Consent in current psychiatric practice and research: An Indian perspective
Furkhan Ali, Gopi Gajera, Guru S Gowda, Preeti Srinivasa, Mahesh Gowda
Indian Journal of Psychiatry, 8 April 2019; 61(10) pp 667-675
Abstract
Consent is a process that allows for free expression of an informed choice, by a competent individual. The consent is considered as one of the important components of health-care delivery and biomedical research today. Informed consent involves clinical, ethical, and legal dimensions and is believed to uphold an individual’s autonomy and the right to choose. It is very important in Indian mental health care as the Mental Healthcare Act (MHCA) 2017 mandates informed consent in admission, treatment, discharge planning, and research intervention/procedures. In 2017, the Indian Council of Medical Research laid down the National Ethical Guidelines for BioMedical and Health Research involving Human Participants for research protocols, which the MHCA advocates. This article gives an overview on the evaluation of consent in clinical practice and also highlights the approach and challenge in psychiatric practice in India.
Category: Cultural/Country Context
The public debate on organ donation and presumed consent in Denmark: Are the right issues being addressed?
The public debate on organ donation and presumed consent in Denmark: Are the right issues being addressed?
Anja M. B. Jensen, Johanne Bjørg Larsen
Scandinavian Journal of Public Health, 11 April 2019
Abstract
The legal framework for organ donation in Denmark is informed consent. But due to the unsatisfactory number of organ donors, Denmark is considering changing legislation to presumed consent. This article discusses the public debate on organ donation and presumed consent in Denmark, and asks whether the right issues are being addressed in the quest towards more available organs and better donor rates? Basing our considerations on the various arguments in the debate and on scientific findings, we question the potential benefits of presumed consent and challenge some of the assumptions and rationalizations that characterize the discussions in Denmark regarding public support, public trust and the role of the family in donation decisions.
Dematerialisation of patient’s informed consent in radiology: insights on current status and radiologists’ opinion from an Italian online survey
Dematerialisation of patient’s informed consent in radiology: insights on current status and radiologists’ opinion from an Italian online survey
Francesca Coppola, Lorenzo Faggioni, Roberto Grassi, Corrado Bibbolino, Agatina Rizzo, Nicoletta Gandolfo, Antonella Calvisi, Carlo Alberto Cametti, Giorgio Benea, Andrea Giovagnoni, Carmelo Privitera, Daniele Regge
La radiologia medica, 2 April 2019; pp 1–8
Abstract
Purpose
To assess the current status of patient’s informed consent (PIC) management at radiological centres and the overall opinion of radiologist active members of the Italian Society of Medical Radiology (SIRM) about PIC dematerialisation through an online survey.
Methods and materials
All members were invited to join the survey as an initiative by the Imaging Informatics Chapter of SIRM. The survey consisted of 11 multiple-choice questions about participants’ demographics, current local modalities of PIC acquisition and storage, perceived advantages and disadvantages of PIC dematerialisation over conventional paper-based PIC, and overall opinion about PIC dematerialisation.
Results
A total of 1791 radiologists (amounting to 17.4% of active SIRM members for the year 2016) joined the survey. Perceived advantages of PIC dematerialisation were easier and faster PIC recovery (96.5%), safer storage and conservation (94.5%), and reduced costs (90.7%). Conversely, the need to create dedicated areas for PIC acquisition inside each radiological unit (64.0%) and to gain preliminary approval for the use of advanced digital signature tools from patients (51.8%) were seen as potential disadvantages. Overall, 94.5% of respondents had a positive opinion about PIC dematerialisation.
Conclusion
Radiologists were mostly favourable to PIC dematerialisation. However, concerns were raised that its practical implementation might face hurdles due to its complexity in current real life working conditions.
Determine the Influence of Social Demography and Access to Information on Giving Consent of Medical Action Toward an Understanding of Informed Consent in Public Hospital With Class C at Pekanbaru [Indonesia]
Determine the Influence of Social Demography and Access to Information on Giving Consent of Medical Action Toward an Understanding of Informed Consent in Public Hospital With Class C at Pekanbaru [Indonesia]
Tri Purnama sari, Doni Jepisah
Journal of Economic Info, 18 February 2019; 6(1)
Abstract
Informed consent is approval of medical action which is given by the patient or his immediate family after obtaining a complete explanation about medical or dentist action that will be performed on that patient. This study aims to determine the influence of social demography and access to information on giving consent of medical action toward an understanding of informed consent in Public hospital with class C at Pekanbaru. This study employs quantitative method with cross sectional analytic design. The population in this study were all Patient or Families of patient who had received medical treatments in inpatient room for three days before the return of patient as much 267 respondent where the total sample of this research are 194 respondents. The sampling technique is Proportional Random Sampling. Data analysis was carried out in three stages: univariate, bivariate, and multivariate analysis. Based on the result of study found that there was a significant relationship between Education variable (p value 0.007 POR 2,368), work variable (p value 0.042 POR 1,937), age (p value 0.017 POR 2,158), Completeness Information (p value 0.001 POR 2,857), Language Delivery (p value 0.002 POR 2,871) with an understanding of the approval of medical action. Based on the results of multivariate test, it was found that education, completeness of information and language of delivery were the most influential factors. The submission of information must be adjusted to the characteristics of consent provider, especially those related to education, completeness of information and language delivery, so that, if things happen that are not desirable after surgery, the patient or family is expected to receive it because before the surgery is done, the doctor has given an explanation to the patient.
The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework
The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework
Giuseppe R. Gristina, Lucia Busatta, Mariassunta Piccinni
Minerva Anestesiologica, 2019 April; 85(4) pp 401-11
Abstract
The Italian Parliament has recently approved a law on informed consent, advance directives and advance care planning. The law also deals with health care proxy and health care decisions for minors and adults who are not able to give consent. The Italian law arrived quite late in comparison with other European countries. After several years of debate on the need to approve such a law, the focus has now shifted to the assessment of the legislative provisions and their impact on clinical practice. In this article, the authors firstly offer an overview of the findings from the empirical research regarding the use of the different legal tools in the field of intensive care medicine; secondly, they present the tools now provided by law no. 219/2017 particularly with regard to the decision-making processes in the Intensive Care Unit (ICU); thirdly, the authors offer a comparison between the new Italian law and other European legal orders, with special reference to France, Spain, Germany and England. The aim of the article is to assess the degree of innovation of the law vis-à-vis the previous framework
Informed Consent for Genetics Research in Italy
Informed Consent for Genetics Research in Italy
Piergiorgio Fedeli, Nunzia Cannovo, Rosa Guarino, Vincenzo Graziano
Open Medicine Journal, 28 February 2019; 6 pp 6-12
Background
Genetic research has become an indispensable instrument for medical research, and the subjects involved have both divergent and convergent interests.
Objective
The possibility of having more detailed genetic information undoubtedly offers benefits for the health of the subject, but could also pose risks and make the subject vulnerable to discrimination. The scientific community has viewed very favorably the public health utility of family history, in which data from a family whose members suffer from chronic pathologies is collected and filed, in order to develop a sort of “stratification of family risk.” Even though in the last decade the scientific and juridical literature has contributed greatly to the topic of biobanks, the perplexities that continue to surround this theme give the idea that current ethical protocols on research are inadequate.
Conclusion
Genetic data must be used not to exploit, but to serve the person. Freedom and responsibility must be the twin guiding lights for establishing parameters for the use of biological samples. An evaluation of how this technology impacts the various aspects of the future of society is urgently needed.
Indigenous Processes of Consent: Repoliticizing Water Governance through Legal Pluralism
Indigenous Processes of Consent: Repoliticizing Water Governance through Legal Pluralism
Deborah Curran
Water, 19 March 2019; 11(3) pp 571
Abstract
While international instruments and a few state governments endorse the “free, prior and informed consent” of Indigenous peoples in decision-making about the water in their traditional territories, most state water governance regimes do not recognize Indigenous water rights and responsibilities. Applying a political ecology lens to the settler colonialism of water governance exposes the continued depoliticizing personality of natural resources decision-making and reveals water as an abstract, static resource in law and governance processes. Most plainly, these decision-making processes inadequately consider environmental flows or cumulative effects and are at odds with both Indigenous governance and social-ecological approaches to watershed management. Using the example of groundwater licensing in British Columbia, Canada as reinforcing colonialism in water governance, this article examines how First Nations are asserting Indigenous rights in response to natural resource decision-making. Both within and outside of colonial governance processes they are establishing administrative and governance structures that express their water laws and jurisdiction. These structures include the Syilx, Nadleh Wut’en and Stellat’en creating standards for water, the Tsleil-Waututh and Stk’emlúpsemc te Secwépemc community assessments of proposed pipeline and mining facilities, and the First Nations of the Nicola Valley planning process based on their own legal traditions. Where provincial and federal environmental governance has failed, Indigenous communities are repoliticizing colonial decision-making processes to shift jurisdiction towards Indigenous processes that institutionalize responsibilities for and relationships with water.
Barriers and Facilitators to Obtaining Informed Consent in a Critical Care Pediatric Research Ward in Southern Malawi
Barriers and Facilitators to Obtaining Informed Consent in a Critical Care Pediatric Research Ward in Southern Malawi
Lucinda Manda-Taylor, Alice Liomba, Terrie E. Taylor, Kristan Elwell
Journal of Empirical Research on Human Research Ethics, 13 March 2019; 14(2) pp 152–168
Abstract
Informed consent is an ethical requirement in clinical research. Obtaining informed consent is challenging in resource-constrained settings. We report results of a formative qualitative study that examined factors that facilitate and hinder informed consent for clinical research among critically ill children in Malawi. We argue that truly informed consent in a pediatric intensive care unit (PICU) is challenged by parental distress, time constraints when balancing care for critically ill patients with research-related tasks, and social hierarchies and community mistrust toward certain research procedures. We interviewed health care providers and parents of children attending a critical care unit to identify potential challenges and solicit strategies for addressing them. Providers and caregivers suggested practical solutions to enhance research participant understanding of clinical trial research, including the use of visual materials, community engagement strategies, and using patients as advocates in promoting understanding of research procedures.
Moving Forward on Consent Practices in Australia
Moving Forward on Consent Practices in Australia
Lisa Eckstein & Rebekah McWhirter
Journal of Bioethical Inquiry, 2018; 15(2) pp 243-257
Abstract
Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants.
Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicenter SNACS study in Senegal
Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicenter SNACS study in Senegal
Fabienne Hejoaka, Marie Varloteaux, Caroline Desclaux-Sall, Sidy Mokhtar Ndiaye, Karim Diop, Aminata Diack, Fatou Niasse, Cecile Cams
Tropical Medicine & International Health, 9 January 2019; 24(3) pp 294-303
Abstract
Objectives
Providing research information in a manageable way to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV-related research. We implemented an informed consent process (IICP) and identified factors associated with the presentation of HIV-infected minors in their studies.
Methods
We enrolled study participants attending 12 pediatric HIV clinics in Senegal. Children ≥7 years were provided with standardized IICP, which involves viewing a video and taking part in extended group discussions. Was evaluated by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points. Factors associated with understanding were identified using a stepwise logistic regression model.
Results
Overall, 112 children, with a median age of 12.9 years (IQR: 10.2-15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding and gave consent to participate in the research. HIV-infected children were more likely than children to be infected (aOR = 3.2, 95% CI: 1.1-9.6). Age, study and education level were not associated with satisfactory understanding.
Conclusion
These findings provide for guidance in the development of the business of business. The implementation of the pediatric HIV research agenda will require a standardized and operational definition of informed consent, integrating the issue of HIV disclosure.