Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 24 May 2024; 14(2) pp 1338-1352
Abstract
Background
The wording of informed consent forms could hinder their comprehension and hinder patients’ autonomous choice. The objective of this study was to analyze the readability and comprehension of anesthesia informed consent forms in a Spanish county hospital.
Methods
Descriptive and cross-sectional study carried out on patients who were going to undergo anesthetic techniques. The readability of the forms was analyzed using the INFLESZ tool and their subjective comprehension using an ad hoc questionnaire.
Results
The analyzed forms presented a “somewhat difficult” legibility. A total of 44.2% of the patients decided not to read the form, mainly because they had previously undergone surgery with the same anesthetic technique. The language used in the forms was considered inadequate by 49.5% of the patients and 53.3% did not comprehend it in its entirety. A statistically significant negative correlation of age and INFLESZ readability score with the overall questionnaire score was found. A statistically significant association was observed as a function of age and educational level with the different criteria of the questionnaire.
Conclusions
The anesthesia informed consent forms presented low readability with limited comprehension. It would be necessary to improve their wording to favor comprehension and to guarantee patients’ freedom of choice.

Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021
Research
Marian Marian, Kathryn M. Barker, Elizabeth Reed, Amanda C. McClain, Rebecka Lundgren, Samantha Hurst, Ramona L. Pérez
BMC Pregnancy and Childbirth, 13 May 2024
Open Access
Abstract
Introduction
Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence.
Methods
We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico’s cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations.
Results
The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care.
Conclusion
While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Informed Consent in Clinical Studies in the Republic of Srpska
Snežana Pantović, Dijana Zrnić
Review of European and Comparative Law, 6 May 2024
Abstract
As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.

Editor’s note: The Republic of Sprska is one of the two entities of Bosnia and Herzegovina.

Analysis of Informed Consent Forms Submitted to Institutional Ethics Committee of a Medical Institute in Southern India: A Cross-sectional Observational Study
Vedavathi Hanumaiah, Shreenivas Prabhakar Revankar, Nagaraja Prasad Sai, Mohammad Arif
Journal of Clinical & Diagnostic Research, 1 April 2024
Abstract
Introduction
Informed consent is an essential component in research involving human participants. However, the informed consent obtained may be incomplete and not fulfill the essential criteria of Informed Consent Forms (ICFs). Although the guidelines for developing ICFs have been clearly spelled out by various research bodies, these guidelines are not followed completely.
Aim
To analyse the ICFs submitted to the Institutional Ethics Committee (IEC) of a Medical Institute in Southern India.
Materials and Methods
The present study was a crosssectional observational study analysing ICFs submitted to the IEC of McGann District Teaching Hospital, Shimoga Institute of Medical Sciences (SIMS), Shivamogga, Karnataka, India, for the period 2014 to January 2023. All research projects containing ICFs during the study period were included in the study. Of the research projects submitted, only 70 had ICFs, and these were subjected to analysis as per Indian Council of Medical Research (ICMR) guidelines criteria. The criteria for ICFs were: statement of research, purpose/methods of the study, duration/frequency of the study, benefits to participants/community, foreseeable risks, discomfort/inconvenience, confidentiality, payment/reimbursement for participation. In addition to these, ICFs were also analysed for additional elements as per ICMR criteria for tissue and blood samples. The results were then subjected to descriptive statistical analysis and presented as mean and percentages.
Results
Many of the required essential elements were present in nearly 50% of ICFs submitted to the IEC, which include information on the basic purpose/methods of the study 70 (100%), identity of the principal investigator/research team 57 (81.42%), freedom to participate/withdraw from the study 55 (78.57%), confidentiality of records 54 (77.14%), and foreseeable risks, discomfort, and inconvenience to participants 35 (50%). Other essential elements like benefits were present to participants/community 28 (40%), payment/reimbursement for participation 28 (40%), duration and frequency 12 (17.14%), statement of research 9 (12.85%), treatment/compensation for injury 4 (5.71%). Regarding additional elements of ICFs for biological samples, ICFs adhered to the ICMR requirements except none of the submitted forms had any information on the period of storage of biological samples.
Conclusion
The ICF is an essential requirement for conducting research. Ensuring adherence of ICF to guidelines is important from a research perspective. The present study concludes that the majority of the essential elements were present in ICFs with a few exceptions like study as research and information on the storage of biological samples, which was nil.