The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the stud

The accelerating impact of AI in biomedical research is driving significant advances in precision medicine. As these systems increasingly shape health outcomes, the imperative to develop trustworthy, reliable, and ethically grounded AI becomes more pressing, particularly in addressing concerns related to data integrity, patient safety, and equitable outcomes. While the potential of AI to transform biomedical research is clear, its responsible integration depends on more than technological capability. Ensuring that these systems are aligned with societal values requires a dual commitment: the operationalization of ethical principles throughout the AI life cycle and the establishment of robust regulatory mechanisms. Ethics provides the normative vision for fairness, accountability, and human dignity, whereas regulation translates these ideals into enforceable standards. This paper explores the convergence of these domains as a necessary foundation for developing trustworthy human-centered AI in biomedical contexts. We provide practical guidance for AI developers and researchers on integrating proactive governance and translating ethical principles into actionable strategies to support equitable and responsible innovation.

Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States.

Editorial board -- Acknowledgements -- List of contributors - - Introduction / Sue Eckstein -- Pt. 1. Section I. Fundamental ethical and legal considerations -- Ch. 1. The ethics of clinical research / Calliope (Bobbie) Farsides -- Ch. 2. Research ethics committees and the law / Ian Kennedy and Phil Bates -- Ch. 3. The regulation of medical research: a historical overview / Richard H. Nicholson -- Section II. The research process -- Ch. 4. The regulation of medical research in the UK / Pamela Charnley Nickols -- Ch. 5. Observational and epidemiological research / Nick Dunn - - Ch. 6. Social survey research / Crispin Jenkinson -- Ch. 7. Approaching qualitative research / Alan Cribb -- Ch. 8. Complementary and alternative medicine: challenges for research ethics committees / Julie Stone -- Ch. 9. The ethical review of student research in the context of the governance arrangements for research ethics committees / Richard Ashcroft and Michael Parker - - Ch. 10. The ethics of genetic research / Ruth Chadwick -- Ch. 11. Research or audit? / Anthony Madden -- Ch. 12. Randomised controlled trials / Hazel Inskip and Richard W. Morris -- Ch. 13. Determining the study size / Hazel Inskip and Richard W. Morris - - Ch. 14. Risk assessment for research participants / Kenneth Calman -- Ch. 15. Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum / Keith Britton and Rosemary Foley -- Ch. 16. A guide to the use of radioactive materials and radiological procedures for research purposes / Niall Moore -- Ch. 17. Indemnity in medical research / Janet Jeffs and Richard Mayon-White -- Ch. 18. The prevention and management of fraud and misconduct: the role of the LREC / Jennifer Blunt and Frank Wells -- Section III. Protecting the interests of research participants -- Section III(A). General principles -- Ch. 19. Understanding clinical trials: a model for providing information to potential participants / Philippa Easterbrook and Joan Houghton -- Ch. 20. The law relating to consent / Andrew Grubb, Rosamund Scott, Penney Lewis and Phil Bates -- Ch. 21. Writing information for potential research participants / Elizabeth Mellor, David K. Raynor and Jonathan Silcock -- Section III(B). Vulnerable participants -- Ch. 23. Research involving vulnerable participants: some ethical issues / Sue Eckstein -- Section IV. International research -- Ch. 24. The ethics of research related to healthcare in developing countries / Nuffield Council on Bioethics -- Pt. II. Section I. Fundamental legal and ethical considerations -- Ch. 25. Ethical principles for medical research involving human subjects / World Medical Association -- Ch. 26. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research / National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research -- Ch. 27. ICH Good Clinical Practice Guideline / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -- Ch. 28. Governance arrangements for NHS research ethics committees / Department of Health -- Ch. 29. The research governance framework for health and social care / Department of Health -- Ch. 30. EU Clinical Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. / The European Parliament and the Council of the European Union -- Ch. 31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings / Council of Europe -- Section II. The research process -- Section II(A) General guidelines -- Ch. 32. Good research practice / Medical Research Council -- Ch. 33 Research: the role and responsibilities of doctors / General Medical Council -- Ch. 34. Guidelines for company-sponsored safety assessment of marketed medicines (SAMM) / Association of the British Pharmaceutical Industry -- Ch. 35. Guidelines for medical experiments in non- patient human volunteers / Association of the British Pharmaceutical Industry -- Ch. 36. Facilities for non-patient volunteer studies / Association of the British Pharmaceutical Industry -- Ch. 37. Multi-cenre research in the NHS - the process of ethical review when there is no local researcher / Central Office for Research Ethics Committees -- Ch. 38 Medical devices regulations and research ethics committees / Medical Devices Agency -- Ch. 39. NHS indemnity - arrangements for clinical negligence claims in the NHS / Department of Health -- Ch. 40. Clinical trial compensation guidelines / Association of the British Pharmaceutical Industry -- Ch. 41. Research ethics: guidance for nurses involved in research or any investigative project involving human subjects / Royal College of Nursing -- Ch. 42. Ethical principles for conducting research with human participants / The British Psychological Society -- Ch. 43. Statement of ethical practice / British Sociological Association -- Section II(B). Tissue and genes -- Ch. 44. Human tissue and biological samples for use in research / Medical Research Council -- Ch. 45. Transitional guidelines to facilitate changes in procedures for handling surplus' and archival material from human biological samples / Royal College of Pathologists -- Ch. 46. Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report) / The Stationery Office/Department of Health - - Ch. 47. Guidance on the supply of fetal tissue for research, diagnosis and therapy / Department of Health -- Ch. 48. Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report-section 1) / Gene Therapy Advisory Committee -- Ch. 49. Report on the potential use of gene therapy in utero / Gene Therapy Advisory Committee -- Ch. 50. Human fertilisation and embryology authority - code of practice (extracts) / Human Fertilisation and Embryology Authority -- Section III. Protecting the interests of research participants -- Section III(A). General principles -- Ch. 51. Guidelines for researchers - patient information sheet and consent form / Central Office for Research Ethics Committees -- Ch. 52. ABPI Guidance note - patient information and consents for clinical trials / Association of the British Pharmaceutical Industry -- Ch. 53. The protection and use of patient information (HSG(96)18/LASSL (96)5) / Department of Health -- Ch. 54. The Caldicott Report on the review of patient-identifiable information - executive summary December 1997 / The Caldicott Committee, Department of Health -- Ch. 55. Personal information in medical research / Medical Research Council -- Ch. 56. Use and disclosure of medical data - guidance on the application of the Data Protection Act, 1998, May 2002 / The Information Commissioner -- Section III(B). Vulnerable participants -- Ch. 57. Guidelines for the ethical conduct of medical research involving children / Royal College of Paediatrics and Child Health: Ethics Advisory Committee -- Ch. 58. Clinical investigation of medicinal products in the paediatric population. / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - - Ch. 59. Guidelines for researchers and for ethics committees on psychiatric research involving human participants - executive summary / Royal College of Psychiatrists -- Ch. 60. The ethical conduct of research on the mentally incapacitated / Medical Research Council -- Ch. 61. Volunteering for research into dementia / Alzheimer's Society -- Ch. 62. Knowledge to care: research and development in hospice and specialist palliative care - executive summary / National Council for Hospice and Specialist Palliative Care Services -- Ch. 63. NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials / National Union of Students - - Ch. 64. Ethical considerations in HIV preventive vaccine research / Joint United Nations Programme on HIV/AIDS (UNAIDS) -- Section IV. International research -- Ch. 65. 2002 international ethical guidelines for biomedical research involving human subjects / Council for International Organisations of Medical Sciences (CIOMS) -- Ch. 66. 1991 international guidelines for ethical review of epidemiological studies / Council for International Organisations of Medical Sciences -- Ch. 67. Operational guidelines for ethics committees that review biomedical research/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TOR) -- Ch. 68. Registration of an institutional review board (IRB) or independent ethics committee (IEC) / Office for Human Research Protections (OHRP) -- Ch. 69. International guidelines on bioethics (informal listing of selected international codes, declarations, guidelines etc. on medical ethics/bioethics/health care ethics/human rights aspects of health). / European Forum for Good Clinical Practice/Council for International Organisations of Medical Sciences -- Inde

Contributors -- Preface -- 1. The quest for a perfect child: how far should the law intervene? / Hazel Biggs -- 2. Conceptions of welfare / Eric Blyth -- 3. Rethinking the pre-conception welfare principle / Emily Jackson -- 4. Paying gamete donors does not wrong the future child / Heather Draper -- 5. Equality of access to NHS-funded IVF treatment in England and Wales / Laura Riley -- 6. Unforeseen uses of preimplantation genetic diagnosis ethical and legal issues / Jess Buxton -- 7. Parenting genetically unrelated children: a comparison of embryo donation and adoption / Fiona MacCallum -- 8. Unconsidered inconsistencies: parenthood and assisted conception / Kirsty Horsey -- 9. Beyond genetic and gestational dualities: surrogacy agreements, legal parenthood and choice in family formation / Robin Mackenzie -- 10. Beyond health and disability: rethinking the 'foetal abnormality' ground in abortion law / Nicolette Priaulx -- 11. The abortion debate today / Ellie Lee -- Inde

The French research ecosystem long resisted extending the ethics regulation processes established for biomedical science into the social sciences. This is now changing. This history of resistance is examined, together with the alternatives proposed. These include self-regulation by professional associations. Consideration is also given to the wider legal environment for French social sciences, particularly the laws on defamation and privacy, which also influence the opportunities for research and for the pursuit of grievances by participants. The introduction of ethics regulation, through IRB-style committees in universities and research organizations, reflects isomorphic pressures from the international research community, reinforced by the impact of the European Union’s General Data Protection Regulations (GDPR) on the application of national privacy law. Nevertheless, outside the specific domain of health-related research, ethics regulation still sits more lightly on French social science than in the anglosphere.

The article is devoted to the issues of clinical research: their ethical and legal regulation at the present time, the history of ethical expertise in the Russian Federation and at Kazan State Medical University. The role of ethical committees as a structure responsible for quality of scientific research and a guarantor of compliance with the principles of ethics, protection of the rights, safety and well-being of research participants is considered. The article presents the working experience of the local ethics committee of Kazan State Medical University on ethical examination of research projects with human participation and analysis of the most common mistakes in preparation of research documentation made by young scientists of clinical departments. The digital information showing typical errors and inaccuracies in the formation of a package of documents for ethical examination, based on the analysis of 284 initiative papers of PhD candidates from clinical departments: every fifth protocol required revision in accordance with the ethical and legal framework adopted in the Russian Federation, in 1.5% of cases the documentation was submitted for already conducted studies (i.e. ost factum), when no changes to its design are possible anymore. Typical mistakes were the following: inability to form research and control groups, calculate a representative number of participants, write an information sheet for a participant in a clinical trial and a sheet of informed consent, going beyond the specialty, desire to prescribe drugs beyond the scope of registered indications, etc. The ways of increasing both the awareness of young researchers and quality of ethical expertise by specialists of the ethics committee are proposed.

OBJECTIVE Aim: To analyze the key principles underlying the legal regulation of biomedical research and evaluate their practical implementation in contemporary legal frameworks. PATIENTS AND METHODS Materials and Methods: This study employs a comprehensive literature review, including academic publications, legal documents, and international guidelines on biomedical research ethics. Qualitative analysis identified core principles of legal regulation. Comparative legal analysis assessed principle implementation across jurisdictions. Case studies of biomedical research projects provided practical insights. A systematic review of ethical committee reports and policy documents highlighted implementation challenges and best practices. CONCLUSION Conclusions: Ethical principles in biomedical research form a complex framework essential for protecting participants' rights while advancing science. A shift from paternalistic models to patient autonomy is evident, yet implementation challenges remain, particularly in balancing information disclosure with potential negative impacts. Evolving biomedical technologies necessitate ongoing principle refinement. Future efforts should focus on improving complex medical information communication, ensuring informed decision-making, addressing vulnerable populations' needs, while maintaining balance between individual rights and societal benefits. Attention is paid to the principle of informed consent, which is fundamental to modern bioethics and medical practice, reflecting the transition from a paternalistic model to a model emphasizing patient autonomy.

Good Clinical Practice (GCP) constitutes the internationally accepted ethical and scientific framework governing the design, conduct, monitoring, and reporting of clinical trials involving human participants. It provides safeguards for the rights, safety, and welfare of research participants while ensuring the integrity and credibility of the data generated. The development of GCP has been shaped by historical milestones, ethical deliberations, and regulatory harmonization across jurisdictions. For this review, evidence was sourced from PubMed, Scopus, and Google Scholar covering the period 1947–2023, with a focus on international and national guidelines, regulatory documents, and peer-reviewed literature relevant to biomedical and dental research. The review highlights its application in both biomedical and dental trials, including challenges unique to dental research such as small sample sizes, high dropout rates, and variability in outcome measures. Furthermore, it synthesizes insights from the literature on challenges and critiques associated with implementation, including issues highlighted during the COVID-19 pandemic, the emergence of digital and decentralized trials, artificial intelligence in monitoring, and the need for inclusivity in trial populations. In conclusion, GCP remains an essential framework for ethically sound and scientifically credible clinical research, and dental researchers in particular should apply these principles rigorously to strengthen trial quality and ensure translation into safe and effective patient care.

Recently, significant advancements have been achieved in the field of biomedical research, including the improvement of new and effective diagnostic tools, novel treatments, as well as a better knowledge of illnesses and their causes. Major favourable progress is promised by current biomedical research, which also undoubtedly presents substantial difficulties. In the multi-layered, dispersed, and complicated structure of research governance, issues like personal or institutional conflicts of interest and risks to the individual, community, and society are not appropriately handled. The current study captures the important milestones in the guideline of biomedical research and advancement in India in terms of public support, government programme initiatives, and global and national regulatory frameworks. As one of the primary systems for regulating the ethical and legal aspects of biomedical research, this essay also examines the duties and responsibilities of the ethics committee.

Background Q-CEP ( Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep ) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil’s national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. Methods An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. Results In 2019–2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% ( n  = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. Conclusions Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world’s largest research ethics evaluation systems.

The paper presents an overview of political and professional committees in the Federal Republic of Germany dealing with issues of biomedical ethics. The prevailing tendencies of paternalistic attitudes, the worst-case scenario argumentation method, and the unfortunate practice of applying general principles rather than mid-level principles in the assessment of concrete challenges in treatment and regulation are analyzed