The Declaration of Helsinki

The ethics of global clinical trials: In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disadvantaged populations?

DOH: Preventing ethical pitfalls while advancing plastic surgery research

Hippocratic Oath is a living document for ethical conduct of the physicians around the world. World Medical Association has been amending the oath as per the contemporary times. Although physicians maintain their ethical standards while treating a patient yet many a times social, administrative and ruling powers either use physicians as their tool of oppression or victimize them for conducting duties as per their oath. The Tuskegee Syphilis Study and Human Radiation Experiments in America, Nazi Experiments in Germany and compulsory sterilization program in India were the studies where States used physicians for the advancement of their rationality or belief. Conversely victimization of physicians in Kosovo, Sri Lanka and incarcerating physicians for treating human immunodeficiency virus/acquired immunodeficiency syndrome patients in some countries is concerning. The Nuremberg code, the Declaration of Geneva, Belmont Report and Declaration of Helsinki are ethical documents while active involvement of Food and Drug Administration through “common rule” resulted in guidelines like International Conference on Harmonization and Good Clinical Practices. Still unethical studies are found in developing countries. Studies such as experimental anticancer drugs in 24 cancer patients without adequate prior animal testing and informed consent in Kerala, studies at All India Institute of Medical Sciences in New Delhi resulted in 49 deaths of children and many more suspicious studies are rampant. Reverting back to the fundamentals of the medical profession; teaching medical ethics and enforcement of “medical neutrality” by embarking some grade of “medical immunity” on the basis of the oath is necessary for ethical conduct of physicians.

Later this year, the US Food and Drug Administration (FDA; Rockville, MD, USA) plans to rewrite its regulations to eliminate any reference to the Declaration of Helsinki (DoH), a document from the World Medical Association (WMA; Ferney‐le‐Voltaire, France) that many consider to be the hallmark of medical ethics (WMA, 2004). This decision, triggered by the 2000 update to the DoH, is the latest move in an increasingly heated debate over medical research ethics. The FDA is reacting in particular to the addition of two controversial paragraphs, which, if adopted in their own regulations, would limit the use of placebos in drug trials and increase the responsibilities of trial sponsors towards research participants. > Unhappy with revisions made to the DoH between 2000 and 2004, the FDA now refers to the 1989 version of the Declaration, which the WMA itself considers invalid Since 1975, the FDA, which decides what medicines are marketed in the USA and therefore influences similar decisions elsewhere, had cited the DoH in its rules for new drug applications from studies conducted outside the USA. Unhappy with revisions made to the DoH between 2000 and 2004, the FDA now refers to the 1989 version of the Declaration, which the WMA itself considers invalid. In the future, the FDA plans instead to refer to the Good Clinical Practice: Consolidated Guidance —a joint effort by drug approval agencies from Europe, the USA and Japan, and pharmaceutical trade organizations (ICH, 1996)—which honours the spirit, but not necessarily the wording, of the DoH. The European Commission (EC), which sets the pace on national drug laws and ethical standards in Europe, is also reluctant to adopt the latest version of the DoH and instead refers to the 1996 version in its 2001 clinical trials directive (EC, 2001) and its 2005 directive on good clinical …

Extracted from text ... The Geneva Convention, recited by most graduates upon admission to the medical profession, and the Helsinki Declaration, which provides ethical principles for medical research involving human subjects, have become part of the everyday vocabulary of physicians throughout the world. In these sad times of escalating conflict we are increasingly grateful for the declarations of Tokyo, which provides 'guidelines for physicians concerning torture and other cruel, inhuman or degrading treatment or punishment in relation to detention and imprisonment', and Malta, which describes 'the ethical management of hunger strikes'. All of these plus regulations for 'the care of the sick and ..

Pragmatism, dynamism and flexibility in research and clinical practice.

IntroductionVenous Thromboembolisms (VTEs) are often preventable. In the UK, 60% of all VTEs are hospital-associated, costing the NHS approximately £200 million. VTE risk assessments ensure patient safety and reduce the...

Background: This interview covers Dr. Peter McCullough’s medical career, experience as an editor of medical journals, and his expertise in areas such as cardiomyopathy, myocarditis, and pericarditis. Aims: The primary aim is to understand Dr. McCullough’s perspectives on various medical topics, including his journey as a cardiologist, the importance of peer review, the phenomenon of Pheidippides cardiomyopathy, the differences between myocarditis and pericarditis, and the significance of ethical principles like the Nuremberg Code and the Declaration of Helsinki. Additionally, the interview aims to explore his concerns about censorship during the COVID-19 pandemic. Methods: The interview follows a question-and-answer format, with the interviewer posing questions to Dr. McCullough on various topics related to his medical career, research interests, and ethical considerations. Results: Dr. McCullough shares his insights on topics such as cardiomyopathy, myocarditis, and pericarditis, emphasizing the importance of peer review, identifying potential biases, and balancing scientific rigor with timely dissemination of findings. He also highlights the significance of the Nuremberg Code and the Declaration of Helsinki in ensuring informed consent and preventing coercion in medical research and treatment. Discussion: Dr. McCullough expresses concerns about censorship during the COVID-19 pandemic, which he believes impacted the ability of medical professionals to freely discuss and disseminate health-related information. He also discusses the potential role of COVID-19 vaccines in causing myocarditis and the need for transparent communication about treatment options and potential complications. Conclusion: The interview provides valuable insights from Dr. McCullough’s extensive medical experience and expertise, covering a range of topics from cardiovascular conditions to ethical principles and the challenges posed by censorship during the COVID-19 pandemic.

PurposeDrawing upon a circular model proposition, Kantian ethics is employed to explore how ethical considerations within AI translate into concrete actions that prioritize transparency, privacy, inclusivity and equality. Additionally, agency theory is applied to understand the relevance of fairness in the interactions between agents, principals and algorithmic systems, particularly in the creation of value through digital platforms.Design/methodology/approachA review of literature on ethical concerns within the AI ecosystem is conducted, proposing a unifying ethical principle and standards. The circular model for ethics in action is then developed, emphasising the responsible use of AI and its role in capturing and creating social value, ultimately contributing to sustainable organizational outcomes. The model also highlights key drivers that shape the ethical framing of AI, as well as the influence of the institutional context on its adoption and effectiveness.FindingsResponsible use of AI positively affects organizational performance and the digital ecosystem via the psychological mechanism of ethical identity. Ethical standards and regulations are the global requirements for the AI ecosystem that are required for achieving a sustainable digital society.Research limitations/implicationsThis study contributes to a comprehensive understanding of the responsible use of AI’s and its practical and theoretical implications for organizations in the current digital ecosystem. Lack of global understanding, awareness and implementation of ethical practice in the AI ecosystem is not yet developed and practice. Future researchers can design a cross-border ethical framework to overcome these limitations. Organizations targeting to increase responsible digital interactions can benefit from maintaining ethical principles through responsible labourers, leaders and all stakeholders involved in the ecosystem.Practical implicationsThis study offers practical guidance for businesses, policymakers and AI practitioners on the ethical use of AI. It emphasizes the need for robust data governance, a “human-first” approach focusing on privacy and accountability and alignment with ethical standards. Given AI’s global reach, international cooperation and standard-setting are essential to navigate diverse regulatory and cultural contexts. The paper also highlights the importance of ethics education for AI developers and practitioners. Investing in training that integrates technical skills with ethical awareness will help build a responsible AI workforce capable of addressing societal impacts and maintaining public trust.Social implicationsThis study underscores the urgent need for responsible AI adoption, highlighting risks such as bias, lack of transparency and privacy concerns. As AI reshapes work, decision-making and governance, its social impact grows – potentially deepening inequalities if left unchecked. The study calls for explainable, fair and inclusive AI systems guided by ethical frameworks that respect human dignity. A “human-first” approach ensures AI supports-not replaces-human agency. By fostering transparency, accountability and cultural sensitivity, organizations can build public trust, empower diverse communities and contribute to a more equitable digital future. Ethical leadership and inclusive design are essential to avoid reinforcing systemic harms.Originality/valueThis study presents an original approach to integrating ethical considerations into the development and deployment of artificial intelligence, by conceptualizing how transparency, accountability and inclusivity can be embedded throughout the AI ecosystem, fostering trust and responsible innovation. Through a comprehensive examination of ethical principles and requirements, we recommend a set of tools and strategies needed to promote ethical AI practices, mitigate risks and maximize societal benefit. Furthermore, this study serves as a roadmap for building AI systems that prioritize human collaboration and uphold fundamental values in the digital age.

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. It has undergone numerous revisions and amendments, the most recent being in Fortaleza–Brazil (2013). This new version includes various improvements and modifications which substantially easier to read, with a greater number of subsections. It is emphasized that the research ethics committee is recognized as a fundamental part of the research, the importance of disseminating research and compulsory informed consent. The Declaration of Helsinki is constantly evolving, and is arguably a document that provides the basis for the undertaking of any research. His knowledge and reading, is mandatory for all health professionals.

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)’s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants.

50th Anniversary of the Declaration of Helsinki: The Double Standard Was Introduced

The working group of the World Medical Association (WMA) has published a revised draft of the Declaration of Helsinki for public consultation till June 15, 2013. There are many positive changes in the document with respect to compensation, education of investigators, informed consent in the case of stored samples, etc. The changes represent a step forward for ethics. However, there may be certain points of concern regarding the implementation of the Declaration.

It is my pleasure to be here in the historic university town of Gottingen and to have the opportunity to address this important and timely symposium on the Freedom of research and control by ethics committees. I will be discussing the European Convention on Human Rights and Biomedicine and will try to put it into the context of the Symposium’s discussion of the World Medical Association’s Declaration of Helsinki. I will be discussing as well the additional Protocols to the Convention, including the one on Biomedical Research.

Chapter 1 - Introduction to applied behavior analysis, ethics, and core ethical principles