In October 2024, the World Medical Association’s Declaration of Helsinki (DoH) underwent comprehensive updates that incorporated feedback from global experts and stakeholders. The revised DoH continues to serve as a cornerstone for international and national regulations on medical research ethics. This paper aims to delve into the 2024 amendments to DoH and assesses their impact on South Korea’s Bioethics and Safety Act (Bioethics Act). This paper analyses the congruences and gaps between the revised DoH and the current Bioethics Act, examining the alignment and gaps between the current Bioethics Act and the revised DoH.This study identified necessary revisions to enhance the ethical conduct of medical research in Korea in accordance with international standards. A comparison between the principles of the revised DoH and the provisions of the Bioethics Act revealed essential adjustments required to align the Bioethics Act with updated ethical guidelines. These findings underscore the broader implications for Korea's regulatory framework on human research ethics, emphasizing the need for a strategic integration of global ethical standards into the country’s legal structure.The revised DoH emphasizes the active role of research participants and the fair inclusion of vulnerable groups. In Korea, the Bioethics Act, last revised in 2013, aligns closely with the DoH but requires further updates to reflect the 2024 amendments.

In October 2024, the World Medical Association’s Declaration of Helsinki (DoH) underwent comprehensive updates that incorporated feedback from global experts and stakeholders. The revised DoH continues to serve as a cornerstone for international and national regulations on medical research ethics. This paper aims to delve into the 2024 amendments to DoH and assesses their impact on South Korea’s Bioethics and Safety Act (Bioethics Act). This paper analyses the congruences and gaps between the revised DoH and the current Bioethics Act, examining the alignment and gaps between the current Bioethics Act and the revised DoH.This study identified necessary revisions to enhance the ethical conduct of medical research in Korea in accordance with international standards. A comparison between the principles of the revised DoH and the provisions of the Bioethics Act revealed essential adjustments required to align the Bioethics Act with updated ethical guidelines. These findings underscore the broader implications for Korea's regulatory framework on human research ethics, emphasizing the need for a strategic integration of global ethical standards into the country’s legal structure.The revised DoH emphasizes the active role of research participants and the fair inclusion of vulnerable groups. In Korea, the Bioethics Act, last revised in 2013, aligns closely with the DoH but requires further updates to reflect the 2024 amendments.

In October 2024, the World Medical Association’s Declaration of Helsinki (DoH) underwent comprehensive updates that incorporated feedback from global experts and stakeholders. The revised DoH continues to serve as a cornerstone for international and national regulations on medical research ethics. This paper aims to delve into the 2024 amendments to DoH and assesses their impact on South Korea’s Bioethics and Safety Act (Bioethics Act). This paper analyses the congruences and gaps between the revised DoH and the current Bioethics Act, examining the alignment and gaps between the current Bioethics Act and the revised DoH.This study identified necessary revisions to enhance the ethical conduct of medical research in Korea in accordance with international standards. A comparison between the principles of the revised DoH and the provisions of the Bioethics Act revealed essential adjustments required to align the Bioethics Act with updated ethical guidelines. These findings underscore the broader implications for Korea's regulatory framework on human research ethics, emphasizing the need for a strategic integration of global ethical standards into the country’s legal structure.The revised DoH emphasizes the active role of research participants and the fair inclusion of vulnerable groups. In Korea, the Bioethics Act, last revised in 2013, aligns closely with the DoH but requires further updates to reflect the 2024 amendments.

In October 2024, the World Medical Association’s Declaration of Helsinki (DoH) underwent comprehensive updates that incorporated feedback from global experts and stakeholders. The revised DoH continues to serve as a cornerstone for international and national regulations on medical research ethics. This paper aims to delve into the 2024 amendments to DoH and assesses their impact on South Korea’s Bioethics and Safety Act (Bioethics Act). This paper analyses the congruences and gaps between the revised DoH and the current Bioethics Act, examining the alignment and gaps between the current Bioethics Act and the revised DoH.This study identified necessary revisions to enhance the ethical conduct of medical research in Korea in accordance with international standards. A comparison between the principles of the revised DoH and the provisions of the Bioethics Act revealed essential adjustments required to align the Bioethics Act with updated ethical guidelines. These findings underscore the broader implications for Korea's regulatory framework on human research ethics, emphasizing the need for a strategic integration of global ethical standards into the country’s legal structure.The revised DoH emphasizes the active role of research participants and the fair inclusion of vulnerable groups. In Korea, the Bioethics Act, last revised in 2013, aligns closely with the DoH but requires further updates to reflect the 2024 amendments.

The Declaration of Helsinki is the first self-regulatory professional standard developed by physicians for guiding medical research. Revised ten times, most recently in October 2024, it continues to evolve as a living document for medical research ethics. This study examined the key components and significance of the most recent revisions.Current Concepts: The Declaration of Helsinki was initially developed in response to unethical research conducted by Nazi doctors during World War II. It has since evolved into a globally recognized ethical framework that shapes both international and domestic law. The 2024 revision resulted from extensive international collaboration within the global community. Notable changes include replacing the term “subjects” with “research participants” and broadening the scope of responsibility to encompass the entire research team, not just the physicians. A new understanding of vulnerability was introduced, underscoring the fair and responsible inclusion of people with vulnerability. In addition, provisions for post-trial access to treatment were strengthened.Discussion and Conclusion: The 2024 revision process was marked by transparency and fairness, ensuring the updated declaration appropriately reflects contemporary challenges in research ethics. This revision incorporates modern developments and addresses evolving issues, including those highlighted by the global pandemic. The updated declaration offers a comprehensive framework for conducting ethical research in the 21st century, promoting a more inclusive, responsible, and transparent approach to research practices.

The Declaration of Helsinki is the first self-regulatory professional standard developed by physicians for guiding medical research. Revised ten times, most recently in October 2024, it continues to evolve as a living document for medical research ethics. This study examined the key components and significance of the most recent revisions.Current Concepts: The Declaration of Helsinki was initially developed in response to unethical research conducted by Nazi doctors during World War II. It has since evolved into a globally recognized ethical framework that shapes both international and domestic law. The 2024 revision resulted from extensive international collaboration within the global community. Notable changes include replacing the term “subjects” with “research participants” and broadening the scope of responsibility to encompass the entire research team, not just the physicians. A new understanding of vulnerability was introduced, underscoring the fair and responsible inclusion of people with vulnerability. In addition, provisions for post-trial access to treatment were strengthened.Discussion and Conclusion: The 2024 revision process was marked by transparency and fairness, ensuring the updated declaration appropriately reflects contemporary challenges in research ethics. This revision incorporates modern developments and addresses evolving issues, including those highlighted by the global pandemic. The updated declaration offers a comprehensive framework for conducting ethical research in the 21st century, promoting a more inclusive, responsible, and transparent approach to research practices.

The Declaration of Helsinki is the first self-regulatory professional standard developed by physicians for guiding medical research. Revised ten times, most recently in October 2024, it continues to evolve as a living document for medical research ethics. This study examined the key components and significance of the most recent revisions.Current Concepts: The Declaration of Helsinki was initially developed in response to unethical research conducted by Nazi doctors during World War II. It has since evolved into a globally recognized ethical framework that shapes both international and domestic law. The 2024 revision resulted from extensive international collaboration within the global community. Notable changes include replacing the term “subjects” with “research participants” and broadening the scope of responsibility to encompass the entire research team, not just the physicians. A new understanding of vulnerability was introduced, underscoring the fair and responsible inclusion of people with vulnerability. In addition, provisions for post-trial access to treatment were strengthened.Discussion and Conclusion: The 2024 revision process was marked by transparency and fairness, ensuring the updated declaration appropriately reflects contemporary challenges in research ethics. This revision incorporates modern developments and addresses evolving issues, including those highlighted by the global pandemic. The updated declaration offers a comprehensive framework for conducting ethical research in the 21st century, promoting a more inclusive, responsible, and transparent approach to research practices.

Background: Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government’s pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. Methods: We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020–February 2021) and the second phase (March 2021–February 2023) for long-term preparedness. Results: The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week:the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). Conclusion As a result of South Korea’s commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

Purpose: With the revision of the Organ and Transplantation Act in 2018, the hand has become legal as an area of transplantable organs in Korea. In January 2021, the first hand allotransplantation since legalization was successfully performed, and we have performed a total of three successful hand transplantation since then. By comparing and incorporating our experiences, this study aimed to provide a comprehensive reconstructive solution for hand amputation in Korea. Materials and Methods: Recipients were selected through a structured preoperative evaluation, and hand transplantations were performed at the distal forearm level. Postoperatively, patients were treated with three-drug immunosuppressive regimen, and functional outcomes were monitored. Results: The hand transplantations were performed without intraoperative complications. All patients had partial skin necrosis and underwent additional surgical procedures in 2 months after transplantation. After additional operations, no further severe complications were observed. Also, patients developed acute rejection within 3 months of surgery, but all resolved within 2 weeks after steroid pulse therapy. Motor and sensory function improved dramatically, and patients were very satisfied with the appearance and function of their transplanted hands. Conclusion Hand transplantation is a viable reconstructive option, and patients have shown positive functional and psychological outcomes. Although this study has limitations, such as the small number of patients and short follow-up period, we should focus on continued recovery of hand function, and be careful not to develop side effects from immunosuppressive drugs. Through the present study, we will continue to strive for a bright future regarding hand transplantation in Korea.