Impact of animation-supported consent on complaints and serious incidents due to failure to inform
D S Wald, L Arrol
QJM: An International Journal of Medicine, 17 August 2021
Summary
Background
Introduction of digital animations to explain medical procedures before consent to treatment (animation-supported consent) has been shown to improve patient-reported understanding of a procedure’s benefits, risks and alternatives.
Aim
We examined whether introduction of animation-supported consent is associated with a change in the incidence of complaints and serious incidents due to failure to inform.
Methods
Multi-language animations explaining 10 cardiac procedures, in coronary intervention, electrophysiology and cardiac surgery, (www.explainmyprocedure.com) were introduced at a London cardiac centre from April 2019. Complaints and serious incidents due to failure to inform were identified from the hospital Datix database for the two years before introducing animation-supported consent (no animation group) and the two years afterwards (animation group), together with the total number of procedures and major complications recorded during these periods. We compared the incidence of complaints and serious incidents, expressed as a proportion of the number of major complications, recorded during each period.
Results
There were 580 complications among 21 855 procedures performed in the no animation group and 411 complications among 18 254 procedures in the animation group. There were 14 complaints or serious incidents due to failure to inform in the no animation group and 3 in the animation group; rates of 2.41% (14/580) and 0.73% (3/411), respectively (P < 0.001 for difference).
Conclusion
In this observational comparison, introduction of animation-supported consent was associated with a 70% reduction in complaints or serious incidents due to failure to inform before consent. This has significant quality and cost implications for improving consent pathways in clinical practice.
Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial
Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial
Benjamin Seeliger, Moritz Z. Kayser, Nora Drick, Jan Fuge, Christina Valtin, Mark Greer, Jens Gottlieb
Patient Education and Counseling, 13 August 2021
Abstract
Objective
This study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience.
Methods
Patients due to undergo first conscious surveillance bronchoscopy following lung transplantation were randomized to receive IC with (intervention group) or without (control group) a graphic narrative illustrating the procedure. The primary endpoint was overall patient satisfaction with the IC. Key secondary endpoints were change in state anxiety level, as measured by State Trait Anxiety Inventory, and a questionnaire assessing satisfaction with IC and adverse experience during bronchoscopy (judged by patient and examiners).
Results
Sixty patients were randomized, and 59 patients were included in the analysis (30 intervention-group; 29 control-group). Overall patient satisfaction was higher in the intervention group 9.5 (25Q–75Q: 8.6–9.8) vs. 8.6 (25Q–75Q: 8.1–9.2), p = 0.028). Change in state anxiety level (before vs after informed consent) was similar between the groups. There were no significant differences in adverse experience during bronchoscopy.
Conclusion
Addition of a graphic narrative illustrating bronchoscopy improved patient satisfaction with IC but did not influence anxiety before and adverse experience during the procedure.
Practice implications
Supplementing the IC process with a procedure-specific graphic narrative may be a simple tool to improve patient satisfaction.
Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review
Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review
Research Article
Angela De Pretto-Lazarova, Domnita Oana Brancati-Badarau, Christian Burri
BMC Public Health, 28 July 2021; 21(1473)
Open Access
Abstract
Background
Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases.
Methods
We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed.
Results
None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently.
Conclusions
Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents.
Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]
Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]
Suzanne Marie King
Walden University, 2021
Open Access
Abstract
Age of consent policies have recently been identified as a barrier to HIV testing among adolescents in HIV endemic Sub-Sahara Africa. Grounded in the modified social ecological model, the purpose of this study was to determine if these policies were related to HIV testing rates and prevalence. In this quantitative research secondary data sets from the Demographic Health Survey were used. This study included all sexually active respondents aged 18 years or below (N=37,015) and then was further limited by respondents that had HIV test results (N=25,107). Binary logistic regression showed that respondents with lower age of consent had higher rates of HIV testing. Compared to respondents with an age of consent of 18 years, respondents with age of consent of 16 were 3 times more likely to have been tested (p<0.001, OR 2.876, 95% CI [2.697, 3.067]), age of consent of 15 were 1.5 times more likely to be tested, age of consent of 14 were 0.5 times less likely to be tested, age of consent of 13 were 5 times more likely to be tested, age of consent of 12 were 3 times more likely to be tested, and age of consent of 11 were 2 times more likely to have been tested. Age of consent was also related to HIV prevalence. For each year decrease in age of consent, odds of being HIV positive increased by 1.2%. The outcomes of this study showed further relationships between HIV testing and age of consent policies. This research can be used to inform updated age of consent policies to ensure that all adolescents can access HIV testing. This research could shed light on the importance of HIV testing for adolescents, their families, and their communities leading to positive social change.
The Rise of the French Doctrine of Informed Consent: Criminal Responsibility for an Unauthorised Medical Experiment – The Case of the Antiquaille Hospital and Subsequent Notable Judgments
The Rise of the French Doctrine of Informed Consent: Criminal Responsibility for an Unauthorised Medical Experiment – The Case of the Antiquaille Hospital and Subsequent Notable Judgments
Anatoliy A. Lytvynenko
Athens Journal of Law, 2021; 7 pp 1-14
Open Access
Abstract
The French doctrine regarding a patient’s informed consent has a long and very rich history, dating back at least to the mid-nineteenth century. Medical malpractice had become a frequent subject of criminal trials and civil litigation against physicians and surgeons in the nineteenth and early twentieth centuries, resulting in French medical case law and its academic scholarship becoming one of the most prominent throughout all the civil law jurisdictions. Simultaneously, medical malpractice lawsuits were not rare in civil or common law jurisdictions. The uniqueness of French jurisprudence lies in the development of a robust body of case law, which formed the basis for patients’ rights, and specifically informed consent and the right to medical data confidentiality. The right to informed consent is a reflection of the patient’s right to their own bodily integrity, which may not be violated for the purpose of treatment, except in an emergency. Moreover, the rule of consent is even stricter if physicians are administering experimental treatment (which is not generally banned, as it may benefit the patient), or conducting certain methods of treatment for purely scientific purposes – as was in the case of the Antiquaille Hospital in Lyon, where a dangerous and experimental method of treatment was used to treat a ten-year-old minor suffering from dermatophytosis, which was not authorised by his guardians. The case, which was adjudicated by the criminal court of Lyon, is historically one of the first legal cases to deal with unconsented treatment conducted for the purpose of a scientific experiment. Over the twentieth century, similar legal cases became more frequent in France.
Renewable energy development on the Indigenous Estate: Free, prior and informed consent and best practice in agreement-making in Australia
Renewable energy development on the Indigenous Estate: Free, prior and informed consent and best practice in agreement-making in Australia
Lily O’Neill, Kathryn Thorburn, Bradley Riley, Ganur Maynard, Esmé Shirlow, Janet Hunt
Energy Research & Social Science, November 2021; 81
Abstract
In Australia, large-scale renewable energy projects are being developed or proposed on lands over which First Nations hold rights and interests. Our review of the literature on renewable energy and First Nations peoples globally indicates that renewable energy projects are likely to present risks in the distribution of socio-economic and environmental impacts, as well as significant opportunities for First Nation benefit. This paper explores the conditions under which First Nations people with communal property rights and interests in their traditional land are likely to derive benefit from large scale renewable energy projects.
We examine ‘free, prior and informed consent’ (FPIC), a widely-recognised international human rights standard that sets out a consent, information and consultation framework for proposed developments on First Nation land. In calling for the just economic inclusion and participation of First Nation people in large-scale renewable energy projects we propose that ‘free, prior and informed consent’ offers a suitable framework for approaching the development of these projects. Furthermore, we detail what is best, and worst, practice in agreement making, based on previous First Nations agreement making experience, predominately with the resource extraction sector.
Engaging Free, Prior and Informed Consent for Mutual Benefit
Engaging Free, Prior and Informed Consent for Mutual Benefit
Rudolph C. Rÿser
Fourth World Journal, Summer 2021; 21(1) pp 98-143
Abstract
The Center for World Indigenous Studies, prompted by inquiries and urgings by leaders of indigenous nations, sponsored the planning, organization and convening of a Congress of Nations and States–the process that began in the summer of 2019. In this article we discuss the Congress as a new international mechanism to facilitate engagement by indigenous nations and states on an equal political plain in pursuit of comity and establishment of cooperative measures for mutual benefit. This article discusses the consequences of the failure of decolonization advanced by the United Nations in 1945 that resulted up to 1.9 billion people from indigenous nations left without their consent inside the boundaries of existing states contributing to social, economic, political and security conflicts demanding relief. More than 5000 nations occupy territories and political space inside states with the states’ claiming those territories and competing for political space by asserting state sovereignty. The article presses forward by emphasizing the importance of the principle of free, prior and informed consent responding to the long list of principles and commitments in the policy areas of economics, environment, culture & society, political governance, security, and justice made by nations and states since 1977. I suggest that existing agreements on principles and commitments if implemented by nations and states may resolve most of the current conflicts. Specific principles and commitments are discussed and sourced to treaties, conventions, declarations, and outcome documents issued by nations and states from 1977 forward.
Editor’s note: The Fourth World Journal is published by the Center for World Indigenous Studies.
Legal and Ethical Challenges in the Construction of China’s Biobanks
Legal and Ethical Challenges in the Construction of China’s Biobanks
Jiajv Chen, Jiayu Huang, Xuekai Xie
Biotechnology Law Report, 26 August 2021
Abstract
China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China’s biobanks have collected a large number of biological samples. The law gives many institutions the right to store and use biological samples; however, due to the absence of government regulation, lack of ethical norms, and unclear legal provisions, the risks related to biosafety are rising. In terms of informed consent, China’s current legislation clearly defines the scope and standard of “informed consent,” but the corresponding boundaries are still vague, and there are loopholes in practical operation. In terms of privacy and confidentiality, Chinese laws do not specify the ownership of genetic information. In the event of genetic risk, Chinese doctors often tell the family members of patients about genetic information. In terms of cross-border supervision of biological samples, the Chinese government not only regulates the entry of biological samples, but also controls the exit of biological samples. In recent years, the corresponding law enforcement and punishment efforts have increased. In terms of trust, China’s biobanks often rely on hospitals. Against the background of tense doctor-patient relationships, biological sample donors do not trust hospitals, which is unfortunate because biological sample donors often donate out of their trust in doctors. In terms of benefit sharing, China’s legal system still lacks clear provisions, and there are disputes about the mode and subject of benefit sharing. In China’s future legislative revision(s), the above aspects should be improved, the ethical traditions of China’s “patriarchal system” should be considered, and a biobanking system in line with China’s national conditions should be formulated.
Family Refusal to Consent Donation: Retrospective Quantitative Analysis of Its Increasing Tendency and the Associated Factors Over the Last Decade at a Spanish Hospital
Family Refusal to Consent Donation: Retrospective Quantitative Analysis of Its Increasing Tendency and the Associated Factors Over the Last Decade at a Spanish Hospital
José Manuel Viñuela-Prieto, Maria Carmen Escarpa Falcón, Francisco Javier Candel, Alonso Mateos Rodríguez, Juan Ignacio Torres González, Francisco del Río Gallegos
Transplantation Proceedings, 19 August 2021
Open Access
Abstract
Background
Organ and tissue recovery remains limited by several factors. This study retrospectively analyzes the factors associated with family refusal to consent to donation at a high-donor-volume Spanish hospital.
Methods
Data regarding the annual number of potential donors and family refusal rates at hospital and regional levels were retrieved from 2008 to 2017. Descriptive, bivariate, and multivariate analyses were performed to detect those factors independently associated with family refusal. Results were cross-validated using the data from years 2018 and 2019 as the validation group. To explore potential inter-relations between factors a Multiple Correspondence Analysis was performed.
Results
A total of 601 family interviews for petition of consent were conducted between 2008 and 2017, 531 (88.4%) resulted in acceptance and 70 (11.6%) resulted in refusal of the donation. Lesser experience of the interviewers (odds ratio [OR], 2.980; P = .001), donation after brain death (OR, 2.485; P = .013), number of interviews conducted per family (OR, 1.892; P < .001), age of the main decision maker (OR, 1.025; P = .045), and high or middle attributed cultural levels (OR, 0.142; P < .001 and OR, 0.199; P < .001 respectively) were observed to be independently associated with the family final decision. The logistic regression model displayed good predictive power for both derivation and validation cohorts, with an overall predictive accuracy of 80.9% (95% confidence interval, 0.747-0.870; P < .001) and 74.4% (95% confidence interval, 0.635-0.854; P = .001), respectively.
Conclusions
Transplant coordination team members having a thorough knowledge of the family decision mechanisms may be a key factor in donation process optimization.
South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study
South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study
Research Article
Francis Akpa-Inyang, Sylvester C. Chima
BMC Medical Ethics volume, 14 August 20121; 22(111)
Open Access
Abstract
Background
The Western-European concept of libertarian rights-based autonomy, which advocates respect for individual rights, may conflict with African cultural values and norms. African communitarian ethics focuses on the interests of the collective whole or community, rather than rugged individualism. Hence collective decision-making processes take precedence over individual autonomy or consent. This apparent conflict may impact informed consent practice during biomedical research in African communities and may hinder ethical principlism in African bioethics. This study explored African biomedical researchers’ perspectives regarding informed consent and potential limitations to the principle of respect for autonomy in African communities.
Methods
We conducted a qualitative study based on in-depth interviews with 12 biomedical researchers, five females and seven males aged 34 to 74 years, currently working at an African university. Interviews lasted 35–40 min each and involved semi-structured open-ended interviews, which allowed participants to offer information about their perceptions and feelings regarding respect for autonomy and informed consent as practised in Africa. Empirical data from the interviews were recorded, transcribed, and analysed using thematic content analysis, together with an interrogation of relevant scientific literature about African communitarian ethics, making evaluations and drawing inferences consistent with the empirical bioethics approach.
Results
Based on these interviews and analysis of relevant literature, we found that informed consent is difficult to apply in an African context because it derives from a Western conception of libertarian rights-based autonomy. Most respondents pointed out that it was challenging to implement informed consent in the African setting. Furthermore, communalism, customary beliefs, spirituality, and relational autonomy are predominant in most African communities, as exemplified by the African moral philosophies of Ubuntu/Botho and Ukama, which emphasize communitarianism over individual rights. We also found that language, education, poverty, and cultural beliefs are barriers to obtaining proper informed consent in African communities.
Conclusions
We conclude that there are limitations to applying the principle of respect for autonomy and informed consent in African communities, especially in the context of human biomedical research. We recommend using a more relational approach, such as Ross’s prima facie duties, to implement informed consent in African communities.
Center for Informed Consent Integrity 