Search results for 'Research legislation' (try it on Scholar)

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  1.  5
    G. Bravo (2003). Knowledge of the Legislation Governing Proxy Consent to Treatment and Research. Journal of Medical Ethics 29 (1):44-50.
    Objective: To assess the knowledge of four groups of individuals regarding who is legally authorised to consent to health care or research involving older patients.Design: A provincewide postal survey.Setting: Province of Quebec, Canada.Participants: Three hundred older adults, 434 informal caregivers of cognitively impaired individuals, 98 researchers in aging and 136 members of research ethics boards .Measurements: Knowledge was assessed through a pretested postal questionnaire comprising five vignettes that describe hypothetical situations involving an older adult who requires medical care (...)
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  2.  13
    S. Aksoy (2005). Making Regulations and Drawing Up Legislation in Islamic Countries Under Conditions of Uncertainty, with Special Reference to Embryonic Stem Cell Research. Journal of Medical Ethics 31 (7):399-403.
    Stem cell research is a newly emerging technology that promises a wide variety of benefits for humanity. It has, however, also caused much ethical, legal, and theological debate. While some forms of its application were prohibited in the beginning, they have now started to be used in many countries. This fact obliges us to discuss the regulation of stem cell research at national and international level. It is obvious that in order to make regulations and to draw (...)
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  3.  2
    L. Trevena (2006). Impact of Privacy Legislation on the Number and Characteristics of People Who Are Recruited for Research: A Randomised Controlled Trial. Journal of Medical Ethics 32 (8):473-477.
    Background: Privacy laws have recently created restrictions on how researchers can approach study participants.Method: In a randomised trial of 152 patients, 50–74 years old, in a family practice, 60 were randomly selected to opt-out and 92 to opt-in methods. Patients were sent an introductory letter by their doctor in two phases, opt-out before and opt-in after introduction of the new Privacy Legislation in December 2001. Opt-out patients were contacted by researchers. Opt-in patients were contacted if patients responded by email, (...)
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  4.  15
    Jan Deckers (2005). Why Current Uk Legislation on Embryo Research is Immoral. How the Argument From Lack of Qualities and the Argument From Potentiality Have Been Applied and Why They Should Be Rejected. Bioethics 19 (3):251–271.
  5. Anthony Vernillo (2008). Pragmatism as a Complementary Approach to Legislation: Closing Regulatory Gaps in Human Subject Research. American Journal of Bioethics 8 (11):15 – 17.
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  6.  4
    Christiane Woopen (1998). MacKellar, Calum (Ed.): Reproductive Medicine and Embryological Research. A European Handbook of Bioethical Legislation. [REVIEW] Medicine, Health Care and Philosophy 1 (1):86-86.
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  7.  1
    Michael Sean Pepper & M. Nőthling Slabbert (2015). Human Tissue Legislation in South Africa: Focus on Stem Cell Research and Therapy. South African Journal of Bioethics and Law 8 (2):4.
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  8.  6
    Carlo Biagioli (forthcoming). Law Making Environment: Model Based System for the Formulation, Research and Diagnosis of Legislation. Artificial Intelligence and Law.
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  9.  1
    L. Gillam & K. Weedon (2005). Medical Research and Involuntary Mental Health Patients: Implications of Proposed Changes to Legislation in Victoria. Monash Bioethics Review 24 (4).
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  10.  1
    R. V. Segsworth (1989). Freedom of Information Legislation and Utilization of Evaluation Research: Exploring Some Relationships. Knowledge in Society 2 (4):49-61.
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  11.  1
    Arja Halkoaho, Mari Matveinen, Ville Leinonen, Kirsi Luoto & Tapani Keränen (2013). Education of Research Ethics for Clinical Investigators with Moodle Tool. BMC Medical Ethics 14 (1):53.
    In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess (...)
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  12.  9
    Anna C. Mastroianni, Ruth R. Faden & Daniel D. Federman (eds.) (1994). Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. National Academy Press.
    Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...
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  13.  11
    Aurora Plomer (2005). The Law and Ethics of Medical Research: International Bioethics and Human Rights. Cavendish.
    This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...
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  14.  23
    Ezekiel J. Emanuel (ed.) (2008). The Oxford Textbook of Clinical Research Ethics. Oxford University Press.
    Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.
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  15.  33
    Ritva Halila (2007). Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice? Science and Engineering Ethics 13 (3):305-313.
    Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a (...)
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  16.  50
    Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
    Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...)
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  17.  4
    Dr Ruth L. Fischbach & Diane C. Gilbert (1995). The Ombudsman for Research Practice. Science and Engineering Ethics 1 (4):389-402.
    We propose that institutions consider establishing a position of “Ombudsman for Research Practice”. This person would assume several roles: as asounding board to those needing confidential consultation about research issues — basic, applied or clinical; as afacilitator for those wishing to pursue a formal grievance process; and as aneducator to distribute guidelines and standards, to raise the consciousness regarding sloppy or irregular practices in order to prevent misconduct and to promote the responsible conduct of research. While there (...)
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  18.  1
    Carla Truyers, Eliane Kellen, Marc Arbyn, Leen Trommelmans, Herman Nys, Karen Hensen, Bert Aertgeerts, Stefaan Bartholomeeusen, Mats Hansson & Frank Buntinx (2010). The Use of Human Tissue in Epidemiological Research; Ethical and Legal Considerations in Two Biobanks in Belgium. Medicine, Health Care and Philosophy 13 (2):169-175.
    This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data are discussed (...)
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  19. Hana Konečná, Tonko Mardešić, Taťána Rumpíková & Tomáš Kučera (2012). Qualitative Research in Reproductive Medicine: From Description to Action. Human Affairs 22 (4):462-474.
    Assisted reproduction , particularly that performed using donated gametes, increases the prospect of healthy babies being delivered to increasing numbers of people striving for parenthood. The psychosocial, ethical and legislative issues related both to the donation and receipt of gametes are perceived as extraordinarily complicated. In 2009, a research project aimed at mapping the issues was drawn up and implemented in the Czech Republic. The project should have provided material for consultation purposes, for the work of ethical and legislative (...)
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  20.  2
    Christian Lenk, Nils Hoppe, Katharian Beier & Claudia Wiesemann (eds.) (2011). Human Tissue Research. A European Perspective on the Ethical and Legal Challenges. Oxford University Press.
    It will be of value to medics and social scientists, human tissue researchers, and policy makers who have an interest in ethical and legal issues of human tissue research.
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  21. García San José & I. Daniel (2010). International Bio Law: An International Overview of Developments in Human Embryo Research and Experimentation. Ediciones Laborum.
     
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  22.  49
    Neema Sofaer, Penney Lewis & Hugh Davies, Care After Research: A Framework for NHS RECs. Health Research Authority.
    Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. (...)
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  23.  5
    M. Strätling, V. E. Scharf & P. Schmucker (2004). Mental Competence and Surrogate Decision-Making Towards the End of Life. Medicine, Health Care and Philosophy 7 (2):209-215.
    German legislation demands that decisions about the treatment of mentally incompetent patients require an ‘informed consent’. If this was not given by the patient him-/herself before he/she became incompetent, it has to be sought by the physician from a guardian, who has to be formally legitimized before. Additionally this surrogate has to seek the permission of a Court of Guardianship (Vormundschaftsgericht), if he/she intends to consent to interventions, which pose significant risks to the health or the life of the (...)
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  24.  57
    Keymanthri Moodley & Landon Myer (2007). Health Research Ethics Committees in South Africa 12 Years Into Democracy. BMC Medical Ethics 8 (1):1-8.
    Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing (...)
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  25. David Lewis (2008). Ten Years of Public Interest Disclosure Legislation in the UK: Are Whistleblowers Adequately Protected? [REVIEW] Journal of Business Ethics 82 (2):497 - 507.
    Purpose The purpose of this article is to assess the operation of the UK’s Public Interest Disclosure Act 1998 (PIDA 1998) during its first 10 years and to consider its implications for the whistleblowing process. Method The article sets the legislation into context by discussing the common law background. It then gives detailed consideration to the statutory provisions and how they have been interpreted by the courts and tribunals. Results In assessing the impact of the legislation’s approach to (...)
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  26.  20
    Susan Dodds & Rachel A. Ankeny (2006). Regulation of hESC Research in Australia: Promises and Pitfalls for Deliberative Democratic Approaches. [REVIEW] Journal of Bioethical Inquiry 3 (1-2):95-107.
    This paper considers the legislative debates in Australia that led to the passage of the Research Involving Human Embryos Act (Cth 2002) and the Prohibition of Human Cloning Act (Cth 2002). In the first part of the paper, we discuss the debate surrounding the legislation with particular emphasis on the ways in which demands for public consultation, public debate and the education of Australians about the potential ethical and scientific impact of human embryonic stem cells (hESC) research (...)
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  27.  21
    Chesmal Siriwardhana, Anushka Adikari, Kaushalya Jayaweera & Athula Sumathipala (2013). Ethical Challenges in Mental Health Research Among Internally Displaced People: Ethical Theory and Research Implementation. [REVIEW] BMC Medical Ethics 14 (1):13-.
    Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of (...)
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  28. Dirk van Rooy & Jacques Bus (2010). Trust and Privacy in the Future Internet—a Research Perspective. Identity in the Information Society 3 (2):397-404.
    With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. Trust and identity lie at (...)
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  29.  3
    Barbara K. Redman (forthcoming). Commentary: Legacy of the Commission on Research Integrity. Science and Engineering Ethics:1-9.
    20 years ago, the Report of the Commission on Research Integrity was submitted to the Secretary of the Department of Health and Human Services and to House and Senate Committees. As directed in enabling legislation, the Commission had provided recommendations on a new definition of research misconduct, oversight of scientific practices, and development of a regulation to protect whistleblowers. Reflecting the ethos of the time, the Commission recommended that institutions receiving Public Health Service (...) funding should provide oversight of all but the most egregious misconduct. The suggested definition of research misconduct was organized around misappropriation, interference and misrepresentation, which would have addressed collaborative/authorship disputes and sabotage in scientific laboratories, both of which remain unaddressed in current policy. The Commission also recommended the Whistleblower Bill of Rights and Responsibilities which would have authorized remedies for whistleblowers who experienced retaliation and sanctions against retaliators. Response from the scientific community was highly critical, and none of the Commission’s recommendations was accepted. No new body has examined issues within the Commission’s charge, there has been no significant Congressional or public pressure to do so, institutions have not been able to sustain standards that would have avoided current concerns about bias and irreproducibility in research, and there is still no entity in science capable of addressing issues assigned to the Commission and other urgent issues. (shrink)
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  30.  37
    Malcolm G. Booth (2007). Informed Consent in Emergency Research: A Contradiction in Terms. Science and Engineering Ethics 13 (3):351-359.
    Improving the treatment of life threatening emergency illness or disease requires that new or novel therapies be assessed in clinical trials. As most subjects for these trials will be incapacitated there is some controversy about they might best protected whilst still allowing research to continue. Recent European and UK clinical trials legislation, which has effectively stopped research into emergency conditions, is discussed. Possible changes to these regulations are proposed.
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  31.  3
    Howard J. Curzer, Gad Perry, Mark C. Wallace & Dan Perry (2016). The Three Rs of Animal Research: What They Mean for the Institutional Animal Care and Use Committee and Why. Science and Engineering Ethics 22 (2):549-565.
    The Institutional Animal Care and Use Committee is entrusted with assessing the ethics of proposed projects prior to approval of animal research. The role of the IACUC is detailed in legislation and binding rules, which are in turn inspired by the Three Rs: the principles of Replacement, Reduction, and Refinement. However, these principles are poorly defined. Although this provides the IACUC leeway in assessing a proposed project, it also affords little guidance. Our goal is to provide procedural and (...)
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  32.  10
    Barry Lyons (2012). Solidarity, Children and Research. Bioethics 26 (7):369-375.
    While research on children is supported by many professional guidelines, international declarations and domestic legislation, when it is undertaken on children with no possibility of direct benefit it rests on shaky moral foundations. A number of authors have suggested that research enrolment is in the child's best interests, or that they have a moral duty or societal obligation to participate. However, these arguments are unpersuasive. Rather, I will propose in this paper that research participation by children (...)
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  33.  2
    Kori Cook, Jeremy Snyder & John Calvert (2015). Attitudes Toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines. [REVIEW] Developing World Bioethics 16 (1).
    There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and (...)
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  34.  4
    Dan Lyons (2011). Protecting Animals Versus the Pursuit of Knowledge: The Evolution of the British Animal Research Policy Process. Society and Animals 19 (4):356-367.
    Animal research in the United Kingdom is regulated by the Animals Act 1986, which requires a government minister to weigh the expected suffering of animals against the expected benefits of a proposed animal research project—the “cost-benefit assessment”—before licensing the project. Research into the implementation of this legislation has been severely constrained by statutory confidentiality. This paper overcomes this hindrance by describing a critical case study based on unprecedented primary data: pig-to-primate organ transplantation conducted between 1995 and (...)
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  35.  1
    Karin Jongsma, Wendy Bos & Suzanne Vathorst (2015). Morally Relevant Similarities and Differences Between Children and Dementia Patients as Research Subjects: Representation in Legal Documents and Ethical Guidelines. Bioethics 29 (9):662-670.
    Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of (...)
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  36.  3
    Olena Grebeniuk (2013). Main Challenges and Prospects of Improving Ukrainian Legislation on Criminal Liability for Crimes Related to Drug Testing in the Context of European Integration. Jurisprudence 20 (3):1249-1270.
    The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is (...)
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  37.  2
    Gunnel Colnerud (2014). Ethical Dilemmas in Research in Relation to Ethical Review: An Empirical Study. Research Ethics 10 (4):238-253.
    The aim of the present article is to contribute empirically derived knowledge about Swedish researchers’ experience of ethical problems, conflicts and dilemmas in their research practice in relation to the ethical vetting legislation and procedure. The study has been carried out using the critical incident technique, with researchers from various disciplines providing examples from their own research practice of problems relating to research ethics. The analysis of the researchers’ responses indicates three phenomena, partly in line with (...)
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  38. Susan L. Crockin (2010). Legal Conceptions: The Evolving Law and Policy of Assisted Reproductive Technologies. Johns Hopkins University Press.
    Embryo litigation -- Access to ART treatment : insurance and discrimination -- General professional liability litigation -- Paternity and donor insemination -- Maternity and egg donation -- Traditional and gestational surrogacy arrangements -- Posthumous reproduction : access and parentage -- Same-sex parentage and ART -- Genetics (PGD) and ART -- ART-related embryonic stem cell legal developments -- ART-related adoption litigation -- ART-related fetal litigation and abortion-related litigation.
     
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  39. Stephen Humphreys (2013). Research Ethics Committees: The Ineligibles. Research Ethics 11 (3):1747016113489944.
    Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.
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  40.  16
    N. Sofaer & D. Strech (2011). Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review. Public Health Ethics 4 (2):160-184.
    Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to (...)
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  41.  3
    Frida Lundmark, C. Berg, O. Schmid, D. Behdadi & H. Röcklinsberg (2014). Intentions and Values in Animal Welfare Legislation and Standards. Journal of Agricultural and Environmental Ethics 27 (6):991-1017.
    The focus on animal welfare in society has increased during the last 50 years. Animal welfare legislation and private standards have developed, and today many farmers within animal production have both governmental legislation and private standards to comply with. In this paper intentions and values are described that were expressed in 14 animal welfare legislation and standards in four European countries; Sweden, United Kingdom, Germany and Spain. It is also discussed if the legislation and standards actually (...)
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  42.  18
    Isabella Paoletti (2014). Ethics and the Social Dimension of Research Activities. Human Studies 37 (2):257-277.
    This study identifies some of the ethical issues that arise in the everyday practice of researching in collecting interactional data. A form of conceptualizing ethics in research is proposed as awareness of the social dimension of research practices and their transformative nature. The collection of ethnographic data—including interviewing, observing, audiovisual recording, and other methods—is achieved by means of social interactions that necessarily imply issues of face, relevance, appropriateness, politeness, and identity, to name a few. Research activities have (...)
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  43.  1
    Johannes Rath, Monique Ischi & Dana Perkins (2014). Evolution of Different Dual-Use Concepts in International and National Law and Its Implications on Research Ethics and Governance. Science and Engineering Ethics 20 (3):769-790.
    This paper provides an overview of the various dual-use concepts applied in national and international non-proliferation and anti-terrorism legislation, such as the Biological and Toxin Weapons Convention, the Chemical Weapons Convention and United Nations Security Council Resolution 1540, and national export control legislation and in relevant codes of conduct. While there is a vast literature covering dual-use concepts in particular with regard to life sciences, this is the first paper that incorporates into such discussion the United Nations Security (...)
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  44.  11
    B. E. Gibson, E. Stasiulis, S. Gutfreund, M. McDonald & L. Dade (2011). Assessment of Children's Capacity to Consent for Research: A Descriptive Qualitative Study of Researchers' Practices. Journal of Medical Ethics 37 (8):504-509.
    Background In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. Methods The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child (...)
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  45.  5
    Jan Lecouturier, Helen Rodgers, Gary A. Ford, Tim Rapley, Lynne Stobbart, Stephen J. Louw & Madeleine J. Murtagh (2008). Clinical Research Without Consent in Adults in the Emergency Setting: A Review of Patient and Public Views. [REVIEW] BMC Medical Ethics 9 (1):9.
    In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients (...)
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  46.  13
    I. H. Kerridge, C. F. C. Jordens, R. Benson, R. Clifford, R. A. Ankeny, D. Keown, B. Tobin, S. Bhattacharyya, A. Sachedina, L. S. Lehmann & B. Edgar (2010). Religious Perspectives on Embryo Donation and Research. Clinical Ethics 5 (1):35-45.
    The success of assisted reproductive technologies (ARTs) worldwide has led to an accumulation of frozen embryos that are surplus to the reproductive needs of those for whom they were created. In these situations, couples must decide whether to discard them or donate them for scientific research or for use by other infertile couples. While legislation and regulation may limit the decisions that couples make, their decisions are often shaped by their religious beliefs. Unfortunately, health professionals, scientists and policy-makers (...)
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  47.  3
    H. R. Fisher, C. McKevitt & A. Boaz (2011). Why Do Parents Enrol Their Children in Research: A Narrative Synthesis. Journal of Medical Ethics 37 (9):544-551.
    Objective Recent legislation mandating the inclusion of children in clinical trials has resulted in an increase in the number of children participating in research. We reviewed the literature regarding the reasons parents chose to accept or decline an invitation to enrol their children in clinical research. Methods We searched for qualitative studies, written in the English language that considered the experiences of parents who had been invited to enrol their children in research. SCOPUS and Web of (...)
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  48.  19
    Lainie Friedman Ross (2006). Children in Medical Research: Access Versus Protection. OUP Oxford.
    Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook are evidence that before the policy shift protection was not always adequate, even for the most vulnerable groups. Additional safeguards for children were first (...)
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  49.  5
    C. Metcalfe, R. M. Martin, S. Noble, J. A. Lane, F. C. Hamdy, D. E. Neal & J. L. Donovan (2008). Low Risk Research Using Routinely Collected Identifiable Health Information Without Informed Consent: Encounters with the Patient Information Advisory Group. Journal of Medical Ethics 34 (1):37-40.
    Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. (...)
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  50.  23
    J. V. McHale (2006). 'Appropriate Consent' and the Use of Human Material for Research Purposes: The Competent Adult. Clinical Ethics 1 (4):195-199.
    The Human Tissue Act 2004 presents a radical change to the legal regulation of the use of human material in England and Wales. The Act presents a broad regulatory framework but much in the practical operation of the legislation will depend upon regulations to be enacted and a new Code of Practice. This article examines 'appropriate consent' for the use of human tissue for research purposes in the context of the living competent adult. It examines the provision of (...)
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