The proxy dilemma: Informed consent in paediatric clinical research – a case study of Thailand
Sheila Varadan, Salin Sirinam, Kriengsak Limkittikul, Phaik Yeong Cheah
Developing World Bioethics, 24 January 2022
Abstract
Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enroll human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child’s enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, if national laws are lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children’s enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research.
Year: 2022
Preoperative Opioid Informed Consent and Prescribing Practices in Children Undergoing Orthopaedic Trauma Surgery
Preoperative Opioid Informed Consent and Prescribing Practices in Children Undergoing Orthopaedic Trauma Surgery
Brendan A. Williams, Lacey C. Magee, Christopher A. Makarewich, Ishaan Swarup, Lia W. McNeely, Apurva S. Shah
Journal of the American Academy of Orthopaedic Surgeons, 24 January 2022; 6(1)
Open Access
Abstract
Introduction
This study sought to examine prescribing practices for pediatric patients undergoing orthopaedic trauma surgery and assess the effect of state-mandated preoperative informed consent for opioids.
Methods
A retrospective single-institution cohort study was done between 2016 and 2018 for surgically managed isolated orthopaedic trauma with cohorting based on the presence of preoperative opioid consent. Analyses examined cohort demographic and procedural factors associated with the number of opioid doses prescribed.
Results
A total of 1,793 patients met the study criteria. The proportion of patients prescribed opioids (P = 0.0378) and the number of doses (P < 0.001) were lower in consented patients. Differences were greater among those receiving solution (versus tablets). No cohort differences were observed in refill needs. Nonopioid medications prescribing increased. Multivariate analysis identified multiple factors, including preoperative opioid consent (P = 0.013) associated with fewer prescribed opioid doses.
Discussion
After the implementation of preoperative opioid consenting, patients were prescribed fewer opioid doses after pediatric orthopaedic trauma surgery. The increased utilization of nonopioid therapies was also evident. These changes occurred despite a shorter length of hospital stay and without changes in the studied proxies of postoperative pain control. An increased awareness of opioid risks through formal consent discussion may help to facilitate reduced reliance on opioids for children in the postoperative period.
Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process
Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process
Voices in Bioethics, 8 January 2022; 8
Suzanne Mistretta
Abstract
As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Federal regulation 45 C.F.R. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative.” A researcher may enroll a subject using short-form consent when a long-form translation in the subject’s native language is not available. However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. The code of federal regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. This author recommends an amendment to federal policy, which is important because it helps ensure the rights of study participants under the principle of justice.
Editor’s note: “Voices in Bioethics operates in partnership with Columbia University Libraries.”
The Unbearable Lightness of Informed Consent in Post Mortem Fertilization
The Unbearable Lightness of Informed Consent in Post Mortem Fertilization
Elena Grasso
European Review of Private Law, 2021; 29(6) pp 945 – 968
Abstract
The current increase in global infertility rate and the consequent access to medically assisted procreation have contributed to the fragmentation of the reproductive process. This is also due to the development of cryopreservation techniques for gametes and embryos, whose use is therefore progressively delayed over time, sometimes even after the death of one of the partners. However, few European countries permit post mortem fertilization. Following a reconstruction of the legislation of those EU Member States allowing the practice, this contribution focuses on the jurisprudential reaction in countries, such as France, Germany and Italy, where post mortem fertilization is prohibited by the legislature. In doing so, the role of informed consent is highlighted, especially where it was not expressed by the deceased, due to an unexpected and sudden fatal event, and the surviving partner wants a child from the deceased. Based on a comparison with the findings of US scholars, this article elaborates further on the advantages of the default option in gamete retrieval for procreative purposes, which is increasingly requested also by parents looking for genetic continuity. Perceived differently outside the Western legal tradition, the lack of offspring opens the doors to recognize the interest of pursuing by post mortem fertilization a family genetic heritage.
The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
Willem Stassen, Sanjeev Rambharose, Lee Wallis, Keymanthri Moodley
PLOS One, 21 January 2022
Open Access
Abstract
Background
Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital emergency care research with delayed consent in the Western Cape community of South Africa.
Methods
This study was an online survey of a stratified, representative sample of community members in the Western Cape province of South Africa. We calculated a powered sample size to be 385, and a stratified sampling method was employed. The survey was based on similar studies and piloted. Data were analysed descriptively.
Results
A total of 807 surveys were returned. Most respondents felt that enrolment into prehospital research would be acceptable if it offered direct benefit to them (n = 455; 68%) or if their condition was life-threatening and the research would identify improved treatment for future patients with a similar condition (n = 474; 70%). Similar results were appreciable when asked about the participation of their family member (n = 445; 66%) or their child (n = 422; 62%) regarding direct prospects of benefit. Overwhelmingly, respondents indicated that they would prefer to be informed of their own (n = 590; 85%), their family member’s (n = 593; 84%) or their child’s (n = 587; 86%) participation in a study immediately or as soon as possible. Only 35% (n = 283) agreed to retention data of deceased patients without the next of kin’s consent.
Conclusion
We report majority agreement of respondents for emergency care research with delayed consent if the interventions offered direct benefit to the research participant, if the participant’s condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. These results should be explored using qualitative methods.
The use of consent forms in a “call from class” model of dental care for Australian Indigenous children
The use of consent forms in a “call from class” model of dental care for Australian Indigenous children
Brief Report
N Stormon
Health Promotion Journal of Australia, 19 January 2022
Open Access
Abstract
Issues addressed
Dental caries is one of the most prevalent non-communicable diseases in children. Indigenous children reported a disproportionately higher prevalence of dental disease compared to their age-matched counterparts. To improve access to dental care a community-controlled service provides culturally appropriate dental services on the site of an Indigenous primary and secondary school. The dental clinic utilises a “call from class” model of care. Consent forms seeking permission to undertake a dental examination without a parent/guardian present during school hours are sent home. When the forms are returned, the student is located in class and a dental examination is undertaken.
Methods
A retrospective audit of dental records from 2019 and 2020 were undertaken. The number of consent forms sent and returned were recorded.
Results
In 2019, 87% (n= 220) of the school population were sent consent forms. Of the forms issued, 70% (n=154) were returned. Almost all students required further treatment (90%, n=137) and were sent a treatment consent form. Of the total student population, 67% (n=171) were not seen or had outstanding treatment from unreturned forms. Proportions of incomplete treatment and unseen students were similar in 2020 (64%, n=173). In this model barriers are lessened by providing a free dental service on the school site.
Conclusions
Consent is an ethical and legal necessity to undertake dental examination and treatment. Using physical forms were effective for gaining consent for most children. However, less than half of the school population’s dental treatment were completed. Future studies should be conducted to explore the acceptability of using consent forms by parents/guardians and different models to gain consent for children from complex social circumstances.
[Quantitative Analysis of Informed Consent on Caesarean Section at Patria IKKT Hospital, West Jakarta]
[Quantitative Analysis of Informed Consent on Caesarean Section at Patria IKKT Hospital, West Jakarta]
Nurmayantih, Nanda Aula Rumana, Daniel Happy Putra, Puteri Fannya
SEHATMAS (Jurnal Ilmiah Kesehatan Masyarakat), January 2022; 1(1) pp 34-40
Abstract
Informed Consent is the consent given by the patient or his family on the basis of an explanation of the medical/surgical action to be performed on the patient and this informed consent must be complete. In performing sectio caesarea, the informed consent sheet is not filled in, so any action taken can be categorized as malpractice. Researchers found that there were still many incomplete informed consent forms, especially informed consent for sectio caesarea surgery. The purpose of the study was to determine the quantitative analysis of informed consent for sectio caesarea at the Patria IKKT Hospital for the period March – April 2021 based on 4 components, namely knowing the completeness of patient identification, author authentication, and completeness of important reports, good records. This type of research is quantitative with descriptive design and data collection techniques are observation, checklist. This research was conducted using systematic random sampling method. The results of the study of 90 informed consent sheets for sectio caesarea, the average completeness of the patient identification filling component was 100%, the important component of filling out the report was an average of 86%, the author’s authentication component had an average of 97.9%, the component of filling out good notes had an average of 97.9%. the average completeness is 93.7%. The results of the recapitulation of quantitative analysis have an average completeness of 94.4%.
Editor’s note: “SEHATMAS is a Scientific Journal published by the Indonesian Science Literacy Foundation”
Patients’ Experience on Practice and Applicability of Informed Consent in Traditional Medical Practice in KwaZulu-Natal Province, South Africa
Patients’ Experience on Practice and Applicability of Informed Consent in Traditional Medical Practice in KwaZulu-Natal Province, South Africa
Research Article
Francis Akpa-Inyang , Elizabeth Ojewole, Sylvester C. Chima
Evidence-Based Complementary and Alternative Medicine, 2022
Open Access
Abstract
Background
Informed consent (IC) is constitutionally protected in South Africa based on individual rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. This study explored patients’ experience on practice and applicability of IC in African traditional medicine (ATM) in Msunduzi and eThekwini municipalities, KwaZulu-Natal province, South Africa, to evaluate whether important elements of IC such as full information disclosure, capacity, understanding, and volition are considered or being applied during ATM.
Methods
This cross-sectional quantitative study was conducted using semistructured questionnaires administered to patients attending traditional health practitioners’ (THPs’) treatment centres. Stata V15.1 was used to analyse variables including descriptive and inferential data analysis.
Results
One hundred and twenty-nine (129) participants completed this study, of which 62% were females. Most participants were in the age range of 26–35 (38.8%). All respondents were IsiZulu home-language speakers, single (62.8%), employed (48%), and with some tertiary education (48.8%). Most patients were informed about their diagnosis (58.9%), treatment benefits (79.8%), and recommended treatment (79.8%). Fewer were informed about risks of treatment (36.4%), right of refusal (3.1%), and risks of refusing recommended treatment (0.8%). All participants reported satisfaction with information disclosed by the THPs and did not feel coerced to accept treatment. Consent was obtained verbally in all cases. The majority of participants (76.7%) sought surrogate assistance when consulting THPS, and 81.4% preferred being informed about all treatment risks. Most respondents also preferred involvement in healthcare decision-making during ATM.
Conclusion
This study reveals that most patients consulting THPs in the KwaZulu-Natal province for treatment are aware of their right to information disclosure and the need to reach agreement before involvement in ATM treatment procedures. The study also showed that some key elements of IC are currently being applied during ATM practice in South Africa.
A New Layer of Informed Consent: Discussions and Documentation Regarding Sensitive Examinations in Surgery
A New Layer of Informed Consent: Discussions and Documentation Regarding Sensitive Examinations in Surgery
Surgical Perspectives
Lauren R. Wilson, Courtney Tanner, Sandra L. Wong
Annals of Surgery, March 2022; 3(1)
Mini-Abstract
A growing number of states have statutes regulating the performance of sensitive examinations on anesthetized patients. The scope of the examinations covered includes breast, pelvic, prostate, and rectal examinations, increasing the impact of these laws on surgeons. There is a broadening focus on obtaining consent for any provider and learner performing these examinations.
American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures
American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures
Guideline
ASGE Standards of Practice Committee, Andrew C. Storm, Douglas S. Fishman, James L. Buxbaum, Nayantara Coelho-Prabhu, Mohammad A. Al-Haddad, Stuart K. Amateau, Audrey H. Calderwood, Christopher J. DiMaio, Sherif E. Elhanafi, Nauzer Forbes, Larissa L. Fujii-Lau, Terry L. Jue, Divyanshoo R. Kohli, Richard S. Kwon, Joanna K. Law, Swati Pawa, Nirav C. Thosani, Sachin Wani, Bashar J. Qumseya
Gastrointestinal Endoscopy, February 2022; 95(2) pp 207-215
Abstract
Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.
Center for Informed Consent Integrity 