Results for ' Informed consent '

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  1.  53
    Research on Medical Records Without Informed Consent.Franklin G. Miller - 2008 - Journal of Law, Medicine and Ethics 36 (3):560-566.
    Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.
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  2.  59
    Phase 1 oncology trials and informed consent.Franklin G. Miller & Steven Joffe - 2013 - Journal of Medical Ethics 39 (12):761-764.
    Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study (...)
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  3.  15
    Utilizing Community Research Committees to Improve the Informed Consent Process.Marc Tunzi, Robert P. Lennon, David Satin & Philip G. Day - 2021 - American Journal of Bioethics 21 (5):73-75.
    Millum and Bromwich’s excellent article provides both conceptual and practical rationale for reexamining the fundamentals of the informed consent process for research and clinical interventi...
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  4.  46
    Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent.Maxwell J. Mehlman & Jessica W. Berg - 2008 - Journal of Law, Medicine and Ethics 36 (3):546-549.
    The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines (...)
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  5.  4
    Gender and emotion in the advocacy for breast cancer informed consent legislation.Theresa Montini - 1996 - Gender and Society 10 (1):9-23.
    This is a qualitative study of the role of gender and emotion in a political setting. The data are from interviews of activists and legislators, as well as from archival accounts of the debates in state legislatures about breast cancer informed consent legislation. I found that proponents for and against the legislation shared the belief that women are more emotional than men. This social belief shaped the political strategies the activists adopted and initially contributed to their effectiveness; however, (...)
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  6.  50
    Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore.Ayesha Humayun, Noor Fatima, Shahid Naqqash, Salwa Hussain, Almas Rasheed, Huma Imtiaz & Sardar Imam - 2008 - BMC Medical Ethics 9 (1):14-.
    BackgroundThe principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations.Material & MethodThe study was conducted at medical out-patient departments (OPDs) of two tertiary care hospitals (one public and one private hospital) of Lahore, selected using multi-stage sampling. 93 patients were selected from each hospital. Doctors' adherence to the principles of informed consent, privacy and (...)
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  7. Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns.Ferdinand Chinedum Maduka-Okafor, Onochie Ike Okoye, Ngozi Oguego, Nnenma Udeh, Ada Aghaji, Obiekwe Okoye, Ifeoma R. Ezegwui, Emmanuel Amaechi Nwobi, Euzebus Ezugwu, Ernest Onwasigwe, Rich E. Umeh & Chiamaka Aneji - 2021 - Sage Publications Ltd: Research Ethics 18 (1):13-23.
    Research Ethics, Volume 18, Issue 1, Page 13-23, January 2022. School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental (...)
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  8.  18
    Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review.Iris Loosman & Philip J. Nickel - 2022 - Science and Engineering Ethics 28 (5):1-19.
    In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed (...)
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  9.  36
    An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives.Unnati Saxena, Debdipta Bose, Mitesh Kumar Maurya, Nithya Jaideep Gogtay & Urmila Mukund Thatte - 2021 - Clinical Ethics 16 (2):144-150.
    Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s guidelines. We evaluated total number of questions, nature of questions and (...)
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  10.  20
    Assessment of Knowledge and Attitudes of Physicians Serving Pediatric Patients on Children›s Rights and Informed Consent in Children.Gürkan Sert, Can Ilgın, Elif Samiye Duru, Canan Kalmaz, Gizem Karagöl, Janda Hasso, Refia Katmer & Sena Ecin - 2018 - Türkiye Biyoetik Dergisi 5 (2):48-63.
    INTRODUCTION[|]The practice of medicine has evolved from old approach, in which all decisions for the patient are taken by physician, to a new approach, which includes patients to the medical decision-making process and endorses informed consent of the patients. In addition to healthcare professionals and patients, parents or legal representatives are stakeholders in the informed consent process of children. The knowledge and attitudes of physicians and medical school students about the informed consent period in (...)
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  11.  9
    Ren lei yi chuan yan jiu huo dong zhong de zhi qing tong yi: lun li, fa lü yu she hui de duo wei si kao = A study on informed consent in human genetic research: from the perspective of ethical, legal and social implications.Chunyan Wu - 2016 - Beijing Shi: Fa lü chu ban she.
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  12.  32
    True wishes: the philosophy and developmental psychology of children's informed consent.Donna Dickenson & David Jones - 1995 - Philosophy, Psychiatry, and Psychology 2 (4):287-303.
    In this article we explore the underpinnings of what we view as a recent" backlash" in English law, a judicial reaction against considering children's and young people's expressions of their own feelings about treatment as their" true" wishes. We use this case law as a springboard to conceptual discussion, rooted in (a) empirical psychological work on child development and (b) three key philosophical ideas: rationality, autonomy and identity.
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  13.  28
    Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research.Victoria Vorholt & Neal W. Dickert - 2019 - Journal of Medical Ethics 45 (1):18-21.
    Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little (...)
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  14.  9
    Avoidance of nocebo effects by coincident naming of treatment benefits during the medical interview for informed consent—Evidence from dynamometry.Nina Zech, Matthias Schrödinger & Ernil Hansen - 2022 - Frontiers in Psychology 13.
    IntroductionIn the context of giving risk information for obtaining informed consent, it is not easy to comply with the ethical principle of “primum nihil nocere.” Carelessness, ignorance of nocebo effects and a misunderstood striving for legal certainty can lead doctors to comprehensive and brutal risk information. It is known that talking about risks and side effects can even trigger those and result in distress and nonadherence to medication or therapy.MethodsRecently, we have reported on significant clinically relevant effects of (...)
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  15.  15
    Racing for Consent: A Feminist Relational Analysis of Informed Consent for Nondiagnostic Breast Cancer Research Biopsies.Skye A. Miner - 2017 - International Journal of Feminist Approaches to Bioethics 10 (2):42-60.
    Mainstream breast cancer social movements such as that of Susan G. Komen have called on all women to race or fight for the cure for breast cancer. They suggest that the fight can be won by buying and wearing pink ribbons, taking part in races and walks, donating money, and participating in research. For some patients with breast cancer, research participation may involve non-diagnostic tumor biopsies. While this clinical research is performed in the hope of gaining new knowledge through the (...)
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  16. Physician-mediated elective whole genome sequencing tests : impacts on informed consent.Magalie Leduc Emily Qian, Bryan Cosca Rebecca Hodges, Laurie McCright Ryan Durigan & Birgit Funke Doug Flood - 2021 - In I. Glenn Cohen, Nita A. Farahany, Henry T. Greely & Carmel Shachar (eds.), Consumer genetic technologies: ethical and legal considerations. New York, NY: Cambridge University Press.
     
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  17. Organ procurement organizations internet enrollment for organ donation: Abandoning informed consent[REVIEW]Sandra Woien, Mohamad Rady, Joseph Verheijde & Joan McGregor - 2006 - BMC Medical Ethics 7 (1):1-9.
    Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for (...) consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. (shrink)
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  18.  31
    Cultural Diversity and Informed Consent.Ellen Agard, Daniel Finkelstein & Edward Wallach - 1998 - Journal of Clinical Ethics 9 (2):173-176.
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  19.  7
    Barriers Encountered Conducting Informed Consent Research.Patricia Agre, Bruce Rapkin, James Dougherty & Roger Wilson - 2002 - IRB: Ethics & Human Research 24 (4):1.
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  20. Rethinking informed consent in bioethics.Neil C. Manson - 2007 - New York: Cambridge University Press. Edited by Onora O'Neill.
    Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They (...)
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  21.  73
    Informed Consent: Foundations and Applications.Joanna Smolenski - 2021 - Dissertation, Cuny Graduate Center
    Since its advent in the 20th century, informed consent has become a cornerstone of ethical healthcare, and obtaining it a core obligation in medical contexts. In my dissertation, I aim to examine the theoretical underpinnings of informed consent and identify what values it is taken to protect. I will suggest that the fundamental motivation behind informed consent rests in something I’ll call bodily self-sovereignty, which I argue involves a coupling of two groups of values: (...)
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  22. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children’s competence to consent to clinical research.Irma M. Hein, Martine C. De Vries, Pieter W. Troost, Gerben Meynen, Johannes B. Van Goudoever & Ramón J. L. Lindauer - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally (...)
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  23. Informed Consent: What Must Be Disclosed and What Must Be Understood?Joseph Millum & Danielle Bromwich - 2021 - American Journal of Bioethics 21 (5):46-58.
    Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer (...)
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  24.  37
    Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting.Joseph Ochieng, Charles Ibingira, William Buwembo, Ian Munabi, Haruna Kiryowa, David Kitara, Paul Bukuluki, Gabriel Nzarubara & Erisa Mwaka - 2014 - BMC Medical Ethics 15 (1):40.
    Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices (...)
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  25. Informed consent to HIV cure research.Danielle Bromwich & Joseph R. Millum - 2017 - Journal of Medical Ethics 43 (2):108-113.
    Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; (...)
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  26.  54
    Informed Consent Procedures: Responsibilities of Researchers in Developing Countries.Soledad Sánchez, Gloria Salazar, Marcia Tijero & Soledad Díaz - 2001 - Bioethics 15 (5-6):398-412.
    We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss (...)
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  27.  5
    Review of Rethinking Informed Consent in Bioethics. [REVIEW]David B. Resnik - 2009 - Studies in Ethics, Law, and Technology 3 (2).
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  28.  46
    Informed Consent, Understanding, and Trust.David B. Resnik - 2021 - American Journal of Bioethics 21 (5):61-63.
    Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...
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  29.  29
    Informed Consent Out of Context.Sven Ove Hansson - 2006 - Journal of Business Ethics 63 (2):149-154.
    Several attempts have been made to transfer the concept of informed consent from medical and research ethics to dealing with affected groups in other areas such as engineering, land use planning, and business management. It is argued that these attempts are unsuccessful since the concept of informed consent is inadequate for situations in which groups of affected persons are dealt with collectively (rather than individually, as in clinical medicine). There are several reasons for this. The affected (...)
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  30. Informed Consent, Big Data, and the Oxymoron of Research That Is Not Research.John P. A. Ioannidis - 2013 - American Journal of Bioethics 13 (4):40 - 42.
    (2013). Informed Consent, Big Data, and the Oxymoron of Research That Is Not Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 40-42. doi: 10.1080/15265161.2013.768864.
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  31.  67
    Informed consent practices in nigeria.Emmanuel R. Ezeome & Patricia A. Marshall - 2008 - Developing World Bioethics 9 (3):138-148.
    Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is (...)
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  32.  15
    Informed consent and health: a global analysis.Thierry Vansweevelt & Nicola Glover-Thomas (eds.) - 2020 - Cheltenham, UK: Edward Elgar Publishing.
    Informed consent is the legal instrument that purports to protect an individual's autonomy and defends against medical arbitrariness. Informed Consent and Health highlights that possession of complete information about all relevant aspects of a proposed treatment is integral to the ability of a patient to make an informed choice. With patient choice at both legislative and judicial levels rising to greater levels of prominence, this timely book examines how the tensions between the rights of patients (...)
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  33.  46
    Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection.Shannon Lydia Spruit, Ibo van de Poel & Neelke Doorn - 2016 - NanoEthics 10 (2):123-138.
    In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent (...)
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  34.  30
    Informed consent in the psychosis prodrome: ethical, procedural and cultural considerations.Sarah E. Morris & Robert K. Heinssen - 2014 - Philosophy, Ethics, and Humanities in Medicine 9:19.
    Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and (...)
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  35.  30
    Rethinking Informed Consent in Research on Heroin‐Assisted Treatment.Susanne Uusitalo & Barbara Broers - 2014 - Bioethics 29 (7):462-469.
    Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus (...)
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  36.  23
    Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal.Sharada P. Wasti, Edwin van Teijlingen, Puspa Raj Pant, Om Kurmi, Nirmal Aryal & Pramod R. Regmi - 2016 - Developing World Bioethics 17 (2):84-89.
    Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and (...)
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  37.  24
    Informed Consent among Clinical Trial Participants with Different Cancer Diagnoses.Connie M. Ulrich, Sarah J. Ratcliffe, Camille J. Hochheimer, Qiuping Zhou, Liming Huang, Thomas Gordon, Kathleen Knafl, Therese Richmond, Marilyn M. Schapira, Victoria Miller, Jun J. Mao, Mary Naylor & Christine Grady - forthcoming - AJOB Empirical Bioethics.
    Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT (...)
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  38.  57
    Informed consent and nudging.William Simkulet - 2018 - Bioethics 33 (1):169-184.
    In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that (...)
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  39.  59
    Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning.Eran Klein - 2016 - Science and Engineering Ethics 22 (5):1299-1317.
    Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, (...)
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  40.  75
    Informed Consent and Fresh Egg Donation for Stem Cell Research: Incorporating Embodied Knowledge Into Ethical Decision-Making.Katherine Carroll & Catherine Waldby - 2012 - Journal of Bioethical Inquiry 9 (1):29-39.
    This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of (...)
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  41.  47
    Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.I. S. Durand-Zaleski, C. Alberti, P. Durieux, X. Duval, S. Gottot, P. Ravaud, S. Gainotti, C. Vincent-Genod, D. Moreau & P. Amiel - 2008 - Journal of Medical Ethics 34 (9):e16-e16.
    Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and (...)
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  42.  86
    Transparency: Informed Consent in Primary Care.Howard Brody - 1989 - Hastings Center Report 19 (5):5-9.
    Current legal standards of informed consent send the wrong message to physicians about their moral and legal expectations. A “transparency” model that sees consent as a conversation process can enhance good medical practice and patient autonomy without foreclosing appropriate judicial review.
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  43.  99
    Informed consent and routinisation.Thomas Ploug & Soren Holm - 2013 - Journal of Medical Ethics 39 (4):214-218.
    This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the (...)
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  44.  24
    Informed consent in clinical practice: a pragmatic interpretation.Rainer Dziewas, Peter Sörös & Henning Henningsen - 2002 - Ethik in der Medizin 14 (3):151-159.
    Definiton of the problem: The current literature concerning the topic of ”informed consent” confronts physicians with a growing demand for extended and sophisticated disclosure duties. Often enough they hardly seem to be feasible, not least because of an actual lack of personnel and time. The problem is to find a realisable way to balance these theoretical and practical considerations. Arguments: The fundamental idea of the concept presented here consists of using the difficulty of a certain decision as standard (...)
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  45.  21
    Informed consent and the psychiatric patient.A. R. Dyer & S. Bloch - 1987 - Journal of Medical Ethics 13 (1):12-16.
    Informed consent is reviewed as it applies to psychiatric patients. Although new legislation, such as the Mental Health Act 1983, provides a useful safeguard for the protection of the civil rights of patients, it could actually reduce their humane care unless applied with sensitivity for the nature of their unique difficulties. In order to guard against this possibility, we suggest that legal requirements should be considered in light of the ethical principles which underlie them. Three principles are considered: (...)
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  46. Informed consent, price transparency, and disclosure.Samuel Director - 2023 - Bioethics 37 (8):741-747.
    In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that (...)
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  47.  33
    Informed Consent and Standard of Care: What Must Be Disclosed.Ruth Macklin & Lois Shepherd - 2013 - American Journal of Bioethics 13 (12):9-13.
    The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination (...)
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  48.  36
    Informed consent, vulnerability and the risks of group-specific attribution.Berta M. Schrems - 2014 - Nursing Ethics 21 (7):829-843.
    People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead (...)
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  49.  62
    Informed consent in texas: Theory and practice.Mark J. Cherry & H. Tristram Engelhardt - 2004 - Journal of Medicine and Philosophy 29 (2):237 – 252.
    The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the (...)
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    Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation.Jodi Halpern, David Paolo & Andrew Huang - 2019 - Journal of Medical Ethics 45 (6):384-387.
    Unrealistic therapeutic beliefs are very common—the majority of patient-subjects enrol in phase 1 trials seeking and expecting significant medical benefit, even though the likelihood of such benefit has historically proven very low. The high prevalence of therapeutic misestimation and unrealistic optimism in particular has stimulated debate about whether unrealistic therapeutic beliefs in early-phase clinical trials preclude adequate informed consent. We seek here to help resolve this controversy by showing that a crucial determination of when such therapeutic beliefs are (...)
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