Kirsten\u00a0Bibbins-Domingo,\u00a0Linda\u00a0Brubaker,\u00a0Greg\u00a0Curfman<\/h3>\n\n\n\nJAMA.\u00a0<\/em>Published online October 19, 2024. doi:10.1001\/jama.2024.22530<\/h3>\n\n\n\nThis JAMA<\/em> issue focuses on important contemporary issues in ethics and medical research and is anchored by 2 Special Communications with their accompanying Viewpoints and Editorials.<\/a><\/p>\n\n\n\nThe first Special Communication is the 2024 revision to the Declaration of Helsinki, published to coincide with the ratification of the Declaration by the assembly of the World Medical Association (WMA).1<\/a><\/sup>\u00a0The WMA was established in 1947 in response to the unethical medical and research practices during and after World War II, and since its foundation has been committed to being a platform for developing global consensus on medical ethics.2<\/a><\/sup>The Declaration of Helsinki was first adopted by the WMA in 1964, establishing a set of ethical principles for medical research involving humans. Although inspired by legal instruments of public international law such as the Nuremberg Code, the Declaration of Helsinki is not an official legal document and the WMA has no legal authority. Rather, the Declaration is an ethical document that remains the most influential code of ethics guiding medical research over 6 decades because of its sound and respected recommendations.3<\/a><\/sup><\/p>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/0\/m_jen240011fa_1729349328.72917.png?Expires=1732487320&Signature=FRumnTm0hxZU26xM2NAetqEsull0vZQX8cG~w9yXpQ300SDltC3fB8Ja0N5dfxbeYSdpU9E44mM9oadEzqRdMDnK8kH3YwgUf2R7HveVXsFezpf9xqHfCC~2nFlmOEW34JqjdeZaEFk8-x-iC-CWIsGZrJkYqZEUYIasHD-q~3gWOPKXz1L43lNgQDkOhFWBIu0JcCfQUk8akQ616oNwzHPDjPfOf69M~u0-S2i~5Yu6k2LynO9urcE~vxVUhVZN5Q3M2Ql-zibxKfoTmzeZ6UvMRuKJQMhii6-b-TJf1EpBf58on0x36mIkX68sT-VXurZQ7pWVxyiE4033QpBn5Q__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\nWhile the fundamental ethical principles of the Declaration are durable, the Declaration has also been revised several times to keep pace with contemporary issues facing the conduct of medical research. The supplement that accompanies the 2024 Declaration of Helsinki facilitates comparison with the 2013 version,4<\/a><\/sup> with specific line edits for the 2024 version.1<\/a><\/sup> Jack Resneck, MD, led the workgroup that oversaw the 2024 revision process; his Viewpoint details the 30-month-long process for garnering important international input for this revision and highlights the key revisions.5<\/a><\/sup><\/a><\/p>\n\n\n\nIn her Viewpoint \u201cDeclaration of Helsinki\u2014Revisions for the 21st Century,\u201d6<\/a><\/sup> Bierer hails the revisions as reflecting \u201ca growing appreciation of global ethical challenges, fair and responsible inclusivity in research, community and local engagement, and the complexity of current interdisciplinary research.\u201d She highlights the Declaration\u2019s emphasis on \u201cresponsible inclusion in research (with appropriate safeguards) to balance the proclivity to protection and exclusion that has led and may lead to persistent health disparities of underrepresented and marginalized groups.\u201d She also notes that both research ethics committees and researchers will have responsibility for implementation of these revised principles.<\/a><\/p>\n\n\n\nThose reflections on the challenges in implementation are echoed by Reis and colleagues in their Viewpoint \u201cFuture-Proofing Research Ethics.\u201d These authors observe that the revised Declaration moves beyond its traditional focus of individual participants in research and will require \u201cconsiderable elaboration and specification if it is to be applied meaningfully by researchers and research ethics committees.\u201d7<\/a><\/sup> The revision emphasizes community engagement in research and global responsibility to avoid waste in research with concerns for the ecological impact of the research enterprise.<\/a><\/p>\n\n\n\nWriting from her perspective as a patient and leader of a patient advocacy organization, Bloom celebrates the 2024 Declaration\u2019s revised language from human \u201csubjects\u201d to \u201cparticipants\u201d and the important emphasis of volunteers as partners in research.8<\/a><\/sup> Her Viewpoint \u201cRevisiting the Declaration of Helsinki\u2014A Patient-Centered Perspective\u201d describes the essential role of engaging patients both as partners in research and in the implementation of the Declaration\u2019s ethical principles.<\/a><\/p>\n\n\n\nSaenz and Carracedo emphasize that the Declaration\u2019s more expansive language is not trivial, and that the \u201cbroader scope of the Declaration of Helsinki is key for LMICs [low- and middle-income countries] and specifically for LMICs in the Americas.\u201d9<\/a><\/sup> In their Viewpoint \u201cThe Revision of the Declaration of Helsinki Viewed From the Americas\u2014Paving the Way to Better Research,\u201d they draw on the recent experience during the COVID-19 pandemic to highlight the types of changes necessary in LMICs in the Americas if the principles outlined in the revised Declaration are to be addressed.<\/a><\/p>\n\n\n\nThis revision also speaks to growing role of artificial intelligence (AI) in health care and research and the importance of protecting participant data; several of the Viewpoints highlight the rapidly accelerating impact of these technologies as a growing concern for the ethical conduct of research. In his Viewpoint \u201cThe Revised Declaration of Helsinki\u2014Considerations for the Future of Artificial Intelligence in Health and Medical Research,\u201d10<\/a><\/sup> Shaw details the importance of ethical data governance, improved AI literacy, and clarity regarding current vs future applications and potential risks of AI as focus areas.<\/a><\/p>\n\n\n\nThe commentors applaud the Declaration of Helsinki as a living document built on a solid ethical foundation; they see the 2024 revision as responsive to contemporary issues in medical ethics. As Bierer observes, while frequency of revisions to the Declaration of Helsinki is not without critics, \u201cit is this very responsiveness that renders its utility, currency, and authority.\u201d6<\/a><\/sup> The commentators all highlight that significant challenges remain for optimal implementation and ethical conduct of medical research.<\/a><\/p>\n\n\n\n\u201cMaking the Ethical Oversight of All Clinical Trials Fit for Purpose\u201d is the other Special Communication in this JAMA<\/em> collection.11<\/a><\/sup> Kass and colleagues examine ethical oversight of clinical research and offer practical recommendations consistent with current regulations that could help to make research oversight better \u201cfit for purpose\u201d for different types of studies.<\/a><\/p>\n\n\n\nIn their introduction, the authors observe that the ethical frameworks that protect participants in research were initially born from a history of research \u201cexploitation, harm, and injustice.\u201d Perhaps because of this history, research regulation has focused on protecting individuals who participate in research, without similar ethical frameworks guiding the use of medical interventions in clinical practice. While this approach provides critical protection to participants in trials of new, experimental, and previously untested interventions, it does not work well for clinical research that is lower risk (eg, implementation science research or comparative effectiveness research studying 2 interventions already established as safe and effective). Instead, the approach creates substantial inefficiencies, \u201cstunning confusion\u201d (regarding what is research and what is quality improvement), and ultimately is misaligned with the sound ethical principles. Within the current regulatory framework, research participants are often overprotected, while patients in clinical practice may be underprotected, particularly when generation of evidence for the most effective approaches to treatment is inhibited. Both Kass and colleagues11<\/a><\/sup> and Lynch and Kramer in their accompanying Editorial12<\/a><\/sup> provide vivid examples from clinical and regulatory practice for how the current approaches may not be in the best interests of patients. Kass and colleagues conclude with a call for 2 concrete changes within the current regulatory framework that would allow ethical oversight to be more \u201cfit for purpose\u201d to the risk and intent of a research study. Revisiting participant research consent practices (\u201cright-sizing\u201d) is integral to this goal.<\/a><\/p>\n\n\n\nThe collection of articles in this issue of JAMA<\/em> provide a rich exploration of the contemporary issues in medical research. Taken together they reaffirm the foundational ethical principles required for the protection of human participants in biomedical research that has informed the regulation of the research enterprise for 6 decades. These articles advance the discussion further, affirming the role and value of well-conducted, ethically sound, patient-centered research for generating the evidence that informs medical care and public health practice. In articulating the importance of research for guiding patient care and the population health, the body of work in this issue of JAMA<\/em> is a call for all of us to adapt to the dynamic shifts in the biomedical landscape while implementing the ethical principles outlined in the Declaration of Helsinki.<\/p>\n","protected":false},"excerpt":{"rendered":"Editor’s Note October 19, 2024 The 2024 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[25,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27086"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086\/revisions"}],"predecessor-version":[{"id":27087,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086\/revisions\/27087"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27086"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27086"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27086"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
This JAMA<\/em> issue focuses on important contemporary issues in ethics and medical research and is anchored by 2 Special Communications with their accompanying Viewpoints and Editorials.<\/a><\/p>\n\n\n\n The first Special Communication is the 2024 revision to the Declaration of Helsinki, published to coincide with the ratification of the Declaration by the assembly of the World Medical Association (WMA).1<\/a><\/sup>\u00a0The WMA was established in 1947 in response to the unethical medical and research practices during and after World War II, and since its foundation has been committed to being a platform for developing global consensus on medical ethics.2<\/a><\/sup>The Declaration of Helsinki was first adopted by the WMA in 1964, establishing a set of ethical principles for medical research involving humans. Although inspired by legal instruments of public international law such as the Nuremberg Code, the Declaration of Helsinki is not an official legal document and the WMA has no legal authority. Rather, the Declaration is an ethical document that remains the most influential code of ethics guiding medical research over 6 decades because of its sound and respected recommendations.3<\/a><\/sup><\/p>\n\n\n\n While the fundamental ethical principles of the Declaration are durable, the Declaration has also been revised several times to keep pace with contemporary issues facing the conduct of medical research. The supplement that accompanies the 2024 Declaration of Helsinki facilitates comparison with the 2013 version,4<\/a><\/sup> with specific line edits for the 2024 version.1<\/a><\/sup> Jack Resneck, MD, led the workgroup that oversaw the 2024 revision process; his Viewpoint details the 30-month-long process for garnering important international input for this revision and highlights the key revisions.5<\/a><\/sup><\/a><\/p>\n\n\n\n In her Viewpoint \u201cDeclaration of Helsinki\u2014Revisions for the 21st Century,\u201d6<\/a><\/sup> Bierer hails the revisions as reflecting \u201ca growing appreciation of global ethical challenges, fair and responsible inclusivity in research, community and local engagement, and the complexity of current interdisciplinary research.\u201d She highlights the Declaration\u2019s emphasis on \u201cresponsible inclusion in research (with appropriate safeguards) to balance the proclivity to protection and exclusion that has led and may lead to persistent health disparities of underrepresented and marginalized groups.\u201d She also notes that both research ethics committees and researchers will have responsibility for implementation of these revised principles.<\/a><\/p>\n\n\n\n Those reflections on the challenges in implementation are echoed by Reis and colleagues in their Viewpoint \u201cFuture-Proofing Research Ethics.\u201d These authors observe that the revised Declaration moves beyond its traditional focus of individual participants in research and will require \u201cconsiderable elaboration and specification if it is to be applied meaningfully by researchers and research ethics committees.\u201d7<\/a><\/sup> The revision emphasizes community engagement in research and global responsibility to avoid waste in research with concerns for the ecological impact of the research enterprise.<\/a><\/p>\n\n\n\n Writing from her perspective as a patient and leader of a patient advocacy organization, Bloom celebrates the 2024 Declaration\u2019s revised language from human \u201csubjects\u201d to \u201cparticipants\u201d and the important emphasis of volunteers as partners in research.8<\/a><\/sup> Her Viewpoint \u201cRevisiting the Declaration of Helsinki\u2014A Patient-Centered Perspective\u201d describes the essential role of engaging patients both as partners in research and in the implementation of the Declaration\u2019s ethical principles.<\/a><\/p>\n\n\n\n Saenz and Carracedo emphasize that the Declaration\u2019s more expansive language is not trivial, and that the \u201cbroader scope of the Declaration of Helsinki is key for LMICs [low- and middle-income countries] and specifically for LMICs in the Americas.\u201d9<\/a><\/sup> In their Viewpoint \u201cThe Revision of the Declaration of Helsinki Viewed From the Americas\u2014Paving the Way to Better Research,\u201d they draw on the recent experience during the COVID-19 pandemic to highlight the types of changes necessary in LMICs in the Americas if the principles outlined in the revised Declaration are to be addressed.<\/a><\/p>\n\n\n\n This revision also speaks to growing role of artificial intelligence (AI) in health care and research and the importance of protecting participant data; several of the Viewpoints highlight the rapidly accelerating impact of these technologies as a growing concern for the ethical conduct of research. In his Viewpoint \u201cThe Revised Declaration of Helsinki\u2014Considerations for the Future of Artificial Intelligence in Health and Medical Research,\u201d10<\/a><\/sup> Shaw details the importance of ethical data governance, improved AI literacy, and clarity regarding current vs future applications and potential risks of AI as focus areas.<\/a><\/p>\n\n\n\n The commentors applaud the Declaration of Helsinki as a living document built on a solid ethical foundation; they see the 2024 revision as responsive to contemporary issues in medical ethics. As Bierer observes, while frequency of revisions to the Declaration of Helsinki is not without critics, \u201cit is this very responsiveness that renders its utility, currency, and authority.\u201d6<\/a><\/sup> The commentators all highlight that significant challenges remain for optimal implementation and ethical conduct of medical research.<\/a><\/p>\n\n\n\n \u201cMaking the Ethical Oversight of All Clinical Trials Fit for Purpose\u201d is the other Special Communication in this JAMA<\/em> collection.11<\/a><\/sup> Kass and colleagues examine ethical oversight of clinical research and offer practical recommendations consistent with current regulations that could help to make research oversight better \u201cfit for purpose\u201d for different types of studies.<\/a><\/p>\n\n\n\n In their introduction, the authors observe that the ethical frameworks that protect participants in research were initially born from a history of research \u201cexploitation, harm, and injustice.\u201d Perhaps because of this history, research regulation has focused on protecting individuals who participate in research, without similar ethical frameworks guiding the use of medical interventions in clinical practice. While this approach provides critical protection to participants in trials of new, experimental, and previously untested interventions, it does not work well for clinical research that is lower risk (eg, implementation science research or comparative effectiveness research studying 2 interventions already established as safe and effective). Instead, the approach creates substantial inefficiencies, \u201cstunning confusion\u201d (regarding what is research and what is quality improvement), and ultimately is misaligned with the sound ethical principles. Within the current regulatory framework, research participants are often overprotected, while patients in clinical practice may be underprotected, particularly when generation of evidence for the most effective approaches to treatment is inhibited. Both Kass and colleagues11<\/a><\/sup> and Lynch and Kramer in their accompanying Editorial12<\/a><\/sup> provide vivid examples from clinical and regulatory practice for how the current approaches may not be in the best interests of patients. Kass and colleagues conclude with a call for 2 concrete changes within the current regulatory framework that would allow ethical oversight to be more \u201cfit for purpose\u201d to the risk and intent of a research study. Revisiting participant research consent practices (\u201cright-sizing\u201d) is integral to this goal.<\/a><\/p>\n\n\n\n The collection of articles in this issue of JAMA<\/em> provide a rich exploration of the contemporary issues in medical research. Taken together they reaffirm the foundational ethical principles required for the protection of human participants in biomedical research that has informed the regulation of the research enterprise for 6 decades. These articles advance the discussion further, affirming the role and value of well-conducted, ethically sound, patient-centered research for generating the evidence that informs medical care and public health practice. In articulating the importance of research for guiding patient care and the population health, the body of work in this issue of JAMA<\/em> is a call for all of us to adapt to the dynamic shifts in the biomedical landscape while implementing the ethical principles outlined in the Declaration of Helsinki.<\/p>\n","protected":false},"excerpt":{"rendered":" Editor’s Note October 19, 2024 The 2024 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[25,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27086"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086\/revisions"}],"predecessor-version":[{"id":27087,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27086\/revisions\/27087"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27086"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27086"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27086"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/figure>\n\n\n\n