The Role of the Nurse in Informed Consent to Treatments: An Observational-Descriptive Study in the Padua Hospital
Veronica Strini, Roberta Schiavolin, Angela Prendin
Clinics and Practice, 2021; 11(3) pp 472-483
Open Access
Abstract
Background
The process to obtain valid informed consent in healthcare reflects many aspects. Healthcare professionals that take care of the patient must provide him all the necessary information and verify his understanding, considering individual characteristics. Nurses are one of the main participants in this process.
Objective
This study assesses nurses’ perceptions of their role in the informed consent process. Material and
Methods
An observational study involving 300 nurses operating in 13 wards of the Padua Hospital, through the submitting of a questionnaire in the period November–December 2018.
Results
The final sample is made up of 206 nurses—27 males (13.11%) and 179 females (86.89%). Work experience, on average 15 years, is significant in determining the answers to questions about opinions and experiences. Age is significant in determining how often nurses provide information to the patient’s family members about the actions to be taken after discharge. The ward was decisive in the responses related to information provided to patients on the nursing care level and the actions to be taken after discharge, and the definition of the nurse’s duties.
Conclusions
The data collected show the need for interventions to reduce the causes of difficult that the nurse has in informing patients.

Gurus and Griots: Revisiting the research informed consent process in rural African contexts
Debate
Richard Appiah
BMC Medical Ethics, 23 July 2021; 22(98)
Open Access
Abstract
Background
Researchers conducting community-based participatory action research (CBPAR) in highly collectivistic and socioeconomically disadvantaged community settings in sub-Saharan Africa are confronted with the distinctive challenge of balancing universal ethical standards with local standards, where traditional customs or beliefs may conflict with regulatory requirements and ethical guidelines underlying the informed consent (IC) process. The unique ethnic, socioeconomic, and cultural diversities in these settings have important implications for the IC process, such as individual decisional autonomy, beneficence, confidentiality, and signing the IC document.
Main text
Drawing on insights and field observations from conducting CBPARs across several rural, highly communal, low literate, and low-income communities in Ghana, we discuss some theoretical, ethico-cultural, and methodological challenges associated with applying the universal, Western individualistic cultural value-laden IC process in sub-Saharan Africa. By citing field situations, we discuss how local cultural customs and the socioeconomic adversities prevalent in these settings can influence (and disrupt) the information disclosure process, individual decisional authority for consent, and voluntariness. We review the theoretical assumptions of the Declaration of Helsinki’s statement on IC and discuss its limitations as an ultimate guide for the conduct of social science research in the highly communal African context. We argue that the IC process in these settings should include strategies directed at preventing deception and coercion, in addition to ensuring respect for individual autonomy. We urge Universities, research institutions, and institutional review boards in Africa to design and promote the use of context-appropriate ethical IC guidelines that take into consideration both the local customs and traditional practices of the people as well as the scientific principles underpinning the universal IC standards.
Conclusion
We recommend that, rather than adopt a universal one-size-fits-all IC approach, researchers working in the rural, highly collectivistic, low literate, socioeconomically disadvantaged settings of sub-Saharan Africa should deeply consider the roles and influence of cultural values and traditional practices on the IC and the research process. We encourage researchers to collaborate with target communities and stakeholders in the design and implementation of context-appropriate IC to prevent ethics dumping and safeguard the integrity of the research process.

Consent to research participation: understanding and motivation among German pupils
Jana Reetz, Gesine Richter, Christoph Borzikowsky, Christine Glinicke, Stephanie Darabaneanu, Alena Buyx
Research Article
BMC Medical Ethics, 16 July 2021; 22(93)
Open Access
Abstract
Background
The EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights.
Method
This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany.
Results
A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process.
Conclusion
Bearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.

Patient Informed Consent Awareness form in Public Hospitals of Punjab, Pakistan
Saadet Khan, Rabia Afzal, Dr. Saba Farooq, Sohail Ahmed
Psychology and Education, 18 November 2020; 58(5) pp 4645-4655
Abstract
In Pakistan hospitals, it is generally observed that informed consent is not obtained, or they are not provided with enough explanations about the forthcoming processes and their future consequences by the healthcare teams. The purposes of this study was to explore patient’s perception of informed-consent in hospitals of Punjab. It was an exploratory study. A total of 120 patients (84male, 36 female) were included in this study. The patients were selected from public hospitals of Punjab after taking informed consent. A pre- designed and pre-structured validated questionnaire was used for data collection from patients who went through surgical/medical procedures. The data was analyzed through SPSS version 20. Results: In this study, 70% male and 30% female participants with different age groups have participated. Frequency analysis of each question was done to check the response against each statement. The results of independent sample t-test show that there is insignificant difference between male and female groups regarding the understanding level, scope, values and function toward patient informed consent. There is lack of awareness about legal implications of signing or not signing of the informed consent among Patients in Punjab. It is concluded that most of the clinical settings in Pakistan are unaware of importance to obtain informed consent when practicing the workplace environment. It should be emphasized that there would be a need to develop an educational program towards inform consent and further reassessed in order to achieve patient autonomy. The studies should be carried out in other provinces of Pakistan to check that all the workplace environment are following informed consent practices in the workplace.

Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study
Ammal M. Metwally, Hala A. Amer, Hend I. Salama, Safaa I. Abd El Hady, Raefa R. Alam, Ahmed Aboulghate, Hanan A. Mohamed, Hanan M. Badran, Amal A. Saadallah, Marwa M. El-Sonbaty, Eman Eltahlawy, Walaa Saad, Amira Mohsen, Ghada A. Abdel-Latif, Asmaa M. Fathy, Amal I. Hassanain, Abdelmoneim Eldali
PLoS One, 14 June 2021
Abstract
Background
Informed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients’/guardians’ experiences about IC and their expectations about its practices’ purposes in general and according to the type of the healthcare facility.
Methods
Self-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced.
Results
IC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: “Helping patient/guardian decide (64.9%)”, “Documenting patient’s/guardian’s decision (59.3%)”, and “Having shared decision (57.3%)”. The perceived purposes of IC to be practiced were: “Informing the patient/guardian (68.4%)”, “Making sure patient/guardian understand (65.3%)” and “Documenting patients/guardians decisions (65.1%)”. “Being a meaningless routine” was reported by the majority to be ranked as a low purpose for IC current and preferred practices.
Conclusion
The practice of IC is common within the Egyptian medical community. Participants believe that information disclosure “Making sure patients understand” has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient’s/guardian’s decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.

Promoting Patient Engagement in Medical Informed Consent – A Qualitative Study of Chinese Doctors’ Communication Strategies
Research Article
Qianwen Joyce Yu, ack Pun
Health Communication, 3 June 2021
Abstract
Patient engagement is now widely endorsed as an essential ingredient for high-quality healthcare, yet there has been limited research on how patient engagement can be facilitated in medical informed consent (IC) communication. To address this gap, a fine-grained discourse analysis was conducted to identify communication strategies adopted by doctors to facilitate information delivery and ascertain patients’ understanding, which translate into an increase in patient engagement. Data was collected from a public hospital in mainland China. Nonparticipating observations of 14 IC sessions were audio-recorded, followed by in-depth, semi-structured interviews with those observed patients. Four communication strategies emerged from the analysis: 1) seeking patients’ understanding of their condition; 2) explaining medical information by reference to shared knowledge and practice; 3) recognizing and addressing patients’ psychological concerns; 4) repeating critical information and checking patients’ understanding through teach-back. The adoption of these strategies enables doctors to tailor the scope and delivery of information to accommodate and address patients’ preferences, rather than defaulting to one-way information dumping. This study sheds light on the complexity of IC and further contributes to the ongoing endeavors to improve IC communication by raising the awareness of the role of patients in making mutually acceptable decisions. These identified strategies can be incorporated into medical communication training to facilitate delivery of healthcare that is sensitive to patients’ needs and expectations.

Community Consent [BOOK CHAPTER]
Henk ten Have, Maria do Céu Patrão Neves
Dictionary of Global Bioethics [Springer 27 May 2021]
Abstract
In medical practice and research the principle of individual prior informed consent has a crucial role to play. However, the emphasis on individuals is not the same across the world. Communities in many cultures and traditions play an important role in determining human well-being and in individuals living their lives to the full. From a global perspective the moral status of a community is recognized in the concept of community consent.

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh
Original Research
Maya Annie Elias, Kerry Woolfall, Maria Moreno Morales, Bensitta Lincy, Ismat Jahan, Samanmali P Sumanasena, Siddarth Ramji, Seetha Shankaran, Sudhin Thayyil
BMJ Global Health, 21 May 2021
Open Access
Abstract
Introduction
Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.
Methods
Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
Results
A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.
Conclusion
Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.

Quality of written informed consent forms for electroconvulsive therapy in Australia: a comparative analysis
Research Article
Karuppiah Jagadheesan, Frances Walker, Vinay Lakra
Australasian Psychiatry, 3 May 2021
Abstract
Objectives
We compared the quality of the written informed consent forms for electroconvulsive therapy (ECT) in Australian jurisdictions.
Method
For this comparative audit-type study, a checklist was developed to compare informed consent forms from different jurisdictions. The main information sources for consent forms were government health department websites and Google. The directors of clinical services were contacted if a consent form was not available through a web source.
Results
Majority of the informed consent forms covered information about ECT, general anaesthesia and alternative treatments, supports available for decision making, and a reference to the right to withdraw consent. Missing information affected information areas such as likely outcome if no ECT, lack of guaranteed response and cultural and linguistic supports.
Conclusions
A standardised consent form that can be used across all jurisdictions can help improve the ECT practice.

Normative framework of informed consent in clinical research in Germany, Poland, and Russia
Research
Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger
BMC Medical Ethics, 1 May 2021; 22(53)
Abstract
Background
Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki.
Methods
For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed.
Results
The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible.
Conclusions
The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements.