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Informed consent and autonomy

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https://www.readbyqxmd.com/read/28993074/obtaining-waivers-of-parental-consent-a-strategy-endorsed-by-gay-bisexual-and-queer-adolescent-males-for-health-prevention-research
#1
Dalmacio Flores, Ross McKinney, Joyell Arscott, Julie Barroso
BACKGROUND: Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. PURPOSE: We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. METHODS: We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data...
September 18, 2017: Nursing Outlook
https://www.readbyqxmd.com/read/28983835/biomedical-big-data-new-models-of-control-over-access-use-and-governance
#2
Effy Vayena, Alessandro Blasimme
Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals...
October 5, 2017: Journal of Bioethical Inquiry
https://www.readbyqxmd.com/read/28981744/using-and-disclosing-confidential-patient-information-and-the-english-common-law-what-are-the-information-requirements-of-a-valid-consent
#3
Victoria Chico, Mark J Taylor
The National Health Service in England and Wales is dependent upon the flow of confidential patient data. In the context of consent to the use of patient health data, insistence on the requirements of an 'informed' consent that are difficult to achieve will drive reliance on alternatives to consent. Here we argue that one can obtain a valid consent to the disclosure of confidential patient data, such that this disclosure would not amount to a breach of the common law duty of confidentiality, having provided less information than would typically be associated with an 'informed consent'...
August 17, 2017: Medical Law Review
https://www.readbyqxmd.com/read/28974311/informed-consent-it-s-more-than-a-signature-on-a-piece-of-paper
#4
Christine S Cocanour
Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent...
September 20, 2017: American Journal of Surgery
https://www.readbyqxmd.com/read/28956967/undertaking-research-on-people-who-lack-decision-making-capacity
#5
Richard Griffith
The Declaration of Helsinki requires that health care research takes place with the informed consent of those who participate in the study. This approach upholds the autonomy of the participants, but restricts research to subjects who have decision-making capacity. The Mental Capacity Act 2005 introduced safeguards that enable researchers to investigate the care and treatment of people with incapacity, while protecting this vulnerable patient group. These safeguards allow people who lack decision-making capacity to benefit from research findings...
October 2, 2017: British Journal of Community Nursing
https://www.readbyqxmd.com/read/28951264/discussing-sarcoma-risks-during-informed-consent-for-nonhysterectomy-management-of-fibroids-an-unmet-need
#6
Brandon-Luke L Seagle, Amy L Alexander, Anna E Strohl, Shohreh Shahabi
There is no reliable way to distinguish symptomatic uterine fibroids from sarcoma without a surgical specimen. Many women with a uterine sarcoma are initially managed without hysterectomy under a presumed fibroid diagnosis, without understanding sarcoma risks. Currently many alternatives to hysterectomy, including medical and procedural interventions, for treatment of fibroids are promoted. The sarcoma incidence among women with presumed fibroids is 0.29% (1/340) to 0.05% (1/2000). Nonmetastatic leiomyosarcoma has a 63% 5-year survival rate whereas metastatic leiomyosarcoma has a 14% 5-year survival rate...
September 23, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28949898/a-randomized-study-of-a-method-for-optimizing-adolescent-assent-to-biomedical-research
#7
Robert D Annett, Janet L Brody, David G Scherer, Charles W Turner, Jeanne Dalen, Hengameh Raissy
PURPOSE: Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. METHODS: Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure...
July 2017: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/28933226/nursing-adherence-to-ethical-codes-in-pediatric-oncology-wards
#8
Raziyeh Beykmirza, Lida Nikfarid, Foroozan Atashzadeh-Shoorideh, Maliheh Nasiri
BACKGROUND: The nature of children's cancer comes with lots of ethical issues. Nurses are encouraged to adhere to ethical codes in their practice. OBJECTIVES: This study aimed to compare the perspectives of nurses and mothers of children with cancer regarding the adherence of nurses to ethical codes. RESEARCH DESIGN: In this descriptive-comparative study, a researcher-made questionnaire was used to assess the amount of adherence to Iranian nurses' code of ethics in perspectives of pediatric oncology nurses and mothers...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28916453/making-the-legal-and-ethical-case-for-universal-screening-for-postpartum-mood-and-anxiety-disorders-in-pediatric-primary-care
#9
Amy Lewis Gilbert, Casey Balio, Nerissa S Bauer
Postpartum depression (PPD), part of a larger spectrum of perinatal mood and anxiety disorders, affects up to 15% of women following the birth of an infant. Fathers may also be affected. PPD not only affects caregivers, but also impacts infants through mechanisms such as inadequate caregiver-infant interactions and non-adherence to safety practices. The negative impact on infants may extend across the life course through adulthood. This article seeks to move the needle toward universal screening for PPD using validated tools in pediatric primary care settings for new caregivers by making the legal and ethical case for this course of action in a manner that is both compelling and accessible for clinicians...
September 12, 2017: Current Problems in Pediatric and Adolescent Health Care
https://www.readbyqxmd.com/read/28905728/what-are-physicians-responsibilities-to-patients-whose-health-conditions-can-influence-their-legal-proceedings
#10
David Beckmann
Correctional populations are disproportionately affected by conditions that affect cognition, such as psychiatric illness and head trauma. Honoring bioethical principles in the care of such patients can be particularly difficult in the correctional setting. However, the approach should not change markedly because a patient is incarcerated. That is, the same standards of respecting patient autonomy and confidentiality should be maintained, and the fact that correctional populations are already marginalized makes it all the more important for clinicians to honor these principles...
September 1, 2017: AMA Journal of Ethics
https://www.readbyqxmd.com/read/28858149/conducting-clinically-based-intimate-partner-violence-research-safety-protocol-recommendations
#11
Jocelyn C Anderson, Nancy E Glass, Jacquelyn C Campbell
BACKGROUND: Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. PURPOSE: The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence...
September 2017: Nursing Research
https://www.readbyqxmd.com/read/28857220/presuming-patient-autonomy-in-the-face-of-therapeutic-misconception
#12
Pat McConville
Therapeutic misconception involves the failure of subjects either to understand or to incorporate into their own expectations the distinctions in nature and purpose of personally responsive therapeutic care, and the generic relationship between subject and investigator which is constrained by research protocols. Researchers cannot disregard this phenomenon if they are to ensure that subjects engage in research on the basis of genuine informed consent. However, our presumption of patient autonomy must be sustained unless we have compelling evidence of serious misunderstanding...
August 30, 2017: Bioethics
https://www.readbyqxmd.com/read/28846521/nontherapeutic-circumcision-of-minors-as-an-ethically-problematic-form-of-iatrogenic-injury
#13
J Steven Svoboda
Nontherapeutic circumcision (NTC) of male infants and boys is a common but misunderstood form of iatrogenic injury that causes harm by removing functional tissue that has known erogenous, protective, and immunological properties, regardless of whether the surgery generates complications. I argue that the loss of the foreskin itself should be counted, clinically and morally, as a harm in evaluating NTC; that a comparison of benefits and risks is not ethically sufficient in an analysis of a nontherapeutic procedure performed on patients unable to provide informed consent; and that circumcision violates clinicians' imperatives to respect patients' autonomy, to do good, to do no harm, and to be just...
August 1, 2017: AMA Journal of Ethics
https://www.readbyqxmd.com/read/28828304/informed-consent-process-a-step-further-towards-making-it-meaningful
#14
REVIEW
Rashmi Ashish Kadam
Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process...
July 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28794548/informed-consent-process-foundation-of-the-researcher-participant-bond
#15
Amrita Sil, Nilay Kanti Das
Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration...
July 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28789658/healthcare-professionals-and-patients-perspectives-on-consent-to-clinical-genetic-testing-moving-towards-a-more-relational-approach
#16
Gabrielle Natalie Samuel, Sandi Dheensa, Bobbie Farsides, Angela Fenwick, Anneke Lucassen
BACKGROUND: This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. METHODS: We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK's National Health Service (data collected 2013-2015)...
August 8, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28774956/ethics-of-patient-activation-exploring-its-relation-to-personal-responsibility-autonomy-and-health-disparities
#17
Sophia H Gibert, David DeGrazia, Marion Danis
Discussions of patient-centred care and patient autonomy in bioethics have tended to focus on the decision-making context and the process of obtaining informed consent, leaving open the question of how patients ought to be counselled in the daily maintenance of their health and management of chronic disease. Patient activation is an increasingly prominent counselling approach and measurement tool that aims to improve patients' confidence and skills in managing their own health conditions. The strategy, which has received little conceptual or ethical analysis, raises important questions about how clinicians ought to foster confidence and a sense of control in their patients without exposing them to blame, stigma and other harms...
October 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28767456/effects-of-anaesthesia-and-analgesia-on-long-term-outcome-after-total-knee-replacement-a-prospective-observational-multicentre-study
#18
Dario Bugada, Massimo Allegri, Marco Gemma, Andrea L Ambrosoli, Giuseppe Gazzerro, Fernando Chiumiento, Doriana Dongu, Fiorella Nobili, Andrea Fanelli, Paolo Ferrua, Massimo Berruto, Gianluca Cappelleri
BACKGROUND: Perioperative regional anaesthesia may protect from persistent postsurgical pain (PPSP) and improve outcome after total knee arthroplasty (TKA). OBJECTIVES: Aim of this study was to evaluate the impact of regional anaesthesia on PPSP and long-term functional outcome after TKA. DESIGN: A web-based prospective observational registry. SETTING: Five Italian Private and University Hospitals from 2012 to 2015. PATIENTS: Undergoing primary unilateral TKA, aged more than 18 years, informed consent, American Society of Anesthesiologists (ASA) physical status classes 1 to 3, no previous knee surgery...
October 2017: European Journal of Anaesthesiology
https://www.readbyqxmd.com/read/28755143/relational-autonomy-in-informed-consent-raic-as-an-ethics-of-care-approach-to-the-concept-of-informed-consent
#19
Peter I Osuji
The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC)...
July 28, 2017: Medicine, Health Care, and Philosophy
https://www.readbyqxmd.com/read/28749063/patients-as-rights-holders
#20
Johan Brännmark
Autonomy and consent have been central values in Western moral and political thought for centuries. One way of understanding the bioethical models that started to develop, especially in the 1970s, is that they were about the fusion of a long-standing professional ethics with the core values underpinning modern political institutions. That there was a need for this kind of fusion is difficult to dispute, especially since the provision of health care has in most developed countries become an ever more important concern of our political institutions, with governments playing a significant role in regulating and facilitating the provision of health care and in many countries even largely organizing it...
July 2017: Hastings Center Report
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