Deception and informed consent in studies with incognito simulated standardized patients: empirical experiences and a case study from South Africa
Original Article
Benjamin Daniels, Jody Boffa, Ada Kwan, Sizulu Moyo
Research Ethics, 22 May 2023
Open Access
Abstract
Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method’s increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.

Consent and refusal of procedures during labour and birth: a survey among 11 418 women in the Netherlands
Original Research
Marit Sophia Gerardina van der Pijl, Margot Klein Essink, Tineke van der Linden, Rachel Verweij, Elselijn Kingma, Martine H Hollander, Ank de Jonge, Corine J Verhoeven
BMJ Quality & Safety, 22 May 2023
Abstract
Background
Informed consent for medical interventions is ethically and legally required; an important aspect of quality and safety in healthcare; and essential to person-centred care. During labour and birth, respecting consent requirements, including respecting refusal, can contribute to a higher sense of choice and control for labouring women. This study examines (1) to what extent and for which procedures during labour and birth women report that consent requirements were not met and/or inadequate information was provided, (2) how frequently women consider consent requirements not being met upsetting and (3) which personal characteristics are associated with the latter.
Methods
A national cross-sectional survey was conducted in the Netherlands among women who gave birth up to 5 years previously. Respondents were recruited through social media with the help of influencers and organisations. The survey focused on 10 common procedures during labour and birth, investigating for each procedure if respondents were offered the procedure, if they consented or refused, if the information provision was sufficient and if they underwent unconsented procedures, whether they found this upsetting.
Results
13 359 women started the survey and 11 418 met the inclusion and exclusion criteria. Consent not asked was most often reported by respondents who underwent postpartum oxytocin (47.5%) and episiotomy (41.7%). Refusal was most often over-ruled when performing augmentation of labour (2.2%) and episiotomy (1.9%). Information provision was reported inadequate more often when consent requirements were not met compared with when they were met. Multiparous women had decreased odds of reporting unmet consent requirements compared with primiparous (adjusted ORs 0.54–0.85). There was considerable variation across procedures in how frequently not meeting consent requirements was considered upsetting.
Conclusions
Consent for performing a procedure is frequently absent in Dutch maternity care. In some instances, procedures were performed in spite of the woman’s refusal. More awareness is needed on meeting necessary consent requirements in order to achieve person-centred and high-quality care during labour and birth.

Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients
Ines Testoni, Lucia Ronconi, Francesca Lampis, Erika Iacona, Josephine Zammarrelli, Sara Pompele, Roberto Valle, Gabriele Boscolo, Diego De Leo
Behavioral Sciences, 19 May 2023
Open Access
Abstract
Informed consent practices in healthcare represent a fundamental element of patient-centred care; however, the traditional use of a written, paper-based description of the medical procedure to obtain informed consent presents many limitations. This research aimed to evaluate the effects of an alternative modality of obtaining informed consent using a brief informative video for patients waiting to undergo a coronary angiography procedure in Italy. The study involved 40 participants—28 males and 12 females (mean age: 68.55, SD = 13.03)—divided equally into two groups: one group received the video-based informed consent and the other received a traditional paper-based form. Each group was asked to fill in two questionnaires; one was created by the researchers to measure the patient’s level of understanding of the given information and the perception of usefulness of the informed consent, and the other was the Depression Anxiety Stress Scales-21 (DASS-21), which evaluates levels of anxiety, depression and stress. A comparison of the results of the two groups showed that videobased informed consent allowed participants to better understand the given information, to feel more confident concerning their subjective comprehension of it and to perceive the video-based informed consent as more useful than the traditional one. The video-based informed consent did not lead to higher levels of anxiety, depression or stress among the participants. It can be hypothesized that video-based formats may represent a more useful, understandable and safe alternative to traditional paper-based informed consent in healthcare.

Editor’s note: The editors recognize the need for further research in this area before conclusions can be drawn.

Implementation in Midwifery Services: A Description Study
Nina Zuhana, Eka Budiarto, Lia Dwi Prafitri, Rini Kristiyanti
Advances in Social Science, Education and Humanities Research, May 2023
Abstract
Midwifery services must be provided by midwives by implementing legal ethics in midwifery. This ethics can be fulfilled by giving informed consent before performing midwifery services. Informed consent is obtained by giving information about the midwifery services that will be provided to the patient and asking the patient to sign the midwifery service agreement sheet indicating that the patient is willing to receive the provided midwifery information and services as well as all the possible consequences. Informed consent is required when midwives provide care for pregnancy, childbirth, postpartum, and newborns. The objective of this study was to identify the implementation of informed consent by midwives in providing midwifery services in health care facilities such as hospitals, health centers, and autonomous midwifery practices. This research was a descriptive study with a cross-sectional approach involving 71 midwives in Pekalongan Regency. It was carried out in March 2021 by distributing questionnaires to the participating midwives who were selected through a quota sampling method. The collected data were analyzed by using central tendency and frequency distribution. The results of data analysis showed that the average age of the participants was 36.5 years old, the average length of work was 12.8 years, and the education level of the majority of them was diploma three (69%). A total of 70.4% of the midwives obtained informed consent before providing midwifery services. This number indicates that there were midwifery services that had not implemented ethical and legal aspects. The ethical and legal noncompliance cases in midwifery services might increase if no effort to achieve 100% informed consent implementation was taken. Therefore, regulation that manage and bind midwives in carrying out informed consent to achieve 100% implementation of it in midwifery services is needed.

Editor’s note: The midwives in this article are practicing in Indonesia.

Status of Informed Consent in Surgical Patients in Hospitals of Sindh Pakistan
Tariq Abdullah, Muhammad Akbar, Shahnawaz Khatti, Ishrat Rahim Katyar, Karim Bux, Muhammad Anwar
Pakistan Journal of Medical & Health Sciences, March 2023
Abstract
Background
Informed consent (IC) is a critical step in ensuring that patients understand implications of their treatment decisions.
Materials and Methods
It is observational cross-sectional study. Non probability purposive sampling was used to collect data from different surgical units. Adult postsurgical patients were questioned using a standardized questionnaire between the first- and fifth-day following surgery in two general hospitals in Sindh province (Hyderabad and Jamshoro). Data was analyzed using SPSS and Microsoft excel.
Results
A total of 78% of individuals who claimed to have read it found informed consent to be easy to understand. Less than half of patients thought information brought them some emotional solace, while 23.2% of patients reported feeling more anxious after hearing information. This study suggests enhancing the process of obtaining consent forms by including additional information and avenues for discussion on written documents rather than relying solely on verbal communication.
Conclusion
Patients under age of sixty and patients who had completed more schooling tended to read written informed consent forms more frequently. Orally communicated pre-operative information suited patients’ requirements better than written informed consent. Surgeon needs to get informed permission from patient and inform them about operation type, potential consequences and other treatment options.

Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study
Indian Journal of Forensic Medicine & Toxicology, 17(2), April-June 2023
Open Access
Abstract
Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits. A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. It is essential that this information be discussed in simple terminology that can be easily readily understood and help the patient to give proper consent for the procedures.

Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study
Francis Akpa-Inyang, Sylvester C. Chima
Journal of Integrative and Complementary Medicine, 17 April 2023
Abstract
Introduction
This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice.
Methods
Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software.
Results
Participants were seven males (64%) and four females (36%), 35–67 years of age, with 5–25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations.
Conclusions
This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University
Cem Dağdelen, Evrim Erdemoğlu
Cureus, 5 April 2023; 15(4)
Open Access
Abstract
Background
This study aimed to evaluate the readability level of consent forms used for interventional procedures in the obstetrics and gynecology clinic and to determine the readability of the texts according to the education level of the patient.
Methodology
This study determined the readability of patient consent forms used before interventional procedures in the gynecology and obstetrics clinic at the Suleyman Demirel University Hospital, Isparta. The consent forms were divided into two main groups according to their use in obstetrics and gynecology procedures. The readability level of consent forms was assessed using two readability formulas developed by Ateşman and Bezirci-Yılmaz, which determine the readability level of Turkish texts in the literature.
Results
When the consent forms were analyzed according to Atesman’s readability formula, they were found to be readable with more than 15 years of education at the undergraduate level, while according to Bezirci-Yılmaz’s readability formula, they were found to be readable with 17 years of education at the postgraduate level.
Conclusions
Easy-to-read consent forms will ensure that patients are more informed about interventional procedures and participate more effectively in the treatment process. There is a need to develop readable consent forms suitable for the general education level.

Editor’s note: Suleyman Demirel University is located in the Karasay region of Kazakhstan.

Cardiac Transplant in Southeast Asia: Challenges and Opportunities
Sulague, N. Cruz, R. Ricardo, P. Alfonso, D. Vervoort
The Journal of Heart and Lung Transplantation, April 2023; 42(4)
Abstract
Purpose
Among the 18.6 million cardiovascular deaths worldwide, 33.5% occurred in Southeast Asia, where cardiovascular diseases constitute 40.2% of all causes of mortality and injury. There is higher prevalence of symptomatic heart failure in Southeast Asian countries compared with the rest of the world. While advances improved cardiac transplantation, challenges remain to make it widely available. The study aims to discuss its challenges and opportunities in Southeast Asia.
Methods
A review of related literature was conducted on PubMed using combinations of variations of key terms such as cardiac transplant, heart transplant, Southeast Asia, and countries within the region. Ministries of health websites in the region were reviewed for cardiac transplant-related policies. The global burden of disease of heart failure-associated conditions from 2000 to 2019 in disability-adjusted life-years were assessed in the Southeast Asian region and other select geographical region using the Institute for Health Metrics and Evaluation Global Burden of Disease Results Tool.
Results
Southeast Asia’s burden of disease is comparable to Western Europe but does not have the same high volume of cardiac centers, health workforce, and robust network of organ donors. Substantial financial risk protection remains limited for most of the countries. Main barriers to organ donation include knowledge gaps, sociocultural and religious restrictions, and lack of infrastructure. At present, all countries follow an opting-in system based on informed consent, except Singapore which follows an opting-out system based on presumed consent. Association of Southeast Asian Nations may be optimized to promote cooperation, physician mobility, improved training, and policymaking.
Conclusion
Southeast Asian countries may benefit from considering opting-out scheme for donation, implementing a national system for organ donation, forming a centralized body directing all transplant activities, and improving public health education on transplantation.

Understanding of informed consent by patients at the Faculty of Dentistry of the University of Costa Rica
José Manuel Fernández Chaves
Medicina Legal de Costa Rica, March 2023
Abstract
Introduction
Informed consent is the result of the evolution of the relationship between health professionals and their patients or users where the principle of autonomy is above anything else. There are many articles on informed consent but none of the studies found assessed whether patients really understand it. The objective of this research was to determine the level of understanding of informed consent by the patients of the Clinic of Oral Surgery of the Faculty of Dentistry of the University of Costa Rica, in the period August to September 2022, by means of a questionnaire that would allow correlating the understanding with the level of schooling.
Materials and methods
A questionnaire was administered to 100 people divided into two parts, one on sociodemographic data and the other to establish the understanding of informed consent and to determine whether the level of schooling was related to the understanding of the same.
Results
The group between 20 and 30 years of age was the largest, of these 51% had university studies, and although the majority (98%) referred to knowing the concept of informed consent, only 33% obtained the correct answers to the clinical questions asked.
Conclusions
Even though patients refer to knowing what informed consent is the results suggest an unclear understanding of important concepts such as complications or immediate or late adverse reactions produced by the effect of dental treatments or surgical procedures.