Parental views on prospective consent: experience from a pilot neonatal randomized control trial
Original Research
Hannah Skelton, Patricia Viola, Traci-Anne Goyen, Pranav Jani
Frontiers in Pediatrics, November 2023
Abstract
Objective
To explore parental perceptions of the consenting process and understanding of the study in a pilot Randomized Controlled Trial wherein extremely premature infants (<29 weeks’ gestation) were recruited either antenatally or by 4-hours of age. We prospectively interviewed parents who had consented, declined consent and missed eligible infants in the Positioning Preterm Infants for Neuroprotection (PIN) study, a low-risk intervention study. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim.
Results
Sixty-two parents participated in the interviews, of those 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. It was suggested that the 4-hour period for obtaining postnatal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative. Parents found the consenting process acceptable and that they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where infants need to be recruited in the immediate neonatal period.
The ethics of informed consent for infants born to adolescents: A case study from Malaysia
The ethics of informed consent for infants born to adolescents: A case study from Malaysia
Research Article
Jeffrey Soon-Yit Lee, Benjamin Wei-Liang Ng, Mohammad Firdaus bin Abdul Aziz
Clinical Ethics, 17 October 2023
Abstract
Adolescent pregnancy results from the complex interaction between various internal and external vulnerabilities. These vulnerabilities persist after the infant’s birth when the adolescent becomes a parent. Adolescent parents are unfairly stereotyped as unmotivated and incompetent. Some legislations prohibit adolescents from giving consent on the grounds of incompetency. Despite being different, “competency” is frequently used interchangeably with “capacity”; thus, incompetent individuals are often mistaken to lack capacity. Consequently, legally incompetent adolescents who became parents are frequently disregarded during their infant’s decision-making process. This article discusses the distinction between the competence and capacity of adolescent parents, the various vulnerabilities that contribute to an adolescent’s incompetency, and advocates respect for the adolescent’s capacity in making decisions for her infant. We propose a workflow for obtaining informed consent for infants born to adolescents ethically guided by the respect for individuals principle while staying within the country’s legal framework.
Engaging with hard-to-reach children and parents using a creative methodology
Engaging with hard-to-reach children and parents using a creative methodology
Kylie Poppe, Angela Abela
Qualitative Research, 12 October 2023
Abstract
This paper delves into the creative methodology adopted whilst engaging in a research study with five families whose young children (aged between 8 and 10 years old) were excluded from school due to social, emotional and mental health difficulties. The complex needs surrounding these families often lead to them being labelled as hard-to-reach and therefore challenging to engage in research. This paper will explore these challenges, the ethical dilemmas that emerged, the constant observation throughout, the reflexivity and flexibility required by the researchers and the relationships forged. Using various creative methods as part of the Mosaic approach both the children and their parents were able to play a part in the meaning-making process throughout the research journey. The culmination of the research study took place in the format of a multi-family group session which provided a safe space for an intergenerational encounter allowing for the children’s and parent’s authentic voices to continue to be heard.
Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a Clinical Trial Among Underrepresented Minorities: A Randomized Pilot Trial
Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a Clinical Trial Among Underrepresented Minorities: A Randomized Pilot Trial
Research article
Brenda Jamerson, Barry Shuster
Journal of Empirical Research on Human Research Ethics, 12 October 2023
Abstract
The informed consent form (ICF) is intended to assure that subject participation in research studies is informed and voluntary. Yet, there is ample evidence that many subjects do not adequately understand the concepts and language in a clinical trial ICF, which may undermine their willingness to participate in a clinical trial. In a randomized setting, we compared a standard read-only ICF to an audio-assisted ICF with or without teach-back. We found that audio-assisted ICFs significantly improved willingness to participate in a mock clinical trial among our sample of primarily African-American participants.
Efficacy of informed consent process using educational videos for skin biopsy procedures
Efficacy of informed consent process using educational videos for skin biopsy procedures
Dichitchai Mettarikanon, Tawanwongsri, Pitchaya Jaruvijitrattana, Sasipaka Sindhusen, Surinnart Charoenchitt, Patsaraporn Manunyanon
Contemporary Educational Technology, 26 September 2023; 15(4)
Open Access
Abstract
The informed consent process is integral to medical procedures, including skin biopsies, which are the definitive method for diagnosing challenging skin lesions. Educational videos are recognized for effective delivery of information for informed consent. This study aimed to evaluate the efficacy of an informed consent process using educational videos to improve patient understanding and reduce preprocedural anxiety. This multicenter, randomized controlled study was conducted during December 2021-June 2023. Participants were randomly assigned to either the video or verbal group in a 1:1 ratio. They completed knowledge and anxiety questionnaires before and after biopsy. The final analysis included 54 participants (verbal group: n=28; video group: n=26) with a mean age of 51.9 years (standard deviation [SD] 18.1), and a balanced gender distribution. Post-intervention knowledge scores (median 10.0; IQR 8.0-10.0) significantly increased compared to pre-intervention scores (median 6.0; IQR 4.0-9.0), p<0.001. Post-intervention Spielberger state-trait anxiety inventory (STAI) scores (median 5.0; interquartile range, IQR 5.0-6.0) significantly decreased compared to pre-intervention scores (median 7.0; IQR 5.0-10.0), p<0.001. Knowledge scores increased more in the video group (median, 2.5; IQR 1.0-5.0) than in the verbal group (median, 1.5; IQR 0.0-4.0), p=0.217. There was no significant difference in STAI score changes between the video group (median 1.0, IQR 0.0-4.0) and the verbal group (median 1.0, IQR 0.0-3.0), p=0.824. Despite statistical insignificance, educational videos exhibited greater effectiveness in enhancing comprehension and demonstrated comparable efficacy in reducing anxiety compared to conventional intervention.
Surgical Consent in the Pediatric Age Group: Parental Perceptions Toward Legal Aspects of Informed Consent
Surgical Consent in the Pediatric Age Group: Parental Perceptions Toward Legal Aspects of Informed Consent
Original Article
Madani Essa
Saudi Journal of Medicine & Medical Sciences, October–December 2023; 11(4) pp 326-331
Abstract
Background
The perceptions of parents/legal guardians may drive their decisions on providing informed consent for minors. Currently, no study from Saudi Arabia has assessed the perceptions of parents/legal guardians toward informed consent for pediatric surgical procedures.
Objective
To determine parents’ perception and understanding of pediatric informed consent for surgeries from Saudi Arabia and determining their level of participation in the decision-making process of the treatment modality.
Methods
This observational cross-sectional study was conducted among parents from the Jazan region of Saudi Arabia with at least one child aged ≤ 12 years. Three aspects of surgical informed consent were evaluated: parents’ awareness, attitude, and understanding of informed consent and its legal issues; the knowledge they sought during informed consent discussions; and parents’ opinions about their respective roles in the decision-making process for the treatment.
Results
A total of 366 responses were included in this study. More than 95% of the participants agreed that informed consent was necessary; however, 94.7% felt that regardless of their beliefs, they had to sign the form. Surprisingly, the majority (61%) believed that any relative can sign the consent form on behalf of the parents/legal guardian. Most respondents believe that pre-operative procedures (80.8%), the cost (93.9%), and the reason for the procedure and its alternatives (87.2%) should be discussed when informed consent is being sought. About 76.5% of the participants wanted to know all the information regarding the procedure; of these, 48.3% responded that they would play a role in deciding the eventual treatment modality.
Conclusion
The findings of this study indicate the need to increase knowledge regarding surgical informed consent among parents in the Jazan region of Saudi Arabia.
Family-based consent and motivation for familial organ donation in Bangladesh: An empirical exploration
Family-based consent and motivation for familial organ donation in Bangladesh: An empirical exploration
Original Article
Sanwar Siraj
Developing World Bioethics, 19 October 2023
Abstract
The government of Bangladesh approved the human organ transplantation law in 1999 and updated it in 2018. This legislation approved both living-related donor and posthumous organ transplantation. The law only allows family members to legally donate organs to their relatives. The main focus of this study was to explore how Bangladeshis make donation decisions on familial organs for transplantation. My ethnographic fieldwork with forty participants (physicians and nurses, a healthcare administrator, organ donors, recipients, and their relatives) disclosed that the organ donation decision was family-based. An assessment of the relationship between religion, culture, and biomedicine leads to the conclusion that deciding on donating organs to relatives is primarily family-based and is perceived to be steeped in Islamic ethical principles and religious cultural tradition. The family-based consent and motivation for donor-recipient pair organ transplantation strengthen an altruistic environment for the family and act as the moral and legal authority that ensures ethical healthcare outcomes for Bangladeshis.
Examining the adequacy of preoperative informed consent in a developing country: Challenges in the era of surgical specialisation
Examining the adequacy of preoperative informed consent in a developing country: Challenges in the era of surgical specialisation
Ede O, Obadaseraye OR, Anichi I, Mbaeze C, Udemezue CO, Basil-Nwachuku C, Madu KA, Iyidobi EC, Anyaehie UE, Nwadinigwe CU, Ngwangwa C, Adetula UE
Developing World Bioethics, 9 October 2023
Abstract
Preoperative informed consent is a legal and ethical requirement that ensures patients understand a procedure, its associated risks and benefits, alternative treatment options, and potential complications to make an informed decision about their care. This cross-sectional study evaluated the informed consent process for major orthopaedic surgeries at a tertiary hospital in Nigeria. A self-administered questionnaire was used to collect data from 120 adult participants. Results showed that many patients do not read the consent form before signing it, and surgeons do not adequately explain the alternatives to surgery, potential risks, and available anaesthetic options. Higher-educated patients are more likely to read the consent form. Surgeons performed well in explaining the nature of the condition and prognosis, the procedure’s potential benefits, and answering patients’ questions. The study emphasises the need to improve the informed consent process to ensure patients understand and can make rational decisions about their healthcare.
Effects of the Informed Health Choices secondary school intervention: A prospective meta-analysis
Effects of the Informed Health Choices secondary school intervention: A prospective meta-analysis
Faith Chesire, Michael Mugisha, Ronald Ssenyonga, Christopher J. Rose, Allen Nsangi, Margaret Kaseje, Nelson K. Sewankambo, Matt Oxman, Sarah E. Rosenbaum, Jenny Moberg, Astrid Dahlgren, Simon Lewin, Andrew D. Oxman
Journal of Evidence-Based Medicine, 21 September 2023
Abstract
Aim
The aim of this prospective meta-analysis was to synthesize the results of three cluster-randomized trials of an intervention designed to teach lower-secondary school students (age 14–16) to think critically about health choices.
Methods
We conducted the trials in Kenya, Rwanda, and Uganda. The intervention included a 2- to 3-day teacher training workshop, digital resources, and ten 40-min lessons. The lessons focused on nine key concepts. We did not intervene in control schools. The primary outcome was a passing score on a test (≥9 of 18 multiple-choice questions answered correctly). We performed random effects meta-analyses to estimate the overall adjusted odds ratios. Secondary outcomes included effects of the intervention on teachers.
Results
Altogether, 244 schools (11,344 students) took part in the three trials. The overall adjusted odds ratio was 5.5 (95% CI: 3.0–10.2; p < 0.0001) in favor of the intervention (high certainty evidence). This corresponds to 33% (95% CI: 25–40%) more students in the intervention schools passing the test. Overall, 3397 (58%) of 5846 students in intervention schools had a passing score. The overall adjusted odds ratio for teachers was 13.7(95% CI: 4.6–40.4; p < 0.0001), corresponding to 32% (95% CI: 6%–57%) more teachers in the intervention schools passing the test (moderate certainty evidence). Overall, 118 (97%) of 122 teachers in intervention schools had a passing score.
Conclusions
The intervention led to a large improvement in the ability of students and teachers to think critically about health choices, but 42% of students in the intervention schools did not achieve a passing score.
Informed Consent and Medicolegal Aspects
Informed Consent and Medicolegal Aspects
Book Chapter
Bernardo Hontanilla, Andrés Ros Magallón
Post-maternity Body Changes, 20 October 2023 [Springer]
Abstract
It is not seldom in our trade that one must face litigation, be it against oneself or when testifying for or against something a colleague has done in their practice. Having a working knowledge of the regulations that permeate the doctor-patient relationship is paramount to building a successful practice and reducing the risks associated with patient care.
This is especially relevant in the field of aesthetic surgery, where a patient is not seeking a treatment that is essentially curative, but one to look like a younger version of themselves or improve their appearance. Often due to the aggressive marketing performed by some surgeons or reality TV, such a patient can present with unrealistic expectations or without even knowing the risks surgery entails, which becomes even more harmful when a third party can be affected by the results of the surgery as it is the case when treating a post-maternity patient.
The aims of this chapter are to provide a basic knowledge of the different kinds of regulations that specifically affect our trade, to bring forward the possible pitfalls when treating a post-maternity patient, and to emphasize the importance of the informed consent both to reduce risk and to improve the doctor-patient relationship.
Center for Informed Consent Integrity 