This Viewpoint explores the 2024 update to the Declaration of Helsinki from the perspective of the Americas and how countries in this region can implement the Declaration’s guidance to ethically govern scientific health research.
{"title":"The Revision of the Declaration of Helsinki Viewed From the Americas—Paving the Way to Better Research","authors":"Carla Saenz, Sarah Carracedo","doi":"10.1001/jama.2024.22270","DOIUrl":"https://doi.org/10.1001/jama.2024.22270","url":null,"abstract":"This Viewpoint explores the 2024 update to the Declaration of Helsinki from the perspective of the Americas and how countries in this region can implement the Declaration’s guidance to ethically govern scientific health research.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Viewpoint discusses the 2024 revisions made to the Declaration of Helsinki as it continues to work toward ensuring research is subject to ethical standards that promote respect for all human participants and protect their rights and interests.
{"title":"Revisions to the Declaration of Helsinki on Its 60th Anniversary","authors":"Jack S. Resneck","doi":"10.1001/jama.2024.21902","DOIUrl":"https://doi.org/10.1001/jama.2024.21902","url":null,"abstract":"This Viewpoint discusses the 2024 revisions made to the Declaration of Helsinki as it continues to work toward ensuring research is subject to ethical standards that promote respect for all human participants and protect their rights and interests.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andreas Alois Reis, Ross Upshur, Keymanthri Moodley
This Viewpoint discusses key revisions of the Declaration of Helsinki 2024 in the context of internationally accepted ethical guidance for human research.
本视点结合国际公认的人类研究伦理指南，讨论了《赫尔辛基 2024 年宣言》的主要修订内容。
{"title":"Future-Proofing Research Ethics—Key Revisions of the Declaration of Helsinki 2024","authors":"Andreas Alois Reis, Ross Upshur, Keymanthri Moodley","doi":"10.1001/jama.2024.22254","DOIUrl":"https://doi.org/10.1001/jama.2024.22254","url":null,"abstract":"This Viewpoint discusses key revisions of the Declaration of Helsinki 2024 in the context of internationally accepted ethical guidance for human research.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Declaration of Helsinki-Revisions for the 21st Century.","authors":"Barbara E Bierer","doi":"10.1001/jama.2024.22281","DOIUrl":"https://doi.org/10.1001/jama.2024.22281","url":null,"abstract":"","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Viewpoint contextualizes the history of the Declaration of Helsinki, analyzes the implications of its latest revision, and emphasizes the need for patient-centricity in research ethics.
{"title":"Revisiting the Declaration of Helsinki—A Patient-Centered Perspective","authors":"Lara Bloom","doi":"10.1001/jama.2024.22077","DOIUrl":"https://doi.org/10.1001/jama.2024.22077","url":null,"abstract":"This Viewpoint contextualizes the history of the Declaration of Helsinki, analyzes the implications of its latest revision, and emphasizes the need for patient-centricity in research ethics.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nancy E. Kass, Ruth R. Faden, Derek C. Angus, Stephanie R. Morain
ImportanceWith the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents.ObservationsUS regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice. For clinical research, however, it has become too much of a one-size-fits-all mechanism. As more comparative effectiveness and other research on widely used clinical interventions are conducted, research oversight should be fit for purpose for these kinds of trials, with the degree of oversight based on 2 morally relevant features of a trial. The first of these features is the degree to which risks and burdens increase or change when research is integrated into clinical care compared with what patient-participants would have experienced in care absent the research. The second is whether the activity restricts meaningful patient decision-making about care in morally important ways: (1) does the research restrict a choice or decision that patients ordinarily are or should be involved in and (2) does research participation remove from patients the ability to make a decision that may be meaningful to them, one based, at least in part, on their values, priorities, logistical or practical considerations, and the like? Whether clinical trials add risk or burden to what patients would otherwise have experienced, and whether studies restrict meaningful decisions patients would or should have had the opportunity to make, should help to determine whether clinical studies are designated as greater than vs minimal risk. Further, it is recommended that investigators and oversight bodies consider streamlined consent procedures for research presenting minimal additional risk or burden and that does not constrain meaningful patient decisions, rather than assuming that waiving all consent requirements is the only alternative.Conclusions and RelevanceEthical oversight of clinical research must be fit for purpose—with greater oversight for studies with greater risks, uncertainties, and impacts on meaningful patient decisions—and more streamlined oversight for other types of research.
{"title":"Making the Ethical Oversight of All Clinical Trials Fit for Purpose","authors":"Nancy E. Kass, Ruth R. Faden, Derek C. Angus, Stephanie R. Morain","doi":"10.1001/jama.2024.0269","DOIUrl":"https://doi.org/10.1001/jama.2024.0269","url":null,"abstract":"ImportanceWith the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents.ObservationsUS regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice. For clinical research, however, it has become too much of a one-size-fits-all mechanism. As more comparative effectiveness and other research on widely used clinical interventions are conducted, research oversight should be fit for purpose for these kinds of trials, with the degree of oversight based on 2 morally relevant features of a trial. The first of these features is the degree to which risks and burdens increase or change when research is integrated into clinical care compared with what patient-participants would have experienced in care absent the research. The second is whether the activity restricts meaningful patient decision-making about care in morally important ways: (1) does the research restrict a choice or decision that patients ordinarily are or should be involved in and (2) does research participation remove from patients the ability to make a decision that may be meaningful to them, one based, at least in part, on their values, priorities, logistical or practical considerations, and the like? Whether clinical trials add risk or burden to what patients would otherwise have experienced, and whether studies restrict meaningful decisions patients would or should have had the opportunity to make, should help to determine whether clinical studies are designated as greater than vs minimal risk. Further, it is recommended that investigators and oversight bodies consider streamlined consent procedures for research presenting minimal additional risk or burden and that does not constrain meaningful patient decisions, rather than assuming that waiving all consent requirements is the only alternative.Conclusions and RelevanceEthical oversight of clinical research must be fit for purpose—with greater oversight for studies with greater risks, uncertainties, and impacts on meaningful patient decisions—and more streamlined oversight for other types of research.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Viewpoint summarizes recent updates to the Declaration of Helsinki, discusses its relevance in the context of artificial intelligence (AI) in health research, and highlights issues that could affect its future implementation as the use of AI in research increases.
{"title":"The Revised Declaration of Helsinki—Considerations for the Future of Artificial Intelligence in Health and Medical Research","authors":"James A. Shaw","doi":"10.1001/jama.2024.22074","DOIUrl":"https://doi.org/10.1001/jama.2024.22074","url":null,"abstract":"This Viewpoint summarizes recent updates to the Declaration of Helsinki, discusses its relevance in the context of artificial intelligence (AI) in health research, and highlights issues that could affect its future implementation as the use of AI in research increases.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Medical News article discusses the latest research linking shingles and other infections to a higher risk of dementia and the vaccines against them to a lower risk.
{"title":"Researchers Are Exploring the Role of Shingles—and a Protective Role of Shingles Vaccine—in Dementia","authors":"Rita Rubin","doi":"10.1001/jama.2024.0227","DOIUrl":"https://doi.org/10.1001/jama.2024.0227","url":null,"abstract":"This Medical News article discusses the latest research linking shingles and other infections to a higher risk of dementia and the vaccines against them to a lower risk.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142448543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"FDA Greenlights Nasal Spray Flu Vaccine for Use at Home.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.21299","DOIUrl":"https://doi.org/10.1001/jama.2024.21299","url":null,"abstract":"","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Stroke Deaths and Burden Increased Around the World From 1990 to 2021.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.21303","DOIUrl":"https://doi.org/10.1001/jama.2024.21303","url":null,"abstract":"","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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