Year: 2022

How Informed is Consent? A Field Experiment

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How Informed is Consent? A Field Experiment
Discussion Paper
Alexandra Avdeenko, Matthias Stelter
Centre for Economic Policy Research, 1 February 2022
Abstract
In an increasingly data-driven world, data protection and the requirement of obtaining informed consent rapidly gain relevance. The intention is to protect data holders. Yet, is consent provided by data holders truly informed? In the context of empirical research, the requirement for informed consent can affect external validity and data quality of the evidence generated. Conducting a survey with 7,752 potential participants in rural Pakistan, we find that respondents are insufficiently informed about important aspects related to their consent. Experimentally changing the consent process, we find that showing an animated video has a negative impact on respondent’s understanding, but additionally engaging them in an interactive dialogue about the informational text significantly improves understanding. Even though we find effects on levels of understanding, we do not find meaningful changes in consent rates and non-response behavior indicating no adverse effects on the quality of the survey.

Editor’s note: The Centre for Economic Policy Research’s network of Research Fellows and Affiliates includes economists conducting research on issues affecting the European economy.

Factorial Structure of Nursing Practices Related to Support for Decision-Making Regarding Consent for Surgery in Elderly Patients with Dementia

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Factorial Structure of Nursing Practices Related to Support for Decision-Making Regarding Consent for Surgery in Elderly Patients with Dementia
Original Research
Sachiko Matsui, Miwa Yamamoto
Yonago Acta Medica, 22 February 2022; 65(1) pp 70–81
Open Access
Abstract
Background
When elderly patients with dementia require highly invasive treatment or surgery for lifethreatening conditions, decisions regarding consent for surgery are made based on informed consent provided by the family, which excludes the patient whose decision-making ability is deemed impaired due to the dementia. This study aimed to clarify the factorial structure of nursing practices related to support for decision-making regarding consent for surgery in elderly patients with dementia.
Methods
An anonymous self-administered questionnaire survey was completed by nurses with three or more years of experience working in orthopedic surgery wards at secondary emergency hospitals in the Kinki area. The survey collected data on participant attributes and nursing practices related to decision-making support. Data were analyzed by exploratory factor analysis (promax rotation) using nursing practice items related to decision-making support as variables. Internal consistency was examined.
Results
Participants were 112 nurses including 108 women (96.4%) and four men (3.6%), with a mean age of 38.3 (±SD 9.8) years. Exploratory factor analysis of the nursing practice items related to decision-making support demonstrated the validity of the observed 24 variables, with a Kaiser-Meyer-Olkin value of 0.858 and a significant Bartlett’s test of sphericity (P < 0.001). Five components with eigenvalues of 1 or more were extracted, including “achieving advocacy for elderly patients with dementia through cooperation among medical professionals,” “advice considering the lifestyles and values of patients and their families,” “support with a deeper understanding of elderly patients with dementia,” “support that helps elderly patients with dementia to express their intentions,” and “nurses’ attendance in IC sessions for elderly patients with dementia.” The Cronbach’s α coefficient for the 24 nursing practice items related to decision-making support was high, at 0.926.
Conclusion
The factorial structure of nursing practice related to support for decision-making regarding consent for surgery in elderly patients with dementia included five factors and 24 items. The reliability and construct validity of the factorial structure were also confirmed.

Editor’s note: Yonago Acta Medica (YAM) is a peer-reviewed journal, specializing in medical sciences, published by Tottori University Medical Press, Japan.

Consent and parental responsibility – the past, the present and the future

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Consent and parental responsibility – the past, the present and the future
Asma Keshtgar, Mohamed Hania, Mohammad O. Sharif
British Dental Journal, 28 January 2022; 232 pp 115 – 119
Open Access
Abstract
Introduction
Informed consent is the ‘permission or agreement’ given by the patient for a proposed action. This paper explores the clinician’s role in obtaining informed consent, provides an overview of consent and parental responsibility in the UK, and presents practical adjuncts to aid dental professionals in ascertaining who has parental responsibility to delineate persons capable of providing assent on behalf of an underage patient.
Consent and parental responsibility
While the principles of consent have largely stayed constant with time, subtleties in parental responsibility legislation exist in different regions of the UK. An audit exploring consent and parental responsibility knowledge among clinicians within the orthodontic department at the UCLH Eastman Dental Hospital demonstrated that none of the respondents met the gold standard (100%). The results ranged from 59-89% with a mean score of 74%. The majority of questions answered incorrectly related to knowledge of parental responsibility.
Conclusion
It is the responsibility of clinicians providing any care within the UK to stay up to date with legislation and regulations regarding consent and parental responsibility. Knowledge-based questionnaires can highlight areas of knowledge deficit which can be addressed through continuous professional development. This paper provides a flowchart summarising parental responsibility and a prefilled parental responsibility questionnaire as adjuncts to simplify the process of dental professionals ascertaining parental responsibility.

Health care providers’ ethical perspectives on waiver of final consent for Medical Assistance in Dying (MAiD): a qualitative study

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Health care providers’ ethical perspectives on waiver of final consent for Medical Assistance in Dying (MAiD): a qualitative study
Research
Caroline Variath, Elizabeth Peter, Lisa Cranley, Dianne Godkin
BMC Medical Ethics, 30 January 2022; 23(8)
Open Access
Abstract
Background
With the enactment of Bill C-7 in Canada in March 2021, people who are eligible for medical assistance in dying (MAiD), whose death is reasonably foreseeable and are at risk of losing decision-making capacity, may enter into a written agreement with their healthcare provider to waive the final consent requirement at the time of provision. This study explored healthcare providers’ perspectives on honouring eligible patients’ request for MAiD in the absence of a contemporaneous consent following their loss of decision-making capacity.
Method
A critical qualitative methodology, using a feminist ethics theoretical lens with its focus on power and relationality, was used to examine how socio-political and environmental contexts influenced healthcare providers’ moral agency and perspectives. Semi-structured interviews were conducted with 30 healthcare providers (13 physicians, six nurse practitioners, nine nurses and two social workers) from across Canada who provide MAiD-related care.
Results
Themes identified include; (1) balancing personal values and professional responsibilities, (2) anticipating strengths and limitations of the proposed waiver of final consent amendment, (3) experiencing ethical influences on decisions to enter into written agreements with eligible patients, (4) recognizing barriers to the enactment of MAiD in the absence of a contemporaneous consent and (5) navigating the potential for increased risks and burden.
Discussion
To our knowledge, this is the first study in Canada to explore healthcare providers’ perspectives on waiving the final consent for MAiD using a written agreement. Most participants supported expanding eligible people’s access to MAiD following loss of capacity, as they believed it would improve the patients’ comfort and minimize suffering. However, the lack of patients’ input at the time of provision and related ethical and legal challenges may impact healthcare providers’ moral agency and reduce some patients’ access to MAiD. Providers indicated they would enter into written agreements to waive final consent for MAiD on a case-by-case basis. This study highlights the importance of organizational, legal and professional support, adequate resources, clear policies and guidelines for the safety and wellbeing of healthcare providers and to ensure equitable access to MAiD.

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

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Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study
Research Article
Zhanqing Hu, Chenxi Ouyang, Jessica Hahne, Kaveh Khoshnood, Jinqiang Zhang, Xiyu Liu, Ying Wu, Xiaomin Wang
Journal of Empirical Research on Human Research Ethics, 28 January 2022
Abstract
This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants’ knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.

The Analysis Causes of Informed Consent in Supporting the Quality of Medical Record In Graha Hospital Medika Banyuwangi

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The Analysis Causes of Informed Consent in Supporting the Quality of Medical Record In Graha Hospital Medika Banyuwangi
Rizqi Aji Aprilia, Erma Sulistyaningsih, Leersia Yusi Rat
International Journal of Innovative Science and Research Technology, December 2021; 6(12)
Abstract
Backgrounds
Informed consent is an agreement given by the patient or family after receiving a clear explanation of the patient’s medical or dental action to be carried out. The standard of completeness of the Informed Consent is based on the Hospital Minimum Service Standard No. 290 of 2008 and the hospital quality standard is 100%. The number of incomplete informed consent at Graha Medika Hospital in the third quarter of 2020 was 11.14%, 26.90%, and 41%, which means that the standard for completeness of informed consent has not been achieved. The purpose of the study was to analyze the factors causing incomplete informed consent.
Methods
The research design used a quantitative approach with a cross-sectional research design. The population and sample were 258 informed consent forms. The unit of analysis was 30 medical doctors who filled out the informed consent. Data analysis used univariate, bivariate with Spearman Rank, and multivariate with Partial Least Square.
Results
The bivariate analysis results showed that the resource indicator had a relationship with the completeness of Informed Consent with a value of 0.005. A multivariate analysis that organizational factors had a relationship with the completeness of Informed Consent with a value of 0.001.
Conclusion
Strengthening the resource sector with a solid organizational commitment will increase the completeness of informed consent, which is inseparable from the quality of the organization’s management function. A good management function will run in harmony with the level of compliance of good service personnel.

Editor’s note: The International Journal of Innovative Science and Research Technology is an open access peer-reviewed international forum for scientists and engineers published in India.

Informed Consent among Hansen’s Disease Patients – A Nigerian Perspective

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Informed Consent among Hansen’s Disease Patients – A Nigerian Perspective`I.A. Meka, A.O. Meka, O.O. Kanu, N. Ekeke, K.O. Adagba, A.O. Iseoluwa – Adelokiki, I. Alobu, J. Offor
African Journal of Health Sciences, November-December 2021; 34(6)
Open Access
Summary
Background
Informed consent entails providing potential participants with adequate information needed to decide whether or not to participate in research. In Nigeria, Hansen’s disease has remained a disease of public health importance. The associated stigmatization often renders patients vulnerable and prone to exploitation. The act of obtaining informed consent from these patients remain an issue of ethical importance. The study aimed to determine the willingness of Hansen’s disease patients to give consent to use their data in the form of pictures, videos and/or oral interviews by a third party.
Materials and Methods
This descriptive cross-sectional study was carried out in three states in Nigeria; Ebonyi, Ogun and Cross River States. Data was collected from consenting participants using researcher-administered semi-structured questionnaires.
Results
The study included 93 respondents with a mean (SD) age of 44.9 (20.1) years. The majority 57 (61.29%) of the respondents were farmers while the majority 67 (72.04%) attained primary education. A total of 26 (27.96%) respondents had suffered discrimination in the course of their disease. In their responses, 83 (89.2%) would allow the use of their pictures, 80 (86.0%) their videos and 86 (92.5%) their recorded oral interviews. Among those who would not give consent, the commonest reasons adduced were an intrusion into privacy and lack of trust.
Conclusion
Though a majority of the patients would give consent for use of their data intrusion into privacy and lack of trust were major constraints for those not willing to give consent. Caregivers and stakeholders should put more effort into trying to win patients’ trust before seeking informed consent.

Informed Consent for Endoscopic Biliary Drainage: Time for a New Paradigm

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Informed Consent for Endoscopic Biliary Drainage: Time for a New Paradigm
Marco Spadaccini, Cecilia Binda, Alessandro Fugazza, Alessandro Repici, Ilaria Tarantino, Carlo Fabbri, Luigi Cugia, Andrea Anderloni
Medicina, 22 February 2022; 58(3) pp 331
Open Access
Abstract
Endoscopic retrograde cholangiopancreatography (ERCP) is considered as the first option in the management of malignant biliary obstruction. In case of ERCP failure, percutaneous transhepatic biliary drainage (PTBD) has been conventionally considered as the preferred rescue strategy. However, the use of endoscopic ultrasound (EUS) for biliary drainage (EUS-BD) has proved similarly high rates of technical success, when compared to PTBD. As a matter of fact, biliary drainage is maybe the most evident paradigm of the increasing interconnection between ERCP and EUS, and obtaining an adequate informed consent (IC) is an emerging issue. The aim of this commentary is to discuss the reciprocal roles of ERCP and EUS for malignant biliary obstruction, in order to provide a guide to help in developing an appropriate informed consent reflecting the new biliopancreatic paradigm.

Informed Consent from a Historical, Societal, Ethical, Legal, and Practical Perspective

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Informed Consent from a Historical, Societal, Ethical, Legal, and Practical Perspective
Original Article
Lee M. Jameson, Sandra K. Al-Tarawneh
Journal of Prosthodontics, 20 February 2022
Abstract
Informed consent is often perceived as a regulatory obligation without recognizing its educational potential in the dynamic provider/patient relationship. This article discusses the complex interaction of ethics, society, and law through a historical and practical perspective. The purpose is to provide the general dentists and specialists with a comprehensive understanding of the complexity and practical dimensions of informed consent.

Consent for Delivery Room Studies: What Can Be Learned from Perceptions of Parents

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Consent for Delivery Room Studies: What Can Be Learned from Perceptions of Parents
Original Paper
Maria C. den Boer, Mirjam Houtlosser, Ruben S. G. M. Witlox, Henriëtte A. van Zanten, Martine C. de Vries, Arjan B. te Pas
Neonatology, 18 February 2022
Open Access
Abstract
Background
Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight into parental experiences with and perceptions of consent for DR studies.
Methods
Semistructured interviews were conducted with parents of very and extreme preterm infants. Interviews were audio-recorded, transcribed, and analyzed using the qualitative data analysis software Atlas. ti V.8.4.
Results
Twenty-five parents were interviewed. Despite being in an emotional and stressful situation, most parents considered being approached for DR studies as valuable. According to parents, this was mostly due to appropriate timing and communication, compassion, and investigators not being obtrusive. Interviewed parents generally decided to accept or decline study participation based on perceived risk. Parents differed widely in how risk of specific study interventions was perceived, but agreed on the fact that parental consent is needed for DR studies that involve risk. There was no consensus among parents on deferred consent for DR studies running at our NICU. However, parents considered deferred consent appropriate for observational studies. Furthermore, it became clear that parental misunderstanding of various aspects of DR studies, including aims, the concept of randomization, and risk associated with specific interventions, was common.
Conclusions
Insight into parental perceptions of consent for DR studies allowed us to determine areas where the validity of parental consent can be improved. Further research on parental perspectives for consent for DR studies will allow us to establish consent procedures that are considered both valid and valuable.