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.
Month: August 2021
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.
Professionalism in Anesthesiology: Honesty and the Informed Consent Process
Professionalism in Anesthesiology: Honesty and the Informed Consent Process
Krishnan S. Ramanujan, Saundra Curry, Stephen H. Jackson
ASA Monitor, August 2021; 85(38)
Abstract
Medical professionalism is one of the core components of the practice of medicine and an evolving concept reflecting the changes in our health care system. In 2002, the ABIM Foundation defined medical professionalism in its Physician Charter, stating that professionalism “supports physicians’ efforts to ensure that the healthcare systems and physicians working within them remain committed both to patient welfare and to the basic tenets of social justice.” (Ann Intern Med 2002;136:243-6) The Physician Charter enumerated three fundamental principles as well as 10 responsibilities by which all physicians should abide, and it soon was adopted by many professional societies, including ASA (Ann Intern Med 2003;138:839-41). Eighteen years after its publication, the Physician Charter remains as the standard for professional conduct in medicine.
An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
Ibrahim Ethem Ay, Mustafa Doğan
Cureus, 26 July 2021; 13(7)
Abstract
Background/Aim
This study aimed to evaluate the comprehensibility of the consent forms used for interventional procedures in the ophthalmology clinic of a university hospital and to determine which texts could be read according to patient age and education level.
Materials and methods
Forty separate consent forms used as the standard for various interventional procedures in the ophthalmology department of a university hospital were evaluated. The comprehensibility formulas used were developed for the Turkish language by Ateşman and Bezirci-Yilmaz.
Results
As a result of the evaluation of the consent forms in this study, a mean of 55.6±5.73 points was obtained according to the Ateşman comprehensibility index, and this value was found to correspond to being understood by eleventh and twelfth-grade school students. According to the Bezirci-Yilmaz comprehensibility index, the mean points of the consent forms were 10.05±2, which corresponded to a level that could be understood by 10th and 11th-grade students.
Conclusion
The comprehensibility level of the consent forms given to patients was found to be low in this study, which was similar to the findings of previous studies in the literature. When preparing informed consent forms, the education level of the country must be taken into consideration.
Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis
Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis
Position Statement
Balato, E. Scala, F. Ayala, A. Bauer, M.-N. Crépy, M. Gonçalo, J. Duus Johansen, S.M. John, T. Rustemeyer, N. Wagner, M. Wilkinson, A. Giménez-Arnau
Journal of The European Academy of Dermatology and Venereology, 19 July 2021
Abstract
Background
To our knowledge, an international consensus is lacking regarding the development of an adequate informed consent form for a patch test (PT) and the information that should be included in such document.
Objectives
The aim of the study was to reach a consensus on the specific points that need to be addressed in a PT consent form.
Methods
A Delphi survey, comprising 2 rounds and 1 final discussion, was used to gather and analyse data, which was conducted over the Internet. Each statement that reached a consensus with the respondents (9 expert dermatologists from Europe) was defined as a median consensus score (MED) of ≥7 and agreement among panelists as an interquartile range (IQR) of ≤3. All study participants were members of the EADV task force on contact dermatitis.
Results
The expert panel addressed several topics that should be included in an informed consent form for a PT: introduction, preparation for PT, testing procedure, allowed activities, adverse events and additional authorizations.
Conclusions
Our results assess recommendations regarding points to be contained in an informed consent form for a PR. Future actions towards standardization and harmonization of this specific consent form are needed.
Center for Informed Consent Integrity 