Uninformed consent: Who knows what Ivan Ilyich would have thought?
Commentary
A D’Imperio, M Ienca, A Maiese, V Fazio, R La Russa
La Clinica Terapeutica, 1 July 2021, 172(4) pp 264-267
Open Access
Abstract
In the modern era, when prolonging life is not an option, the end-of-life discussions are unavoidably influenced by Neuroethics. Despite this, it is interestingly evident how the sentiments of a terminal patient of 1885 and a physician of 2020, are still comparable. This paper presents the arguments behind the so-called “Therapeutic Misconception” and the aim of palliative care to provide dying patients support. It is essential to address priorities of informed consent, signed before any remedy is provided. A key component of the newest Neuroscience research is the analysis of motivation and free will. So, it is necessary to comprehend if the patient struggles to feel at peace with these aspects of his “right to die”: Is he free to choose or is he influenced by the doctors? Is this confusion an example of “Therapeutic Misconception”? Is his Informed Consent totally “Informed”? In order to broaden our understanding, we account for many critical situations, such as the mentally impaired Psychiatric patients or the famous Italian case of Eluana Englaro. In addition, we suggested some current approaches such as Artificial Intelligence, useful in preserving some cognitive functions the patient may have lost. Furthermore, research in this field is very critical and in some Catholic countries like Italy, people faced difficulties accepting the idea of the “Anticipated directives”. In general, whatever the mental status and whatever the terminal state, the patients seem still far from handling their own auto-determination and their Consent, even if the ultimate goal is to die with dignity.
Ethical Aspects of Informed Consent in Dementia
Ethical Aspects of Informed Consent in Dementia
Ethical Viewpoint Paper
Dhruv Parmar
Global Bioethics Enquiry, 2021; 9(1)
Open Access
Excerpt
Informed Consent is an ethical and legal obligation that a medical practitioner or researcher must take in order to explain the treatment plan or enrol a participant in a research trial. In this process the participant or patient is informed about all the aspects of the treatment or trial in detail, which are important for the participant or patient to decide after studying these aspects in detail whether they want to voluntarily confirm their participation in the trial or is willing to undergo the said procedure or treatment. The concept is based on the principle of the Nuremberg Code, The Declaration of Helsinki, and the Belmont Report.
The informed consent is described in ethical codes and regulations for human subject’s research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study. The same is applicable when an Individual undergoes a medical procedure, surgery or takes certain medications. No individual has the right to infringe a person’s fundamental right, thus “Informed Consent” is an important and ethical tool…
Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Sonya Gaches
Journal of Childhood Studies, July 2021; 46(2)
Open Access
Abstract
Utilizing the four features of informed consent from the guiding document Ethical Research Involving Children, the article illustrates how the informed consent process was carried out with young children from the initial planning stages through the ongoing research’s focused conversations. Specifically, the questions of what would be needed to acquire informed consent from the children and what assurances could there be that young children understood the research and how its results would be disseminated are addressed. The article concludes with suggestions for what other researchers might consider and include in their local contexts.
Editor’s note: The abstract references the 2013 unicef report Ethical Research Involving Children.
Implementing Informed Consent with Knowledge Graphs
Implementing Informed Consent with Knowledge Graphs
Anelia Kurteva
European Semantic Web Conference, ESWC 2021 Satellite Events, 21 July 2021; pp 155-164
Abstract
The GDPR legislation has brought to light one’s rights and has highlighted the importance of consent, which has caused a major shift in how data processing and sharing are handled. Data sharing has been a popular research topic for many years, however, a unified solution for the transparent implementation of consent, in compliance with GDPR that could be used as a standard, has not been presented yet. This research proposes a solution for implementing informed consent for sensor data sharing in compliance with GDPR with semantic technology, namely knowledge graphs. The main objectives are to model the life cycle of informed consent (i.e. the request, comprehension, decision and use of consent) with knowledge graphs so that it is easily interpretable by machines, and to graphically visualise it to individuals in order to raise legal awareness of what it means to consent and the implications that follow.
Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?
Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?
N Di Fazio, B Fineschi, M Caporale, Z Del Fante, G Volonnino, P Santoro, R La Russa
La Clinica Terapeutica, 1 July 2021, 172(4) pp 253-255
Open Access
Abstract
Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge’s permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP’s informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.
The History and Policy Evolution of Waivers of Informed Consent in Research
The History and Policy Evolution of Waivers of Informed Consent in Research
Austin Connor Kassels, Jon F Merz
The Journal of Legal Medicine, January-June 2021; 41(1-2) pp 1-28
Abstract
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person’s abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would “destroy or invalidate” critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.
Free, Prior, and Informed Consent: A Struggling International Principle
Free, Prior, and Informed Consent: A Struggling International Principle
Emily M. McCulloch
Public Land & Resources Law Review, June 2021; 44(5)
Open Access
Excerpt
Global development diminishes the voices of indigenous populations around the world. Resource extraction and commercial use threaten even the most isolated groups. In an effort to develop enforceable rights for indigenous peoples, the United Nations Declaration of the Rights of Indigenous Peoples sought to protect indigenous peoples through the principle of the Free, Prior, and Informed Consent (“FPIC”). This paper focuses on why the FPIC is struggling to take hold in the international community.
Gurus and Griots: Revisiting the research informed consent process in rural African contexts
Gurus and Griots: Revisiting the research informed consent process in rural African contexts
Debate
Richard Appiah
BMC Medical Ethics, 23 July 2021; 22(98)
Open Access
Abstract
Background
Researchers conducting community-based participatory action research (CBPAR) in highly collectivistic and socioeconomically disadvantaged community settings in sub-Saharan Africa are confronted with the distinctive challenge of balancing universal ethical standards with local standards, where traditional customs or beliefs may conflict with regulatory requirements and ethical guidelines underlying the informed consent (IC) process. The unique ethnic, socioeconomic, and cultural diversities in these settings have important implications for the IC process, such as individual decisional autonomy, beneficence, confidentiality, and signing the IC document.
Main text
Drawing on insights and field observations from conducting CBPARs across several rural, highly communal, low literate, and low-income communities in Ghana, we discuss some theoretical, ethico-cultural, and methodological challenges associated with applying the universal, Western individualistic cultural value-laden IC process in sub-Saharan Africa. By citing field situations, we discuss how local cultural customs and the socioeconomic adversities prevalent in these settings can influence (and disrupt) the information disclosure process, individual decisional authority for consent, and voluntariness. We review the theoretical assumptions of the Declaration of Helsinki’s statement on IC and discuss its limitations as an ultimate guide for the conduct of social science research in the highly communal African context. We argue that the IC process in these settings should include strategies directed at preventing deception and coercion, in addition to ensuring respect for individual autonomy. We urge Universities, research institutions, and institutional review boards in Africa to design and promote the use of context-appropriate ethical IC guidelines that take into consideration both the local customs and traditional practices of the people as well as the scientific principles underpinning the universal IC standards.
Conclusion
We recommend that, rather than adopt a universal one-size-fits-all IC approach, researchers working in the rural, highly collectivistic, low literate, socioeconomically disadvantaged settings of sub-Saharan Africa should deeply consider the roles and influence of cultural values and traditional practices on the IC and the research process. We encourage researchers to collaborate with target communities and stakeholders in the design and implementation of context-appropriate IC to prevent ethics dumping and safeguard the integrity of the research process.
Consent to research participation: understanding and motivation among German pupils
Consent to research participation: understanding and motivation among German pupils
Jana Reetz, Gesine Richter, Christoph Borzikowsky, Christine Glinicke, Stephanie Darabaneanu, Alena Buyx
Research Article
BMC Medical Ethics, 16 July 2021; 22(93)
Open Access
Abstract
Background
The EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights.
Method
This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany.
Results
A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process.
Conclusion
Bearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.
Patient Informed Consent Awareness form in Public Hospitals of Punjab, Pakistan
Patient Informed Consent Awareness form in Public Hospitals of Punjab, Pakistan
Saadet Khan, Rabia Afzal, Dr. Saba Farooq, Sohail Ahmed
Psychology and Education, 18 November 2020; 58(5) pp 4645-4655
Abstract
In Pakistan hospitals, it is generally observed that informed consent is not obtained, or they are not provided with enough explanations about the forthcoming processes and their future consequences by the healthcare teams. The purposes of this study was to explore patient’s perception of informed-consent in hospitals of Punjab. It was an exploratory study. A total of 120 patients (84male, 36 female) were included in this study. The patients were selected from public hospitals of Punjab after taking informed consent. A pre- designed and pre-structured validated questionnaire was used for data collection from patients who went through surgical/medical procedures. The data was analyzed through SPSS version 20. Results: In this study, 70% male and 30% female participants with different age groups have participated. Frequency analysis of each question was done to check the response against each statement. The results of independent sample t-test show that there is insignificant difference between male and female groups regarding the understanding level, scope, values and function toward patient informed consent. There is lack of awareness about legal implications of signing or not signing of the informed consent among Patients in Punjab. It is concluded that most of the clinical settings in Pakistan are unaware of importance to obtain informed consent when practicing the workplace environment. It should be emphasized that there would be a need to develop an educational program towards inform consent and further reassessed in order to achieve patient autonomy. The studies should be carried out in other provinces of Pakistan to check that all the workplace environment are following informed consent practices in the workplace.
Center for Informed Consent Integrity 