Informed consent process: ethical and practical challenges in clinical trials regarding subject enrollment, protection, and informed consent in developing countries (India, Pakistan & Iran)
Andaleeb Fatima
History & Philosophy of Medicine, 21 April 2021
Open Access
Abstract
In this study, we are discussing the rationale behind informed consent in clinical trials in developing countries. It elaborates how informed consent has remained an ethical and practical issue. Poverty, endemic diseases, and a lack of investment in healthcare systems influence the ease of conducting and selecting trials that can benefit the people of developing countries. Differences in cultural perspectives, religious beliefs, a lack of formal training for clinical staff, children, time zone difference, literacy, vulnerable population, and language barriers for subject enrollment, protection, and informed are also challenges. This report doesn’t only highlight the right the wrongs of the past or reiterate cases where clinical trials have hurt subjects in developing countries. The current study investigates the conditions of human research in developing countries to make them more ethically sound. The extends proposals to investigators, scientists, governments, sponsors, and other groups who are interested where appropriate.

Knowledge and practices of seeking informed consent for medical examinations and procedures by health workers in the Democratic Republic of Congo
Doudou Nzaumvila, Patrick Ntotolo, Indiran Govender, Philip lukanu, JD Landu Niati, Didier Sanduku, Tombo Bongongo
African Journals Online, 16 April 2021; 21(1)
Open Access
Abstract
Background
Informed consent (IC) is linked to the ethical principle of respecting patient autonomy, respect for human rights and ethical practice, while in many countries it is a standard procedure. Anecdotally, it should be noted that in the Democratic Republic of Congo (DRC) in many instances ICs are not obtained systematically. To date, no research appears to have been conducted on this matter. This study aimed to assess the knowledge and practice of obtaining IC from patients among health care providers (HCP) in the DRC.
Methods
This was a cross-sectional study, with a convenient sampling of 422 participants. Data from the questions were collected on an imported Microsoft Excel spreadsheet for review at INSTAT.TM The authors set IC’s accurate knowledge and practice at 80% or higher. The Fisher Exact test was used to compare categorical association results, and a p-value < 0.05 was considered statistically significant.
Results
Results showed that giving information in detail to patients on their medical condition was associated with formal training on medical ethics and IC (p: 0.0028; OR: 1.894; CI: 1.246 to 2.881), which was also associated with answering the patient’s questions in detail (p: 0.0035; OR: 1.852; CI: 1.236 to 2.774). About 127(30.09 %) of participants scored 80% or higher. Extracurricular training was associated with withholding information from patients, up to 27 times more than other factors (p< 0.0001; OR: 27.042; CI: 13.628 to 53.657). when it comes to get IC, HCP with many years of practice scored better than others, in one of the question the odd ratio was closer to 7 ( p< 0.0001; OR: 6.713; CI: 4.352 to 10.356). Only 47(11.14%) of the participants scored 80% or more of the questions about practice of IC.
Conclusion
For a variety of reasons, knowledge and practice of IC among HCPs was very low. A common programme for the country as part of formal training might lead to an improvement. In addition, patients’ education on IC should be displayed in waiting areas at all medical centres.

Validation of the factors influencing family consent for organ donation in the UK
Original Article
M. K. Curtis A. R. Manara S. Madden  C. Brown  S. Duncalf  D. Harvey  A. Tridente  D. Gardiner
Anaesthesia, 16 April 2021
Summary
Between 2013 and 2019, there was an increase in the consent rate for organ donation in the UK from 61% to 67%, but this remains lower than many European countries. Data on all family approaches (16,896) for donation in UK intensive care units or emergency departments between April 2014 and March 2019 were extracted from the referral records and the national potential donor audit held by NHS Blood and Transplant. Complete data were available for 15,465 approaches. Consent for donation after brain death was significantly higher than for donation after circulatory death, 70% (4260/6060) vs. 60% (5645/9405), (OR 1.58, 95%CI 1.47–1.69). Patient ethnicity, religious beliefs, sex and socio‐economic status, and knowledge of a patient’s donation decision were strongly associated with consent (p < 0.001). These factors should be addressed by medium‐ to long‐term strategies to increase community interventions, encouraging family discussions regarding donation decisions and increasing registration on the organ donor register. The most readily modifiable factor was the involvement of an organ donation specialist nurse at all stages leading up to the approach and the approach itself. If no organ donation specialist nurse was present, the consent rates were significantly lower for donation after brain death (OR 0.31, 95%CI 0.23–0.42) and donation after cardiac death (OR 0.26, 95%CI 0.22–0.31) compared with if a collaborative approach was employed. Other modifiable factors that significantly improved consent rates included less than six relatives present during the formal approach; the time from intensive care unit admission to the approach (less for donation after brain death, more for donation after cardiac death); family not witnessing neurological death tests; and the relationship of the primary consenter to the patient. These modifiable factors should be taken into consideration when planning the best bespoke approach to an individual family to discuss the option of organ donation as an end‐of‐life care choice for the patient.

Obstacles to Obtaining Informed Consent from the Perspective of Transplant Coordinators: A Qualitative Study
Research Article
Alireza Shamsaeefar, Nasrin Motazedian, Fatemeh Rahmanian, Saman Nikeghbalian, Seyed Ali Malek-Hosseini
Hepatitis Monthly, 5 April 2021; 21(2)
Abstract
Background
The lack of consent to donate body organs leads to an increase in the death rate of patients on the waiting list for transplantation. Unwillingness of families is known as the main obstacle to organ donation, and the media has an essential role in motivating organ donation.
Objectives
This study aimed to explore obstacles to obtaining consent for organ donation from transplant coordinators’ perspective throughout Iran.
Methods
In this qualitative study, 13 in-depth semi-structured face-to-face interviews were conducted with transplant coordinators from November 2018 to March 2019. The participants were investigated using a purposive sampling method. The participants’ age and work experience ranged between 32 – 49 years and 6 – 25 years, respectively. Open-ended questions were asked from the participants in a private room. An experienced interviewer explained the study’s objectives to the coordinators, and each interview lasted on average 50 minutes. The interview scripts were analyzed using a content analysis method.
Results
The findings highlighted the difficulty of obtaining consent from brain-dead patients’ families. The obstacles could be internal or external. External determinants were healthcare providers’ lack of empathy, inadequate consultation from doctors outside the hospital, media content, and uninformed comments from relatives. Internal determinants were hoping for recovery, denial, and disagreement among family members.
Conclusions
The healthcare team should have a better connection with families to obtain organ donation consent from them. Therefore, a training program must be developed for the treatment team so that they show more supportive behavior and improve quality of care in hospitals before and after brain death.

Health workers’ perspectives on informed consent for caesarean section in Southern Malawi
Research Article
Wouter Bakker, Siem Zethof, Felix Nansongole, Kelvin Kilowe, Jos van Roosmalen, Thomas van den Akker
BMC Medical Ethics, 29 March 2021; 22(33)
Open Access
Abstract
Objective
Informed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers’ beliefs and experiences related to principles and practice of informed consent.
Methods
Qualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a focus group discussion were used to collect data. Participants were 22 clinical officers, nurse-midwives and midwifery students involved in maternity care. Data were analysed to identify themes and construct an analytical framework.
Results
Definition and purpose of informed consent revolved around providing information, respecting women’s autonomy and achieving legal protection. Due to fear of blame and litigation, health workers preferred written consent. Written consent requires active participation by the consenting individual and was perceived to transfer liability to that person. A woman’s refusal to provide written informed consent may pose a dilemma for the health worker between doing good and respecting autonomy. To prevent such refusal, health workers said to only partially disclose surgical risks in order to minimize women’s anxiety. Commonly perceived barriers to obtain a fully informed consent were labour pains, language barriers, women’s lack of education and their dependency on others to make decisions.
Conclusions
Health workers are familiar with the principles around informed consent and aware of its advantages, but fear of blame and litigation, partial disclosure of risks and barriers to communication hamper the process of obtaining informed consent. Findings can be used to develop interventions to improve the informed consent process.

Multicomponent Informed Consent with Marshallese Participants
Research Article
Rachel S. Purvis, Britni L. Ayers, Cari A. Bogulski, Kyle F. Kaminicki, Lauren K. Haggard-Duff, Lynda A. Riklon, Anita Iban, Rotha Mejbon-Samuel, Rumina Lakmis, Sheldon Riklon, Joseph W. Thompson, Pearl A. McElfish
Journal of Empirical Research on Human Research Ethics, 29 March 2021
Abstract
Pacific Islanders are the second fastest-growing population in the United States; however, Pacific Islanders, and Marshallese specifically, are underrepresented in health research. A community-based participatory research (CBPR) approach was used to engage Marshallese stakeholders and build an academic-community research collaborative to conduct health disparities research. Our CBPR partnership pilot tested a multicomponent consent process that provides participants the option to control the use of their data. Consent forms used concise plain language to describe study information, including participant requirements, risks, and personal health information protections, and were available in both English and Marshallese. This study demonstrates that when provided a multicomponent consent, the vast majority of consenting study participants (89.6%) agreed to all additional options, and only five (10.4%) provided consent for some but not all options. Our description of the development and implementation of a multicomponent consent using a CBPR approach adds a specific example of community engagement and may be informative for other indigenous populations.

Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Research Article
Mariana Rodriguez-Patarroyo, Angelica Torres-Quintero, Andres I. Vecino-Ortiz, Kristina Hallez, Aixa Natalia Franco-Rodriguez, Eduardo A. Rueda Barrera, Stephanie Puerto, Dustin G. Gibson, Alain Labrique, George W. Pariyo, Joseph Ali
Journal of Empirical Research on Human Research Ethics, 25 September 2020
Abstract
Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.

Towards building a culturally informed consent process in Central Asia
Research Article
Christopher M. Whitsel, Martha C. Merrill
Central Asian Survey, 26 March 2021
Abstract
Researchers working in Central Asia often report difficulty obtaining Western-style signed informed consent statements. The principles underlying informed consent were developed in cultures characterized by low-power distance and individualism, low context communication and a rules basis, whereas many Central Asian cultures emphasize high-power distance, collectivism, high-context communication and relationships. Yet, consent is an important principle. We interviewed scholars who grew up in Central Asia, but completed graduate work in the United States, Canada or the UK, to ask their recommendations for developing a culturally appropriate consent process. The common themes that arose include working within a network, building relationships of trust with potential participants and not utilizing legal-type documentation as a basis for consent.

Providing emergency medical care without consent: How the ‘emergency principle’ in Australian law protects against claims of trespass
Sam Boyle, Nikola Stepanov
Emergency Medicine Australasia, 24 March 2021
Abstract
In a medical emergency, the usual requirement to obtain consent before giving treatment does not apply. This exception to the general rule on consent to medical treatment is known as the ‘emergency principle’. By considering a case scenario, and by adjusting the facts to this scenario, we explain the circumstances in which the emergency principle will protect practitioners from an action in trespass. Although the fundamentals of this principle are uncontroversial, there are a number of uncertainties and inconsistencies in this law in relation to certain parameters. For example, whether a practitioner would ever be obliged to seek consent from a substitute decision‐maker before providing emergency treatment is not clearly or consistently explained. We suggest the law should be clarified.

Informed Consent in the Health Care System: An Overview from a Dental Perspective in Saudi Arabia
Review Article
Nassar A.A., Demyati A.K.
Saudi Journal of Health Systems Research, March 2021; 1 pp 11–15
Open Access
Abstract
Background
Patient autonomy in the health care system is achieved by the vital principle of providing informed consent. Throughout history, informed consent gained recognition and improved to include more aids and steps to formalize and standardize the process of obtaining proper consent in medical and dental practice. Regardless of the type of informed consent obtained before the treatment, it should include an adequate understandable description of nature and diagnosis of the disease, treatment plan, proper alternatives, risks, and limitations.
Summary
There is limited information in the ethics literature covering critical concepts related to different dental procedures in Saudi Arabia. In Saudi Arabia, informed consent in dentistry is not well-documented. As everything is evolving and changing in Saudi society, litigation has progressed and impacted dentistry. This overview will help in addressing aspects related to informed consent and closing the gaps in the dental health care system in Saudi Arabia, managing complex ethical issues associated with dental patients. In addition, providing recommendations and shedding some light on the importance of informed consent will improve the situation of the informed consent process in Saudi Arabia.
Key Messages
Informed consent allows patients to be part of the decision-making process, and it provides legal protection for the practitioners from practice lawsuit cases. Dentists should take extra care in documenting the consent process and patient’s choice regarding their treatment to avoid unfavorable consequences. In Saudi Arabia, attention should be drawn toward the crucial role of informed consent, and more studies should be published in order to enrich the knowledge and to improve the health care system.