Informed Consent for Surgical Care in East Africa
Journal of Advances in Medicine and Medical Research, 13 December 2021
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
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
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.
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.
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.
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
Juliana Carvalho Rocha Alves da Silva, Helaine Carneiro Capucho
Revista da Associação Médica Brasileira, November 2021; 67(11)
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.
Quantitative-qualitative research with a questionnaire instrument.
Greater retention of information and fewer wrong answers were observed after the application of the e-IC.
The use of e-IC is of great value to research participants in Brazil.
Knowledge on Informed Consent for Blood Transfusion Among Patients in Hospital Melaka and Its Associated Factors
Mohd Hilmi Senin, Bakiah Shaharuddin, Nor Amiza Mat Amin, Mastura Sopian
Malaysian Journal of Medicine and Health Sciences, November 2021; pp 22-31
To perform blood transfusion, a physician should obtain informed consent from the patient. However, previous studies have shown a poor transfer of knowledge from the doctor to the patient regarding blood transfusion, with conflicting information as recollected by patients from informed consent discussions. This study aims to describe knowledge of informed consent for blood transfusion from the patients’ perspective.
A cross-sectional study was performed from October 2019 to May 2020 at Hospital Melaka. The instrument used in this study was a structured, validated questionnaire written in the Malaysian language. Respondents aged 18 and above, who had given their consent for blood transfusion within three days, were recruited using purposive sampling. Logistic regression was used to investigate potential predictors for good knowledge.
Data analysis was performed on 239 sets of returned questionnaires, which showed that 85.8% of the respondents had good knowledge scores. Additionally, 94.1% of them were aware that informed consent is mandatory before the blood transfusion procedure. The lowest percentage of correct responses (43.9%) was regarding the timing of the informed consent. Respondents with a history of undergoing transfusion more than once (AOR = 2.18; 95% CI = 1.02, 4.65; p = 0.04), and practicing Buddhism as a religion (AOR = 0.36; 95% CI = 0.15–0.86; p = 0.02) showed significant associations with knowledge.
The respondents in this study were relatively knowledgeable about informed consent for blood transfusion. However, further analysis revealed the deficiency of knowledge among the respondents in several aspects of this topic. The findings can help Malaysian health authority plan for interventions that would improve knowledge of informed consent on blood transfusion among patients and the public.
Cross-Cultural and Religious Critiques of Informed Consent [BOOK]
Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic
Routledge, 29 November 2021
This book explores the challenges of informed consent in medical intervention and research ethics, considering the global reality of multiculturalism and religious diversity. Even though informed consent is a gold standard in research ethics, its theoretical foundation is based on the conception of individual subjects making autonomous decisions. There is a need to reconsider autonomy as relational—where family members, community and religious leaders can play an important part in the consent process. The volume re-evaluates informed consent in multicultural contexts and features perspectives from Buddhism, Confucianism, Hinduism, Christianity, Judaism and Islam. It is valuable reading for scholars interested in bioethics, healthcare ethics, research ethics, comparative religions, theology, human rights, law and sociology.
Exception from Informed Consent for Biomedical Research in Emergency Settings: A Study from Jordan
Samah F. Al-Shatnawi, Karem H. Alzoubi, Rawand A. Khasawneh, Omar F. Khabour, Basima A. Almomani
Heliyon, 23 November 2021
Research conduction in emergency settings is of paramount importance to promote knowledge and experiences related to treating acutely ill patients. However, the complexity of situations creates a considerable ethical challenge facing researchers who basically deal with emergent cases. This study aimed to determine attitudes of healthcare providers (HCPs) towards exception from informed consent (EFIC) and enrollment willingness in emergency research in Jordan.
A quantitative research with face-to-face questionnaire was conducted by an interviewer during 6-month period in 2019. Survey measures included items related to EFIC policy and overall willingness of HCPs to participate or support their family members’ participation in emergency research.
A total of 151 HCPs in the emergency departments (EDs) in Jordan was recruited. Positive attitude toward emergency research dominated among participants; about 21.9% of participants reported previous experience in the conduction of emergency research and 12.3% had related publications. Regarding EFIC policy, there was a general consensus of disagreement to most of the examined items. There was a trend to lower support of EFIC policy when questioned about the enrollment of family members or public in emergency research, however, the application of EFIC was accepted for self-enrollment of respondents in emergency research. No significant differences (P = 0.37), among participants from different disciplines, were reported regarding the attitudes towards EFIC items or willingness to enroll in emergency research.
Generally, HCPs reported an overall positive support to emergency research despite a consensus of disagreement related to EFIC terms. Therefore, it is recommended to pursue future studies to compare well informed subjects; recruited from well-developed institutions in regard to emergency research potentials; with the present basic attitudinal surveillance in order to dissipate the effect of such confounder and to get better insight of the actual attitudes related to emergency research and EFIC. In addition, efficient multidisciplinary communication channels between researchers and policy makers can lather the way to collaborative research with simultaneous innovative delivery of quality emergency care.
An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB
Ann R. Johnson, Lisa M. Rigtrup, John VanBuren, Erin Rothwell, J. Michael Dean
Ethics & Human Research, 9 November 2021
In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site’s community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution’s human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site’s community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.
Consent to minimally invasive tissue sampling procedures in children in Mozambique: A mixed-methods study
Khátia Munguambe, Maria Maixenchs, Rui Anselmo, John Blevins, Jaume Ordi, Inácio Mandomando, Robert F. Breiman, Quique Bassat, Clara Menéndez
PLoS One, 8 November 2021
Minimally invasive tissue sampling (MITS), also named minimally invasive autopsy is a post-mortem method shown to be an acceptable proxy of the complete diagnostic autopsy. MITS improves the knowledge of causes of death (CoD) in resource-limited settings. Its implementation requires understanding the components of acceptability, including facilitators and barriers in real-case scenarios.
We undertook a mixed-methods analysis comparing anticipated (hypothetical scenario) and experienced (real-case scenario) acceptability of MITS among relatives of deceased children in Mozambique. Anticipated acceptability information was obtained from 15 interviews with relatives of deceased children. The interview focus was on whether and why they would allow the procedure on their dead child in a hypothetical scenario. Experienced acceptability data were obtained from outcomes of consent requested to relatives of 114 deceased children during MITS implementation, recorded through observations, clinical records abstraction and follow-up informal conversations with health care professionals and semi-structured interviews with relatives.
Ninety-three percent of relatives indicated that they would hypothetically accept MITS on their deceased child. A key reason was knowing the CoD to take preventive actions; whereas the need to conform with the norm of immediate child burial, the secrecy of perinatal deaths, the decision-making complexity, the misalignment between MITS’ purpose and traditional values, lack of a credible reason to investigate CoD, and the impotency to resuscitate the deceased were identified as potential points of hesitancy for acceptance. The only refusing respondent linked MITS to a perception that sharing results would constitute a breach of confidentiality and the lack of value attached to CoD determination. Experienced acceptability revealed four different components: actual acceptance, health professionals’ hesitancy, relatives’ hesitancy and actual refusal, which resulted in 82% of approached relatives to agree with MITS and 79% of cases to undergo MITS. Barriers to acceptability included, among others, health professionals’ and facilities’ unpreparedness to perform MITS, the threat of not burying the child immediately, financial burden of delays, decision-making complexities and misalignment of MITS’ objectives with family values.
MITS showed high anticipated and experienced acceptability driven by the opportunity to prevent further deaths. Anticipated acceptability identified secrecy, confidentiality and complex decision-making processes as barriers, while experienced acceptability revealed family- and health facility-level logistics and practical aspects as barriers. Health-system and logistical impediments must also be considered before MITS implementation. Additionally, the multiple components of acceptability must be taken into account to make it more consistent and transferrable.
Perceptions of Singaporeans towards informed consent: a cross-sectional survey
Mehek Gupta, Sudharsan Madhavan, Felicia Siok Ying Teo, Jee Keem Low, Vishal G Shelat
Singapore Medical Journal, 31 October 2021
In a patient-centric health system, it is essential to know patients’ views about informed consent. The objective of this study was to understand the perceptions of the local population regarding informed consent.
Spanning across six weeks from January 2016 to March 2016, a cross-sectional survey of adults attending General Surgery outpatient clinics at Tan Tock Seng Hospital was performed. Sociodemographic data, lifestyle and health-related information, perception and purpose of consent forms, and decision-making preferences were studied.
445 adults participated in the survey. Most participants were below 40 years old (n = 265, 60.1%), female (n = 309, 70.1%) and degree holders (n = 196, 44.4%). 56.9% of participants wanted to know every possible risk, while 28.3% wanted to know common and serious risks. On multivariate analysis, age (age 61-74 years: odds ratio [OR] 11.1, 95% confidence interval [CI] 2.2-56.1, p = 0.004; age > 75 years: OR 22.2, 95% CI 1.8-279.1, p = 0.017) was a predictor of not wanting to know any risks. Age also predicted risk of disclosure for death (age 61-74 years: OR 13.4, 95% CI 4.2-42.6, p < 0.001; age > 75 years: OR 32.0, 95% CI 4.5-228.0, p = 0.001). Most participants (48.1%) preferred making shared decisions with doctors, and an important predictor was employment status (OR = 4.8, 95% CI 1.9-12.2, p = 0.001).
Sociodemographic factors and educational level influence decision-making, and therefore, the informed consent process should be tailored for each patient.
Compliance with the Informed Consent to Blood Transfusion: Constraints and Physic for the Developing Africa
Joseph Aondowase Orkuma, George N. Ayia, Mernan Roselynda Ikwue, Joseph Ojobi, Gomerep Samuel Simji
Asian Journal of Medicine and Health, 9 July 2021; 19(7) pp 78-91
The informed consent to blood transfusion is a patient centered care where the health care provider is ethically obliged and legally compelled to disclose the details, alternatives and consequences of a procedure such as blood donation or transfusion and obtain from the patient a prior consent before it is carried out. However, this newly evolving practice is largely constrained in many developing countries of Africa and this study sought to identify constraints and advance remedies. Literature search on PubMed, PubMed Central, Google Scholar, and African Journal on Line (AJOL) as well as print material literatures where applicable was used to retrieve 66 publications whose contents met the criteria for inclusion into the study. Constraints range from nondisclosure or defective disclosure, knowledge gaps of health care providers and non-comprehension of consent-based information by patients, illiteracy, religious and cultural practices, poor funding and administrative bottlenecks like non provision of consent forms or consent-based information materials as well as weak structures of effective oversight for compliance of health institutions by governmental regulating agencies. Physic like deployment of contentious professional development (CPD) activities for different professionals, focused training on consent-related guidelines, public awareness and education on prevailing social, religious and cultural impediments, research and localization of institution specific challenges. Additionally, proactive economic policies like the deployment of insurance indemnity covers for healthcare workers with negligent liabilities in order to dissuade health care providers from practicing defensive medicine which is inimical to quality health care delivery. There is a need for more researches on constraints prevalent in each developing country in Africa for a more appreciable advancement of the practice.
Editor’s note: We recognize some of the variable sentence structure in the abstract above.