How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya
Emily Nyariki, Robert R. Lorway, Omu Anzala, Joyce M. Olenja
African Journal of Health Sciences, 20 June 2022; 35(2)
Abstract
Introduction
Informed consent (IC) is a key yardstick for the ethical and legal conduct of clinical research involving human subjects. However, the extent to which it meets its obligations in low-income settings remains under-examined. This study explored the views and experiences of informed consent among research participants at the KAVI-Institute for Clinical Research, Nairobi, Kenya.
Materials and Methods
A mixed-methods study was conducted between March and June 2014. Participants were drawn from six selected KAVI-ICR studies. Data collection involved a survey questionnaire with 164 participants and in-depth interviews with 44 participants purposively selected from the survey questionnaire respondents. Descriptive statistics via SPSS and thematic analysis via Atlas Ti were used, for quantitative and qualitative data analysis respectively.
Results
The majority of participants had learnt about the KAVI studies from friends (41%) and community mobilisers/ peer educators (47%). The information relayed by these relations regarding participation had led some participants to reach their decisions before undergoing the informed consent process. All participants reported attending information meetings, passed the assessment of understanding tests, and autonomously gave their written consent. Incomplete understanding of research concepts such as randomization and associated terminologies, placebo, and vaccine-induced positivity were expressed.
Conclusion
Beyond understanding the information received before enrolment, participants’ decisions are shaped by individual and community factors as well as trust relations with trial staff and own friends. There is, therefore, a need for innovative approaches to implementing and evaluating informed consent in low-resource settings.

Informed consent: an empty promise? A comparative analysis between Italy and England, Wales, and Scotland
Research Article
Caterina Milo
Medical Law International, 16 June 2022
Open Access
Abstract
Informed consent (IC), as the process of sharing information between patients and clinicians before undertaking a medical treatment, signals a number of ‘good intentions’. IC, in its theoretical formulation, can be seen as valuing the expertise and contributions of both clinicians and patients, giving expression to the aspirations of both promoting patient autonomy and facilitating doctors to work in partnership with their patients. The Supreme Court judgement in Montgomery v Lanarkshire Health Board1 and the Italian legislation on IC2 are, in this respect, worthy of analysis as both provide valid examples of these ‘good intentions’. However, the reality of how IC has been translated in courtrooms does not always match the expectations. This article, through a comparative reflection, will claim that a gap between the ‘law in theory’ and the ‘law in practice’ is common to both legal systems. The article ultimately claims that changes in both legal and policy approach are needed in order to better safeguard IC.

Clinical adolescent decision-making: parental perspectives on confidentiality and consent in Belgium and The Netherlands
Research Article
Jana Vanwymelbeke, David De Coninck, Koen Matthijs, Karla Van Leeuwen, Steven Lierman, Ingrid Boone, Peter de Winter, Jaan Toelen
Ethics & Behavior, 15 June 2022
Abstract
This study investigated Belgian and Dutch parental opinions on confidentiality and consent regarding medical decisions about adolescents. Through an online survey, we presented six cases (three on confidentiality, and three on consent) to 1,382 Belgian and Dutch parents. We studied patterns in parental confidentiality and consent preferences across and between cases through binomial logistic regressions and latent class analysis. Participants often grant the right to consent for a treatment to the adolescent, but the majority diverges from the adolescent’s preferences regarding confidentiality. More educated participants would rather not be informed about cases regarding a sexually transmitted disease or depression than lower educated participants. Further analysis shows that participants’ preferences correspond to authoritative (47%), permissive (30%) and authoritarian (17%) parenting styles. Belgian and Dutch parents are willing to grant some degree of autonomy, but they want to be informed about specific health issues. Parental views on confidentiality and granting consent appear to mirror existing parenting styles.

Evaluating Knowledge, Practice, and Barriers to Informed Consent Among Professional and Staff Nurses in South Africa: An Empirical Study
Sylvester C. Chima
Canadian Journal of Bioethics, 13 June 2022; 5(2) pp 44-70
Abstract
Background
Informed consent (IC) is an ethical and legal obligation protected by constitutional rights to bodily integrity, well-being, and privacy in South Africa. The National Health Act 2003 codified IC regulations, requiring that all healthcare professionals inform patients about diagnosis, risks, benefits, options, and refusal rights while factoring in patients’ language and literacy levels.
Objectives
This study’s primary aim was to determine the extent of South African professional/staff nurses’ compliance with current IC regulations and ascertain socio-cultural impediments impacting proper IC practice.
Methods
A cross-sectional survey using semi-structured questionnaires was used to evaluate knowledge and practice of IC among nurses in KwaZulu-Natal province. Data were analyzed using SPSS, v.21. Descriptive statistics, chi-squared tests, and content analysis were used to compare nursing domains.
Results
Three hundred fifty-five (355) nurses, 92% females, with 1 to 41 years of professional experience, completed this study. Information disclosed by nurses to patients included diagnosis (77%), treatment benefits (71%), risks (69%), recommendations (65%), risks of refusal (80%), and right of refusal (67%). Nurses (80%) felt information disclosure was adequate, while 85% reported that patients understood disclosed information.
Conclusions
Nurses practicing in local public hospitals had moderate knowledge of IC regulations. Practical implementation appeared deficient. Barriers to IC included language, workload, time constraints, lack of interpreters, and skewed gender norms in the nursing profession. Nurses require continuing professional education in healthcare law and ethics, a “corps of trained interpreters”, and gender transformation in the nursing profession to improve IC practice and overall quality of healthcare service delivery in South Africa.

Informed Consent: The Surgical Patient’s Experience in a Tertiary Hospital in Northwest Nigeria
B A Grema, S T Tanimu, G C Michael, I Aliyu, S A Aji, I U Takai, A I Sulaiman
West African Journal of Medicine, 27 May 2022; 5 pp 471-478
Abstract
Background
Obtaining informed consent (IC) before a surgical procedure is the cornerstone of medical practice. The practice of IC continues to evolve as litigations increase. Most studies on patients’ perspectives of IC are either old or were done in southern Nigeria. This study assessed the surgical patients’ IC experience in a tertiary hospital in northwest Nigeria.
Methods
This cross-sectional study assessed 244 consecutive patients who had elective surgeries in surgical departments of a tertiary hospital. Pretested questionnaires were used to collect data regarding their perception of the meaning of IC, the process of obtaining it, satisfaction with how it was obtained, and factors associated with satisfaction on how consent was obtained.
Results
Most were females (61.9%); their mean age was 34.8±14.3 years; 52.9% and 61.9% of respondents did not believe that IC enables patient-clinician shared decision-making or patient’s self-decision making, respectively. Most were allowed to ask questions (83.2%), received information on the surgical procedure (91.4%), diagnosis (97.9%); however, 38.5% and 48.8% did not receive information about surgical procedures’ immediate and long-term complications, respectively. Surgical procedure explanation was mostly provided by Resident Doctors (53.7%). Most (88.9%) were satisfied with how IC was obtained; satisfaction was associated with being allowed to ask questions, receiving explanations on diagnosis, surgical-procedure, complications of surgery, available alternative treatments, and when the resident/ consultants gave the explanation (all P<0.05).
Conclusion
Deficiencies exist in the process of getting IC. Satisfaction with this process was high though associated with following the recommended strategies. Improving the IC process will require appropriate interventions in this and similar settings.

The Doctrine of Patient’s Informed Consent in the Legislation and Jurisprudence of Czech Republic and the Latvian Republic
Urkevich Tatjana Ivanivna, Anatoliy Anatoliyovych Lytvynenko
Medicne parvo, 2022; 1(29) pp 49-94
Abstract
The article represents the history, emergence and the contemporary state of development of the legal doctrine of the patient’s informed consent to medical interventions in Czech Republic, Austria and the Latvian Republic. The authors focus on the vaults of the doctrine of the doctor’s obligation to abstain from conducting any medical interventions without the consent, or against the will of the patient, since the expression of the patient’s will is the central element of his right to self-determination. In order to discover the main features of informed consent in the civil law perspective, the authors discuss the historical and current legal developments of the legal institute of patient’s informed consent. The authors conclude that the formation of the institute owes to the right to body integrity and limitation of the exercise of medical profession by practitioners, and that the civil law doctrine of informed consent differs from Anglo-American tort law, relying on statutory-based civil liability for negligence, as well as minor penal liability for battery, an occasional interpretation of unauthorized medical intervention. The authors emphasize, that the existing bodies of Austrian, Czech and Latvian case law relating to informed consent, which span for over a century, are sufficient to become a branch of Continental medical malpractice case law alongside with aged and well-developed French or Belgian medical jurisprudence, whereas the Latvian medical jurisprudence, despite having a rich history of emergence since the 1920s, has developed a solid body of case law in regard with patient’s rights relatively recently.

Editor’s note: Medicne pravo is published by the Danylo Halytskyi Lviv National Medical University.