The Role Of Husbands And Midwives’ Motivation For Compliance With Providing Informed Consent In Cito Sc Actions At Merauke Regional Hospital

2 September 2024 ~ paigefitzsimmons ~ Leave a comment

The Role Of Husbands And Midwives’ Motivation For Compliance With Providing Informed Consent In Cito Sc Actions At Merauke Regional Hospital
Hermin Langdo Layuk, Reny Yuli Astutik, Eri Puji Kumalasari, Devy Putri Nursanti
Journal Of Health Science Community, August 2024; pp70-78
Abstract
Informed consent is a critical aspect of medical practice, including emergency caesarean section (SC) or Cito. Compliance with informed consent becomes more complex because it involves quick decisions in emergency situations, Informed consent compliance with Cito SC actions can be influenced by the husband’s role and midwife’s motivation. This study aims to determine the influence of the role of husbands and midwives’ motivation on compliance with the provision of informed consent in cito SC actions at Merauke Regional Hospital. This study used an Observational Analytics research design with a cross sectional approach. Sampling was carried out using the total sampling technique and a sample of 15 respondents was obtained, the independent variable consists of the role of the husband and the motivation of the midwife then the dependent variable used is the adherence of giving informed consent. The Chi-Square test is used to determine the relationship between two categorical variables. The results of the study of 15 respondents were obtained, most respondents had supporting husband role criteria, namely as many as 8 respondents (53.3%), Most respondents received poor midwife motivation which was as many as 8 respondents (53.3%) and most respondents included the criteria for compliance with informed concent on Cito SC Actions. The results of the analysis using the Chi-Square statistical test obtained the results of p = 0.005 and 0.019 <0.05, then H0 was rejected and H1 was accepted, which means that there is an influence on the role of the husband and the motivation of midwives on Compliance with Giving Informed Consent to Pregnant Women Who Perform Cito SC Actions at Merauke Regional Hospital. The role of the husband and the motivation of midwives play a very significant role in shaping the compliance of informed consent to pregnant women. Collaboration between patients, husbands, medical teams is the main key.

Editor’s note: Merauke Regional Hospital is located in Indonesia.

Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings

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Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings
Priyanka Gupta, Vishwajeet Singh, Prince Pareek
Indian Journal Of Medical Ethics, July-September 2024
Abstract
Background
Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients’ religious beliefs, and may even have medicolegal implications.
Methods
This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients’ families, and their willingness and ability to provide alternative surfactants based on parental preferences.
Results
A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations.
Conclusion
Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist

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Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist
Yoon Jin Lee, Sun Ju Lee, Su Jin Kang, Dae Ho Lee, Kyun-Seop Bae, Jong Woo Chung, Byung Soo Kim, Byung Soo Kim, Jin Seok Kim, Myung Ah Lee
Journal of KAIRB, 2024; 6(1) pp 5-16
Abstract
Purpose
The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children’s comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials.
Methods
The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics.
Results
Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents’ consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th–6^th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lowergrade elementary school students (1st–4th grade) could understand the explanations if they were made simpler.
Conclusion
It is suggested that not only elementary school students (7–12 years old) but also middle school students (13–15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

Editor’s note: This is a Korean language publication of the Korean Association of Institutional Review Boards.

Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research

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Editor’s Note:
We recognize a growing literature which argues [in whole or in part] that norms requiring the individual, prior, free, express and informed consent of persons to be involved in research must accommodate notions which integrate terms such as ‘community-driven’, ‘decolonized’, or ‘culturally-appropriate’ and which insist that consent processes “prioritize local/indigenous values and protocols.” As an editorial policy, we have decided to group such literature together in this section of the digest.
Broadly, we recognize that this literature raises critically important issues around consent integrity. Our Center for Informed Consent Integrity is actively developing a position on this matter, mindful of core guidance in research involving human participants overall, and selected instruments such as the Universal Declaration on Bioethics and Human Rights [2005] which notes:
Article 12. Respect for cultural diversity and pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.
We will keep readers advised of our progress. If you have an interest in participating in our working group, please contact Paige Fitzsimmons [paige.fitzsimmons@ge2p2global.org].

Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research
Review Article
Richard Appiah, Giuseppe Raviola, Benedict Weobong
Journal of Empirical Research on Human Research Ethics, 18 March 2024
Open Access
Abstract
Objective
This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them.
Methods
We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa.
Results
Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model.
Conclusions
A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

Informed consent form for platelet rich plasma injections: evidence-based and legally guide for orthopaedic surgeons

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Informed consent form for platelet rich plasma injections: evidence-based and legally guide for orthopaedic surgeons
Research
Madhan Jeyaraman, Satvik N. Pai, Migliorini Filippo, Naveen Jeyaraman, Ravichandran Venkatasalam, Arulkumar Nallakumarasamy, Manish Khanna, Bishnu Prasad Patro, Shilpa Sharma, Ravi Velamor Rangarajan
European Journal of Medical Research, 17 August 2024
Open Access
Abstract
Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons’ defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

Shared Decision-Making and Informed Consent Legislation in Clinical Decision Making

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Shared Decision-Making and Informed Consent Legislation in Clinical Decision Making
Yeoran Yoon, Hyuna Bae
Korean Journal of Medical Ethics, 30 June 2024; 27(2) pp 71-87
Abstract
This article examines shared decision-making, a concept that extends beyond informed consent to safeguard patients’ right to self-determination in medical decision-making, emphasizing mutuality with patients. After reviewing the relevant legislation concerning consent, we argue that there are limitations to using this legislation as a basis for integrating shared decision-making across various medical domains. We assess the applicability, acceptability, and consistency of this legislation within the medico-legal system. In particular, we scrutinize the roles of so-called “participants” in shared decision-making, the content of shared information, and potential legal liabilities stemming from deficiencies in this process. Through this examination, we analyze legal precedents concerning the duty to inform and propose policy adjustments necessary for the institutionalization of shared decision-making within the medico-legal framework.

Editor’s note: This is a Korean language publication.

Deferred Consent in Emergency Trauma Research: A Qualitative Study Assessing the Healthcare Professional’s Opinions

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Deferred Consent in Emergency Trauma Research: A Qualitative Study Assessing the Healthcare Professional’s Opinions
Injury, 15 August 2024
Zynab Noori, Niek J. Vianen, Esther M.M. Van Lieshout, Erwin J.O. Kompanje, Iscander M. Maissan, Michiel H.J. Verhofstad, Mark G. Van Vledder
Abstract
Introduction
Severely injured patients are often incapacitated to provide informed consent for clinical studies. Deferred consent could facilitate unbiased enrollment in studies involving these patients. Little is known about how healthcare professionals (HCPs) perceive deferred consent and how this impacts patient enrollment. The aim of this study was to identify factors that could influence HCPs decision-making during recruitment of patients for interventional studies in (pre)hospital emergency trauma research.
Methods
This was a qualitative study in which physicians and nurses working in prehospital or in-hospital care were interviewed using a semi-structured interview guide. Interviews were audio-recorded, transcribed, and analyzed according to thematic analysis as described by Braun and Clarke.
Results
Ten semi-structured interviews were conducted with six physicians and four nurses. Eight themes were identified as being relevant consent related factors influencing HCPs’ decision-making during patient recruitment in studies using deferred consent: 1) HCPs’ lack of knowledge; 2) Patients’ and proxies’ inability to be informed; 3) Practical (im)possibilities for informed consent; 4) Nature of intervention; 5) HCPs’ personal beliefs; 6) Importance of emergency care research; 7) HCPs’ trust in legal base; and 8) Communication and collaboration.
Conclusions
Eight consent-related factors influencing HCPs’ decision making were identified. Insufficient knowledge about consent procedures among HCPs leads to significant negative attitudes towards deferred consent.

Follow Informed Patient Consent in Clinical Teaching in Order to Achieve a Truly Patient-Centered Approach

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Follow Informed Patient Consent in Clinical Teaching in Order to Achieve a Truly Patient-Centered Approach
Research Article
Hongnan Ye
Journal of Patient Experience, 14 August 2024
Open Access
Abstract
Patient- and disease-focused clinical teaching is considered the cornerstone of medical education. Current clinical teaching is increasingly taking place in outpatient settings, but this can cause discomfort to patients. Although many professional organizations have developed a set of ethical considerations in response to this issue to use these considerations to guide clinics in their outpatient procedures, these guidelines are not well adhered to in outpatient practice. My experience as an eczema patient in a dermatology outpatient is good evidence of this. In my opinion, there is nothing inherently wrong with the pedagogy of medical students observing clinical interactions in outpatient settings; the real problem lies in not informing the patient of the medical student’s presence or allowing the patient to exercise his or her right of refusal. Therefore, the following recommendations are made: First, academic medical centers should provide regular training to doctors and medical students to ensure that they are fully aware of what is contained in the ethical guidelines established by the professional organizations and that they recognize the importance of adhering to these guidelines in clinical practice. Second, each clinical teaching activity should have the informed consent of the patient and be based on the patient’s wishes. Finally, it is recommended that hospitals establish appropriate evaluation mechanisms to assess doctors’ compliance with the ethical guidelines and provide continuing education and training for doctors and medical students who fail to comply.

Consent for interventions during childbirth: A national population-based study

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Consent for interventions during childbirth: A national population-based study
Clinical Article
Marianne Jacques, Anne Alice Chantry, Anne Evrard, Nathalie Lelong, Camille Le Ray, the ENP2021 Study Group
Gynecology & Obstetrics, 2 August 2024
Open Access
Abstract
Objective
To assess the frequency and determinants of medical interventions during childbirth without women’s consent at the population level.
Methods
The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition.
Results
Women reporting failure to seek consent were 44.7% (CI: 42.6–47.0) for oxytocin administration, 60.2% (CI: 55.4–65.0) for episiotomy, and 36.6% (CI: 33.3–40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06–1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68–0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11–1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13–1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28–1.96).
Conclusion
Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women’s involvement in decision making during childbirth.