Ethical and Legal Obligations for Research Involving Pregnant Persons in a Post-Dobbs Context.

In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure the ethical conduct of research with pregnant people in an evolving legal environment.

25 años del asunto di bella: ¿qué enseñanzas éticas nos deja? / 25 years from di bella affair: what ethical lessons does it leave us?

Hace 25 años, en 1998, ante la demanda de que la Sanidad Pública asumiera el coste del tratamiento alternativo del cáncer propuesto por el Profesor Luigi Di Bella -que incluía hormonas, vitaminas y, en ocasiones, quimioterapia- el Parlamento italiano aprobó realizar ensayos clínicos con pacientes oncológicos avanzados para conocer la eficacia de esta terapia. Aunque los estudios en fase II paralelos que se llevaron a cabo en diversos tumores demostraron la falta de actividad del esquema, algunos profesionales han seguido empleándolo desde entonces y han publicado unos resultados aparentemente prometedores en diversas revistas científicas. Este ejemplo real plantea tres escenarios éticos interesantes. El primero es el de la ética de los tratamientos alternativos propuestos por profesionales de la medicina o del ámbito académico que no consiguen distinguir entre hipótesis y eficacia real, algo que influye también en las ex pectativas que genera en pacientes y familiares que deben afrontar una patología potencialmente mortal con pocas o ninguna expectativa de curación con los tratamientos tradicionales. El segundo escenario es el del diseño de ensayos clínicos y la buena práctica para llevarlos a cabo, que fue también motivo de debate en relación con el método Di Bella. Y el último, la ética de las publicaciones científicas. Desde el año 2000, los seguidores de Di Bella han publicado 13 trabajos de calidad limitada con series de pacientes, la mayoría de ellos en una revista de pago por publicación en cuyo comité de editores se encuentra Giuseppe Di Bella, hijo del profesor Di Bella (AU)

Twenty-five years ago, in 1998, the Italian Parliament approved to implement clinical trials in patients with advanced cancer to know the efficacy of an alternative cancer treatment that associated hormones, vitamins and, occasionally, chemotherapy proposed by Professor Luigi Di Bella. It was the answer to people demanding Public Health assume the cost of this therapy. Although parallel phase II trials in various tumors demonstrated the lack of activity, some professionals have continued to use this method since then and have published apparently promising results a few various scientific journals. This real example raises three interesting ethical scenarios. The first one is the ethics of alternative treatments proposed by medical pro fessionals or from the academic field. In these cases, the difficulty in differentiating between hypothesis and real efficacy. This problem impacts on patients and relatives’ expectations who must face a potentially fatal disease with little or no hope of a cure with traditional treatments. The second scenario is the design and good practice in the development of clinical trials, which was also the subject of debate in relation to the Di Bella method. And the last one, the ethics of scientific publications. Di Bella’s followers published since 2000 12 papers with limited quality on series of patients treated with his method, the majority in a pay-per-publication journal of which Giuseppe Di Bella, son of Professor Di Bella, is included in the board of editors (AU)

Coproducing health research with Indigenous peoples.

The coproduction of health research represents an important advance in the realm of participatory methodologies, which have evolved over the past five decades. This transition to a collaborative approach emphasizes shared control between academic researchers and their partners, fostering a more balanced influence on the research process. This shift not only enhances the quality of the research and the evidence generated, but also increases the likelihood of successful implementation. For Indigenous peoples, coproduced research represents a critical development, enabling a shift from being mere 'subjects' of research to being active controllers of the process-including addressing the extractive and oppressive practices of the past. In this Review, we explore how research coproduction with Indigenous peoples is evolving. An 'Indigenous turn' embraces the concept of shared control while also considering the principles of reciprocity, the incommensurability of Western and Indigenous knowledge systems, divergent ethical standards, strategic and political differences, and the broader impact of processes and outcomes. To illustrate these ideas, we present examples involving New Zealand's Maori communities and offer recommendations for further progress.

¿Cómo afectan la Ley 8/2021 y la ley 6/2022 a la investigación biomédica desarrollada en España? / ¿Com afecten la Llei 8/2021 i la Llei6/2022 a la investigació biomèdica desenvolupada a Espanya? / How do Act 8/2021 and Act 6/2022 affect biomedical research carried out in Spain?

La implementación de la Convención de Derechos de las Personas con Discapacidad obliga a los Estados Partes a realizar reformas legales que afectan a las normas que regulan la participación de las personas con discapacidad en la investigación biomédica clínica, en especial en los ensayos clínicos con medicamentos. En España, se ha tenido que reformar el Código Civil y la Ley General de Derechos de las Personas con Discapacidad para adecuar el ejercicio de la capacidad jurídica y para garantizar la accesibilidad cognitiva. Estas reformas podrían servir como modelo de las reformas que deben implementarse en otros países.(AU)

La implementació de la Convenció dels Drets de les Persones amb Discapacitat obliga als Estats Parts a realitzar reformes legals que afecten les normes que regulen la participació de les persones amb discapacitat en la investigació biomèdica clínica, especialment en els assaigs clínics amb medicaments. A Espanya, s'ha hagut de reformar el Codi Civil i la Llei General de Drets de les Persones amb Discapacitat per adequar l'exercici de la capacitat jurídica i garantir l'accessibilitat cognitiva. Aquestes reformes podrien servir com a model per a les reformes que han d'implementar-se en altres països.(AU)

The implementation of the Convention on the Rights of Persons with Disabilities obliges the States Parties to carry out legal reforms that affect the norms that regulate the participation of persons with disabilities in clinical biomedical research, especially in clinical trials with drugs. In Spain, the Civil Code and the General Act on the Rights of Persons with Disabilities have had to be reformed to adapt the exercise of legal capacity and to guarantee cognitive accessibility. These reforms could serve as a model for reforms to be implemented in other countries.(AU)

Bridge-building between communities: Imagining the future of biomedical autism research.

A paradigm shift in research culture is required to ease perceived tensions between autistic people and the biomedical research community. As a group of autistic and non-autistic scientists and stakeholders, we contend that through participatory research, we can reject a deficit-based conceptualization of autism while building a shared vision for a neurodiversity-affirmative biomedical research paradigm.

Ethical challenges in research on sexual dysfunction.

Despite more than a century of research on sexual dysfunction, there has been limited attention to ethical concerns. This is problematic because sex research involves complex ethical questions that generate confusion for ethics review and have not been addressed by ethical guidelines. We analyze two questions. First, does sexual content raise the risk profile of a research protocol? We argue that there is nothing inherent in sexual content that makes a study high risk and that many sexual dysfunction studies involve no more than minimal risk. Second, we ask whether research interventions that involve seeing participants undressed or having physical contact with a research subject are permissible? We argue that these interventions raise an important ethical challenge-they often involve sexual dysfunction researchers engaging in interventions that would not be conducted in their standard practice. To resolve this, we propose an expertise-based account of the permissibility of sexual dysfunction research.

Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness.

This Viewpoint discusses the difficult task of creating a stakeholder-driven, evidence-based approach to assessing institutional review board effectiveness beyond regulatory compliance.

Protección de datos en investigación clínica: ¿pseudonimización o anonimización? / [Data protection in clinical research: pseudonymization or anonymization?]

Se pretende analizar la necesidad de codificar los datos de los participantes de un estudio de salud, así como las técnicas que se pueden emplear como medida de protección, analizando sus características, ventajas e inconvenientes y abordándose desde un punto de vista semi-práctico, al desarrollarse brevemente algunas técnicas de codificación. (AU)

Te aim is to analyse the need to code the data of the participants of a health study, as well as the techniques that can be used to do so, analysing their characteristics, advantages and disadvantages and approaching it from a semi-practical point of view, by briefly developing some coding techniques. (AU)

Strengths, gaps, and future directions on the landscape of ethics-related research for spinal cord injury.

Spinal cord injury (SCI) affects between 250,000-500,000 people globally each year. While the medical aspects of SCI have received considerable attention in the academic literature, discourse pertaining to its ethical implications is more limited. The experience of SCI is shaped by intersecting demographic and identity factors such as gender, race, and culture that necessitate an intersectional and value-based approach to ethics-related research that is properly situated in context. Given this background, we conducted a content analysis of academic studies exploring the perspectives and priorities of individuals with SCI published in peer-reviewed journals in the decade between 2012-2021. Terms pertaining to SCI and ethics were combined in a search of two major publication databases. We documented overall publication patterns, recruitment and research methods, reporting of demographic variables, and ethics-related discourse. Seventy (70) papers met inclusion criteria and were categorized by their major foci. Findings reveal a gap in reporting of participant demographics, particularly with respect to race and ethnicity, geographic background, and household income. We discuss these person-centered themes and gaps that must be closed in the reporting and supporting of SCI research.

The Ethics of Expanded Access Research.

This Viewpoint discusses the benefits of expanded access research, the usefulness of expanded access data, the issues surrounding cost and transparency, and the adjusted role of institutional review boards.

Can the Research Team-Participant Relationship Ground Ancillary-Care Obligations?

Discussion of medical researcher teams' ancillary-care obligations has long been dominated by partial-entrustment theory, developed in 2004 by the author of this article, in collaboration with Leah Belsky. Critics of the limited scope of the special ancillary-care obligations defended by that theory, however, argue that a better theory would take fuller account of the relationship that develops between individual research participants and members of the research team. Nate W. Olson and Thaddeus Metz have each put forward well worked-out versions of such a relationship-based account of ancillary-care obligations. This article critically evaluates these accounts, concluding that while each of them is vulnerable to various criticisms, each also crucially facilitates understanding of this relationship: Olson brings out well how research participants can find that role not just beneficial but also deeply meaningful, and Metz, drawing on African ethical traditions, emphasizes that when things go well, participants are involved as partners in the research effort. Yet the article closes by arguing that the partial-entrustment theory, surprisingly, can take on board each of these lessons. As so enhanced, it may actually be the best available relationship-based theory of this subject.