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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.
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Investigación Biomédica , Consentimiento Informado , Humanos , Consentimiento Informado/legislación & jurisprudencia , Consentimiento Informado/ética , Estados Unidos , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Bancos de Muestras Biológicas/legislación & jurisprudencia , Bancos de Muestras Biológicas/ética , Línea Celular Tumoral , Manejo de Especímenes/éticaRESUMEN
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.
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Investigación Biomédica , Médicos , Facultades de Medicina , Humanos , Investigación Biomédica/legislación & jurisprudencia , Docentes MédicosRESUMEN
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.
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Bibliometría , Estética , Humanos , Técnicas Cosméticas/tendencias , Consentimiento Informado/legislación & jurisprudencia , Investigación Biomédica/legislación & jurisprudencia , Cirugía Plástica/legislación & jurisprudencia , Cirugía Plástica/tendencias , Publicaciones Periódicas como AsuntoRESUMEN
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.
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Investigación Biomédica , Conflicto de Intereses , Conflicto de Intereses/legislación & jurisprudencia , Humanos , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , AlemaniaRESUMEN
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.
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Países en Desarrollo , Salud Global , Humanos , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Difusión de Innovaciones , Cooperación InternacionalRESUMEN
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.
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Investigación Biomédica , Humanos , Investigación Biomédica/legislación & jurisprudencia , Sujetos de Investigación/legislación & jurisprudenciaRESUMEN
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.
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Bancos de Muestras Biológicas , Consentimiento Informado , Neoplasias , Humanos , Masculino , Femenino , Polonia , Neoplasias/psicología , Neoplasias/terapia , Persona de Mediana Edad , Bancos de Muestras Biológicas/ética , Bancos de Muestras Biológicas/legislación & jurisprudencia , Consentimiento Informado/legislación & jurisprudencia , Consentimiento Informado/ética , Adulto , Anciano , Encuestas y Cuestionarios , Percepción , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Obtención de Tejidos y Órganos/ética , Obtención de Tejidos y Órganos/legislación & jurisprudencia , Donantes de Tejidos/psicología , Donantes de Tejidos/éticaRESUMEN
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.
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Investigación Biomédica , Responsabilidad Legal , Selección de Paciente , Femenino , Humanos , Embarazo , Investigación Biomédica/legislación & jurisprudencia , Lactancia , Mujeres Embarazadas , Estados UnidosRESUMEN
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.
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Experimentación Animal , Bienestar del Animal , Bienestar del Animal/legislación & jurisprudencia , Bienestar del Animal/ética , Experimentación Animal/legislación & jurisprudencia , Experimentación Animal/ética , Animales , Alemania , Investigación Biomédica/legislación & jurisprudenciaRESUMEN
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.
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Investigación Biomédica , Análisis Ético , Egipto , Humanos , Suecia , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Ética en Investigación , Francia , Consentimiento Informado/ética , Consentimiento Informado/legislación & jurisprudencia , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Valores Sociales , Sujetos de Investigación/legislación & jurisprudencia , Experimentación Humana/ética , Experimentación Humana/legislación & jurisprudencia , Unión Europea , Comités de Ética en InvestigaciónAsunto(s)
Microbiología , Medidas de Seguridad , Humanos , Investigación Biomédica/legislación & jurisprudencia , Investigación Biomédica/organización & administración , Microbiología/legislación & jurisprudencia , Microbiología/organización & administración , Medidas de Seguridad/legislación & jurisprudenciaRESUMEN
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.
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Bancos de Muestras Biológicas , España , Bancos de Muestras Biológicas/legislación & jurisprudencia , Bancos de Muestras Biológicas/ética , Humanos , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudenciaRESUMEN
Efforts to ban "gain-of-function" research on viruses and bacteria worry scientists.
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Investigación Biomédica , Mutación con Ganancia de Función , Wisconsin , Investigación Biomédica/economía , Investigación Biomédica/legislación & jurisprudencia , Bacterias/genética , Bacterias/patogenicidad , Virus/genética , Virus/patogenicidad , Hongos/genética , Hongos/patogenicidadRESUMEN
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.
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Inteligencia Artificial , Investigación Biomédica , Política de Salud , Invenciones , Legislación Médica , Educación de Postgrado en Medicina , Medicina , Inteligencia Artificial/legislación & jurisprudencia , Política de Salud/legislación & jurisprudencia , Invenciones/legislación & jurisprudencia , Investigación Biomédica/legislación & jurisprudenciaAsunto(s)
Investigación Biomédica , Gobierno Federal , Política , Apoyo a la Investigación como Asunto , Ciencia , Argentina , Apoyo a la Investigación como Asunto/economía , Apoyo a la Investigación como Asunto/legislación & jurisprudencia , Investigación Biomédica/economía , Investigación Biomédica/legislación & jurisprudencia , Investigación Biomédica/tendencias , Ciencia/economía , Ciencia/legislación & jurisprudencia , Ciencia/tendenciasAsunto(s)
Investigación Biomédica , COVID-19 , Coronavirus , Organización de la Financiación , National Institutes of Health (U.S.) , Humanos , Investigación Biomédica/economía , Investigación Biomédica/legislación & jurisprudencia , Investigación Biomédica/tendencias , COVID-19/epidemiología , COVID-19/transmisión , COVID-19/virología , National Institutes of Health (U.S.)/economía , National Institutes of Health (U.S.)/legislación & jurisprudencia , Política , Estados Unidos , Zoonosis Virales/epidemiología , Zoonosis Virales/transmisión , Zoonosis Virales/virología , AnimalesRESUMEN
Biden signs bill streamlining pot studies and production.