Research involving the dead, especially heart-beating cadavers, may facilitate the testing of potentially revolutionary and life-saving medical treatments. However, to ensure that such research is conducted ethically, it is essential to: (1) identify appropriate standards for this research and (2) assign institutional responsibility and a mechanism for oversight. Protocols for research involving the dead should be reviewed by a special committee and assessed according to nine standards intended to ensure scientific merit, to protect deceased (...)
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  26.  31
    The Case for a New System for Oversight of Research on Human Subjects.K. Jamrozik - 2000 - Journal of Medical Ethics 26 (5):334-339.
    The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At (...)
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  27.  51
    Therapeutic Cloning Research and Ethical Oversight.M. Spriggs - 2003 - Journal of Medical Ethics 29 (4):207-208.
    Cloning Trevor, a story about therapeutic cloning research, appeared in the June issue of The Atlantic Monthly. The story gives a human face to the people whom therapeutic cloning could benefit. It presents an argument for government funding and it puts the usual calls for a moratorium on embryonic stem cell research to allow for more debate, in a less favourable light. The story also highlights some problems with ethical oversight.
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  28.  10
    Henry K. Beecher and the Oversight of Research in Children.John Lantos - 2016 - Perspectives in Biology and Medicine 59 (1):95-106.
    Henry K. Beecher’s famous 1966 article on ethically problematic medical research was a pivot point. It came at the end of two decades of soul-searching among researchers and philosophers. It ushered in an era of legislation and regulation to address the complex issues that had been extensively discussed by Beecher and others. That soul-searching began with the Nuremberg trials and the disturbing recognition of how far the Nazi doctors had strayed from professional ethical norms. It led, eventually, to the (...)
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  29.  20
    Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight.Sibusiso Sifunda David Buchanan, Shamagonam James Nasheen Naidoo & Priscilla Reddy - 2008 - Public Health Ethics 1 (3).
    Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the ethical warrants (...)
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  30.  12
    Commentary: Emerging Technologies Oversight: Research, Regulation, and Commercialization.Robbin Johnson - 2009 - Journal of Law, Medicine and Ethics 37 (4):587-593.
    This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at “oversight” in three phases — research and development, regulatory (...)
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  31.  17
    Ethical Oversight in Quality Improvement and Quality Improvement Research: New Approaches to Promote a Learning Health Care System.Kevin Fiscella, Jonathan N. Tobin, Jennifer K. Carroll, Hua He & Gbenga Ogedegbe - 2015 - BMC Medical Ethics 16 (1):63.
    Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.
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  32.  35
    The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.Nancy E. Kass, Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis & Tom L. Beauchamp - 2013 - Hastings Center Report 43 (s1):4-15.
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  33.  24
    A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review.Alex John London - 2012 - Journal of Law, Medicine and Ethics 40 (4):930-944.
    This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good.
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  34.  17
    Ethical Oversight of Research on Patient Health Care.Mildred Z. Solomon & Ann Bonham - 2013 - In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell. pp. 2-3.
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  35.  42
    Incarceration, Restitution, and Lifetime Debarment: Legal Consequences of Scientific Misconduct in the Eric Poehlman Case: Commentary On: “Scientific Forensics: How the Office of Research Integrity Can Assist Institutional Investigations of Research Misconduct During Oversight Review”.Samuel J. Tilden - 2010 - Science and Engineering Ethics 16 (4):737-741.
    Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter and (...)
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  36.  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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  37.  17
    Children Enrolled in Parents' Research: A Uniquely Vulnerable Group in Need of Oversight and Protection.L. L. Shepherd, K. Read & D. T. Chen - 2013 - IRB: Ethics & Human Research 35 (3):1-8.
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  38.  4
    Oversight: Community Vulnerabilities in the Blind Spot of Research Ethics.Nicholas G. Cragoe - 2017 - Research Ethics 15 (2):1-15.
    In spite of many and varied concerns that the processes of institutional ethical review are flawed, cumbersome, and in need of reform, these processes do provide effective protection in certain sit...
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  39. The Research-Treatment Distinction : A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.Nancy E. Klass [ - 2013 - In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell.
     
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  40.  8
    Health Research with Big Data: Time for Systemic Oversight.Effy Vayena & Alessandro Blasimme - 2018 - Journal of Law, Medicine and Ethics 46 (1):119-129.
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  41.  24
    RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
  42.  10
    Ethical Oversight of Research on Patient Care.Mildred Z. Solomon & Ann C. Bonham - 2013 - Hastings Center Report 43 (s1):S2-S3.
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  43. Future Directions for Oversight of Stem Cell Research in the United States: An Update.Cynthia B. Cohen & Mary A. Majumder - 2009 - Kennedy Institute of Ethics Journal 19 (2):195-200.
  44.  22
    Future Directions for Oversight of Stem Cell Research in the United States.Cynthia B. Cohen & Mary A. Majumder - 2009 - Kennedy Institute of Ethics Journal 19 (1):79-103.
  45.  19
    The Oversight of Human Gene Transfer Research.LeRoy Walters - 2000 - Kennedy Institute of Ethics Journal 10 (2):171-174.
  46.  6
    Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.Alex John London & Jonathan Kimmelman - 2019 - Hastings Center Report 49 (4):31-41.
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  47.  6
    Institutional Review Board Oversight of Citizen Science Research Involving Human Subjects.David B. Resnik - 2019 - American Journal of Bioethics 19 (8):21-23.
    Volume 19, Issue 8, August 2019, Page 21-23.
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  48.  26
    Committee for Oversight of Research Involving the Dead : Insights From the First Year.Laurel L. Yasko, Mark Wicclair & Michael A. Devita - 2004 - Cambridge Quarterly of Healthcare Ethics 13 (4):327-337.
  49.  45
    A Brief History of Biomedical Research Ethics in Iran: Conflict of Paradigms.Kiarash Aramesh - 2015 - Developing World Bioethics 15 (2):107-112.
    During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers (...)
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  50. Oversight of Human Subject Research: The Role of the States.Jack Schwartz - forthcoming - National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979 Telephone: 301-402-4242• Fax: 301-480-6900• Website: Www. Bioethics. Gov.
     
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