Month: April 2023

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Informed Consent: A Monthly Review
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April 2023 :: Issue 52

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_April 2023

Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products

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Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products
Original
Andrea G. Jaramillo Vélez, Margarita Aguas Compaired, Montserrat Granados Plaza, Eduardo L. Mariño, Pilar Modamio
Farmacia Hospitalaria, 16 March 2023
Abstract
Objective
The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.
Methods
Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.
Results
Very good concordance was obtained in both checklists (k ≥ 0.81, p b 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items.
Conclusion
The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Editor’s note: This is a Spanish language publication. Farmacia Hospitalaria is a publication of the Spanish Hospital Pharmacy Society.

Decisions to Enter Phase I Oncology Clinical Trials: Effectual and Ethical Informed Consent

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Decisions to Enter Phase I Oncology Clinical Trials: Effectual and Ethical Informed Consent
Stephanie Solomon Cargill, Natalie Hardy
Patient Education and Counseling, April 2023
Abstract
When faced with advanced stage cancer, patients consider participating in Phase I oncology clinical research trials. The likelihood of patients benefiting from trial interventions is low (5%). Although scholarship has found that participants overestimate the benefit interventions, research has failed to assess the social context that may influence how potential participants evaluate their decision to participate. This understanding is critical for ethical informed consent procedures. Thus, the aim of this pilot project was to examine oncology patients’ decisions to enroll in Phase 1 trials. In-depth interviews were conducted with eight adults who were invited to participate in Phase 1 oncology clinical trials. Analysis was guided by Problematic Integration Theory (PI, e.g., Babrow, 2001), providing a framework for understanding tensions among desires and expectations, particularly when faced with uncertainty. Researchers took an iterative analytical approach shifting between respondents’ viewpoints and PI theory. Analysis revealed that participants understood that when invited to the trial, their current treatments were ineffective. In facing the tension between the likelihood of benefitting from the trial intervention with the hope that the intervention would be successful (and incur few negative side effects), participants faced an ambivalent situation. Thus, participants entered conversations with research coordinators anticipating to enter the trial with few uncertainties. Participants expressed a desire for more information about the chances the trial would effectively treat their cancer, but trust that the medical team was acting in their best interest, providing hope.

Stakeholder perspectives on informed consent for the use of genomic data by commercial entities

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Stakeholder perspectives on informed consent for the use of genomic data by commercial entities
Webinar Report
Baergen Schultz, Francis E Agamah, Cornelius Ewuoso, Ebony B Madden, Jennifer Troyer, Michelle Skelton, Erisa Mwaka
Journal of Medical Ethics, 20 March 2023
Abstract
In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated with H3Africa (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context.

Ethical Considerations of Genome Sequencing for Pediatric Patients

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Ethical Considerations of Genome Sequencing for Pediatric Patients
Michelle M Sergi, Melissa C Keinath, Jonathan Fanaroff, Kathryn E Miller
Seminars in Pediatric Neurology, 1 March 2023
Abstract
Advancements in genetic testing in the healthcare setting, most recently genomic sequencing, has enhanced our ability to diagnose genetic conditions. These advances include increased accessibility and affordability of genomic technologies. With expanded use comes the potential for significant ethical challenges for clinicians, particularly considering the implications of testing a child for one condition and incidentally finding a different condition or health risk. In this focused review, we address various ethical considerations from informed consent to the rights of a child undergoing genetic testing.

Right To Consent In Informed Consent For Medical Treatment For People With Mental Health Disorders

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Right To Consent In Informed Consent For Medical Treatment For People With Mental Health Disorders
Santi Novia Ayu Kurniawati, Erna Dyah Kusumawati
International Journal of Business, Economics and Law, April 2023; 28(3)
Open Access
Abstract
Based on the philosophy of legal protection, this article seeks to determine the interpretation of the meaning of mental disorders according to the Civil Code and the application of informed consent to medical treatment for people with mental disorders governed by the Civil Code. Based on the principle of legal protection, this article also seeks to determine the implementation of informed consent to medical treatment for people with mental problems. In this study, the normative law method is being employed. The study’s findings reveal that one interpretation of the idea of mental disorder, based on Article 433 of the Civil Code which reads, “Any adult who is constantly dumb, sick of the brain, or dark-eyed should be put under guardianship, even when he is occasionally proficient with his mind.” maintains that mental disorder is a sort of inability to act or incompetence to conduct a legal act. Following the requirements of the Civil Code, even if those under guardianship are adults, they are considered legally incapable. Due to their inability to act for themselves, individuals with mental problems must give informed consent to medical treatment through family members or legal guardians. The application of informed consent to medical treatment for people with mental problems is governed by the Civil Code, which requires physicians to acquire permission from the patient’s family (supporters, according to the Civil Code). Due to their inability to make decisions for themselves, people with mental disorders cannot give informed permission for medical treatment. However, under Law No. 18 of 2014 concerning Mental Health, social services will assume the role of guardian if the patient has no family or relatives.

Editor’s note: The Civil Code referenced in this abstract is present in Indonesia.

Cardiac Interventions In The Absence Of Assent: An Ethical Dilemma

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Cardiac Interventions In The Absence Of Assent: An Ethical Dilemma
Complex Clinical Cases
Cooper B. Kersey, Beteal Ashinne, Jeffrey Keenan, James N. Kirkpatrick
Journal of the American College of Cardiology, March 2023
Open Access
Abstract
Background
Cardiovascular practitioners increasingly encounter complex treatment decisions, further complicated when patient decisional-capacity is impaired. We present an ethical conundrum of a patient without decision-making capacity who declined a life-saving surgery.
Case
A 63-year-old woman with schizophrenia and a prior history of mitral and aortic valve endocarditis was found to have recurrent endocarditis of her bioprosthetic mitral valve. Surgical management was recommended, but the patient declined. During a formal capacity assessment, the patient was deemed unable to comprehend her medical condition or the consequences of refusing surgery. The patient then developed transient complete heart block. Goals of care discussions revealed that the patient valued life prolongation and amelioration of her symptoms.
Decision-making
The patient’s durable power of attorney gave consent to proceed with the surgery. Surrogate decision-making rests on substituted judgement (based on knowledge of what the patient would have wanted) or best interest standards (based on beneficence or non-maleficence). The hospital ethics team supported the decision to proceed with surgery over the objections of the patient, in light of the prognosis without surgery, the likelihood of surgical benefit, and the values and goals the patient espoused. The ethics consult team also recommended seeking assent for the surgery from the patient. Assent is not required in addition to consent from a surrogate, but it oftentimes facilitates interventions without chemical or physical restraints. Ultimately, the patient provided passive assent and underwent successful re-do mitral and aortic valve replacements and was discharged in stable condition.
Conclusion
We highlight a case in which cardiovascular clinicians encountered a patient without decision-making capacity refusing a life-saving intervention. Cardiovascular clinicians should be familiar with important ethical elements involved in complex decision-making, including autonomy and its limits, substituted judgement and best interests standards, and standards and laws pertaining to surrogate decision-makers.

Parents’ and child welfare workers’ understandings of consent to emergency placements

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Parents’ and child welfare workers’ understandings of consent to emergency placements
Research Article
A.S. Storhaug, M.K. Fylkesnes, E. Langsrud, Ø. Christiansen
Nordic Social Work Research, 22 March 2023
Abstract
Emergency placements of children are often made in haste and experienced as dramatic. This article is based on interviews with 9 parents who have consented to emergency placements and their caseworkers. We explore parents’ reasons for giving their consent to placement and the child welfare workers’ understanding of these consents. This leads to a discussion of what constitutes valid consent from parents in emergency cases. Relational autonomy is applied as a perspective to understand the context and influencing factors of parental consent. The results, derived by thematic analysis, show three main themes regarding parents’ reasons for their consent: (1) The child wanted to move out, (2) the parents couldn’t manage the situation, and (3) parents felt the child welfare service (CWS) gave them no choice. Parents experience a high degree of pressure in the context of giving their consent, either from their child or the CWS. Asymmetrical power dynamics between the CWS and parents were highly present and relevant in parents’ reasons for consent, especially when the CWS communicated that the alternative to consent is coercive placement. Furthermore, it is often unclear to the parents what consent entails. This is especially evident through CWS’s regulation of child-parent contact. In the discussion, we emphasize a high degree of awareness on the part of CW workers with regards to understanding how contextual and relational factors influence parent’s choice to consent; when consent is valid; how far consent extends, and the potential weakening of parents’ legal security when a voluntary placement is conducted.

Perceptions of pediatric deceased donor consent: A survey of organ procurement organizations

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Perceptions of pediatric deceased donor consent: A survey of organ procurement organizations
Gretchen B Chapman, Alison Butler, Mandy Lanyon, Justin Godown, Daniel J Lebovitz
Pediatric Transplant, 21 March 2023
Abstract
Background
Children awaiting transplantation face a high risk of waitlist mortality due to a shortage of pediatric organ donors. Pediatric donation consent rates vary across Organ Procurement Organizations (OPOs), suggesting that some OPOs might utilize more effective pediatric-focused donor recruitment techniques than others. An online survey of 193 donation requestor staff sheds light on the strategies that OPO staff utilize when approaching potential pediatric deceased organ donors.
Methods
In collaboration with the Association of Organ Procurement Organizations, the research team contacted the executive directors and medical directors of all 57 of the OPOs in the US. Of these, 51 OPOs agreed to participate, and 47 provided contact information for donation requestor staff. Of the 379 staff invited to participate in the survey, 193 provided complete responses.
Results
Respondents indicated more comfort approaching adult donors than pediatric donors, and they endorsed approach techniques that were interpersonal and emotional rather than professional and informative. Respondents were accurate in their perceptions about which donor characteristics are associated with consent. However, respondents from OPOs with high consent rates (according to data from the Scientific Registry of Transplant Recipients), and those from OPOs with low consent rates were very similar in terms of demographics, training, experience, and reported techniques.
Conclusions
Additional research is needed to better determine why some OPOs have higher consent rates than others and whether the factors that lead to high consent rates in high-performing OPOs can be successful when implemented by lower-performing OPOs.

Children’s ages of consent to non-urgent heart surgery: The views of two paediatric cardiology teams

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Children’s ages of consent to non-urgent heart surgery: The views of two paediatric cardiology teams
Original Article
Priscilla Alderson, Hannah Bellsham-Revell, Liz King, Trisha Vigneswaran, Jo Wray
Children & Society, 4 March 2023
Open Access
Abstract
Paediatric cardiology practitioners and related experts report unusually young ages when they begin to inform children about their non-urgent heart surgery and begin to respect children’s consent or refusal. Research methods included observations in two paediatric cardiology units, audio-recorded interviews with 45 experts, and qualitative data analysis. Significantly younger ages were cited than are usually recommended in the clinical and legal literature. Interviewed practitioners took seriously children’s consent to or refusal of a heart transplant from around 6 years, and a child’s firm refusal of induction of anaesthesia from around 4 years, when surgery might be postponed.