Evaluating Egg Donor Recruitment Strategies in Czech ART Clinics: A Critical Analysis of Informed Consent and Ethical Considerations
Anna De Bayas Sanchez, Jitka Fialová, Hana Konečná, Francisco Güell
Czech Sociological Review, 2024; 60(3) pp 321-346
Abstract
There is a high demand for egg donors in the Czech Republic, driven by international couples’ interest in assisted reproductive procedures due to affordable treatment, no waiting list, and an extended age limit for recipients up to 49 years. For a population of 10.5 million, the country has 48 reproductive clinics. This study aims to evaluate Czech egg donor recruitment campaigns through the lens of free, informed, and specific consent requirements. A quantitative-qualitative analysis of recruitment strategies from 29 unique clinic websites in Czechia was conducted, with 12 sites specifically designed for marketing purposes. The analysis was based on 14 criteria. Of the 29 clinic websites, only three did not indicate compensation amounts, ranging from 800 to 1400 EUR. Thirteen clinics did not provide information on risks associated with oocyte donation, with one falsely stating no risks exist. Twenty-two websites used emotionally evocative quotes and images. Thirteen clinics did not disclose time commitments, and one provided misleading information. Seventeen clinics omitted conditions for donor refusal and the number of allowable donations. Eighteen clinics did not offer post-donation referrals. Conversely, 15 clinics highlighted psychological benefits, and 23 emphasized health benefits. None fully complied with international guidelines on oocyte donation. Analysed websites lack sufficient information for responsible egg donation decisions. The emphasis on compensation, benefits, and suggestive graphics creates an image of safe, community-oriented donation, potentially leading to inadequate understanding of health risks and commodification of the female body.
Category: Cultural/Country Context
Do patients actually understand? An evaluation of the informed consent process for endoscopic procedures in rural Uganda
Do patients actually understand? An evaluation of the informed consent process for endoscopic procedures in rural Uganda
Abhishek R. Mogili, Daniel Mukisa, Peter Campbell, Angellica Giibwa, Moses Binoga, Arthur Emoru, Anna T. Kalumuna, Joseph O. Damoi, Chelsia Melendez, Jerome Waye, Michael L. Marin, Linda P. Zhang
Surgical Endoscopy, 14 June 2024
Abstract
Introduction
Improving surgical access in low- and middle-income countries is vital for the 5 billion people who lack safe surgical care. Tailoring a culturally sensitive approach to consent is essential for patient comprehension and comfort, thereby alleviating the effects of resource constraints and advancing equitable care. This study examines the consenting process for endoscopy at Kyabirwa Surgical Center in Kyabirwa, Jinja, Uganda, to assess patients’ knowledge and attitudes as a potential barrier to participating in endoscopic procedures.
Methods
All adult upper endoscopy (EGD) and colonoscopy patients were recruited to participate in a survey of their demographics, knowledge, and attitudes toward their procedure. All patients received a standard consultation explaining the procedure and its risks and benefits.
Results
75 patients were included; median age was 54 years and 56% (n = 42) were women. 92% (n = 69) of patients had never had an endoscopy before and 73% (n = 55) of patients were scheduled for an EGD while the remaining 27% (n = 20) were scheduled for a colonoscopy. Most patients 80% (n = 60) had a basic understanding of what an endoscopy is and 87% (n = 65) its diagnostic purpose. Few patients 15% (n = 11) knew of the most common side effects or if they would have a surgical scar 27% (n = 20). Overall, 46.7% (n = 35) of patients were moderately or severely fearful of getting an endoscopy. Additionally, 45.3% (n = 34) of patients were moderately or severely fearful of receiving anesthesia during their endoscopic procedure. Despite this fear, most patients 85.3% (n = 64) stated that they understood the benefits of the procedure either very well or extremely well.
Conclusions
Most patients understood the role that an endoscopic procedure plays in their care and its potential benefits. Despite this, many patients continued to have high levels of fear associated with both the endoscopic procedure and with receiving anesthesia during their procedure. Future patient education should focus on addressing patients’ fears and the risks of undergoing an endoscopy, which may improve the utilization of surgical services.
Consent and Educational Sensitive Exams on Anesthetized Patients: Experiences of Medical Students Across Canada
Consent and Educational Sensitive Exams on Anesthetized Patients: Experiences of Medical Students Across Canada
Phoebe Friesen, Wan-Li Sun, Sarah Towle
Journal of Obstetrics and Gynaecology Canada, 13 June 2024
Abstract
Objective
This study investigates experiences of medical students across Canada related to consent for educational sensitive (i.e., pelvic, rectal) exams under anesthesia (EUAs).
Methods
A bilingual online questionnaire was developed and distributed to medical students across Canada.
Results
Of 134 respondents, 63% had performed a pelvic EUA, 35% a rectal EUA, and 11% another sensitive EUA during their training. For those who had performed pelvic EUA, 28% were unsure if consent had taken place, 26% reported no specific consent, 20% reported specific consent, and 25% had mixed experiences of consent. For rectal EUAs, 48% reported no specific consent, 37% were unsure if consent had taken place, 13% reported that there had been specific consent, and 2% reported mixed experiences. Most respondents were uncomfortable (36%) or not sure if they were comfortable (32%) with how the consent process was handled for student pelvic EUAs; 31% were comfortable. In open-ended responses, respondents described a variety of experiences related to variability, discomfort, and authority.
Conclusion
Non-consensual educational sensitive EUAs continue to take place in medical training across Canada, although practices of consent are highly variable. The majority of respondents reported being uncomfortable or unsure if they are comfortable with how consent for educational sensitive EUAs was practiced during their training, and some respondents struggled to express their discomfort given the power dynamics at play.
Navigating the Ethical Terrain towards a Responsible Adoption of Health Information Systems: Recommended Ethical Pathways
Navigating the Ethical Terrain towards a Responsible Adoption of Health Information Systems: Recommended Ethical Pathways
Namgay Rinchen, Sonam Yoezer
Bhutan Health Journal, 28 May 2024
Abstract
Health Information System (HIS) improves healthcare data accuracy, care coordination, resource allocation, and informed decision-making. However, ethical concerns arise with data security, privacy, informed consent, and patient autonomy. This paper discusses the benefits and drawbacks of HIS and offers recommendations to address the ethical issues, crucial for countries like Bhutan undergoing healthcare digital transformation with Electronic Patient Information System (e-PIS) adoption. The main recommendations are: educating system personnel, establishing regulatory and ethical frameworks, implementing strong security standards, obtaining informed consent from patients, and enabling patients to access their own records. An integrated approach that balances technology and ethics is needed to successfully adopt HIS.
Dentists’ perspectives, practices, and factors associated with informed consent process for fixed prosthodontic treatment: a cross-sectional study of kampala metropolitan area, Uganda
Dentists’ perspectives, practices, and factors associated with informed consent process for fixed prosthodontic treatment: a cross-sectional study of kampala metropolitan area, Uganda
Research
Barbara Ndagire, John Barugahare, Sudeshni Naidoo, Joaniter Nankabirwa, Joan Nakayaga, Charles Mugisha Rwenyonyi
BMC Oral Health, 27 May 2024
Open access
Abstract
Background
Dentists have a legal and ethical obligation to obtain informed consent from patients before carrying out treatment. In Uganda, the process of obtaining informed consent in dentistry is not well documented. The aim of the present study was to determine dentists’ perspectives and practices regarding informed consent to fixed prosthodontic treatment (FPT) in Kampala Metropolitan, Uganda.
Methods
A quantitative cross-sectional study was conducted among 153 dentists from July to September 2023. Data were collected using a semi-structured self-administered questionnaire that included both closed- and open-ended questions. The questionnaire included items on participants’ sociodemographic information, perspectives, and practices about informed consent for FPT. Perspectives were rated using ten items on a five-point Likert scale. The minimum possible total score was 10, and the maximum possible score was 50. Descriptive statistics and Poisson regression were used to summarize and analyze the quantitative data, and the significance level was set at p < 0.05. Open-ended items were analyzed using content analysis.
Results
The majority (83.9%) of the participants were general dentists with working experience ranging from 1 to 38 years and a median of 8 years. The majority were familiar with the concept of informed consent and had positive perspectives regarding its use for FPT. The mean score for perspectives was 39.27 (SD, 5.42). However, there were variations in the practices of the dentists. More than three-quarters (87.6%) reported that they always obtained the patient’s informed consent before FPT. Less than a third (29.4%) obtained written consent for FPT. About half of the dentists provided information regarding the procedure, benefits, and risks of treatment during the consent process. Bivariate analysis showed that the use of written consent for FPT was significantly (p < 0.05) associated with having a work experience of more than 10 years and having had training involving informed consent after undergraduate studies.
Conclusion
The present study provides baseline data regarding perspectives and practices regarding informed consent for FPT among dentists in Uganda. It is recommended that regular training courses be developed to highlight the importance of improved informed consent practices for patient protection and to instruct dentists about obtaining valid informed consent. There is a need for future research to streamline guidelines for the informed consent process in dental care in Uganda.
Knowledge, and Practice of Nurses regarding informed consent at Friendship Hospital in Sudan
Knowledge, and Practice of Nurses regarding informed consent at Friendship Hospital in Sudan
Zeinab Taha Ali Omer
Egyptian Journal of Health Care, June 2024
Abstract
Aim
To assess the knowledge and practice of nurses about informed consent at Friendship Hospital in Sudan.
Methods
A descriptive cross-sectional hospital-based methodology was used. A hundred nurses enrolled in a study as total coverage, and data were gathered using an interview questionnaire. SPSS version 22 was used to analyze the data.
Results
The study had A hundred participants, 69%Female making up most of the sample. The majority of participants age range between 35-39years. A large number of participants had 7-10 years of experience. Regarding the informed consent process, half of the participants (50%) reported that they had enough information about the informed consent process. Also, forty percent of participants informed the patients about the risks and complications of their planned treatment.
Conclusion
In conclusion, the study found that half of the participants knew the process of consent. Majority of participants were aware that mental status was an important indicator of the ability to consent.
Recommendations
The findings manifest the need for an efficient education program that concentrates on learning nurses about consent.
Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study
Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 24 May 2024; 14(2) pp 1338-1352
Abstract
Background
The wording of informed consent forms could hinder their comprehension and hinder patients’ autonomous choice. The objective of this study was to analyze the readability and comprehension of anesthesia informed consent forms in a Spanish county hospital.
Methods
Descriptive and cross-sectional study carried out on patients who were going to undergo anesthetic techniques. The readability of the forms was analyzed using the INFLESZ tool and their subjective comprehension using an ad hoc questionnaire.
Results
The analyzed forms presented a “somewhat difficult” legibility. A total of 44.2% of the patients decided not to read the form, mainly because they had previously undergone surgery with the same anesthetic technique. The language used in the forms was considered inadequate by 49.5% of the patients and 53.3% did not comprehend it in its entirety. A statistically significant negative correlation of age and INFLESZ readability score with the overall questionnaire score was found. A statistically significant association was observed as a function of age and educational level with the different criteria of the questionnaire.
Conclusions
The anesthesia informed consent forms presented low readability with limited comprehension. It would be necessary to improve their wording to favor comprehension and to guarantee patients’ freedom of choice.
Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021
Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021
Research
Marian Marian, Kathryn M. Barker, Elizabeth Reed, Amanda C. McClain, Rebecka Lundgren, Samantha Hurst, Ramona L. Pérez
BMC Pregnancy and Childbirth, 13 May 2024
Open Access
Abstract
Introduction
Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence.
Methods
We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico’s cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations.
Results
The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care.
Conclusion
While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.
Informed Consent in Clinical Studies in the Republic of Srpska
Informed Consent in Clinical Studies in the Republic of Srpska
Snežana Pantović, Dijana Zrnić
Review of European and Comparative Law, 6 May 2024
Abstract
As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.
Editor’s note: The Republic of Sprska is one of the two entities of Bosnia and Herzegovina.
Analysis of Informed Consent Forms Submitted to Institutional Ethics Committee of a Medical Institute in Southern India: A Cross-sectional Observational Study
Analysis of Informed Consent Forms Submitted to Institutional Ethics Committee of a Medical Institute in Southern India: A Cross-sectional Observational Study
Vedavathi Hanumaiah, Shreenivas Prabhakar Revankar, Nagaraja Prasad Sai, Mohammad Arif
Journal of Clinical & Diagnostic Research, 1 April 2024
Abstract
Introduction
Informed consent is an essential component in research involving human participants. However, the informed consent obtained may be incomplete and not fulfill the essential criteria of Informed Consent Forms (ICFs). Although the guidelines for developing ICFs have been clearly spelled out by various research bodies, these guidelines are not followed completely.
Aim
To analyse the ICFs submitted to the Institutional Ethics Committee (IEC) of a Medical Institute in Southern India.
Materials and Methods
The present study was a crosssectional observational study analysing ICFs submitted to the IEC of McGann District Teaching Hospital, Shimoga Institute of Medical Sciences (SIMS), Shivamogga, Karnataka, India, for the period 2014 to January 2023. All research projects containing ICFs during the study period were included in the study. Of the research projects submitted, only 70 had ICFs, and these were subjected to analysis as per Indian Council of Medical Research (ICMR) guidelines criteria. The criteria for ICFs were: statement of research, purpose/methods of the study, duration/frequency of the study, benefits to participants/community, foreseeable risks, discomfort/inconvenience, confidentiality, payment/reimbursement for participation. In addition to these, ICFs were also analysed for additional elements as per ICMR criteria for tissue and blood samples. The results were then subjected to descriptive statistical analysis and presented as mean and percentages.
Results
Many of the required essential elements were present in nearly 50% of ICFs submitted to the IEC, which include information on the basic purpose/methods of the study 70 (100%), identity of the principal investigator/research team 57 (81.42%), freedom to participate/withdraw from the study 55 (78.57%), confidentiality of records 54 (77.14%), and foreseeable risks, discomfort, and inconvenience to participants 35 (50%). Other essential elements like benefits were present to participants/community 28 (40%), payment/reimbursement for participation 28 (40%), duration and frequency 12 (17.14%), statement of research 9 (12.85%), treatment/compensation for injury 4 (5.71%). Regarding additional elements of ICFs for biological samples, ICFs adhered to the ICMR requirements except none of the submitted forms had any information on the period of storage of biological samples.
Conclusion
The ICF is an essential requirement for conducting research. Ensuring adherence of ICF to guidelines is important from a research perspective. The present study concludes that the majority of the essential elements were present in ICFs with a few exceptions like study as research and information on the storage of biological samples, which was nil.