Informed Consent Rates For Neonatal Randomized Controlled Trials In Low And Lower-Middle Income Countries Versus High-Income Countries: A Systematic Review
Denise Jones, Syed Taha, Michael S. Jones, Melissa Bauserman, Stuti Pant, Carl Bose, Sudhin Thayyil, Jackie K. Patterson and Paolo Montaldo
Pediatrics, March 2021; 147(3) pp 246-247
Abstract
Background – Consent rates for research studies in low- and lower middle-income countries (LMICs) are often greater than 90%. Uniformly high consent rates raise ethical concerns regarding the extent to which consent is both autonomous and informed. This study aimed to characterize consent rates for neonatal randomized controlled trials (RCTs) in LMICs compared to high-income countries (HICs). Methods – We searched MEDLINE, EMBASE and Cochrane for neonatal RCTS in LMICs or HICs published between 2013 and 2018. Given the disproportionately high number of HIC articles in the initial search, we used a random number generator to select a subset of HIC…

Written Informed Consent—Translating into Plain Language. A Pilot Study
Agnieszka Zimmermann, Anna Pilarska, Aleksandra Gaworska-Krzemińska, Jerzy Jankau, Marsha N. Cohen
Healthcare, 20 February 2021; 9(2)
Abstract
Background
Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form.
Methods
Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability.
Results
The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible.
Conclusions
There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

Enhancing the ethical conduct of a longitudinal cluster-randomized trial of psychosocial stimulation intervention for children with complicated severe acute malnutrition through Rapid Ethical Assessment: a qualitative study
Research Article
Tesfalem T. Tessema, Andamlak G. Alamdo, Eyoel B. Mekonnen, Fanna A. Debele, Juhar A. Bamud, Teklu G. Abessa & Tefera Belachew Lema
BMC Medical Ethics, 4 February 2021; 22(10)
Open Access
Abstract
Background
Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial.
Methods
This REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach.
Result
Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized.
Conclusion
Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient.

Knowledge, Attitude, and Practice about informed consent amongst Resident doctors at Rural Medical Institute of Central India
Shashank Gotarkar, Prakash Mohite, Kumar Bijyendra Sourabh, Alka Rawekar
Indian Journal of Forensic Medicine & Toxicology, January-March 2021; 15(1)
Open Access
Abstract
Informed consent is the process by which the treating health-care provider discloses appropriate information to the patient so that the patient may make a voluntary choice to accept or refuse treatment. There are few studies done amongst the medical residents in India about informed consent. The residents are the stepping stone of the Medical profession, it is proposed that the perception about the informed consent amongst the residents shall be sought.Hence, the study was undertaken with the aim, to appraise the knowledge, attitude, and practices of residents of all three years toward ‘informed consent taking’ with the objectives of assessing and comparing the knowledge, attitude and practices of obtaining informed consent. The survey questionnaire was circulated and data was collated. It was developed in Knowledge, Attitude and practice domain and analysis was done. Based on the result, it was concluded that, in all three domains, there was ascendency of Knowledge, Attitude and Practice in three years of resident doctors.

Ethical Dimensions in Research – Informed Consent and Female Gender in Nigeria [BOOK CHAPTER]
Olufunke Olufunsho Adegoke
Africa’s Radicalisms and Conservatisms; Brill, 15 January 2021; Chapter 17 pp 321-340
Abstract
Women in any society are germane to its continual existence and development. Their contribution to development cannot be neglected and undermined. However, there is the persistence of gender inequality in many places in Africa (carried over perhaps from traditional African societies). Such inequality marginalizes the societies from the gains of development. The inequality manifests itself in many areas including in research. This chapter postulates that there has to be a re-evaluation of female gender status quo on informed consent in research. There are issues of contention which arises in the context of the local environment, spousal consent and of importance is the level of education with the contextual understanding of the informed consent in any research. It is a system of social stratification and differentiation on the basis of sex, which provides material advantages to men while simultaneously placing severe constraints on the roles and activities of women. Evidence based researches have disclosed that women are not well informed and this over shadows their judgment on appropriate decision making. This observation calls for the need of culturally competent and sensitive approaches that addresses identity specific barriers in research when designing consent forms. There is the need for gender mainstreaming in research implementation and ethical process especially informed consent. The attainment of gender equality is not only seen as an end itself and human right issues, but as a prerequisite for the achievement of sustainable development.

Challenges of Obtaining Informed Consent in Poorly Coordinated and Funded Healthcare Services: Papua New Guinea Situation
Alfred P. Minei, Sam O. Kaipu
Journal of Health Science, July-August 2020; 8(4)
Open Access
Abstract
During a semi-structured interview we ask the participants several questions based on the perceived role of the interviewee within the informed consent process. We asked questions pertaining to how informed consent unravels itself across barriers. Few question topics included how the issue of socio-economic, geography and custom of the people are addressed, and how the medical professionals deal with different groups of people and how the interviewees understood informed consent. Interviews for each group were asked with different sets of questions and were open enough to allow for probing questions in order to gain additional information when the opportunity presented itself. The data were analyzed using interpretative approaches and the various themes and concepts from each question and response qualitatively counted and uncovered patterns in the various group perspectives. We examined the participants’ perspectives and opinions using a visual table for comparing themes and concepts, and we presented the interviewees’ views.

The Quality of Obtaining Surgical Informed Consent for Cesarean Section in Public Hospitals of Iran
Shadi Sabetghadam, Sedighe Rezaie Chamani, Zahra Amirkhanzadeh Barandouzi, Sedigheh Sedigh Mobarakabadi, Yalda Donyaei Mobarrez
Journal of Holistic Nursing and Midwifery, 2021; 31(1) pp 1-7
Abstract
Introduction
Nowadays, about 50-65% of births in Iran occur by Cesarean Section (CS). Informed consent (IC) is one of the most important ethical, legal and professional requirements of a surgical procedure.
Objectives
This study aims to assess the quality of obtaining surgical IC from women underwent CS in public hospitals of Iran.
Materials and Methods
In this analytical study with cross-sectional design, 300 postpartum women who had CS referred to two public hospitals in Rasht, Iran were participated through stratified random sampling method in 2016. Data were collected using a two-part researcher-made questionnaire. Collected data were analyzed by using descriptive statistics, Kruskal-Wallis test, Mann-Whitney U test, and Spearman’s correlation test.
Results
The mean age of participants was 29.84 ± 5.9 years. The majority of them (45.3%) had education lower than high school. The overall mean score for the quality of obtained IC was 62.23±23.38, out of 150 points. Regarding its dimensions, quality of acquiring IC form (20.21±7.12, out of 40 points), provision of CS-related information (15.67±11.10, out of 45 points), voluntariness (7.53±6.95, out of 25), and the physician–patient relationship (18.81±8.87, out of 40 points) were perceived poor. Women’s educational level had a significant correlation with the IC quality dimensions of voluntariness (P=0.0001) and physician–patient relationship (P=0.043). The number of deliveries (P=0.008), live births (P=0.031), and stillbirth (P=0.0001) had a significant correlation with acquiring the IC form. The voluntariness was significantly associated with the number of live births (P=0.023) and stillbirth (P=0.001). The physician-patient relationship dimension was significantly associated with the number of pregnancies (P=0.023) and abortions (P=0.0001). The overall quality of obtained IC was significantly correlated with the women’ age (r= 0.162, P= 0.005).
Conclusion
Most of women in Iran are not informed enough about the CS and its consequences. Health care providers should pay more attention to the women’s characteristics when obtaining IC for the CS.  We recommend essential changes in the process of obtaining surgical IC for the CS in public hospitals of Iran. Obtaining IC during pregnancy may reduce unnecessary CSs.

Power-Laden (Mis)Understandings Surrounding Written Voluntary Informed Consent Procedures in Postcolonial Southern Africa
Michelle R. Brear
The Qualitative Report, 4 December 2020; 25(13) pp 71-89
Abstract
Written voluntary informed consent (VIC) procedures are the standard approach for operationalising the ethical principle of respect for persons’ autonomy in qualitative research. However, achieving fully informed and truly voluntary consent is challenging, particularly in qualitative research and/or postcolonial contexts. Evidence about (mis)understandings (i.e., unintended meanings) surrounding VIC comes primarily from participants in quantitative, biomedical research. I aim to advance knowledge about qualitative research participants’ (mis)understandings of VIC. I used ethnographic methods to document the evolving (mis)understandings participants attached to written VIC procedures in two postcolonial settings, Eswatini and South Africa. All participants provided me consent to document their interactions as co-researchers in participatory research, in which they learned about, designed and implemented VIC procedures. I analysed the data interpretively and abductively, informed by Bourdieu’s theory of practice. Participants valued the opportunity to decide and sign consent to participate but held (mis)understandings of study information and signing, which evolved as they participated. Many (mis)understandings were shaped by what the unfamiliar act of signing symbolised to them (i.e., binding, contractual agreements that protected the researcher/university and through which they relinquished their rights), from their positions of marginalisation amidst economic/material, cultural and social power inequalities. In postcolonial settings, requiring qualitative research participants to sign consent forms likely undermines the ethical principle of respect that VIC is intended to operationalise. Based on these findings I recommend alternative non-written procedures are used to operationalise the principle of respect in postcolonial qualitative research settings.

Participant understanding of informed consent in a multidisease community-based health screening and biobank platform in rural South Africa
Nothando Ngwenya, Manono Luthuli, Resign Gunda, Ntombizonke A Gumede, Oluwafemi Adeagbo, Busisiwe Nkosi, Dickman Gareta, Olivier Koole, Mark Siedner, Emily B Wong, Janet Seeley
International Health, 9 November 2020; 12(6) pp 560–566
Abstract
Background
In low- and middle-income settings, obtaining informed consent for biobanking may be complicated by socio-economic vulnerability and context-specific power dynamics. We explored participants experiences and perceptions of the research objectives in a community-based multidisease screening and biospecimen collection platform in rural KwaZulu-Natal, South Africa.
Methods
We undertook semi-structured in-depth interviews to assess participant understanding of the informed consent, research objectives and motivation for participation.
Results
Thirty-nine people participated (individuals who participated in screening/biospecimen collection and those who did not and members of the research team). Some participants said they understood the information shared with them. Some said they participated due to the perceived benefits of the reimbursement and convenience of free healthcare. Most who did not participate said it was due to logistical rather than ethical concerns. None of the participants recalled aspects of biobanking and genetics from the consent process.
Conclusions
Although most people understood the study objectives, we observed challenges to identifying language appropriate to explain biobanking and genetic testing to our target population. Engagement with communities to adopt contextually relevant terminologies that participants can understand is crucial. Researchers need to be mindful of the impact of communities’ socio-economic status and how compensation can be potentially coercive.