Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study
Research Article
Zhanqing Hu, Chenxi Ouyang, Jessica Hahne, Kaveh Khoshnood, Jinqiang Zhang, Xiyu Liu, Ying Wu, Xiaomin Wang
Journal of Empirical Research on Human Research Ethics, 28 January 2022
Abstract
This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants’ knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.

The Analysis Causes of Informed Consent in Supporting the Quality of Medical Record In Graha Hospital Medika Banyuwangi
Rizqi Aji Aprilia, Erma Sulistyaningsih, Leersia Yusi Rat
International Journal of Innovative Science and Research Technology, December 2021; 6(12)
Abstract
Backgrounds
Informed consent is an agreement given by the patient or family after receiving a clear explanation of the patient’s medical or dental action to be carried out. The standard of completeness of the Informed Consent is based on the Hospital Minimum Service Standard No. 290 of 2008 and the hospital quality standard is 100%. The number of incomplete informed consent at Graha Medika Hospital in the third quarter of 2020 was 11.14%, 26.90%, and 41%, which means that the standard for completeness of informed consent has not been achieved. The purpose of the study was to analyze the factors causing incomplete informed consent.
Methods
The research design used a quantitative approach with a cross-sectional research design. The population and sample were 258 informed consent forms. The unit of analysis was 30 medical doctors who filled out the informed consent. Data analysis used univariate, bivariate with Spearman Rank, and multivariate with Partial Least Square.
Results
The bivariate analysis results showed that the resource indicator had a relationship with the completeness of Informed Consent with a value of 0.005. A multivariate analysis that organizational factors had a relationship with the completeness of Informed Consent with a value of 0.001.
Conclusion
Strengthening the resource sector with a solid organizational commitment will increase the completeness of informed consent, which is inseparable from the quality of the organization’s management function. A good management function will run in harmony with the level of compliance of good service personnel.

Editor’s note: The International Journal of Innovative Science and Research Technology is an open access peer-reviewed international forum for scientists and engineers published in India.

Informed Consent among Hansen’s Disease Patients – A Nigerian Perspective`I.A. Meka, A.O. Meka, O.O. Kanu, N. Ekeke, K.O. Adagba, A.O. Iseoluwa – Adelokiki, I. Alobu, J. Offor
African Journal of Health Sciences, November-December 2021; 34(6)
Open Access
Summary
Background
Informed consent entails providing potential participants with adequate information needed to decide whether or not to participate in research. In Nigeria, Hansen’s disease has remained a disease of public health importance. The associated stigmatization often renders patients vulnerable and prone to exploitation. The act of obtaining informed consent from these patients remain an issue of ethical importance. The study aimed to determine the willingness of Hansen’s disease patients to give consent to use their data in the form of pictures, videos and/or oral interviews by a third party.
Materials and Methods
This descriptive cross-sectional study was carried out in three states in Nigeria; Ebonyi, Ogun and Cross River States. Data was collected from consenting participants using researcher-administered semi-structured questionnaires.
Results
The study included 93 respondents with a mean (SD) age of 44.9 (20.1) years. The majority 57 (61.29%) of the respondents were farmers while the majority 67 (72.04%) attained primary education. A total of 26 (27.96%) respondents had suffered discrimination in the course of their disease. In their responses, 83 (89.2%) would allow the use of their pictures, 80 (86.0%) their videos and 86 (92.5%) their recorded oral interviews. Among those who would not give consent, the commonest reasons adduced were an intrusion into privacy and lack of trust.
Conclusion
Though a majority of the patients would give consent for use of their data intrusion into privacy and lack of trust were major constraints for those not willing to give consent. Caregivers and stakeholders should put more effort into trying to win patients’ trust before seeking informed consent.

The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
Willem Stassen, Sanjeev Rambharose, Lee Wallis, Keymanthri Moodley
PLOS One, 21 January 2022
Open Access
Abstract
Background
Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital emergency care research with delayed consent in the Western Cape community of South Africa.
Methods
This study was an online survey of a stratified, representative sample of community members in the Western Cape province of South Africa. We calculated a powered sample size to be 385, and a stratified sampling method was employed. The survey was based on similar studies and piloted. Data were analysed descriptively.
Results
A total of 807 surveys were returned. Most respondents felt that enrolment into prehospital research would be acceptable if it offered direct benefit to them (n = 455; 68%) or if their condition was life-threatening and the research would identify improved treatment for future patients with a similar condition (n = 474; 70%). Similar results were appreciable when asked about the participation of their family member (n = 445; 66%) or their child (n = 422; 62%) regarding direct prospects of benefit. Overwhelmingly, respondents indicated that they would prefer to be informed of their own (n = 590; 85%), their family member’s (n = 593; 84%) or their child’s (n = 587; 86%) participation in a study immediately or as soon as possible. Only 35% (n = 283) agreed to retention data of deceased patients without the next of kin’s consent.
Conclusion
We report majority agreement of respondents for emergency care research with delayed consent if the interventions offered direct benefit to the research participant, if the participant’s condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. These results should be explored using qualitative methods.

The use of consent forms in a “call from class” model of dental care for Australian Indigenous children
Brief Report
N Stormon
Health Promotion Journal of Australia, 19 January 2022
Open Access
Abstract
Issues addressed
Dental caries is one of the most prevalent non-communicable diseases in children. Indigenous children reported a disproportionately higher prevalence of dental disease compared to their age-matched counterparts. To improve access to dental care a community-controlled service provides culturally appropriate dental services on the site of an Indigenous primary and secondary school. The dental clinic utilises a “call from class” model of care. Consent forms seeking permission to undertake a dental examination without a parent/guardian present during school hours are sent home. When the forms are returned, the student is located in class and a dental examination is undertaken.
Methods
A retrospective audit of dental records from 2019 and 2020 were undertaken. The number of consent forms sent and returned were recorded.
Results
In 2019, 87% (n= 220) of the school population were sent consent forms. Of the forms issued, 70% (n=154) were returned. Almost all students required further treatment (90%, n=137) and were sent a treatment consent form. Of the total student population, 67% (n=171) were not seen or had outstanding treatment from unreturned forms. Proportions of incomplete treatment and unseen students were similar in 2020 (64%, n=173). In this model barriers are lessened by providing a free dental service on the school site.
Conclusions
Consent is an ethical and legal necessity to undertake dental examination and treatment. Using physical forms were effective for gaining consent for most children. However, less than half of the school population’s dental treatment were completed. Future studies should be conducted to explore the acceptability of using consent forms by parents/guardians and different models to gain consent for children from complex social circumstances.

[Quantitative Analysis of Informed Consent on Caesarean Section at Patria IKKT Hospital, West Jakarta]
Nurmayantih, Nanda Aula Rumana, Daniel Happy Putra, Puteri Fannya
SEHATMAS (Jurnal Ilmiah Kesehatan Masyarakat), January 2022; 1(1) pp 34-40
Abstract
Informed Consent is the consent given by the patient or his family on the basis of an explanation of the medical/surgical action to be performed on the patient and this informed consent must be complete. In performing sectio caesarea, the informed consent sheet is not filled in, so any action taken can be categorized as malpractice. Researchers found that there were still many incomplete informed consent forms, especially informed consent for sectio caesarea surgery. The purpose of the study was to determine the quantitative analysis of informed consent for sectio caesarea at the Patria IKKT Hospital for the period March – April 2021 based on 4 components, namely knowing the completeness of patient identification, author authentication, and completeness of important reports, good records. This type of research is quantitative with descriptive design and data collection techniques are observation, checklist. This research was conducted using systematic random sampling method. The results of the study of 90 informed consent sheets for sectio caesarea, the average completeness of the patient identification filling component was 100%, the important component of filling out the report was an average of 86%, the author’s authentication component had an average of 97.9%, the component of filling out good notes had an average of 97.9%. the average completeness is 93.7%. The results of the recapitulation of quantitative analysis have an average completeness of 94.4%.

Editor’s note: “SEHATMAS is a Scientific Journal published by the Indonesian Science Literacy Foundation”

Patients’ Experience on Practice and Applicability of Informed Consent in Traditional Medical Practice in KwaZulu-Natal Province, South Africa
Research Article
Francis Akpa-Inyang , Elizabeth Ojewole, Sylvester C. Chima
Evidence-Based Complementary and Alternative Medicine, 2022
Open Access
Abstract
Background
Informed consent (IC) is constitutionally protected in South Africa based on individual rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. This study explored patients’ experience on practice and applicability of IC in African traditional medicine (ATM) in Msunduzi and eThekwini municipalities, KwaZulu-Natal province, South Africa, to evaluate whether important elements of IC such as full information disclosure, capacity, understanding, and volition are considered or being applied during ATM.
Methods
This cross-sectional quantitative study was conducted using semistructured questionnaires administered to patients attending traditional health practitioners’ (THPs’) treatment centres. Stata V15.1 was used to analyse variables including descriptive and inferential data analysis.
Results
One hundred and twenty-nine (129) participants completed this study, of which 62% were females. Most participants were in the age range of 26–35 (38.8%). All respondents were IsiZulu home-language speakers, single (62.8%), employed (48%), and with some tertiary education (48.8%). Most patients were informed about their diagnosis (58.9%), treatment benefits (79.8%), and recommended treatment (79.8%). Fewer were informed about risks of treatment (36.4%), right of refusal (3.1%), and risks of refusing recommended treatment (0.8%). All participants reported satisfaction with information disclosed by the THPs and did not feel coerced to accept treatment. Consent was obtained verbally in all cases. The majority of participants (76.7%) sought surrogate assistance when consulting THPS, and 81.4% preferred being informed about all treatment risks. Most respondents also preferred involvement in healthcare decision-making during ATM.
Conclusion
This study reveals that most patients consulting THPs in the KwaZulu-Natal province for treatment are aware of their right to information disclosure and the need to reach agreement before involvement in ATM treatment procedures. The study also showed that some key elements of IC are currently being applied during ATM practice in South Africa.

Informed Consent for Surgical Care in East Africa
Richard Wismayer
Journal of Advances in Medicine and Medical Research, 13 December 2021
Open Access
Abstract
In the developed world one of the pillars of ethical conduct in surgical practise is informed surgical consent. In low income developing countries only a few researchers have explored the practise of surgical consent pre-operatively. During the informed consent process, the patient has a right to make an autonomous and independent decision about his/her surgical treatment after having been provided the necessary information by the surgeon caring for the patient. Patient autonomy and independent decision-making is recommended by the World Medical Association (WMA) Declaration of Lisbon. Family and cultural background, education, religion and socioeconomic status may all influence informed consent in surgical practise. In East Africa, few studies have reviewed consent practises among surgeons to document best surgical practise and identify areas that need improvement in the East African setting. This review reports the author’s personal experience of the practise of surgical consent among surgeons in Uganda and reviews the specific challenges faced in East Africa. In Uganda, the administration and documentation of informed consent is still inadequate. Better medical ethics education and proper communication skills training in medical schools needs to be addressed. Refresher courses on medical ethics and communication skills may also be necessary for fully trained surgeons.

Patient’s knowledge, attitudes and practices on informed consent in a clinical setting; A study done at Colombo North Teaching Hospital in Sri Lanka
Research Article
N. S. Perera, B. P. P. Perera, P. Paranitharan
Sri Lanka Journal of Forensic Medicine, Science & Law, 3 December 2021; 12(2) pp 11-18
Abstract
Introduction
The signing of a consent form is a process with legal and ethical implications. It is required that informed written consent be obtained from a patient for an invasive procedure after proper explanation of the risks, benefits and alternative procedures.
Objective
To determine knowledge, attitudes and practices related to informed consent among patients.
Materials and Methods
A cross sectional descriptive study was carried out over a period of one year in a Tertiary care hospital in Sri Lanka. The participants were medical or surgical inward patients who were 18 years or above, who had consented to invasive procedure or surgery. The quantitative data of 420 patients were analyzed.
Results
Majority (96%) agreed that consent is important in medical practice. Many (61%) were of the view that it helps to make an informed decision. Majority (92%) preferred a doctor, who can explain more in the consent process than a nursing officer (11%). However, 61% were of the view that consent should be taken from the patient and relatives both, even if the patient is competent of giving consent. Majority of the participants (84%) wanted to discuss with family members before giving consent.
Conclusion
Majority of patients were aware of the concept of consent in medical practice and preferred the doctor and family members to be involved in the decision-making process. This finding is important to adopt a doctor-patient-family model in the consent taking process while respecting the patient’s wishes.

Virtual consent and the use of electronic informed consent form in clinical research in Brazil
Original Article
Juliana Carvalho Rocha Alves da Silva, Helaine Carneiro Capucho
Revista da Associação Médica Brasileira, November 2021; 67(11)
Summary
Objective
In view of the need to apply term free and informed consent (IC) in clinical research involving humans, in accordance with the Brazilian ethical standards (CNS Resolution No. 466/2012), it is necessary to assess whether this practice is being effective and can be improved. The aim of this study was to evaluate the use of the IC in electronic format (e-IC), regarding its feasibility and suitability, as a complement to the written/physical consent form.
Methods
Quantitative-qualitative research with a questionnaire instrument.
Results
Greater retention of information and fewer wrong answers were observed after the application of the e-IC.
Conclusions
The use of e-IC is of great value to research participants in Brazil.