Informed Consent in Human Subjects Research: A Comparison of International and Saudi Arabian Guidelines
May M. Al-Madaney, Roberto Andorno, Margrit Fässler
Journal of Clinical Research & Bioethics, 11 December 2023
Open Access
Abstract
Objective
Informed Consent (IC) is an essential requirement for the conduct of medical research involving human subjects. Since the Nuremberg Code was adopted in the aftermath of the Second World War, various international guidelines have specified the conditions for a valid IC for medical research. Among the most relevant guidelines are the World Medical Association’s Declaration of Helsinki, the guidelines of the Council of International Organization of Medical Sciences (CIOMS), and the Good Clinical Practice Guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP). This paper aims to compare the above-mentioned international guidelines with Saudi Arabia’s Law of Ethics of Research on Living Creatures regarding the requirements for IC. The comparison also includes some relevant regional and domestic laws. The objective of the study is to determine whether the compared regulations coincide regarding the requirements for a valid IC or whether they show significant differences, and to what extent such requirements are also present in Saudi Arabia’s regulations.
Methods
We conducted a content comparative analysis of the above-mentioned guidelines regarding five elements of IC: Disclosure, comprehension, voluntariness, competence, and form of consent. These five topics were subdivided into 44 subtopics. Then we compared and critically analyzed their similarities and differences.
Results
The similarities and differences observed in the seven guidelines are summarized under the five components of IC mentioned above and regarding 44 selected subtopics.
Conclusion
The analysis of the above-mentioned guidelines shows that while the most basic components of IC are present in all the compared documents, there are some differences between them. Specifically, the study found that the Saudi Arabian regulations include 26 of the 44 subtopics considered and that most of the elements that are missing relate to the disclosure of information to participants.

Editor’s note: Figure from p. 4 of article summarizing informed consent elements from various ethical guidelines.

An Audit of Preoperative Informed Consent in Surgical Patients at a Tertiary Care Hospital in Lahore, Pakistan
Muhammad Umer Shafique, Muhammad Salman Saleem, Maryam Saghir, Mohammad Saad Javaid, Mohammad Saad, Ahmad Sadiq, Hafiz U. Shibli, Muhammad Ahmad Khalid, Farhan Saleem
Cureus, 7 December 2023; 15(12)
Open Access
Abstract
    Informed consent plays a crucial role in modern clinical practice, representing a fundamental aspect of patient rights and medical ethics. The purpose of informed consent is to ensure that patients fully comprehend the procedures to which they are providing consent and the recognition that the surgeon is not guilty of battery. Moreover, clinicians safeguard themselves against potential repercussions by documenting the risks adequately conveyed to patients before performing surgery. Therefore, the significance of informed consent cannot be overstated. This survey encompassed patients from various surgical departments who underwent surgery in April 2023 at a tertiary care hospital. For the survey participants above the age of 18 were selected undergoing either emergency or elective surgical procedures. The survey employed a structured questionnaire for interviews, assessing whether patients had given informed consent before surgery. The questionnaire also inquired whether patients received information about the diagnosis, proposed surgical procedure, associated risks, and any available alternative treatment options. Furthermore, patients were asked about the proposed anesthesia type and whether the associated risks were communicated to them before the surgery.
A random selection of 50 patients was done for this study, and the process of block randomization was used with the help of a computer app to reduce bias and allow the representation of the various surgical subspecialties present in the tertiary care hospital. No evidence of consent being taken was present in two patients(4%) or the document on which the consent was signed was not present in the file. Only 48% of the patients acknowledged that they fully understood the provided information. While 60% of the patients were informed about the type of anesthesia proposed, a mere 8% were provided information regarding anesthesia risks. None of the patients in the emergency setting signed the consent form themselves, regardless of their capability to do so. Conversely, only 24% of the patients in the elective setting signed the consent form themselves. The study revealed that the quality of informed consent signing in this tertiary care hospital is below average. Healthcare professionals, including doctors and staff, need education regarding the importance of informed consent and the patient’s right to comprehend any procedure or intervention to which they are subjected. A shift in the paradigm of decision-making about a patient’s health needs to emphasize that the patient is the most critical entity in these decisions.
The main aim of the study is twofold, primarily we want to analyze the existing method of taking informed consent by comparison with the guidelines and check whether the current practice of informed consent achieves its goal of involving the patients in their treatment. Secondarily, we want to discuss the effect that patient-doctor communication might have on the delivery of the above-mentioned information.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension
Emma Verástegui, Ricardo Páez, Oscar Arrieta
Gaceta Médica de México, 2023; 159(5) pp 426-431
Abstract
Background
The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described.
Objective
To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined.
Results
More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF.
Conclusion
It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

Editor’s note: Gaceta Médica de México is the official scientific dissemination of the National Academy of Medicine of Mexico.

Opinions and practices of midwives working in the delivery rooms on informed consent in vaginal deliveries
Pervin Sahiner, Nevin Utkualp
African Journal of Reproductive Health 2023; 27(11) pp 18-25
Abstract
Obtaining informed consent from women for vaginal birth both safeguards their autonomy and establishes a legal foundation for midwives. This study aimed to determine the opinions and practices of midwives on obtaining valid informed consent for vaginal deliveries. This descriptive study was conducted between November 2021 and December 2022 in two different cities of Turkey, Bursa and Kocaeli. Data were analyzed with Chi-square test. In the study all midwives who had not received ethics training had a common perception that informed consent merely involved obtaining a signature and was a standard practice for vaginal birth (p=0.002). In the study, 92.9% of the midwives reported that they found it necessary to obtain informed consent in vaginal deliveries, 97.6% reported that they provided verbal information. However, information provided by midwives for valid informed consent was mostly not comprehensive (range 44.4%-80.2%). Most midwives (80.2%) focused on highlighting the benefits of vaginal birth for mothers, with comparatively less emphasis on communicating information regarding the potential risks and complications associated with vaginal birth for newborns. The high percentage of midwives who considered it necessary to obtain informed consent in vaginal deliveries in our study suggests that these midwives are well aware of the significance of informed consent.