Ethics Considerations Regarding Donors’ and Patients’ Consent
Book Chapter
Jeremy Sugarman
Brain Organoids in Research and Therapy, 10 July 2022; pp 121-130 [Springer]
Abstract
Informed consent is a crucial factor in determining whether particular uses of brain organoids for research and clinical translation are ethically acceptable. In the context of basic research, the consent of donors whose tissues are used to derive brain organoids is of primary concern, whereas in clinical translation the consent of both allogeneic donors and patients may be relevant. In this chapter, I examine key ethics considerations related to informed consent for brain organoid research and clinical translation. In order to do so, I first describe both a standard conceptual approach to informed consent that aims at meeting the ethical goal of respecting the autonomy of persons and some of the other ethically relevant functions of informed consent. This conceptual work provides a foundation for mapping ethics considerations related to informed consent in regard to the decision-making capacity and voluntariness of those being asked to consent, disclosure requirements associated with brain organoids in general and for particular proposed uses that involve morally significant aspects, threats to understanding that must be overcome, and considerations for authorization. Finally, I offer some suggestions for grappling with such informed consent challenges related to brain organoids.
Year: 2022
The Scope of Consent
The Scope of Consent
Joseph Millum
The Philosophical Quarterly, 2 July 2022
Extract
Suppose you come to my house and I invite you in. ‘I’m just heading out’, I say, ‘but make yourself at home’. I have consented to you remaining in my house, but what else? In your home, you put your feet up on the coffee table, so may you now do that in mine? If I complain that you’ve left crumbs from eating biscuits in my bed, can you defend yourself on the grounds that I told you to make yourself at home? These questions concern the scope of my consent. How we should ascertain the scope of someone’s consent is the topic of Tom Dougherty’s book. The book is divided into three main parts, each corresponding to a view about what fixes the scope of consent: the mental account, the successful communication account, and the evidential account, which Dougherty favours…
Informed Consent: A Monthly Review
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July 2022
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_July 2022
Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
NIH – Office of Science Policy/Office of Extramural Research, May 2022; pp 1-7
Introduction
…The following resource… outlines suggested points to consider when addressing data and biospecimen storage and sharing for future use in consent language and provides supplemental sample language that could be modified as needed when developing informed consent documents. Of note, the sample language provided below is designed to be incorporated into a primary research consent document. The use of the sample language by itself does not address federal, state, local, tribal, or international requirements that may apply to the primary research. Furthermore, this resource is designed for research consent documents; it does not address the storage and sharing of data and biospecimens initially collected for clinical purposes. Use of the information provided in this resource, including sample language, is completely voluntary.
Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives
Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives
Gonasagrie Nair, Siti M. Kabanda, Meagan M.M. Jacobs-Alfred, Adetayo E.A. Obasa, Michael G. McCaul, Keymanthri Moodley
South African Journal of Science, 31 May 2022; 5
Open Access
Abstract
The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate.
Improving first-in-human and window-of-opportunity informed consent forms through participant feedback
Improving first-in-human and window-of-opportunity informed consent forms through participant feedback
Anna Avinger, Hannah Claire Sibold, Gavin Paul Campbell, Eli Rowe Abernethy, John Bourgeois, Tekiah McClary, Shannon M. Blee, Margie D. Dixon, R. Donald Harvey, Rebecca D. Pentz
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Open Access
Abstract
Background
Although patient advocates have created templates for standard consent forms, assessing patient preferences for First in Human (FIH) and Window of Opportunity (WO) trials consents is important given their unique risks. FIH trials are the first time a drug is tested in humans. In WO trials, treatment naïve patients receive a therapeutic agent in the window of time between diagnosis and standard of care (SOC) surgery. Our goal was to determine patient-preferred presentation of important information in FIH and WO consent forms.
Methods
The study consisted of two phases: (1) analysis of consents for FIH and WO oncology trials open at a cancer center between 2019 and 2022; (2) interview patients who had reviewed consents for FIH or WO trials during the consent process. FIH consents were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH info). The WO consents were analyzed for the location(s) of information stating the risk that trial may delay SOC surgery (WO info). Participants were asked about their preferred placement of the information in their own trial’s consent form and whether the consent was clear. Interviews were audio-recorded and double coded. Consent form analysis was compared to patients’ preferences.
Results
25 consents [20 FIH; 5 WO] were analyzed. 19/20 FIH consent forms included FIH info, and 4/5 WO consent forms included WO info. 42 patients were approached [19 FIH; 23 WO]; 34 [17 FIH; 17 WO] participated. 12/17 (71%) WO participants thought that the trial explanation in the consent form was clear. Conversely, only 9/17 (53%) FIH participants found it clear.
Conclusions
Patients preferred that the important FIH and WO information be placed early in the consent, though exactly where varied. 82% of FIH participants wanted FIH information in the purpose, while only 19% of WO participants clearly preferred that WO information be in the purpose, and 41% preferred WO information to remain in the risks section. Using consent templates that reflect patient preferences accurately is essential for ethical informed consent; however, a one-size fits all approach may not accurately capture patient preferences, so multiple templates may be necessary.
Coercion and non-consent during birth and newborn care in the United States
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.
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.
Center for Informed Consent Integrity 