Coercion and non-consent during birth and newborn care in the United States
Original Article
Rachel G. Logan, Monica R. McLemore, Zoë Julian, Kathrin Stoll, Nisha Malhotra, Saraswathi Vedam
Birth, 23 June 2022
Open Access
Abstract
In the United States, Black, Indigenous, and People of Color (BIPOC) experience more adverse health outcomes and report mistreatment during pregnancy and birth care. The rights to bodily autonomy and consent are core components of high-quality health care. To assess experiences of coercion and nonconsent for procedures during perinatal care among racialized service users in the United States, we analyzed data from the Giving Voice to Mothers (GVtM-US) study.
Methods
In a subset analysis of the full sample of 2700, we examined survey responses for participants who described the experience of pressure or nonconsented procedures or intervention during perinatal care. We conducted multivariable logistic regression analyses by racial and ethnic identity for the outcomes: pressure to have perinatal procedures (eg, induction, epidurals, episiotomy, fetal monitoring), nonconsented procedures performed during perinatal care, pressure to have a cesarean birth, and nonconsented procedures during vaginal births.
Results
Among participants (n = 2490), 34% self-identified as BIPOC, and 37% had a planned hospital birth. Overall, we found significant differences in pressure and nonconsented perinatal procedures by racial and ethnic identity. These inequities persisted even after controlling for contextual factors, such as birthplace, practitioner type, and prenatal care context. For example, more participants with Black racial identity experienced nonconsented procedures during perinatal care (AOR 1.89, 95% CI 1.35–2.64) and vaginal births (AOR 1.87, 95% CI 1.23–2.83) than those identifying as white. In addition, people who identified as other minoritized racial and ethnic identities reported experiencing more pressure to accept perinatal procedures (AOR 1.55, 95% CI 1.08–2.20) than those who were white.
Discussion
There is a need to address human rights violations in perinatal care for all birthing people with particular attention to the needs of those identifying as BIPOC. By eliminating mistreatment in perinatal care, such as pressure to accept services and nonconsented procedures, we can help mitigate long-standing inequities.
Month: July 2022
Formal Models for Consent-Based Privacy
Formal Models for Consent-Based Privacy
Neda Peyrone, Duangdao Wichadakul
Journal of Logical and Algebraic Methods in Programming, 20 June 2022
Abstract
The General Data Protection Regulation (GDPR) has changed the way businesses handle personal data. The GDPR is a set of conditions within the European Union (EU) law on data protection and privacy. The law requires software systems that store and manage personal data to use only the necessary information (‘data minimisation’) and manage the information fairly and appropriately (‘lawfulness, fairness and transparency’). Furthermore, personal data that can lead to direct or indirect identification must be kept safe. Therefore, the risk management of personal data within software mainly depends on the developers’ experience. The consent under the GDPR is an agreement between organizations (‘data controllers’) and individuals (‘data subjects’), which provides provisions for protecting personal data. The data controller must gain explicit consent from the data subject before collecting and processing the data. Hence, consent management is an essential component of a software system. This research proposes a set of formal models for consent management that take Privacy by Design (PbD) into account. We used the Event-B method to formalize the proposed models close to a real system. The Rodin platform proved each Event-B model to be corrected and deadlock-free. We also described how developers could transform Event-B models into the actual codes and demonstrated this result by mapping Event-B models into class diagrams. The proposed models meet consent compliance and privacy awareness requirements. In particular, the models cover certain aspects of privacy, including managing the consent of data subjects and controlling authorized access based on the data subject’s consent.
Consent and the Right to Privacy
Consent and the Right to Privacy
Kevin Mills
Journal of Applied Philosophy, 2 June 2022
Abstract
There is currently intense debate about the significance of user consent to data practices. Consent is often taken to legitimate virtually any data practice, no matter how invasive. Many scholars argue, however, that user consent is typically so defective as to be ‘meaningless’ and that user privacy should thus be protected by substantive legislation that does not rely (or does not rely heavily) on consent. I argue that both views rest on serious mistakes about the validity conditions for consent. User consent is sufficiently impoverished that it does not guarantee legitimacy but is not so impoverished as to be ‘meaningless’; it can legitimate data practices that are independently reasonable but not those that are exploitative. Since many valuable data practices must be consented to if they are to be legitimate (or so I argue), our privacy legislation should continue emphasizing the importance of user consent, even if auxiliary protections are also desirable.
Informed consent in a tuberculosis genetic study in Cameroon: information overload, situational vulnerability and diagnostic misconception
Informed consent in a tuberculosis genetic study in Cameroon: information overload, situational vulnerability and diagnostic misconception
Research Article
Ali Ibrahim Mohammed-Ali, Eyoab Iyasu Gebremeskel, Emmanuel Yenshu, Theobald Nji, Apungwa Cornelius Ntabe, Samuel Wanji, Godfrey B Tangwa, Nchangwi Syntia Munung
Research Ethics, 14 June 2022
Open Access
Abstract
Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study (TBGEN-Africa) in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception (research participants consider research as part of medical diagnosis), and information overload and situational vulnerability (consent at a time of physical and emotional distress). There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception.
Information Assessment for the Implementation of Electronic Informed Consent for Genetic Studies in a High Complexity Hospital
Information Assessment for the Implementation of Electronic Informed Consent for Genetic Studies in a High Complexity Hospital
Juan Descalzo, Eliana Frutos, Romina Rebrij, Daniel Luna, Sonia Benítez
Studies in Health Technology and Informatics, 6 June 2022; 290 pp 227-229
Abstract
The objective of this study was to investigate and analyze the most relevant aspects that influence the development and implementation of electronic informed consent for genetic studies. Interviews were conducted with experts in the area within our institution, the different informed consents available and the number of genetic studies requested in the last 5 years were analyzed. Professionals acknowledged the ethical dilemmas related to the genetic studies and the importance of having an electronic informed consent that not only provides the patient with the information necessary to understand the implications of the study, but also be flexible enough to adapt to the various genetic studies today. The development of informed consent is a challenge for health IT professionals, due to the complexity of the information it contains and the ethical implications it represents.
Parental informed consent comprehension in childhood cancer clinical trials: Associations with social determinants of health
Parental informed consent comprehension in childhood cancer clinical trials: Associations with social determinants of health
Paula Aristizabal, Shilpa Nataraj, Bianca Perdomo, Elena Martinez, Jesse Nodora, Courtney D Thornburg
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Abstract
Background
Adequate informed consent (IC) comprehension is an ethical right prior to participation in clinical trials. Research investigating IC comprehension and associations with social determinants of health (SDoH) is lacking. We assessed whether SDoH and related contextual factors were associated with parental IC comprehension in therapeutic childhood cancer clinical trials.
Methods
We prospectively enrolled parents of children with newly-diagnosed cancer. Univariable and multivariable regression were used to assess whether objective IC comprehension and related domains (Purpose/Procedures/Randomization, Risks/Benefits, Alternatives, and Voluntariness) were associated with SDoH (ethnicity, marital status, language, education attainment, employment, insurance, socio-economic status, health literacy [HL]) and contextual factors (cancer type, voluntariness, satisfaction with IC).
Results
Of 223 parents included, 112 (50%) were Hispanic and 38% of Hispanics were monolingual Spanish-speaking. In adjusted multivariable analyses, limited HL was significantly associated with lower overall IC comprehension (β = -7.22; 95% CI, -10.9 to -3.59; P < 0.001) and lower comprehension of Purpose/Procedures/Randomization (β = -7.53; 95% CI, -11.3 to -3.73; P < 0.001), Risks/Benefits (β = -8.14; 95% CI, -15.5 to -0.772; P = 0.031), and Alternatives (β = -17.0; 95% CI, -30.5 to -3.57; P = 0.013). Preferred Spanish language of written/verbal medical information was significantly associated with lower comprehension of Purpose/Procedures/Randomization (β = -8.50; 95% CI, -15.1 to -1.89; P = 0.012) and Voluntariness (β = -20.1; 95% CI, -34.9 to -5.33; P = 0.008). Lower satisfaction with informed consent (β = 0.988; 95% CI, 0.460 to 1.52; P < 0.001) and single marital status (β = -4.42; 95% CI, -7.81 to -1.02; P = 0.011) were significantly associated with lower IC comprehension.
Conclusions
Among parents of children with newly diagnosed cancer who provided consent for their child’s participation in a therapeutic clinical trial, limited HL was consistently associated with lower IC comprehension in all domains analyzed, except for Voluntariness. Spanish language preference for medical information was associated with lower comprehension of two domains; and lower satisfaction was associated with lower overall IC comprehension. These findings suggests that parents with limited HL, limited English-proficiency, and lower satisfaction may not fully comprehend the IC and thereby not truly make informed decisions. Our findings highlight the potential role of language-concordant interventions tailored to the participant’s HL level in order to ultimately improve IC comprehension and contribute to a reduction of disparities in clinical trial participation and promote equitable translation of discoveries and treatments to underserved groups.
Should Children Be Enrolled in Clinical Research in Conflict Zones?
Should Children Be Enrolled in Clinical Research in Conflict Zones?
Case and Commentary
Dónal O’Mathúna, Nawaraj Upadhaya
AMA Journal of Ethics, June 2022
Abstract
This commentary examines 4 ethical issues in a case of clinicians considering conducting research on children in conflict zones: (1) whether any time or resources should be taken away from treating acute injuries in order to conduct research; (2) obtaining consent for children to participate in research, which is particularly challenging given that children can be separated from parents or guardians; (3) whether the research is feasible at the moment, since starting research that stands little chance of being completed is ethically questionable; and (4) maintaining neutrality, impartiality, and humanity. Research that puts participants and researchers at risk of additional harm must be considered carefully. Here, we propose that both research and clinical care might occur simultaneously when researchers engage humbly with involved communities as the research is being designed, conducted, and reported in order to understand and resolve ethical issues involved.
Relational ethics, informed consent, and informed assent in participatory research with children with complex communication needs
Relational ethics, informed consent, and informed assent in participatory research with children with complex communication needs
Invited Review
Leni Van Goidsenhoven, Elisabeth De Schauwer
Developmental Medicine & Child Neurology, 28 April 2022
Open Access
Abstract
There is a need for qualitative participatory research involving children with intellectual disability and complex communication needs (CCNs), but procedural ethics cannot always adequately respond to the associated realities. To tackle this challenge, procedural ethics can be expanded with relational ethics to engage with consent and assent practices in participatory research projects. By drawing on several key incidents of participatory research with children with CCNs, we explore the complex moral spaces and times of ambivalent and iterative (dis)engagements within research processes. We reconceptualize the consent/assent terrain as a relationally constituted process, more aligned with the overall epistemological frameworks of participatory research and ensuring (disabled) children’s ongoing and meaningful involvement in research.
Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review
Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review
Original Article
Marcela Colom, Peter Rohloff
BMJ Paediatrics Open, 5 December 2018; 2
Open Access
Abstract
Introduction
Conducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.
Methods
We conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.
Results
The search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.
Conclusions
A scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.
Guiding Principles and Common Pitfalls of Capacity Assessment
Guiding Principles and Common Pitfalls of Capacity Assessment
Book Chapter
Dede Ukueberuwa O’Shea, Nicolette Gabel, Sarah Aghjayan, Maximilian Shmidheiser, Ross Divers
A Casebook of Mental Capacity in US Legislation, 2022 [Routledge]
Abstract
Psychologists must consider many complexities of professional practice and individual rights when conducting capacity assessments. This chapter reviews principles and standards that guide psychologists in conducting these evaluations. This chapter provides an overview of foundational abilities of an individual’s decisional capacity according to contemporary models, followed by a discussion of the widely accepted assumptions of decisional capacity assessment: inclusivity, decision-relativity, all-or-nothing assessment, value neutrality, and independence from diagnosis. In conducting capacity assessments, psychologists will also benefit from an understanding of the key bioethics principles of autonomy, beneficence, nonmaleficence, justice, informed consent, and voluntarism. This chapter then reviews specific standards of ethical practice relevant to capacity determinations that are outlined by the American Psychological Association (APA) and medical organizations. This chapter provides details on informed consent procedures in the context of evaluating decisional capacity, as well as standards that describe the need to practice within boundaries of competence, handle third party request for services, cooperate with other professionals, maintain confidentiality and make ethical disclosures, and limit conflicts of interest. Finally, this chapter discusses common pitfalls that psychologists may face when conducting capacity assessments and outline recommendations for best practices in gathering information and working with patients of diverse histories.
Center for Informed Consent Integrity 