Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

Exploring attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study.

BACKGROUND: Improving our understanding of household incomes and what constitutes financial insecurity can help us to better understand how financial insecurity is experienced and how this can change over time within and between individuals and populations. However, financial circumstances are often perceived as sensitive and stigmatising, particularly within some ethnic minority groups. This research aims to explore attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study, in order to obtain validated income and benefits data and to better understand the impact of community interventions on the financial security of its participants and their families. METHODS: This research utilises an observational study design to explore consent rates, attitudes and variation in sociodemographic factors between participants of an experimental birth cohort in a deprived and ethnically diverse setting who consent and do not consent to financial data linkage. RESULTS: Overall, participants were equally likely to consent and decline consent for financial data linkage. Measures of socioeconomic insecurity were associated with being more likely to provide consent for financial data linkage. Participants who were not employed (OR 1.49 95% CI 0.93, 2.40) and were more financially insecure (OR 1.85 95% CI 1.14, 3.93) were more likely to provide consent for financial data linkage. Where the participant's first language was a language other than English, participants were also less likely to provide consent for data linkage (OR 0.65 95% CI 0.39, 0.98). The choice of consent for financial data linkage was not associated with: ethnicity; relationship factors; employment status of the participant's partner; person present at time of recruitment; and measures of health, such as general health, mental health, wellbeing and health-related quality of life. CONCLUSIONS: This research sets out an approach to obtaining validated income and benefits data, as a proxy measure for financial security, within an experimental birth cohort study in a deprived and ethnically diverse setting. It achieves good consent rates and demonstrates greater input from those who report greater potential need for financial support. Further research should be conducted to further understand the interplay of language spoken in this context.

Patient-Centered Surgical Care for Children in Low and Lower-Middle Income Countries (LMICs) - A Systematic Scoping Review of the Literature.

PURPOSE: Studies exploring patient-centered care (PCC) in pediatric surgery have been disproportionately concentrated in high-income countries. This review aims to characterize the adoption of key PCC domains in low and lower-middle income countries (LMICs). METHODS: Seven databases were searched from inception until January 2023 to retrieve relevant articles in pediatric surgery in LMICs. We focused on six key PCC domains: patient-reported outcomes (PROs), patient-reported experiences (PREs), shared decision-making (SDM), patient/parent education, patient/parent satisfaction, and informed consent. RESULTS: Of 8050 studies screened, 230 underwent full-text review, and 48 were finally included. Most were single-center (87.5%), cross-sectional studies (41.7%) from the South-East Asian (35.4%) and Eastern Mediterranean regions (33.3%). Studies most frequently focused on postoperative care (45.8%) in pediatric general surgery (18.8%), and included 1-3 PCC domains. PREs (n = 30), PROs (n = 16) and patient/parent satisfaction (n = 16) were most common. Informed consent (n = 2) and SDM (n = 1) were least studied. Only 13 studies directly elicited children's perspectives. Despite all studies originating in LMICs, 25% of first and 17.8% of senior authors lacked LMIC affiliations. CONCLUSION: The adoption of PCC in LMICs appears limited, focusing predominantly on PROs and PREs. Other domains such as informed consent and SDM are rarely addressed, and the voice of children and young people is rarely heard in their care. Opportunities to enhance PCC in LMICs abound, with the potential to improve the surgical care of children in resource-limited settings. LEVEL OF EVIDENCE: III.

Chapitre 5. From individuals to social: The needs for a global ethics overview in pharmacogenomics.

As a part of personalized medicine, pharmacogenomics (PGx) allows practitioners to provide the right drug for a given patient, in accordance with the result of a genetic test. This practice raises many ethical issues that are discussed in the literature, sometimes within the larger context of personalized medicine. This article is based on a literature review that is original insofar as it is interdisciplinary and based on an approach that articulates individual and social rights. Here, we propose to reconsider some classic ethical issues, such as informed consent, incidental findings and data protection which are raised by genetic testing and also by PGx in the same or in a different way. We also analyse broader collective issues around racialization and health equality. Our purpose is to contribute in drawing links and parallels between individual rights and collective rights using a social approach. This analysis discusses these ethical issues in research and in clinical setting, understanding the treatment of the individual in his dual quality of patient and research participant.

Law Commission of India report on the age of consent: Denying justice and autonomy to adolescents.

The 22nd Law Commission of India (henceforth, the Commission) [1], in its recent 283rd report, offered its recommendation on the question of age of consent (AoC) to sexual activity. Two High Courts which have seen several cases of non-exploitative consensual sex involving adolescent girls, filed by the police under "sexual assault", had referred this issue to the Commission. The substantive matter before the Commission was whether to lower the AoC to prevent unnecessary prosecutions and resolve the contradictions in sexual violence laws. In this regard, we find the report rather disappointing. It is a lost opportunity to decriminalise adolescent sexuality, to restore the autonomy of adolescent girls over their bodies, uphold their sexual and reproductive rights, and respect their evolving capacity to exercise their sexuality. The Commission has also let go of a chance to undo a highly protectionist clause in the Protection of Children from Sexual Offences Act (POCSO), 2012 [2] which renders all sexual activity of individuals under the age of 18 an offence. It failed to reiterate the progressive recommendations made by the Justice Verma Committee Report in 2013 [3] in this regard, which had come after extensive deliberations and were widely welcomed by stakeholders.

Ethics of Managing an Adolescent Living with Disability.

An ethical challenge arose when the parents of an adolescent girl living with severe intellectual disability requested for a permanent surgical intervention (hysterectomy) that would cause cessation of menstruation and reduce the possibility of pregnancy following nonconsensual sex. The family background was rural with poor access to extended family/community support, financial and social welfare resources. The parental distress was real with the adolescent incompetent to give informed consent. Is a non-therapeutic hysterectomy in an adolescent living with severe intellectual disability ethical? Views of a pediatrician, adolescent specialist, nurse, and an ethicist referring to literature suggesting an approach to an ethical decision are discussed herein.

Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo.

BACKGROUND: The long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants' retention and understanding of the trial information after two years of participation in a vaccine trial. METHODS: In total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC). Individual scores obtained from a questionnaire (test of understanding, TOU), specifically designed to assess the understanding of the consent at baseline, were collected before the clinical trial started and at one-year and two-year intervals. RESULTS: TOU scores were high in the beginning of the trial (median TOU = 10/10), but significantly decreased in both the first and second years following (median TOU = 8/10 in year 1 and median TOU = 9/10 in year 2, p-value < 0.0001). The decrease in scores was significantly higher among individuals with occupations requiring shorter education such as midwives (median TOU = 7/10 in year 1 and 8/10 in year 2, pvalue = 0.025). Furthermore, older participants exhibited poorer retention of information compared to younger individuals (median TOU = 8/10 vs 9/10, p-value = 0.007). CONCLUSION: We observed a significant decline in the informational knowledge of informed consent, specifically in terms of basic knowledge on the study vaccine and trial procedures. As participant safety and understanding is a paramount ethical concern for researchers, it is crucial for participants to fully comprehend the study's objectives and potential risks. Therefore, our findings suggest the need for clinical researchers to re-explain participants to optimize the protection of their rights and wellbeing during the research.

Financial ''risk-sharing'' or refund programs in assisted reproduction: an Ethics Committee opinion.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.

"My Blood, You Know, My Biology Being out There ": Consent and Participant Control of Biological Samples.

The widespread and persistent underrepresentation of groups experiencing health disparities in research involving biospecimens is a barrier to scientific knowledge and advances in health equity. To ensure that all groups have the opportunity to participate in research and feel welcome and safe doing so, we must understand how research studies may be shaped to promote inclusion. In this study, we explored the decision to participate in hypothetical research scenarios among African American adults (n = 169) that varied on the basis of four attributes (form of consent, reason for research, institutional affiliation and race of the researcher). Findings indicate that participants were largely willing to contribute to biobanks but significantly preferred opportunities where they had control over the use of their biological samples through tiered or study-specific forms of consent. Broad consent procedures, although common and perhaps preferred by participants with high trust in researchers, may amount to an exclusionary practice.

Informed consent for capacity assessment.

In this paper we examine the role of informed consent to capacity assessment, focussing primarily on the two jurisdictions of England and Wales, and Ireland. We argue that in both jurisdictions, a capacity assessment should be regarded as a distinct intervention, separate from the 'original' intervention at issue, and that specific informed consent to the assessment should generally be sought in advance. As part of this, we consider what information should be provided so as to ensure informed consent. Having established a baseline requirement for informed consent, we also recognise that informed consent to assessment will not always be possible, either because the person is unable to understand the information about assessment or because the person refuses to be assessed and so, in the final part of the article, we explore how to proceed when informed consent is either not possible or not forthcoming, including an analysis of the implications of the statutory presumption of capacity.

Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study.

The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.

Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures.

PURPOSE: Youth aged 15-19 years and parents of minors aged 15-17 years in sub-Saharan Africa are under-represented in empirical consent research. Thus, knowledge is limited concerning the adequacy of consent procedures and need for strategies to improve consent comprehension among these groups. We assessed comprehension following standard consent procedures and evaluated an enhanced procedure among Kenyan youth and parents. METHODS: Participants were adolescents aged 15-17 years (n = 273), their parents (n = 196), and young adults aged 18-19 years (n = 196). We used a quasi-experimental cohort design to implement standard and enhanced (single condition: extended discussion, test/feedback) consent procedures. Participants completed a 21-item informed consent comprehension assessment instrument. RESULTS: After standard consent procedures, mean comprehension scores were 11.36, 13.64, and 13.43 (score range: 0-21) among adolescents, young adults, and parents, respectively. About 6.2% of adolescents, 19.6% of young adults, and 21.4% of parents answered ≥ 80% of the questions correctly. After the enhanced procedures, comprehension scores (15.87 adolescents, 17.81 young adults, and 16.77 parents) and proportions answering ≥ 80% of the questions correctly (44.9% adolescents, 76.8% young adults, and 64.3% parents) increased significantly. Regression analysis indicated statistically significant differences (p < .001) in comprehension scores between the enhanced and standard groups (ß = 3.87 adolescents, ß = 4.03 young adults, and ß = 3.60 parents) after controlling for sociodemographic factors. DISCUSSION: Enhancing consent procedures with extended discussions, quizzes, and additional explanation where understanding is inadequate is a promising approach for improving comprehension. However, poorer comprehension among adolescents compared to young adults and parents underscores the need for research to identify additional approaches to improve understanding.

PRESIDENTIAL ADDRESS: Lessons from Africa: Ubuntu, solidarity, dignity, kinship, and humility.

This paper addresses bioethics in the context of the coronavirus disease 2019 (COVID-19) pandemic. The Introduction (Section 1) highlights that at the field's inception, infectiousness was not front and center. Instead, infectious disease was widely perceived as having been conquered. This made it possible for bioethicists to center values such as individual autonomy, informed consent, and a statist conception of justice. Section 2 urges shifting to values more fitting for the moment the world is in. To find these, it directs attention to the Global South, and in particular, Africa, and to the values of ubuntu, solidarity, dignity, kinship, and humility. The paper concludes (in Section 3) that 21st-century challenges facing bioethics are increasingly global, and calls on bioethicists themselves to be more globally inclusive in their approaches.

Grounds for admitting a mentally ill person without their consent to a psychiatric hospital under the application procedure. / Przeslanki przyjecia osoby chorej psychicznie bez jej zgody do szpitala psychiatrycznego w trybie wnioskowym.

OBJECTIVES: The purpose of this article is to present the authors´ comments on the analysis of the conditions for admitting a person to a psychiatric hospital against their will on the basis of a judgment issued by a guardianship court as part of proceedings initiated at the request of an authorized entity, and the assumptions contained therein are based on applicable normative acts. METHODS: The method of analyzing the current provisions of medical law was used, and of the social security law were also referred to. The judicature of the courts, in particular the Supreme Court, was collected, presented and considered, which constitute a practical guide in assessing whether or not the conditions for admitting a patient to a psychiatric hospital without their consent have been met. RESULTS: Placing a mentally ill person in a psychiatric hospital without their consent, in a situation where the person does not pose a direct threat to their health and life, or to the health and life of third parties, and does not pose a threat to public safety, is quite a specific restriction of the human right to freedom, sanctioned by the state. CONCLUSIONS: The provision of Article 29 (1) of the Mental Health Act is a special provision, it should be interpreted strictly, without referring to the principles of broad interpretation or analogy, and the supreme directive of the courts' actions should be the requirement that the ruling should be purposeful from the point of view of the good and interest of the person concerned.

In safe hands: child health data storage, linkage and consent for use.

While there is potential for societal benefit from linkage and integration of large datasets, there are gaps in our understanding of the implications for children and young people, and limited inclusion of their views within this discourse. We aimed to understand the views and expectations of children, young people and their parents/caregivers in Aotearoa New Zealand regarding child health data storage, linkage and consent for use. This qualitative study included 24 Maori and non-Maori children, young people and their families across five focus groups, recruited from a community-based health service. A mixed Maori and non-Maori research team facilitated participant recruitment and data collection. Child, adolescent and parent/caregiver groups were held separately. Sessions were audio-recorded and the verbatim transcripts were analysed thematically. We identified three themes: (i) I am more than a number: seeing patients as people; (ii) In safe hands: data as power; and (iii) What are your intentions with my data? Consent as an active relationship. A key challenge was the reductive and stigmatizing potential of data integration for minoritised groups. Hypothetical discussions of data sharing and linkage were contingent on trust between the participant and the health professional, with negotiated data ownership. Consent was conceived as an active relationship needing renewal and renegotiation as children reached adulthood. Current consent processes for ongoing use of child data require further deliberation. Without a strong ethical and child rights-based approach to issues of child health data management, consent and linkage, we risk exacerbating health inequities and experiences of breach of trust.

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study.

BACKGROUND: Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. METHOD: We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted. RESULTS: Our analysis identified four interrelated themes surrounding participants' ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. CONCLUSIONS: Participant's agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.