The ethical‐legal requirements for adolescent self‐consent to research in sub‐Saharan Africa: A scoping review

The ethical‐legal requirements for adolescent self‐consent to research in sub‐Saharan Africa: A scoping review
Busisiwe Nkosi, Brian Zanoni, Janet Seeley, Ann Strode
Bioethics, 14 October 2021
Open Access
Abstract
Support for the enrolment of adolescents in research has been constrained by uncertainties in parental involvement, and the lack of clarity in the ethical and legal frameworks. We conducted a scoping review to examine articles that explored the opinion of scholars on the question of adolescent consent and conditions for parental waivers in research in sub‐Saharan Africa (SSA). Guided by the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) tool, we searched electronic databases (PubMed, EMBASSE, EBSCOHOST) and also reviewed the references of articles identified for additional relevant literature. We included full text English articles focusing on adolescent consent and parental waivers in SSA that were published between 2004 and 2020. We excluded studies focusing on healthcare, theses, and reviews. We reviewed a total of 21 publications from South Africa (n = 12), Kenya (n = 4) and Botswana, Malawi, Nigeria, Uganda and Zimbabwe (n = 1 each). We identified four broad thematic issues: the current position regarding parental waivers and self‐consent; parental involvement in the consent process; the role of community approval or consent when adolescent self‐consent approaches were used; and complexities and ambiguities in legal requirements and ethical guidelines on adolescent consent. Our findings show inconsistencies and ambiguities in the existing legal and ethical frameworks within and across different countries, and underscore the need for consistent and clearer guidance on parental waivers and adolescent self‐consent. Harmonization of the legal and ethical frameworks taking into account varying contexts is critically important to ensure research on adolescents in SSA meets adolescents’ specific unmet needs.

Bell v Tavistock: Rethinking informed decision-making as the practical device of consent for medical treatment

Bell v Tavistock: Rethinking informed decision-making as the practical device of consent for medical treatment
Research Article
Abeezar I. Sarela
Clinical Ethics, 27 December 2021
Abstract
The decision of the High Court in Bell v Tavistock has excited considerable discussion about lawful consent for puberty-blocking drug treatment for children with gender dysphoria. The present paper draws attention to a wider question that surfaces through this case: is informed decision-making an adequate practical tool for seeking and obtaining patients’ consent for medical treatment? Informed decision-making engages the premises of the rational choice theory: that people will have well-crystallised health goals; and, if they are provided with sufficient information about medical treatments, then they will be able to choose the treatment that satisfies their goals. Whilst appealing, the informed decision-making paradigm is assailed by various fallacies, which apply not only to children but also to adults. In Bell v Tavistock, the High Court seems to have recognised such fallacies, and it rejected informed decision-making as an adequate tool for consent from children with gender dysphoria. Similar considerations apply to adults in various situations. Thus, Bell v Tavistock can be seen as an attempt to refine the views on the consent that were expressed by the Supreme Court in Montgomery. It can be inferred that the Supreme Court did recognise the limitations of informed decision-making, but it did not develop this point. Further work is required to formulate an adequate model of decision-making, and Bell v Tavistock serves as a useful reminder to rethink informed decision-making as the device for consent.

Informed Consent for Surgical Care in East 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

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

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.

Knowledge on Informed Consent for Blood Transfusion Among Patients in Hospital Melaka and Its Associated Factors

Knowledge on Informed Consent for Blood Transfusion Among Patients in Hospital Melaka and Its Associated Factors
Original Article
Mohd Hilmi Senin, Bakiah Shaharuddin, Nor Amiza Mat Amin, Mastura Sopian
Malaysian Journal of Medicine and Health Sciences, November 2021; pp 22-31
Open Access
Abstract
Introduction
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.
Methods
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.
Results
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.
Conclusion
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.

Patient and Clinician Perceptions of Informed Consent and Decision Making About Accepting KDPI > 85 Kidneys

Patient and Clinician Perceptions of Informed Consent and Decision Making About Accepting KDPI > 85 Kidneys
Karolina Schantz, Elisa J. Gordon, Unsun Lee, Maria Rocha, John Friedewald, Daniela P. Ladner, Yolanda Becker, Richard Formica, Peter P. Reese, Dixon Kaufman, Masoud Barah, Marissa Walker, Om Mehrotra, Dania Viveros, Sanjay Mehrotra
Transplantation Direct, January 2022; 8(1) pp e1254
Abstract
Background
Although the impact of the kidney donor profile index (KDPI) on kidney discard is well researched, less is known about how patients make decisions about whether to give consent for KDPI > 85 kidney offers.
Methods
We conducted in-depth, semistructured interviews with 16 transplant recipients, 15 transplant candidates, and 23 clinicians (transplant surgeons, nephrologists, and nurse coordinators) to assess and compare perceptions of transplant education, informed consent for KDPI > 85 kidneys‚ and the decision-making process for accepting kidney offers. Thematic analysis was used to analyze qualitative data.
Results
Four themes emerged: (1) patients reported uncertainty about the meaning of KDPI or could not recall information about KDPI; (2) patients reported uncertainty about their KDPI > 85 consent status and a limited role in KDPI > 85 consent decision making; (3) patients’ reported willingness to consider KDPI > 85 kidneys depended on their age, health status, and experiences with dialysis, and thus it changed over time; (4) patients’ underestimated the survival benefit of transplantation compared with dialysis, which could affect their KDPI > 85 consent decision making.
Conclusions
To better support patients’ informed decision making about accepting KDPI > 85 kidneys, centers must ensure that all patients receive education about the trade-offs between accepting a KDPI > 85 kidney and remaining on dialysis. Additionally, education about KDPI and discussions about informed consent for KDPI > 85 kidneys must be repeated at multiple time points while patients are on the waiting list.

Should medical students perform pelvic exams on anaesthetised patients without explicit consent?

Should medical students perform pelvic exams on anaesthetised patients without explicit consent?
Research Article
Chloe Bell, Nathan Emmerich
Clinical Ethics, 28 December 2021
Abstract
There have been many reports of medical students performing pelvic exams on anaesthetised patients without the necessary consent being provided or even sought. These cases have led to an ongoing discussion regarding the need to ensure informed consent has been secured and furthermore, how it might be best obtained. We consider the importance of informed consent, the potential harm to both the patient and medical student risked by the suboptimal consent process, as well as alternatives to teaching pelvic examinations within medical school. The subsequent discussion focuses on whether medical students should perform pelvic examinations on anaesthetised patients without personally ensuring that they have given their explicit consent. Whilst we question the need to conduct pelvic examinations on anaesthetised patients in any circumstance, we argue that medical students should not perform such exams without personally securing the patients informed consent.

Perceptions and practices regarding the process of obtaining informed consent from surgical patients at a tertiary care hospital

Perceptions and practices regarding the process of obtaining informed consent from surgical patients at a tertiary care hospital
Cross-sectional Study
Muhammad Asharib Arshad, Naureen Omar, Muhammad Zaid Amjad, Khalid Bashir, Muhammad Irfan, Irfan Ullah
Annals of Medicine and Surgery, 22 December 2021
Abstract
Background
Proper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.
Methods
A cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was
performed by using SPSS version 23.
Results
Out of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).
Conclusion
The patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.

Upgrading the Chemotherapy Consent: Trading in Paper for Tablet

Upgrading the Chemotherapy Consent: Trading in Paper for Tablet
Lesley Wu, Cardinale B. Smith, Jessica Parra, Mark Liu, Haley Hines Theroux, Aarti S. Bhardwaj
JCO Oncology Practice, 15 December 2021
Abstract
Purpose
Our institution participated in the Oncology Care Model, which required us to include many of the 13 elements of the National Academy of Medicine (NAM) care plan into care pathways for our patients. We optimized our existing chemotherapy consent process to meet this need and maximized completion.
Methods
Our multidisciplinary committee developed a three-phase Plan-Do-Study-Act process in our breast cancer clinic: (1) update and educate providers on our paper chemotherapy form with multiple components of the NAM care plan including prognosis and treatment effects on quality of life; (2) piloted an electronic chemotherapy consent form to decrease the administrative burden; and (3) autopopulated fields within the electronic consent. We assessed feedback after cycle 1 and created a Pareto chart. The outcome measure was percent completion of chemotherapy consent documents.
Results
Baseline monthly random chart audit of 40 patients revealed 20% of paper chemotherapy consent forms were completed in their entirety among patients. When we re-educated clinicians about the new paper consent containing the NAM elements, compliance rose to nearly 30%. A Pareto chart confirmed that content redundancy and wordiness were leading to under-completion. After creating and piloting the electronic consent, compliance increased to 90%. Finally, autopopulation with drop-down selections increased and sustained completion to 100%.
Conclusion
Incorporating regulatory requirements into an existing workflow using Plan-Do-Study-Act methodology can reduce administrative burden on clinicians. Additional use of innovative technology can further increase clinician compliance with regulatory requirements while delivering high-value quality care to patients with cancer.