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.

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.

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.

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.

Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?

The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such.

When and how to include vulnerable subjects in clinical trials.

There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.

Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia.

Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science. J Am Geriatr Soc 68:S37-S42, 2020.

[Research ethics: French regulations and applications in radiation oncology]. / Éthique de la recherche : réglementations françaises et applications en oncologie radiothérapie.

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.

Protecting Participants in Genomic Research: Understanding the "Web of Protections" Afforded by Federal and State Law.

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the "web" of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

Advance Research Directives: Legal and Ethical Issues and Insights from a National Survey of Dementia Researchers in Australia.

Advance research directives (ARDs) are a means by which people can document their wishes about research participation in the event of future incapacity. ARDs have been endorsed in some ethics guidelines and position statements, however, formal legal recognition is limited. A few empirical studies have investigated the views of researchers and other stakeholders on ARDs and tested strategies to implement such directives. To further knowledge in this area, we undertook a survey of dementia researchers in Australia (n= 63) to examine their views on ARDs. Most of the survey respondents (>80%) thought ARDs would promote autonomy in decision-making and enable opportunities for people with cognitive impairment to be included in research. Respondents indicated concern about directives not being available when needed (71%) and that ethics committees would not accept ARDs (60%). Few respondents had used ARDs, but a majority (from 57-80%) would be willing to offer ARDs for a range of research activities, such as observing behaviour and taking measures, blood samples or scans. Nearly all respondents (92%) agreed that current dissent should override prior wishes stated in an ARD. The survey findings are contextualised with attention to ethics guidelines, laws and practices to support advance research planning.

Oncology Research: Clinical Trial Management Systems, Electronic Medical Record, and Artificial Intelligence.

OBJECTIVE: To discuss the implications of electronic systems and regulations regarding the use of electronic systems implemented during the conduct of a clinical trial and identify the impact of such platforms on oncology nurses' responsible for providing care to the research participant. DATA SOURCES: Peer-reviewed journal articles, internet, book chapters, and white papers. CONCLUSION: Electronic systems are being increasingly used in the conduct of clinical research. Electronic systems enable the capability to streamline data transfer, remote enrollment capabilities, greater transparency of the trial conduct, improved research documentation, and clearer audit trails. The oncology nurse is at the center of implementation of electronic systems to support the conduct of clinical research and enables safe and effective care to the research participant. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses are vital to the successful outcome of clinical research studies and are key members of the clinical research team. Electronic systems move beyond traditional data collection in clinical trials with multiple benefits. Such systems may enhance the successful completion and adherence of the clinical trial and maintain the safety of the individual consented to research trial.

Human Subjects Protection and Federal Regulations of Clinical Trials.

OBJECTIVES: To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant's informed consent, and the role the oncology clinical research nurse has within the clinical trial setting. DATA SOURCES: Peer-reviewed journal articles, internet, book chapters, white papers. CONCLUSION: Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process.

Experts reflecting on the duty to recontact patients and research participants; why professionals should take the lead in developing guidelines.

Sequencing technology is increasing the scale of information that could benefit patients who have been tested in the past. This raises the question whether professionals have a duty to recontact such patients or their families. There is currently no clear basis for a legal duty to recontact, and professional guidelines are limited. We conducted interviews with 14 senior professionals from the Netherlands and UK to obtain a range of opinions on what obligations are estimated to be possible or desirable. There was (near) consensus that a lack of resources currently inhibits recontacting in clinical practice, that recontacting is less desirable in research, that information on recontacting should be part of informed consent, and that a legal duty should follow professional standards. There was a diversity of opinions on the desirability of a more systematic approach, potential obligations in hybrid clinical-research projects, and who should bear responsibility for seeking updates. Based on the literature, legal framework and these interviews, we conclude that a general duty to recontact is unlikely, but that in specific circumstances a limited duty may apply if the benefit to the individual is significant and the burden on professionals not too extensive. The variation in opinion demonstrates that further deliberations are desirable. The development of guidelines-a process the European Society of Human Genetics has begun-is important to ensure that the courts, in deciding a recontacting case, can take into account what professionals consider responsible standards in this field.

Transnational policy migration, interdisciplinary policy transfer and decolonization: Tracing the patterns of research ethics regulation in Taiwan.

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on 'principlism' and committee-based review were imported from the United States. Professionalisation of research ethics displaced other longer-standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples' rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self-referential and attend to the social, economic and political context within which regulation operates.

The rise and fall of an opt-out system.

Introduction: In Denmark, citizens participate in register-based research without the possibility of opting out. However, in 1995 it was made possible for Danish citizens to register an opt-out called 'researcher protection' [forskerbeskyttelse], which implied that researchers could not contact people to invite them to participate in research projects, such as clinical trials or questionnaries, based on their registrations in national registers. Data already registered could still be used for research. In 2014, this possibility of opt-out was revoked by law. Aims: The aims of this paper are to understand how the Danish researcher protection system came about, why it was terminated and what we can we learn from this example. Methods: We conducted a descriptive analysis of a copy of the former researcher protection register along with policies and media debate surrounding the rise and revocation of the researcher protection system. Results: Our results show how both the inception and the abolishment of researcher protection appear to be ad hoc and without specified criteria of success. An examination of the recorded entries in the researcher protection registry could have led to changes in its administration as an alternative to its total abolition. Conclusions: In future opt-out systems, there should be focus on monitoring register practices and the purpose and criteria for evaluation must be defined prior to implementation.

International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials.

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia? / ¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia?

Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.