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.

[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.

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.

Wisconsin bill would restrict pathogen studies.

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

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.

New U.S. law aims to light up medical research on cannabis.

Biden signs bill streamlining pot studies and production.

A Decision 85 Years in the Making.

On October 6, 2022, President Biden announced that he is taking steps to pardon those convicted of simple marijuana possession at the federal level and reconsider the classification of cannabis as a Schedule I substance. At the same time, Congress is working to pass legislation to streamline research in the cannabis space. These efforts signal that federal marijuana laws that have been in place for the past 85 years have created a multitude of problems, including barriers to research, and the federal government is finally considering decisions to create change.

Leo Alexander's Blueprint of the Nuremberg Code.

BACKGROUND: Nazi Germany surrendered to the Allies on May 8, 1945. Six months later, the Allies tried the surviving leaders of Nazi Germany at the first Nuremberg trial. Later, the United States conducted 12 additional trials. The first one, The Unites States of America versus Karl Brandt et al., has been dubbed the Doctors' Trial. During the trial, the prosecution relied on the testimony of Dr. Andrew Ivy and Dr. Leo Alexander. At the end of the trial, Judge Sebring enunciated 10 principles needed to conduct human subject research-the Nuremberg Code. Authorship of the Code has been the subject of dispute, with both Ivy and Alexander claiming sole authorship. METHODS: In the summer of 2017, I visited Duke University Medical Center's Archives and surveyed the contents of boxes labeled "Alexander's papers." I also explored online databases with information on the Doctors' Trial. Pertinent documents were compared across collections, and against scholarly works on the topic. RESULTS: Box 3 of Alexander's papers at Duke University Medical Center's Archives contains a three-page document with six principles that, nearly word for word, were included in what is known as the Nuremberg Code. Alexander's name and appointment are typed at the end of the document. CONCLUSIONS: Although the Nuremberg Code is likely to have been an unplanned collaboration among members of the prosecuting team and the judges, I present evidence suggesting that Alexander drafted the blueprint and was the main contributor to the final version of the Code.

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.