Elements Of Consent Research Articles

Assent Described: Exploring Perspectives From the Inside

The purpose of this study was to describe the informed consent and assent experience for oncology research from the perspective of the participants: adolescents, their parents, and their physician providers. This descriptive mixed-methods study included the pilot use of the Quality of Informed Consent Questionnaire (QuIC) with an adolescent population and semi-structured interviews with adolescents, their parents, and their physician providers within 48-72 hours of the informed consent and assent discussion for a pediatric oncology clinical trial and again 6-9 weeks later. Adolescents and their parents scored considerably lower on part A of the QuIC than part B indicating a lower level of objective understanding of key elements of informed consent and assent. Qualitative interviews highlight participants' self-reported poor memory or recollection of key details of the informed consent and assent discussion paralleling the QuIC findings for objective understanding. Findings from this pilot descriptive study suggest that adolescents and their parents feel more informed than they actually are. This dichotomy of experience seems to have been mitigated by a strong sense of trust in and connection with their physician provider. Further exploration of adolescent and parent viewpoints regarding what they value as important in the content of the informed consent and assent and how that content is delivered is warranted. Additionally, understanding the origin of participants' misunderstanding of the key elements of consent and assent may illuminate areas for future intervention-based research focused on improving the overall quality of informed consent and assent discussions.

An Assessment of Nutrition and Physical Activity Among Black College Women

Transitioning to college represents a critical time period in which healthy eating can become a challenge and physical activity levels decline. Those that do not meet the guidelines for dietary intake and physical activity are at a higher risk for diseases such as diabetes and obesity. To better understand some behaviors that may contribute to these diseases this study examined the dietary intake and physical activity behaviors of black college women. Participants were recruited using flyers placed in common areas on Florida A&M University’s campus. Prior to completing the 30-item questionnaire the participants received a letter of introduction which contained all elements of consent. Analyses of the data was completed using Statistical Package for the Social Sciences (SPSS) version 22. A total of 157 participants completed the questionnaire. On average the participants were graduate students, lived off campus and had a Body Mass Index between 18.5-24.9. Since entering college almost 47% of the participants agreed that their diet has become worse and 25% of the of the participants indicated that they participate in physical activity at least two days per week. In the case of diet and classification 67.7% of the juniors reported that their diet is worse since entering college (p-value< 0.05). This study sheds light on the dietary intake and physical activity behaviors of black women that attend Florida A&M University. It also provides a foundation to develop a culturally sensitive health education program that addresses the levels of the socioecological model.

Capoeira Angola e suas relações com o mito da democracia racial brasileira

A capoeira é manifestação cultural largamente conhecida pelos brasileiros e estrangeiros, como parte da cultura e identidade brasileiras. Entretanto, sendo cultura popular negra deve ser compreendida na sua relação com a cultura dominante, em que estão presentes elementos de resistência e consentimento (HALL, 2013). No século XIX e início do XX, a capoeira foi intensamente reprimida pelo Estado, afastando racial e etnicamente o negro da construção da identidade nacional (REIS, 2000). Na década de 30, uma nova narrativa de identidade brasileira, conhecida como democracia racial brasileira, valorizou a integração cultural e biológica das três raças no Brasil (SCHWARZ, 2012; MUNANGA, 1996). Junto às outras manifestações culturais e religiosas, a capoeira é valorizada e integrada ao Estado (PIRES, 2010). O texto pretende trazer apontamentos para se reavaliar o modo de relacionamento da capoeira angola com as questões raciais e étnicas, a partir do questionamento do mito da democracia racial e das contribuições dos estudos culturais (MUNANGA, 1996; CARONE; BENTO, 2002; HALL, 2013).

Consent and the use of force: an examination of ‘intervention by invitation’ as a basis for US drone strikes in Pakistan, Somalia and Yemen

Drone strikes are becoming a key feature of the United States' global military response to non-state actors, and it has been widely adduced that these strikes have been carried out with the consent of the host states in which such non-state actors reside. This article examines the degree to which assertions of consent (or ‘intervention by invitation’), provided as a justification for drone strikes by the United States in Pakistan, Yemen and Somalia, can be said to accord with international law. First the article provides a broad sketch of the presence of consent in international law. It then analyses in detail the individual elements of consent as provided by Article 20 of the International Law Commission Draft Articles of State Responsibility. These require that consent should be ‘valid’, given by the legitimate government and expressed by an official empowered to do so. These elements will be dealt with individually, and each in turn will be applied to the cases of Pakistan, Yemen and Somalia. Finally, the article will examine the breadth of the exculpatory power of consent, and the extent to which it can preclude the wrongfulness of acts carried out in contravention of international law other than the prohibition of the use of force under Article 2(4) of the Charter of the United Nations.

Consent to Psychiatric Treatment: From Insight (into Illness) to Incite (a Riot)

The aim of this chapter is to go back to the basics on consent to treatment, starting with the right to refuse and building from there. Part II addresses the leading judicial statements on the value of medical self-determination, and in light of these statements, considers what is at stake in psychiatric treatment choice. Part III explores the three core elements of valid consent to treatment — namely that consent be voluntary, informed and capable — with attention to variation in the law among provinces and territories, and some lines of analysis and critique specifically applicable to mental health care contexts. Part IV considers new directions in law and policy clustering around the concept of supported decision-making — a concept forged through domestic and international disability rights advocacy, which urges fundamental re-examination of the interrelationship of legal capacity, autonomy and distributive justice.

Mid-urethral slings on YouTube: quality information on the internet?

Scant literature exists about the quality of urogynecological content on social media. Our objective was to measure the accuracy and comprehensiveness of YouTube videos related to mid-urethral sling (MUS) procedures. YouTube was searched using the terms "mid-urethral sling," "vaginal tape," "TVT," "TOT," "TVT surgery," and "TOT surgery." Duplicates and videos with less than 1,000 views were excluded. We developed a standardized questionnaire for this project, assessing each video's target audience, main purpose, relevance, informed consent elements, surgical steps, and bias. The primary outcome was the presence of all elements of informed consent. Inter-rater reliability (IRR) was calculated using the Fleiss' kappa statistic. Descriptive statistics were also obtained. Five reviewers each rated 56 videos. Mean IRR was moderate (Fleiss' kappa 0.58 ± 0.24). Video content was classified as physician educational material (67.9%), patient information (16.1%), advertisement (10.7%), lawsuit recruitment (1.8%), and unclear (3.6%). MUS was the primary topic for 82.1% of the videos. The remainder discussed other types of anti-incontinence procedures or prolapse surgery. None of the videos mentioned all four elements of informed consent. Of 32 videos demonstrating surgical technique, none showed the complete list of pre-determined surgical steps. The mean number of listed steps was 7.6/16. Only four videos mentioned at least one post-operative patient instruction. A marketing element was shown in 26.8% of videos. Patient information about MUS on YouTube is lacking and often biased. Physicians and students viewing YouTube videos for educational purposes should be cognizant of the variability in the surgical steps demonstrated.

Informed Consent of Living Kidney Donors: Pitfalls and Best Practice

Informed consent is clearly considered the ethical bedrock fundamental to living organ donation, a procedure lacking medical benefits for its participants. Recent guidelines have focused on strengthening content components of living kidney donor informed consent, including Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) policies that prescribe key components, and integration of the Independent Living Donor Advocate (ILDA), as mandated by Centers for Medicare and Medicaid Services (CMS) and the OPTN/UNOS. The European Union member states’ Working Group on Living Donation provided recommendations for care standardization in the “Toolbox Living Kidney Donation,” including integration of an independent clinician advocate. However, even with these changes, studies suggest inconsistency in informed consent elements across transplant programs, and retrospective studies show that although the vast majority of living donors (LDs) reflect back positively on the experience of donation, some describe lacking complete knowledge of risks (or process) before donation. Processes to assure achievement of informed consent remain in the purview of individual transplant centers to implement and measure. Herein, methods to assess prospective LD intentionality, voluntariness, and understanding of risks/benefits are described, with promising techniques highlighted and recommendations for best practice outlined. Specific clinical challenges are addressed, including ambivalence, risk of secondary gain, and difficulty integrating understanding of risks. Finally, additional content elements are proposed to improve validity of informed consent in specific clinical circumstances.

Patients' views of consent for research enrollment during acute myocardial infarction.

The goal of this study was to improve understanding of patients' perspectives of informed consent for clinical trial enrollment during ST-elevation myocardial infarction (STEMI). STEMI research poses challenges regarding informed consent due to time constraints, symptom severity, and potential cognitive impairment. An interview study was embedded within a clinical trial of an ischemic post-conditioning procedure for STEMI. An interactive, structured interview guide was used. Twenty interviews were conducted (median 1.5 days after initial procedure). Only 11/20 (55%) initially remembered being asked to participate in a trial. Comprehension of study details and the research process was limited; for example, many patients believed their decision was primarily clinical or that the study intervention was clearly superior. Patients described limitations regarding their ability to make a decision, including pain, discomfort, lack of time, and stress. However, patients generally felt they were able to make a decision at presentation and wanted to be the primary decision maker; few supported surrogate decision-making by family or physicians. This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.

Quality indicators common to all GI endoscopic procedures

Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge (1). The American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG), and the American Gastroenterological Association (AGA) have continually promoted the ideal that all patients have access to high-quality GI endoscopy services. A high-quality endoscopy is an examination in which patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.

Quality indicators common to all GI endoscopic procedures.

Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge (1). The American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG), and the American Gastroenterological Association (AGA) have continually promoted the ideal that all patients have access to high-quality GI endoscopy services. A high-quality endoscopy is an examination in which patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.

Informed consent as a requirement for probation work with (in)voluntary clients: Probationers’ and probation officers’ perspectives

Offenders’ consent is incorporated in Croatian legislation as a necessary element for the execution of probation measures and sanctions. However, legal provisions, which are in accordance with contemporary European recommendations, provide only a basic framework for the implementation of such measures and sanctions. In this article, we argue that some elements of consent may be questionable and that changes to related practices are possible. After describing legal documents on this topic, we present the results of focus groups with probation officers and probationers with regard to the implementation of consent. Their perceptions and personal experiences provided us with valuable insights about and for practice and served as additional support for future recommendations.

KEJAHATAN KEKERASAN SEKSUAL (PERKOSAAN) DITINJAU DARI PERSPEKTIF KRIMINOLOGI

This study aims to describe and analyze in depth abaout sexual violence (rape) from persepektive of criminology. The methods that are in the form of normative research approach conceptually, with the study of documents as well as primary and secondary legal materials. Arrangements regarding crimes of sexual violence (rape) subject to the provisions of Article 285 of the Penal Code which has elements that must be met, one of which is the absence of violence. Any element of violence is an element that distinguishes the crime of rape with another morality set forth in Penal Code. In the perspective of criminology that really is not an element of violence that will be the main point, but the element of consent. Elements of consent is a decisive and qualify an act as rape or not. In addition,it also examined the factors causing crimes of sexual violence (rape) and mitigation efforts.

Substituted Consent: From Lunatics to Corpses

This analysis traces the origins and evolution of the doctrine of surrogate or substituted judgment, especially its application to medical treatment, including non-therapeutic sterilisation, decisions regarding life and death choices, and more recently, removal of sperm or eggs from incompetent, dying or dead males and females. It argues that the doctrine, which has been acknowledged to be a legal fiction, has an effect of devolving legal and moral responsibility for life and death choices, as well as non-consensual, non-beneficial intrusive procedures, from the competent decision-makers to the incompetent patient. It focuses on the subjective nature of the substituted judgment standard; the problematic nature of evidence propounded to establish the putative choices of the incompetent person; lack of transparency relating to the conflict of interest in the process of substituted judgment decision-making; and the absence of voluntariness, which is an essential element of a valid consent.

Information provision in cervical screening in Australia.

The National Cervical Screening Program and associated state and territory organisations are responsible for promoting cervical screening. Communication via multiple media channels encourages women to be screened. However, some communications are not clear about the risk of cervical cancer and the protective capacity and reliability of the Pap test. The potential harms of screening are rarely presented. Women usually receive Pap tests from general practitioners, who often screen opportunistically during appointments. Screening targets and incentive payments encourage high screening rates. Consent is an important ethical principle in the delivery of all health care. Provision of material information is one of the elements of valid consent. The combination of arguably ambiguous communications, screening participation targets and opportunistic testing under time pressure seems likely to undermine opportunities for women to be informed. Of particular concern are women who are less likely to benefit, those who are more likely to experience harm, and some groups of disadvantaged women. Improved communications could include providing patients with information on the absolute risk of cervical cancer, and the morbidity and mortality benefits and harms of screening. Screening programs internationally have begun providing such information. Areas for further research include the appropriate roles of the programs, screeners and individuals in providing and seeking information. Such work would identify the optimum method for informing women in the screening process.

The basic principles of consent

In the first of a series of articles on the principles of patient consent, Richard Griffith outlines the elements of a real consent and the importance of obtaining consent to the propriety of a cardiac nurse's practice

Empire's Law: A Genealogy of Territorial Sovereignty and Secession Before National Self-Determination

In the contemporary world, the problem of secession presents itself as a conflict between self-determination and territorial integrity in international law, and between principles of consent of the governed and indivisibility of the state in constitutional law. It has not always been so in the history of the modern state since 1648. Before the modern revolutions gave rise to modern nationalism, the elements of self-determination and popular consent were absent in both domestic and international law and politics. Territory was largely treated as the property as the sovereign king of the composite kingly states. With various legal means including conquest, dynastic inheritance, discovery, and occupation, the sovereign kings aggregated land and augmented his state territories in Europe and America. Secessions were rare during that time: only the Dutch Revolt and the Independence of Portugal. And they were just a flip side of the logic of the composite kingly states.

Informed Consent for Cardiac Procedures: Deficiencies in Patient Comprehension With Current Methods

Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements. Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements. One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively. Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension.

Ruhollah Khomeini’s Political Thought: Elements of Guardianship, Consent, and Representative Government

Ayatollah Ruhollah Khomeini is often described in secondary literature as a political actor who advocated religious absolutism. This paper argues that Khomeini’s theory can best be characterized not simply as a theory of guardianship by the Islamic jurisprudent but instead as a theory of limited guardianship . In the public speeches and statements that he delivered during the drafting of the Islamic Republic’s first constitution in 1979, Khomeini is clear that the necessary conditions of political legitimacy are, firstly, popular consent to government, secondly, public approval of the guardian, and finally, popular representation in a legislative assembly. These public statements are consonant with Khomeini’s description of Islamic government in Najaf in 1970, where he recognizes that the guardian is fallible, that the fallibility of human reason may lead people to establish inadequate political conventions, and that there is a certain injustice in imposing government upon a public that does not consent to it. His 1970 lectures do not contradict his post-revolutionary thought also because Khomeini in 1970 gives no indication that he disapproves of – though he makes no explicit statement that he approves of – representative, parliamentary government.

Making out and making do: how employees resist and make organisational change work through consent in a UK bank

This article draws on fieldwork conducted in the back‐office of a major retail UK bank and explores how, when introducing change, management drew on contradictory normative and rational discourses. Its primary concern is to explore how, in this context, employees engaged in contradictory acts that combined elements of both resistance (‘making out’) and consent (‘making do’) that are difficult to disentangle. It is argued that although both are moves within the game, they can be distinguished from each other because the former works against the grain of corporate intentions, whereas the latter works with them.

Written informed consent for living liver donor evaluation: Compliance with centers for medicare and medicaid services and organ procurement and transplantation network guidelines and alibi offers

We examined written informed consent forms for living liver donor evaluations to determine whether they incorporated elements required by the Centers for Medicare and Medicaid Services (CMS) and suggested by the Organ Procurement and Transplantation Network (OPTN). We contacted each of the 41 US centers that performed at least 1 living donor liver transplant in 2011; 37 centers reported active living donor evaluation programs. Twenty-six centers shared their consent form for living donor evaluation (response rate = 70%). Each document was double-coded for consent element content. We found that 57% of the centers included the 9 mandated CMS elements. Although the OPTN guidelines are non-binding, 78% of the centers used consent forms that addressed at least two-thirds of the elements recommended by OPTN. Only 17% of the centers provided written offers of an alibi to donors who withdrew from the evaluation. On the basis of our findings, we offer suggestions that may be relevant to ongoing revisions to the OPTN living liver donor consent policy and may help centers to improve the clarity of their written consent forms.