Consent forms: the participation of children in research

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Consent forms: the participation of children in research
Research
Flavia Andrade Nunes Fialho, Ieda Maria Ávila Vargas Dias, Marisa Palacios de Almeida Rego
Revista Bioética, April – June 2022; 30(2)
Abstract
The Resolution 466/2012 of the National Council of Health establishes the term of assent as compulsory for research carried out with children. However, the resolution presents the definition of assent without specifying the terms necessary for the document. This gap makes current and pertinent the approach of this topic by this study, which aims to discuss the participation of children in research. The results present a theoretical framework from which we can reflect on the ethics of Research with children, considering their vulnerability, which can lead to irreparable situations. We conclude that the theme must remain in the academic and professional debates since, on top of being a dynamic reality, this population segment has many specificities.

Editor’s note: This abstract refers to the National Council of Health in Brazil.

Informed Consent in Medical Law in the Romanian Legal System: A Comparative Perspective

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Informed Consent in Medical Law in the Romanian Legal System: A Comparative Perspective
Camelia Mihăilă
Journal of Intercultural Management and Ethics, 2022
Open Access
Abstract
This paper aims to analyse the principle of consent in the medical act from a comparative law perspective. While the introduction gives a brief presentation of the definition of consent from the perspective of legal doctrine, the content of the paper analyses some legislative landmarks in the Romanian legal system, as well as in the French and Spanish legal systems. Consent is one of the basic principles of modern medical bioethics and an essential element of the validity of the medical contract, ensuring respect for human dignity and protection of the patient’s bodily integrity. While Romanian law is based more on the idea of information, Spanish law analyses consent from the point of view of a personalist right, including it in the short list of personal rights enshrined in Law 1/1982 on the protection of honour, image and privacy. French law, on the other hand, has a long history of case law regulating consent in medical acts, with the Teysier and Mercier cases being worth mentioning.

Cameroon: New Law on Medical Research Involving the “Human Person” Adopted

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Cameroon: New Law on Medical Research Involving the “Human Person” Adopted
Article
Nicolas Boring
The Global Legal Monitor, Library of Congress, 2022
Excerpt
On April 27, 2022, the Parliament of Cameroon adopted a law providing a new framework for medical research involving the “human person.” This law places a particular emphasis on the right to information and the free, informed, and written consent of the participants. It also provides guarantees regarding respect for privacy and confidentiality of personal data and respect for human integrity, dignity, and vulnerability…
Background to the Law
According to Cameroonian press reports, the new law was drafted in reaction to a scandal involving the trial of a preventive treatment for AIDS conducted in 2004 by the American NGO Family Health International on sex workers in Douala “in violation of [their] ethical and deontological rights.” The new law also represents a response to the recent proliferation in Cameroon of clinical trials of COVID-19 treatments conducted without rigorous controls.
Content of the Law
The newly enacted law delimits the scope of consent for medical research involving minors (articles 15 and 16), disabled persons (articles 17 and 18), and pregnant women (articles 19 and 20). It also provides a framework for medical research on in vivo fetuses and in vivo embryos (articles 19 to 22). Finally, the law addresses research conducted on stillborn children (articles 23 and 24) and on the dead (articles 27 and 28)…

Navigating accountability in humanitarian photography at sea: a snapshot of embedded photographer practices in obtaining informed consent during I/NGO search and rescue operations in the Mediterranean

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Navigating accountability in humanitarian photography at sea: a snapshot of embedded photographer practices in obtaining informed consent during I/NGO search and rescue operations in the Mediterranean
Masters Thesis
Arran Smith
Uppsala University, 2022
Abstract
This thesis aims to contribute to ethical discussions on the production of photography in different humanitarian contexts, and in circumstances where it is facilitated by nongovernmental and international non-governmental organisations (I/NGOs). Humanitarian photography is often reproduced and circulated in various forms by different actors, highlighting the need for research on the actions, decisions, and interactions that influence how these images are produced. An extensive literature review captures the many ethical challenges surrounding humanitarian photography and provides an overview of related standards. A conceptual framework is then built around informed consent as an accountability mechanism, with consideration for certain relational and situational factors that influence the quality and effectiveness of the process of obtaining consent. Emphasising photographer and organisational accountability, an analysis of how photographers apply the concept of informed consent and its potential as an accountability mechanism is explored through the case study of embedded photographers in search and rescue (SAR) I/NGO operations in the Mediterranean Sea. Four semi-structured in-depth interviews were completed with photographers involved in SAR I/NGO missions in the Mediterranean from 2015 to 2021. The interviews suggest that a continuous and deliberate process of individual, organisational, and collaborative self-regulation unfolds throughout a mission, largely through verbal communication and body language, in an effort to obtain consent to take or use images of people who have been rescued. Use of formal means such as written consent forms are only rarely used. Photographs during the rescues were generally taken without prior consent, and photographers’ ability to obtain meaningful subsequent informed consent was easily compromised due to the unpredictable conditions during SAR operations and the variation across I/NGO-photographer partnerships. These findings support the need for further dialogue in this context to ensure that practices and processes related to the production of humanitarian photography, such as obtaining informed consent, are compatible with humanitarian principles, respect the rights and dignity of people affected by crisis, and foster greater accountability.

Refugee Attitudes Towards Patient Autonomy-Based Ethics of Informed Consent

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Refugee Attitudes Towards Patient Autonomy-Based Ethics of Informed Consent
Book Chapter
Sukran Sevimli
Practices, Challenges, and Prospects of Digital Ethnography as a Multidisciplinary Method, 2022 [IGIG Global]
Abstract
The objective of this study was to identify refugees’ attitudes concerning the autonomy-based ethics of informed consent and to determine whether these attitudes varied by gender. A quantitative methodology was adopted for this study. Questions were scored using a Likert-type scale and face-to-face interviews were conducted with 610 refugees who had migrated to Turkey from MENA and Caucasia countries. Refugees from eleven countries participated in the survey, of whom the majority were men (62.5% male versus 37.5% female). Autonomy is a fundamental principle of human rights and medical ethics. Refugees from MENA countries, where the concept of autonomy is contrary to the deeply-held traditional religious views of much of the population, in general, have a poor grasp of informed consent as a patient right. Traditional values steeped in patriarchy constitute an obstacle to women making decisions regarding their own lives in MENA and Caucasia countries. Therefore, the practice of informed consent is of critical importance in helping to reduce gender differentials in healthcare.

Informed consent for surgical case reports

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Informed consent for surgical case reports
Mohamed Onyango, Brian Kariuki
The Annals of African Surgery, 30 June 2022
Open Access
Excerpt
Informed consent is one of the most essential pillars of medical research ethics (1). It encompasses the medical ethical principle of autonomy which enables the participants to decide on whether or not to partake in a study without any coercion (2). It also enables patients to make informed decisions after critically analyzing the implications of the facts presented by the surgeon (3). It is of great importance that surgeons apply specific informed consent rules for specific study designs they undertake. The majority of studies submitted to surgical journals are case reports, but the process for obtaining quality informed consent is still insufficient. In addition, some journals do not have well-defined informed consent protocols for case report studies. This editorial thus aims to highlight case report specific rules for informed consent for surgeons to employ prior to commencement of their research…

Are Consent Forms Used in Cardiology Clinics Easy to Read?

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Are Consent Forms Used in Cardiology Clinics Easy to Read?
İbrahim Etem Dural
Archives of the Turkish Society of Cardiology, 30 June 2022
Open Access
Abstract
Objective
Informed consent forms are a contract between the patient and the doctor before the medical diagnosis and treatment. It is extremely important that the patient can read and understand such forms. The purpose of the present study was to investigate the readability levels of consent forms recommended by the Turkish Society of Cardiology used in cardiology clinics.
Methods
The number of words, syllables, letters, and characters of 20 consent forms that are used in cardiology clinics were calculated. The readability scores were calculated by using the formulas of Ateşman and Bezirci–Yılmaz.
Results
It was found that the cardiology consent forms were readable at the 11th or 12th grade according to the Ateşman Index and at the high school level according to the Bezirci–Yılmaz Index.
Conclusion
We suggest that the informed consent forms recommended by the Turkish Society of Cardiology must be simplified from the level that requires high school education to the level that requires 6 years of education, which is the average schooling year in Turkey.

Patients’ Choice, Consent, and Ethics in Patient Blood Management

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Patients’ Choice, Consent, and Ethics in Patient Blood Management
James P. Isbister, Bronwyn L. Pearse, Alana S. Delaforce, Shannon L. Farmer
Anesthesia & Analgesia, September 2022; 135(3) pp 489-500
Infographic
Picture 1
Abstract
…Patients must be informed of their diagnosis, the nature, severity and prognosis of the disease, and treatment options along with risks and benefits. They should be involved in decision-making regarding their management. However, as part of this process, there are multifaceted medical, legal, ethical, and economic issues, encompassing shared decision-making, patient choice, and informed consent. Furthermore, variability in patient circumstances and preferences, the complexity of medical science, and the workings of health care systems in which consent takes place can be bewildering, not only for the patient but also for clinicians obtaining consent…

How Informed Is Your Informed Consent: Evaluating Differences Between Resident and Attending Obtained Consents for Cholecystectomy

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How Informed Is Your Informed Consent: Evaluating Differences Between Resident and Attending Obtained Consents for Cholecystectomy
Kathleen E. Singer, Jennifer E. Baker, Nora C. Elson, Taylor E. Wallen, Ann Salvator, Ralph C. Quillin, Jeffrey J. Sussman, Amy T. Makley, Michael D. Goodman
Journal of Surgical Education, 24 August 2022
Abstract
Objective
There is considerable variability in surgeons’ approach to write and obtain informed consent for surgery, particularly among resident trainees. We analyzed differences in procedures and complications described in documented surgical consents for cholecystectomy between residents and attendings. We hypothesized that attending consents would describe more comprehensive procedures and complications than those done by residents.
Design
This is a retrospective analysis of 334 patients who underwent cholecystectomy. Charts were queried for demographics, surgical approach, whether the consent was completed electronically, and which provider completed the consent. Specifically, consents were evaluated for inclusion of possible conversion to open procedure, intraoperative cholangiogram, bile duct injury, injury to nearby structures, reoperation, bile leak, as well as if the consent matched the actual procedure performed.
Setting
This study was conducted at an accredited general surgery training program at an academic tertiary care center in the Midwest.
Participants
This was a review of 334 patients who underwent cholecystectomy over a 1 year period.
Results
Of all documented consents analyzed, 153 (47%) specifically included possible intraoperative cholangiogram, 156 (47%) included bile duct injury, 76 (23%) included injury to nearby structures, 22 (7%) included reoperation, and 62 (19%) included bile leak. In comparing residents and attendings, residents were more likely to consent for bile duct injury (p = 0.002), possible intraoperative cholangiogram (p = 0.0007), injury to nearby structures (p < 0.0001), reoperation (p < 0.0001), and bile leak (p < 0.0001).
Conclusions
Significant variation exists between documentation between resident and attending cholecystectomy consents, with residents including more complications than attendings on their consent forms. These data suggest that experience alone does not predict content of written consents, particularly for common ambulatory procedures. Education regarding the purpose of informed consent and what should be included in one may lead to a reduction in variability between providers.

Shared Consent: Acknowledging the Subjectivity of Surgical Decision-making

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Shared Consent: Acknowledging the Subjectivity of Surgical Decision-making
Surgical Perspectives
Paul J.Kepper, Sean C. Wightman, Baddr A. Shakhsheer
Annals of Surgery, 22 August 2022
Excerpt
Surgeons aspire to make data-driven decisions to provide the highest level of patient care. Evidence-based medicine mandates utilization of the best available data to guide decision making. The decision to offer an operation, however, is more than an evaluation of clinical evidence. Clinical expertise applies evidence-based medicine to a specific patient and tailors the practice of medicine to individual patient situations and preferences. Clinicians fill the gaps in the evidence with expertise developed over years of experience and training. Bridging these gaps is often described as the “art of surgery”; it is inherently subjective. Shared consent is the process that acknowledges subjectivity in decision-making. Shared consent is the foundation for a cooperative cognitive model between patient and surgeon, interpreting the available data through the lens of patient preference while relying on surgeon expertise…