Spanish online survey on informed consent for the performance of paracentesis. Do we have it? Do we use it?
Javier Jiménez Sánchez, Lidia Serrano Díaz, Diana Chuni Jiménez, Miguel Ruiz Moreno, Blanca Gallego Pérez, Carmen María Marín Bernabé, María Gómez Lozano, Daniel García Belmonte, Rosa Gómez Espín, Isabel Nicolás de Prado, José Enrique Hernández Ortuño, Esperanza Egea Simón, Juan José Martínez Crespo
Revista Española de Enfermedades Digestivas, 15 October 2020
Abstract
Introduction
informed consent is necessary for invasive procedures as a document that guarantees the ethical health relationship and patient safety.
Aims
to analyze whether we have and use informed consent documents for paracentesis in our hospitals and to obtain data on the technique.
Methods
a descriptive observational study was performed during December 2019, via a cross-sectional survey disseminated through social networks, aimed at specialists and residents of gastroenterology.
Results
two hundred and three anonymous surveys were included (55.2 % gastroenterologist and 44.8 % residents) from 74 hospitals in 34 Spanish provinces. Ninety respondents (44.3 %) stated that they had the document in their centers. Of these, 29 (32.2 %) always provided it, 31 (34.4 %) provided it sometimes and 21 (23.3 %) never. Seventy-two professionals (35.5 %) answered that they did not have it and 41 (20.5 %) selected “unknown”. Of these, 77 (68.1 %) considered it was necessary to create this document, 31 (27.4 %) did not think it was necessary and five (4.4 %) did not answer. With regards to the technique, 173 (85.2 %) performed paracentesis under direct visualization and 30 (14.8 %) were eco-guided on most occasions. One hundred and nine (53.7 %) always applied local anesthetic, 80 (39.4 %) sometimes and 14 (6.9 %) did not. One hundred and sixty-seven respondents (82.3 %) considered it to be a simple technique versus 36 (17.7 %) who thought that it was of intermediate complexity. In terms of risk, 150 (73.5 %) considered it was low and 52 (25.6 %), medium. Ninety-nine (48.8 %) experienced minor complications and 37 (18.2 %) experienced major complications.
Conclusions
paracentesis is a common technique in digestive services and could be associated with complications, even though it is considered to be simple and safe. Due to the important intra- and inter-hospital variability that this technique presents, we consider standardized training in this technique is necessary, as well as the creation, spread and use of informed consents.

Approach to Informed Consent in Telepsychiatric Service: Indian Perspective
Guru S Gowda, Arun Enara, Furkhan Ali, Mahesh R Gowda, Chethan Basavarajappa, Channaveerachari Naveen Kumar, Suresh Bada Math
Indian Journal of Psychological Medicine, 14 October 2020
Open Access
Abstract
Consent is an essential and important medico-legal prerequisite for a patient’s treatment. This necessitates the service provider to participate in the informed consent process and discuss the risk-benefit of the proposed treatment, the best available treatment, engage in shared decision-making process, opportunity to convey their view and thereby limit chances of legal liability for all parties. The clinician should have ample knowledge and skill pertaining to the informed consent process and also have adequate understanding of medical ethics and law. This article provides an overview on informed consent pertaining to telepsychiatric services in India.

Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Research Article
Mariana Rodriguez-Patarroyo, Angelica Torres-Quintero, Andres I. Vecino-Ortiz, Kristina Hallez, Aixa Natalia Franco-Rodriguez, Eduardo A. Rueda Barrera, Stephanie Puerto, Dustin G. Gibson, Alain Labrique, George W. Pariyo, Joseph Ali
Journal of Empirical Research on Human Research Ethics, 25 September 2020
Abstract
Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.

Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country
Research Article
Samer Swedan, Omar F. Khabour, Karem H. Alzoubi, Alaa A.A. Aljabali
Heliyon, 9 September 2020; 6(9)
Abstract
Research involving human subjects requires strict adherence to ethical principles, including informed consent and assuring data confidentiality. Herein, a questionnaire was utilized to assess compliance of graduate students who conduct research involving human subjects in Jordan with proper practices related to informed consent and maintaining of data confidentiality. Among the 251 respondents, 55.4% were from health-related fields, 61.4% undertook research involving humans, and 48.6% did research requiring institutional review board approval. Only 37.1% of respondents reported exposure to research ethics education during their graduate study. Satisfactory adherence to informed consent practices was reported at rates of 56.0%–67.5%. Satisfactory adherence to practices related to data confidentiality and study participants’ anonymity was reported at rates of 67.3%–74.7%. Sharing of data or samples with others was reported at a rate of 24.3%. The rates of adherence to proper informed consent practices and practices that maintain data confidentiality were less than ideal. Significant policy changes need to be implemented to address these issues.

Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent
Eunice Kamaara, Camillia Kong, Megan Campbell
Bioethics, 14 November 2019
Abstract
Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like‐for‐like, designative translations which often involve the ‘indigenization’ of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re‐examination of how researchers develop and present protocols to institutional ethics review boards.

A comparison of MITS counseling and informed consent processes in Pakistan, India, Bangladesh, Kenya, and Ethiopia
Commentary
Anam Shahil Feroz, Christina Paganelli, Milka Bunei, Beza Eshetu, Shahana Parveen, Sayyeda Reza, Chaitali Sanji, Shiyam Sunder Tikmani, Shivaprasad S. Goudar, Guruprasad Goudar, Sarah Saleem, Elizabeth M. McClure, Robert L. Goldenberg
Reproductive Health, 12 August 2020; 17(120)
Open Access
Abstract
Globally, more than 5 million stillbirths and neonatal deaths occur annually. For many, the cause of death (CoD) is unknown. Minimally invasive tissue sampling (MITS) has been increasingly used in postmortem examinations for ascertaining the CoD in stillbirths and neonates. Our study compared the counseling and consent methods used in MITS projects in five countries in Africa and south Asia. Key informant interviews were conducted with researchers to describe the characteristics and backgrounds of counselors, the environment and timing of consent and perceived facilitators and barriers encountered during the consent process. Counselors at all sites had backgrounds in social science, psychology and counseling or clinical expertise in obstetrics/gynecology or pediatrics. All counsellors received training about techniques for building rapport and offering emotional support to families; training duration and methods differed across sites. Counselling environments varied significantly; some sites allocated a separate room, others counselled families at the bedside or nursing stations. All counsellors had a central role in explaining the MITS procedure to families in their local languages. Most sites did not use visual aids during the process, relying solely on verbal descriptions. In most sites, parents were approached within one hour of death. The time needed for decision making by families varied from a few minutes to 24 h. In most sites, extended family took part in the decision making. Because many parents wanted burial as soon as possible, counsellors ensured that MITS would be conducted promptly after receiving consent. Barriers to consent included decreased comprehension of information due to the emotional and psychological impact of grief. Moreover, having more family members engaged in decision-making increased the complexity of counselling and achieving consensus to consent for the procedure. While each site adapted their approach to fit the context, consistencies and similarities across sites were observed.

The Standard of Disclosure in Informed Consent Decision Making in Medical Practice in Malaysia
Ambikai S Thuraisingam
Asian Journal of Law and Governance, 10 August 2020; 2(1) pp 1-14
Abstract
This is a conceptual paper to analyse the standard of disclosure in informed consent decision making in the medical practice in Malaysia. This study reviews literature on the history of the standard applied in the informed consent requirement among patients and its consequences in healthcare practice. It aims to evaluate the crucial elements of patient centricness particularly the factors that affect the voluntariness and competency of the patient in giving consent. This paper reviews the existing literature surrounding the phenomenon of giving consent for medical treatment in the healthcare, particularly on how the concept of shared decision making affects the consent requirement. This study provides an overview of the perplexing nature of disclosure in shared decision making and the various concerns that have surrounded the topic leading to its recognition. Hence in Malaysia, there is no specific law which governs the provisions for shared decision making in informed consent in the healthcare practice. This study aims to explore the Malaysian Medical Council Guideline on Consent for Treatment of Patients by Registered Medical Practitioner (MMC Guideline on Consent) and the current Malaysian laws to determine whether they are sufficient to address the principle of shared decision making requirement patients. The study reviews the existing case laws and literature on the historical development of the elements of shared decision making, subsequently, the findings of the perusal of the MMC Guideline on Consent and the current statutory laws are presented and discussed. Finally, lack of empirical evidence is recognised in this paper and several suggestions are made for future research and recommendation for enactment of a new law pertaining to shared decision making in informed consent to medical treatment.

Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions
Vina Vaswani, Abha Saxena, Seema K. Shah, Ricardo Palacios, Annette Rid
Bioethics, 10 August 2020
Abstract
In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process.

Local customs and implications for informed consent process in research in African low and middle income countries. Challenges in information disclosure, understanding and voluntariness. [THESIS]
Miguel Paulo
Utrecht University Repository, Faculty of Humanities Theses, 2020
Abstract
The process of requesting informed consent for participation in research has been widely addressed in various international guidelines, such as the Belmont Report, the Nuremberg code and the Declaration of Helsinki. Currently, the Declaration of Helsinki is the predominant ethical guideline for conducting research with human subjects. It has an extensive section dedicated to informed consent, meant to embed in researchers the understanding of the importance and underlying core values of informed consent. While the predominant justification for informed consent requirement rests on respect for autonomy, I will argue for prevention of deception and coercion as the core value to substantiate informed consent in collaborative research in African low and middle income countries (henceforth LMIC). By using principlism as a framework, I will explore how the conflict between respect for autonomy and nonmaleficence provide support for my stance. In this paper, I scrutinize how local customs intertwined in the historical and socio-cultural context of LMIC in Africa, shape underlying dynamics in the informed consent communication process by disrupting information disclosure, understanding and voluntariness. Those aspects intersect with underlying pillars of autonomous choice, resulting in presumably undermined autonomy. Consequently, I argue that the researcher-research subject ought to be based on grounds of trust and trustworthiness in order to still validate the relevance of informed consent as currently applied. I end by arguing that a deliberative approach should be attained in improving the quality of informed consent in those settings. To this end, the intuitionist model by Heidt could be conducive for deliberations on identifying moral grounds for justifying informed consent requirements when meeting the presuppositions of the rational choice theory is not attainable.