Patients’ decision-making in the informed consent process in a hierarchical and communal culture
Original Article
Astrid Pratidina Susilo, Brahmaputra Marjadi, Jan van Dalen, Albert Scherpbier
The Asia Pacific Scholar, 3 September 2019; 4(3) pp 57-66
Open Access
Abstract
Objective
To investigate patients’ decision-making in the informed consent process in a hierarchical and communal culture.
Methods
This qualitative study took place in an Indonesian hospital and was conducted in line with the Grounded Theory approach. Fifteen patients and twelve family members were interviewed to understand the patients’ decision-making process and factors that contributed to this process. Interview transcripts were analysed using the constant comparison method.
Results
Patients used information to develop an explanation of their illness and treatment. They consented to a medical procedure if information from their physicians matched their own explanation. An increasing severity of the disease urged patients to decide, even when a satisfying explanation had not been developed. A hierarchical relationship between physicians and patients hampered patients’ discussing concerns or sharing emotions with their physicians. To maintain a harmonious relation with their physicians, patients accepted that some questions remained unanswered even after a decision had been made.
Conclusion
The strong hierarchical and communal context added to the complexity in the physician-patient relationship and consequently influenced patients’ decision-making. In addition to strengthening physicians’ communication skills, involving other health professionals as patient advocates or mediators is recommended to ensure patients make voluntary and informed decisions.

Informed Consent as Fulfillment of Rights and Obligations in Therapeutic Transactions Indonesian Medical Services
Teguh Anindito
Advances in Social Science, Education and Humanities Research, 2019; 358
Abstract
The informed consent principle functions to protect the autonomy and integrity of individuals who have the right to make their own choices freely for treatment to be carried out by doctors/medical personnel. According to MKDKI 80% of the 135 cases reported were caused by poor communication between doctors and patients. This study aims to analyze informed consent in therapeutic transactions as a fulfillment of rights and obligations for doctors and patients. The research was conducted in a normative juridical method, emphasizing the norms in legislation, theories, and doctrines related to health law, especially the study of informed consent. The data obtained is analyzed by the logic of deduction, taking into account the legal concept in the system of legislation. The results of the study find that urgency of informed consent is to protect and increase patient autonomy, protect patients and prevent manipulative and coercive actions and increase the attitude of self-awareness of the medical team. Therefore, medical personnel must be rational as both medics and moralists. Medical personnel needs to pay attention to the implementation of informed consent and standard professional practice in accordance with applicable regulations.

Nigerian laws on informed consent before a surgical procedure
Research Article
Mabel Ijeoma Ezeuko
Medico-Legal Journal, 7 October 2019 
Abstract
Informed consent is a process of communication between a clinician and a patient, which results in the patient’s agreement to undergo a medical procedure. Rule 19 Part A: Code of Medical Ethics of Nigeria and Section 23 of the National Health Act 2004 prescribe the process of obtaining consent before a medical intervention. The equitable law of torts and/or criminal liabilities that deal with medical negligence should be invoked more often by patients whose right to informed consent is denied by medical practitioners.

Patients’ informed consent to medical services in Georgia
Research Article
Tengiz Verulava, Revaz Jorbenadze, Vakhtang Surguladze
Medico-Legal Journal, 3 October 2019 
Abstract
Informed consent requires that a patient understands the purpose, benefits and potential risks of a medical or surgical intervention and then agrees to it. It is important not only ethically and legally but for the effectiveness of care. Studies show that, in some cases, patients have no real information on the medical service to be provided so their informed consent is just a formality. This study aims to determine problems arising from a patient’s informed consent. As part of a cross-sectional study, surgical patients were interviewed using a semi-structured questionnaire. 34% of patients (n = 68) did not know what the surgical intervention was; 57% (n = 114) received sufficient information on their diagnosis and methods of treatment; however, 26% (n = 52) agreed with it only partially; 62% (n = 124) of patients knew they needed surgery; 66% (n = 132) were adequately informed on risks and benefits of alternative ways of treatment; 58% (n = 116) were informed of potential risks during surgery. The study demonstrated patients need to be better informed about different treatment options, consequences of treatment refusal. Doctors have to provide information to patients in a manner understandable to them. Medical personnel need to be educated as to what constitutes informed consent and the importance of adhering to such requirements.

Clinical information, informed consent and medical deontology. A recent relationship
García-Guerrero J
Cuadernos de bioética, September-December 2019; 30(100) pp 303-313
Abstract
In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, seeking the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health.

Editor’s note: This is a Spanish Language publication.

A Content Evaluation of Informed Consent Documents for Invasive Procedures Used in Health Facilities in Southern Nigeria
Pierre Oziegbe Okukpon, Essy Clementina Isah, Emmanuel Friday Osagiede, Joseph Okoeguale, Isaac Newton Omoregbe, Monday Osaro Osagiede
International Journal of Recent Innovations in Medicine and Clinical Research, 31 July 2019
Open Access
Abstract
Introduction
A properly-designed informed consent form could help in the use and preservation of relevant information as well as enrich the worth of patient-physician dealings. This research sought to find out if informed consent forms used in health facilities in Benin City, Edo State contained the essential elements of informed consent.
Methods
The study was carried out in 38 health facilities (3 public health facilities, and 35 private health facilities) in Benin City, the administrative headquarter of Edo State, South-south, Nigeria. A checklist was utilized to appraise informed consent documents used in these health facilities to determine their adequacy in terms of the critical elements contained in it. The checklist was developed based on the contents of the prototype form (proforma) provided by the Medical and Dental Council of Nigeria (MDCN). The checklist consisted of “Yes” and “No” sections corresponding to the 16 items considered necessary for valid consent documentation.
Results
None of the consent forms in public health facilities had a notation that the benefits of proposed management or procedure were clarified, that the patient clearly understood the language of presentation or that the choice to ruminate on the procedure for a while prior to giving assent was offered to the patient. Only 11.4% of forms examined in private health facilities had a notation that the benefits and risk of the intended management option or procedure were explained to the patient.
Conclusion
Many consent forms currently in use in health facilities in Benin City did not wholly adopt the contents of the proforma provided by the MDCN. Most informed consent documents examined in this study lacked the essential elements of informed consent.

Assessing informed consent practices during normal vaginal delivery and immediate postpartum care in tertiary-level hospitals of Bangladesh
Research Paper
Md Abdul Karim, Syed Imran Ahmed, Jannatul Ferdous, Bushra Zarin Islam, Henok Ayalew Tegegne, Bachera Aktar
European Journal of Midwifery, May 2019; 3(10)
Open Access
Abstract
Introduction
This study was conducted to assess the informed consent practices during normal vaginal delivery (NVD) process and immediate postpartum care in the tertiary-level hospitals of Bangladesh.
Methods
A cross-sectional study was conducted at Dhaka Medical College Hospital (DMCH) and Sir Salimullah Medical College & Mitford Hospital (SSMCH) in November 2015. The study population and respondents were mothers who gave normal vaginal childbirth within the past 24 hours and received postpartum care in the study sites (N=190). The interview of every alternate mother from the patient register was conducted by researchers using a structured questionnaire. Descriptive analysis of findings was carried out using MS Excel 2013.
Results
The study findings revealed the complete absence of informed consent practices during NVD and postpartum care in the tertiary-level hospitals in Bangladesh. Consent (not informed consent) was taken from 95% of the mothers before proceeding with the NVD process, 50–72% of examinations (except breast examination, 0%) and 8–72% of procedures during postpartum care. Choice and preferences of mothers for taking an alternative process/examination/procedure were absent in all cases.
Conclusions
The Respectful Maternity Care (RMC) Charter endorsed informed consent as one of the basic rights of child-bearing women. Absence of informed consent practices in the study sites indicates disrespect to maternity care and violation of this right. The Standard Clinical Management Protocols of Bangladesh also lacks clarification of this right. Improvement of the existing protocol, increased awareness and practices are essential to address protection of this right.

Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks
Kathleen M. Brelsford, Ernesto Ruiz, Catherine M. Hammack, and Laura M. Beskow
Ethics & Human Research, September-October 2019; 41(5) pp 16-27
Open Access
Abstract
A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. Most of those who received the simplified form felt it contained the right amount of information, compared with fewer than half of those who received the traditional form. Qualitative results allowed us to identify overarching issues related to tone, formality, and voice that may affect prospective participants’ trust and willingness to participate. Certain characteristics of written Spanish are seemingly at odds with recommended actions to simplify consent forms; thus, even when significant empirical effort has been expended to develop simplified consent materials in English, additional work is needed to ensure the accuracy, comprehensibility, and cultural-congruence of Spanish-language translations.

Informed Consent in Thailand: What Standard Is It? Which One Should It Be?
Khajorndej Direksoonthorn
Asia Pacific Journal of Health Law & Ethics, July 2019; (12)3 pp 1-32
Open Access
Abstract
The concept of informed consent has long been observed in the Thai medical community. However, an appropriate standard prescribing a physician’s duty to disclose medical information has never been comprehensively discussed in Thailand. Moreover, to the best of my knowledge, the Supreme Court of Thailand has never decided any case where a party claims informed consent as a cause of action either. This paper seeks to fill that gap. I also anticipate that this kind of cause of action will definitely be the disputed issue for the Supreme Court to decide in the foreseeable future.

In this paper, I provide the analysis of the current statute governing informed consent in Thailand. More importantly, I argue that the appropriate standard of disclosure for Thailand should be the professional or physician-based standard. The physician has a duty to disclose only the information other reasonable physicians would reveal to their patients in similar circumstances. For Thailand, this standard is more suitable than the patient-centered standard in terms of both cultural and legal contexts. The standard can effectively safeguard the patient autonomy as well as work to his/her advantage in litigation. The U.S. doctrine of informed consent is comparatively discussed throughout the paper.