Challenges of the informed consent in some countries of the MENA region: A Literature Review

Challenges of the informed consent in some countries of the MENA region: A Literature Review
Review
T. Habiba, K. Richaa, F. Abou-Mrad
Ethics, Medicine and Public Health, December 2021; 19
Summary
Background
The world of medicine has seen a shift from a paternalistic to a patient-centred approach along with a surge in medical research in the MENA region. This medical revolution is accompanied by ethical challenges, most importantly concerning the informed consent. Countries in the MENA region have become aware of this, as several studies aim to study these challenges, their cause, and their solution. This article summarizes all the major findings of these studies.
Methods
A total of 36 articles were reviewed in order to form a proper idea about the importance of informed consent and its applicability in some countries of the MENA region. Literature review included the following countries: Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, UAE, and Yemen. Excluding criteria were studies conducted in a country not considered to be part of the MENA region and articles not relevant to our objectives.
Results
Challenges of the informed consent in the MENA region are the result of several interrelated factors unique to this region including cultural, religious, and legislative factors.
Conclusion
Efforts have been made to improve the ethical behaviour of physicians in the MENA region, however we are still far behind as several undeniable factors play a significant role, thus forcing an adapted informed consent form and procedure to every country and every population.

OP23 Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed?

OP23 Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed?
Stuti Pant, Maya Annie Elias, Kerry Woolfall, Sudhin Thayyil
Journal of Epidemiology & Community Health, 15 September 2021; SSM Annual Scientific Meeting Oral presentations, Obesity Diabetes & Global Health
Abstract
Background
Parental consent rates for neonatal interventional trials are significantly higher in Low and middle-income countries (LMIC) than in high-income countries, raising concerns about the credibility of the consent processes (Patterson et al PLOS One 2021). We conducted a mixed-methods study to understand the informed consent process in a neonatal cooling trial [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 six 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 the A-V records of the consent process using a 5-point Likert scale on three parameters – Empathy, Information, Autonomy. Additionally, 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 health care professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
Results
In HELIX trial, a total of 475 parents were approached, of which 408 (86%) consented. Of these, 294 A-V records were analysed. Median (Interquartile range) score for empathy, information, autonomy was 5 (0), 5 (1) and 5 (1) respectively. However, thematic analysis suggested that the parental decision to participate was based on a 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. Lower levels of parental education and misinformation further convoluted the voluntary informed consent process. Parents were visibly incapacitated, and many told the doctor to do whatever is best for the baby. Clinicians lacked equipoise and were biased towards cooling therapy as it was already a standard of care in high-income countries, and this influenced parental decision making. However, the HELIX trial results subsequently showed cooling was harmful and increased mortality in these settings.
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 to ensure truly informed trial participation.

Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns

Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns
Research Article
Ferdinand Chinedum Maduka-Okafor, Onochie Ike Okoye, Ngozi Oguego, Nnenma Udeh, Ada Aghaji, Obiekwe Okoye, Ifeoma R Ezegwui, Emmanuel Amaechi Nwobi, Euzebus Ezugwu, Ernest Onwasigwe, Rich E Umeh, Chiamaka Aneji
Research Ethics, 8 September 2021
Open Access
Abstract
School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents.

Informed Consent in Russia: Misuse and Abuse

Informed Consent in Russia: Misuse and Abuse
Irina S. Mylnikova
Medical Ethics, 31 March 2021
Open Access
Abstract
Even T. Beauchamp and J. Childress, the founders of ethical principlism, noted that in practice the principles of bioethics, which they might have formulated, may conflict, and adherence to one principle may violate the other. To date, the conflict between the principle of autonomy and the doctrine of informed consent, and the principle of vulnerability formulated ten years later (one of the principles introduced by P. Kemp) and the necessity to take care of the patient is one of the major irreconcilable conflicts. This conflict is especially severe in Russia, where the informed consent was immediately enshrined as a statutory provision without prior discussion with the medical and non-medical communities, which gave rise to numerous opportunities for misuse and abuse, and stepped up the bureaucratic pressure both on patients, who became more vulnerable, and the physicians, who started using the informed consent to their advantage, sometimes being openly market oriented. The growth of mutual mistrust, sometimes reaching the level of aggression, forces one to find a remedy for this situation. In the author’s view, this requires revision of the patient’s autonomy concept and the concept of informed consent considering the acceptance of the patient’s intense vulnerability and the patient’s need for the healthcare specialists’ (physicians and nurses) personal involvement and care. It may be helpful to consult the writings of the ethics of care, feminist ethics and other ethical trends representation, as well as the results of field research aimed to combine principles of freedom and patient care in a given situation.

Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]

Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]
Suzanne Marie King
Walden University, 2021
Open Access
Abstract
Age of consent policies have recently been identified as a barrier to HIV testing among adolescents in HIV endemic Sub-Sahara Africa. Grounded in the modified social ecological model, the purpose of this study was to determine if these policies were related to HIV testing rates and prevalence. In this quantitative research secondary data sets from the Demographic Health Survey were used. This study included all sexually active respondents aged 18 years or below (N=37,015) and then was further limited by respondents that had HIV test results (N=25,107). Binary logistic regression showed that respondents with lower age of consent had higher rates of HIV testing. Compared to respondents with an age of consent of 18 years, respondents with age of consent of 16 were 3 times more likely to have been tested (p<0.001, OR 2.876, 95% CI [2.697, 3.067]), age of consent of 15 were 1.5 times more likely to be tested, age of consent of 14 were 0.5 times less likely to be tested, age of consent of 13 were 5 times more likely to be tested, age of consent of 12 were 3 times more likely to be tested, and age of consent of 11 were 2 times more likely to have been tested. Age of consent was also related to HIV prevalence. For each year decrease in age of consent, odds of being HIV positive increased by 1.2%. The outcomes of this study showed further relationships between HIV testing and age of consent policies. This research can be used to inform updated age of consent policies to ensure that all adolescents can access HIV testing. This research could shed light on the importance of HIV testing for adolescents, their families, and their communities leading to positive social change.

Legal and Ethical Challenges in the Construction of China’s Biobanks

Legal and Ethical Challenges in the Construction of China’s Biobanks
Jiajv Chen, Jiayu Huang, Xuekai Xie
Biotechnology Law Report, 26 August 2021
Abstract
China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China’s biobanks have collected a large number of biological samples. The law gives many institutions the right to store and use biological samples; however, due to the absence of government regulation, lack of ethical norms, and unclear legal provisions, the risks related to biosafety are rising. In terms of informed consent, China’s current legislation clearly defines the scope and standard of “informed consent,” but the corresponding boundaries are still vague, and there are loopholes in practical operation. In terms of privacy and confidentiality, Chinese laws do not specify the ownership of genetic information. In the event of genetic risk, Chinese doctors often tell the family members of patients about genetic information. In terms of cross-border supervision of biological samples, the Chinese government not only regulates the entry of biological samples, but also controls the exit of biological samples. In recent years, the corresponding law enforcement and punishment efforts have increased. In terms of trust, China’s biobanks often rely on hospitals. Against the background of tense doctor-patient relationships, biological sample donors do not trust hospitals, which is unfortunate because biological sample donors often donate out of their trust in doctors. In terms of benefit sharing, China’s legal system still lacks clear provisions, and there are disputes about the mode and subject of benefit sharing. In China’s future legislative revision(s), the above aspects should be improved, the ethical traditions of China’s “patriarchal system” should be considered, and a biobanking system in line with China’s national conditions should be formulated.

Family Refusal to Consent Donation: Retrospective Quantitative Analysis of Its Increasing Tendency and the Associated Factors Over the Last Decade at a Spanish Hospital

Family Refusal to Consent Donation: Retrospective Quantitative Analysis of Its Increasing Tendency and the Associated Factors Over the Last Decade at a Spanish Hospital
José Manuel Viñuela-Prieto, Maria Carmen Escarpa Falcón, Francisco Javier Candel, Alonso Mateos Rodríguez, Juan Ignacio Torres González, Francisco del Río Gallegos
Transplantation Proceedings, 19 August 2021
Open Access
Abstract
Background
Organ and tissue recovery remains limited by several factors. This study retrospectively analyzes the factors associated with family refusal to consent to donation at a high-donor-volume Spanish hospital.
Methods
Data regarding the annual number of potential donors and family refusal rates at hospital and regional levels were retrieved from 2008 to 2017. Descriptive, bivariate, and multivariate analyses were performed to detect those factors independently associated with family refusal. Results were cross-validated using the data from years 2018 and 2019 as the validation group. To explore potential inter-relations between factors a Multiple Correspondence Analysis was performed.
Results
A total of 601 family interviews for petition of consent were conducted between 2008 and 2017, 531 (88.4%) resulted in acceptance and 70 (11.6%) resulted in refusal of the donation. Lesser experience of the interviewers (odds ratio [OR], 2.980; P = .001), donation after brain death (OR, 2.485; P = .013), number of interviews conducted per family (OR, 1.892; P < .001), age of the main decision maker (OR, 1.025; P = .045), and high or middle attributed cultural levels (OR, 0.142; P < .001 and OR, 0.199; P < .001 respectively) were observed to be independently associated with the family final decision. The logistic regression model displayed good predictive power for both derivation and validation cohorts, with an overall predictive accuracy of 80.9% (95% confidence interval, 0.747-0.870; P < .001) and 74.4% (95% confidence interval, 0.635-0.854; P = .001), respectively.
Conclusions
Transplant coordination team members having a thorough knowledge of the family decision mechanisms may be a key factor in donation process optimization.

South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study

South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study
Research Article
Francis Akpa-Inyang, Sylvester C. Chima
BMC Medical Ethics volume, 14 August 20121; 22(111)
Open Access
Abstract
Background
The Western-European concept of libertarian rights-based autonomy, which advocates respect for individual rights, may conflict with African cultural values and norms. African communitarian ethics focuses on the interests of the collective whole or community, rather than rugged individualism. Hence collective decision-making processes take precedence over individual autonomy or consent. This apparent conflict may impact informed consent practice during biomedical research in African communities and may hinder ethical principlism in African bioethics. This study explored African biomedical researchers’ perspectives regarding informed consent and potential limitations to the principle of respect for autonomy in African communities.
Methods
We conducted a qualitative study based on in-depth interviews with 12 biomedical researchers, five females and seven males aged 34 to 74 years, currently working at an African university. Interviews lasted 35–40 min each and involved semi-structured open-ended interviews, which allowed participants to offer information about their perceptions and feelings regarding respect for autonomy and informed consent as practised in Africa. Empirical data from the interviews were recorded, transcribed, and analysed using thematic content analysis, together with an interrogation of relevant scientific literature about African communitarian ethics, making evaluations and drawing inferences consistent with the empirical bioethics approach.
Results
Based on these interviews and analysis of relevant literature, we found that informed consent is difficult to apply in an African context because it derives from a Western conception of libertarian rights-based autonomy. Most respondents pointed out that it was challenging to implement informed consent in the African setting. Furthermore, communalism, customary beliefs, spirituality, and relational autonomy are predominant in most African communities, as exemplified by the African moral philosophies of Ubuntu/Botho and Ukama, which emphasize communitarianism over individual rights. We also found that language, education, poverty, and cultural beliefs are barriers to obtaining proper informed consent in African communities.
Conclusions
We conclude that there are limitations to applying the principle of respect for autonomy and informed consent in African communities, especially in the context of human biomedical research. We recommend using a more relational approach, such as Ross’s prima facie duties, to implement informed consent in African communities.

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda
Research Article
Dan Kabonge Kaye
BMC Medical Ethics, 28 July 2021; 22(104)
Open Access
Abstract
Background
Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs).
Methods
This was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.
Results
Respondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.
Conclusion
Respondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.

Informed consent and responses of surgical patients: A study in North India

Informed consent and responses of surgical patients: A study in North India
Aman Dev Singh, Ritu Rochwani, Simmi Oberoi
National Journal of Physiology Pharmacy and Pharmacology, 9 July 2021; 11(8) pp 925-929
Open Access
Abstract
Background
A patient’s decision about his or her treatment without being pressurized by their health-care provider is his right and termed as autonomy. Informed consent means that a patient is not merely signing a paper but the whole process in which he is imparted knowledge regarding his disease, diagnostic options, and details regarding intervention modalities for his/her condition. As informed consent is patient’s right and key to trust/relationship between doctor and patient, it is imperative that consent is in layman’s language and the process is completely understood and appropriately documented. In India, there are very less studies conducted for the informed consent.
Aims and Objectives
With this background, the present study was conducted in a tertiary care hospital at Patiala, Punjab, with the objectives – (1) to determine levels of awareness and understanding regarding contents of informed consent and (2) to analyze the patient’s perspective of the process of informed consent in a tertiary care hospital setting.
Materials and Methods
A cross-sectional survey was carried out among the patients who had undergone elective or emergency surgery in the surgical departments of general surgery, obstetrics and gynecology, orthopedics, otolaryngology, ophthalmology, urology, and plastic surgery at a tertiary care teaching hospital at Patiala, Punjab, during October–December 2013. Around 400 post-operative randomly selected patients were interviewed using pre-structured questionnaire. Permission was obtained from the Institutional Ethics Committee.
Results
A total of 400 post-operative patients were randomly selected for this study. Patients himself/herself responded in 60.5% of cases. Only 255 (69.29%) knew about proposed procedure, while 122 (33.15%) were informed about alternate treatment. Almost half (n = 170, 46.19) of them received information about type of anesthesia and only 51 (13.48%) were informed about its complications. In 32 (8%) cases, patients perceived that no informed consent was taken although record was available of the same.
Conclusion
Informed consent enjoys an irrefutable position in clinical practice as a safeguard of patient’s rights. It also minimizes the chances of legal action against the treating physician if a complication arises from the proposed therapy. There is a dire need to alert the doctors and health-care providers.