Biospecimen research and the law.

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Medical School Regulatory Compliance Burdens for the Physician-Scientist.

Medical school research faculty is increasingly required to complete more comprehensive and time consuming compliance steps for regulatory oversight. These relate to animal studies, information technology, biosafety, and human resources. For physician-scientists, the additional role in clinical care adds to these research areas with regulatory compliance in patient care and ever-growing web trainings. The sum of all these compliance regimes is a considerable time and cost burden, diminished research performance, and disengagement of faculty from colleagues, collaborations, and institutions. Many research and clinical compliance processes were put in place, often using legacy systems, in well-meaning attempts to address straightforward regulations in humane animal care, safe use of biological agents, and medical care delivery. However, their accumulation and negative impact on faculty performance demand time, energy, and resources that impact academic productivity. There are solutions to a relentlessly increasing regulatory load for research faculty, which involve vertical integration, convergence, and performance assessment in medical school and health system compliance regimes. ANN NEUROL 2024;96:417-422.

Nonfinancial Conflict of Interest in Medical Research: Is Regulation the Right Answer.

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.

Academic visualization study of aesthetic medicine management and related legal research since 2000.

BACKGROUND: Aesthetics medicine, a controversial branch of clinical medicine known for its high degree of commercialization, faces numerous conflicts, particularly in some developing countries. The global aesthetics medicine industry requires enhancements of its legal and supervision framework and risk management systems. AIMS: This paper aimed to provide a comprehensive visual analysis of academic achievements related to regulatory and legal issues in the field of aesthetic medicine and to identify its development trends and research hotspots. METHODS: The Web of Science Core Collection was employed to retrieve relevant studies, resulting in a total of 602 research articles after selection. Utilizing bibliometric methods and CiteSpace, this study analyzed the primary countries, institutions, authors, journals, hotspots, frontiers, and trends in this domain. RESULTS: The findings indicated rapid increases in the number of published papers. The United States emerged as the leading contributor with 131 research papers and the highest intermediate centrality. Eleven keyword clusters were identified, with "adolescence" and "office-based surgery" being the most recent topics. We also analyzed the trends and frontiers of legal research in medical aesthetics. CONCLUSION: The importance of informed consent has been increasingly emphasized, and research in the field of medical aesthetics has been gradually expanding beyond individual cosmetic procedures. The management system has become more comprehensive, moreover, guidelines and medical laws have been continually published, with research shifting toward a holistic perspective that encompasses patients, medical aesthetic providers, and regulatory authorities in the study of medical aesthetics regulation and legislation. This paper also proposes some innovative directions for future research and applications.

Constitutional and legal status of the subject during biomedical research.

OBJECTIVE: Aim: To find out the peculiarities of constitutional and legal status of the subject during biomedical research. PATIENTS AND METHODS: Materials and methods: A synergistic approach helps predict possible fluctuations and vectors of development, taking into account various social and technical processes of influence on the status of the subject; comprehensive - involves the analysis of the research subject within the framework of a combination of different scientific schools, concepts and methods and provides opportunities for the development of unified standards, benchmarks, principles and general norms of legal regulation. CONCLUSION: Conclusions: The constitutional-legal status of the subject is the position of the subject (patient, object of research) established and established by the norms of constitutional law, which distinguishes him as a special subject of legal relations in the process of conducting biomedical research and consists of a set of rights and obligations and specifics of the legal liability of its participants.

Global health reciprocal innovation: ethical, legal and regulatory considerations.

Global health reciprocal innovation (GHRI) is a recent and more formalised approach to conducting research that recognises and develops innovations (eg, medicines, devices, methodologies) from low- and middle-income countries (LMICs). At present, studies using GHRI most commonly adapt innovations from LMICs for use in high-income countries (HICs), although some develop innovations in LMICs and HICs. In this paper, we propose that GHRI implicitly makes two ethical commitments: (1) to promote health innovations from LMICs, especially in HICs, and (2) to conduct studies on health innovations from LMICs in equitable partnerships between investigators in LMICs and HICs. We argue that these commitments take a significant step towards a more equal global health research enterprise while helping to ensure that populations and investigators in LMICs receive equitable benefits from studies using GHRI. However, studies using GHRI can raise potential ethical concerns and face legal and regulatory barriers. We propose ethical, legal and regulatory considerations to help address these concerns and barriers. We hope our recommendations will allow GHRI to move the global health research enterprise forward into an era where all people are treated equally as knowers and learners, while populations in both LMICs and HICs benefit equitably from studies using GHRI.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.

BACKGROUND: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. MATERIALS AND METHODS: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. RESULTS: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. CONCLUSIONS: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns.

[Current regulations in the Animal Welfare Act and the significance for animal research]. / Aktuelle Regelungen im Tierschutzgesetz und Bedeutung für die tierexperimentelle Forschung.

Due to the legal implantation of the 3R principle, the number of laboratory animals decreased significantly over the past 10 years. In this article, the historical development of animal experiments over the last decade will be presented in the context of the current regulations of the Animal Welfare Act. It points out bureaucratic obstacles to the approval of animal experiments, which jeopardize Germany as a research location for both academia and industry. The article presents constructive proposals for solutions. This should be done in accordance with the DFG recommendation to ensure efficient biomedical research while maintaining the highest animal welfare standards.

Including Pregnant and Lactating Women in Clinical Research: Moving Beyond Legal Liability.

This Viewpoint summarizes a new report from the National Academies of Sciences, Engineering, and Medicine that encourages the inclusion of pregnant and lactating individuals in clinical research.

Wisconsin bill would restrict pathogen studies.

Efforts to ban "gain-of-function" research on viruses and bacteria worry scientists.

Biobanking Legislation in Spain: Advancing or Undermining Its Ethical Values?

Biobanks are important resources for improving public health and individual care. Some legal frameworks can be more or less conducive to advancing the potential benefits of biobanks. The purpose of this article is to assess biobanking legislation and practices in Spain to determine how well they fare in such a regard. We focus here on some of the primary ethical values that ground relevant legislation and that we believe are consistent with promoting biobanking benefits: the value of scientific research; efficient use of scarce resources; and respect for the dignity of donors. We argue that although Spanish regulations advance these values in important ways, they also have provisions that undermine them and thus risk limiting the potential benefits of biobanks. We offer some suggestions for improvement.

How Do Policymakers Regulate AI and Accommodate Innovation in Research and Medicine?

In this Medical News article, JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, and Alondra Nelson, PhD, the Harold F. Linder Professor at the Institute for Advanced Study, discuss effective AI regulation frameworks to accommodate innovation.

¿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)

Ética en investigación: de los principios a los aspectos prácticos / Research ethics: From principles to practical aspects

La realización de cualquier investigación con seres humanos o sus muestras biológicas requiere una valoración ética previa con el fin de evitar riesgos y problemas a todos los actores del proceso. La legislación al respecto es muy amplia, y hace hincapié en la preservación de los derechos de los pacientes en relación con los principios universales de autonomía, beneficencia y justicia. En este manuscrito se revisan las normativas sobre ensayos clínicos, estudios observacionales con medicamentos, proyectos de biobanco o cualquier otro tipo de estudio que se pueda realizar en el ámbito de la salud. Así mismo se analiza el papel de los comités de ética en investigación, la protección de datos y las bases de la integridad científica. (AU)

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity. (AU)

Marco ético y jurídico en la investigación científica en chile: acreditación de comités ético científicos / Ethical and legal framework in scientific research from Chile: functioning of accredited scientific ethics committees

RESUMEN: La investigación científica en seres humanos es fundamental para el desarrollo y avance en la ciencia de la salud y para el bienestar de la sociedad. La necesidad de contar con principios éticos explícitos y un marco regulatorio, permitió en el año 2001 la aprobación de la Norma sobre Regulación de Ensayos Clínicos en Seres Humanos. La ley 20.120 (2006), norma la investigación científica en el ser humano, describe aspectos centrales para el desarrollo de la investigación, dando sustento legal a la creación de los Comités Éticos Científicos (CEC), entidades colegiadas que tienen por objeto velar por la protección de la vulneración de derechos y libertades de los participantes, pudiendo aprobar o rechazar los protocolos de los proyectos. En Chile al año 2021 se registran 62 CEC acreditados. La región Metropolitana concentra el 58,2 %, la zona Norte un 11,2 % y en el sur del país un 30,6 %, de ellos solo el 12,9 % están acreditados para evaluar ensayos clínicos aleatorizados (ECA). Los criterios éticos internacionales más utilizados son la Declaración de Helsinki, pautas éticas sobre la salud, bienestar y los derechos de los pacientes; El Consejo Internacional de Ciencias Médicas (CIOMS) que protege en entornos vulnerables de escasos recursos; y el Informe Belmont en la protección de los sujetos de investigación. Se concluye que las guías éticas nacionales e internacionales son pautas que guardan relación con la adecuada protección jurídica de los participantes, velando por el respeto a la autonomía, la justicia y la selección justa de los participantes, a través del consentimiento informado voluntario. El desarrollo de una cultura de conducta ética en la investigación se debe basar en tres dimensiones generales; el ambiente humano, ambiente político y mecanismos de la sociedad civil.

SUMMARY: Scientific research in human beings is essential for the development and advancement of health science and for the well-being of society. The need to have explicit ethical principles and a regulatory framework allowed in 2001 the approval of the Standard on the Regulation of Clinical Trials in Human Beings. Law 20,120 (2006), regulates scientific research in human beings and describes central aspects for the development of research, giving legal support to the creation of Scientific Ethics Committees (SEC), collegiate entities whose purpose is to ensure the protection of the vulnerability of rights and freedoms of the participants, being able to approve or reject the protocols of the projects. In Chile by 2021, 62 accredited CECs are registered. The Metropolitan region concentrates 58.2 %, the North zone 11.2 % and in the south of the country 30.6 %, of which only 12.9 % are accredited to evaluate randomized clinical trials (RCTs). The most widely used international ethical criteria are the Helsinki Declaration, ethical guidelines on health, well-being and the rights of patients; The International Council of Medical Sciences (CIOMS) that protects in vulnerability low-resource settings; and the Belmont Report on the protection of research subjects. It is concluded that the national and international ethical guidelines are appropriate legal ethical guidelines and risk-benefit ratio that protect the participants, ensuring respect for the autonomy, justice and fair selection of the participants, through voluntary informed consent. The development of a culture of ethical conduct in research must be based on three general dimensions; the human environment, political environment and mechanisms of civil society.

Ética y jurisprudencia administrativa de los derechos de los sujetos de investigación en pandemia (COVID-19): función de los comités éticos científicos: Chile / Ethics and administrative jurisprudence of the rights of subjects of research in pandemic (COVID-19): role of the scientific ethics committees: Chile

RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.

SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.

Las investigaciones biomédicas y los reportes de caso realizados en la Caja Costarricense de Seguro Social requieren autorización para su publicación científica / Biomedical investigations and case reports carried out at the Caja Costarricense de Seguro Social require authorization for scientific publication

Resumen Objetivo: La mayoría de colaboraciones recibidas para su publicación en Acta Médica Costarricense surgen de las investigaciones realizadas en la Caja Costarricense de Seguro Social, estas cumplen con las disposiciones que establece la ley sobre investigación biomédica y su reglamento, así como con la diversa normativa que tiene esta institución sanitaria. En el contexto de la revisión constante y actualización periódica de normas para la publicación en esta revista, el objetivo de este trabajo fue analizar los requerimientos vigentes en la Caja Costarricense de Seguro Social para la publicación de las investigaciones biomédicas realizadas en sus servicios. Métodos: Se realizó una investigación documental con una búsqueda dirigida sobre tales disposiciones en la página oficial del Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social; el análisis se amplió con los elementos regulatorios del consentimiento informado. Resultados: Se encontró que los investigadores deben solicitar una autorización al área de Bioética del Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social para publicar, o comunicar en actividades científicas las investigaciones biomédicas que han sido realizadas en la institución; así mismo se estipula la gestión para dar a conocer los reportes de casos y la solicitud se tramita con el cumplimiento de una serie de requisitos. Conclusión: Las investigaciones biomédicas realizadas en la Caja Costarricense de Seguro Social requieren la solicitud de una autorización y el cumplimiento de una serie de requisitos para la publicación en la bibliografía científica o su exposición en una actividad científica, al igual que los reportes de caso. Es por tanto, necesario que el/los investigador/es gestionen oportunamente la autorización institucional.

Abstract Aim: Most of the contributions received for publication in this journal arise from the investigations carried out by the Caja Costarricense de Seguro Social, these comply with the provisions established by the law on biomedical research and its regulations, as well as with the various regulations that it has this health institution. In the context of the constant review and periodic updating of standards for publication in this journal, the objective of this work was to analyze the current requirements in the Caja Costarricense de Seguro Social for the publication of biomedical research carried out in its services. Methods: A documentary investigation was conducted with a directed search about regulations was made on the official website of the Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social; information was compiled and analyzed, then prepared for orderly display; the analysis was extended with the regulatory elements of informed consent. Results: It was found that researchers must request an authorization from the Bioethics area to publish, or communicate in scientific activities, the biomedical research that has been carried out in the institution. Likewise, the management to publicize the case reports is stipulated and the request is processed with the fulfillment of a series of requirements. Conclusion: The authorization request and the requirements apply to biomedical research and case reports, whether a publication is sought in the scientific literature or its exposure in a scientific activity; therefore, it is the responsibility of the researcher to manage the institutional authorization in a timely manner.