Pub Date : 2024-07-08eCollection Date: 2024-07-01DOI: 10.1093/jlb/lsae014
Lisa A Verity, Ana Santos Rutschman, Michael S Sinha
{"title":"The pressing need for FDA regulation of tattoo ink.","authors":"Lisa A Verity, Ana Santos Rutschman, Michael S Sinha","doi":"10.1093/jlb/lsae014","DOIUrl":"https://doi.org/10.1093/jlb/lsae014","url":null,"abstract":"","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11228856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141565200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-07eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae008
Francis X Shen, Susan M Wolf, Frances Lawrenz, Donnella S Comeau, Kafui Dzirasa, Barbara J Evans, Damien Fair, Martha J Farah, S Duke Han, Judy Illes, Jonathan D Jackson, Eran Klein, Karen S Rommelfanger, Matthew S Rosen, Efraín Torres, Paul Tuite, J Thomas Vaughan, Michael Garwood
Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.
{"title":"Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight.","authors":"Francis X Shen, Susan M Wolf, Frances Lawrenz, Donnella S Comeau, Kafui Dzirasa, Barbara J Evans, Damien Fair, Martha J Farah, S Duke Han, Judy Illes, Jonathan D Jackson, Eran Klein, Karen S Rommelfanger, Matthew S Rosen, Efraín Torres, Paul Tuite, J Thomas Vaughan, Michael Garwood","doi":"10.1093/jlb/lsae008","DOIUrl":"https://doi.org/10.1093/jlb/lsae008","url":null,"abstract":"<p><p>Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11157461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141297330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-04eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae010
Robert Cook-Deegan, Janis Geary, Kara Hapke, Zuzana Skvarkova, Marina Filipek, Jillian Leaver
Genetic testing for inherited cancer risk changed dramatically when the US Supreme Court handed down unanimous rulings in Mayo v. Prometheus (2012) and Myriad v. Association for Molecular Pathology (2013). Those decisions struck down claims to methods based on 'laws of nature' (Mayo) and DNA molecules corresponding to sequences found in nature (Myriad). Senators Thom Tillis (R-NC) and Christopher Coons (D-DE) introduced legislation that would abrogate those decisions and specify narrow statutory exclusions to patent-eligibility in §101 of the US Patent Act. What would be the consequences of doing so? The Supreme Court decisions coincided with changes in how genetic tests were performed, reimbursed and regulated. Multi-gene sequencing supplanted oligo-gene testing as the cost of sequencing dropped 10,000-fold. Payers dramatically changed reimbursement practices. Food and Drug Administration regulation was proposed and remains in prospect. Databases for clinical interpretation made data freely available, augmenting a knowledge commons. The spectacular implosion of Theranos tempered investment in molecular diagnostics. These factors all complicate explanations of why venture capital funding for molecular diagnostics dropped relative to other sectors. Restoring patent-eligibility would put renewed pressure on other patent doctrines, such as obviousness, enablement and written description, that were not raised in the Supreme Court cases.
{"title":"Sorry you asked? <i>Mayo, Myriad</i>, and the battles over patent-eligibility.","authors":"Robert Cook-Deegan, Janis Geary, Kara Hapke, Zuzana Skvarkova, Marina Filipek, Jillian Leaver","doi":"10.1093/jlb/lsae010","DOIUrl":"https://doi.org/10.1093/jlb/lsae010","url":null,"abstract":"<p><p>Genetic testing for inherited cancer risk changed dramatically when the US Supreme Court handed down unanimous rulings in <i>Mayo v. Prometheus</i> (2012) and <i>Myriad v. Association for Molecular Pathology</i> (2013). Those decisions struck down claims to methods based on 'laws of nature' (<i>Mayo</i>) and DNA molecules corresponding to sequences found in nature (<i>Myriad</i>). Senators Thom Tillis (R-NC) and Christopher Coons (D-DE) introduced legislation that would abrogate those decisions and specify narrow statutory exclusions to patent-eligibility in §101 of the US Patent Act. What would be the consequences of doing so? The Supreme Court decisions coincided with changes in how genetic tests were performed, reimbursed and regulated. Multi-gene sequencing supplanted oligo-gene testing as the cost of sequencing dropped 10,000-fold. Payers dramatically changed reimbursement practices. Food and Drug Administration regulation was proposed and remains in prospect. Databases for clinical interpretation made data freely available, augmenting a knowledge commons. The spectacular implosion of Theranos tempered investment in molecular diagnostics. These factors all complicate explanations of why venture capital funding for molecular diagnostics dropped relative to other sectors. Restoring patent-eligibility would put renewed pressure on other patent doctrines, such as obviousness, enablement and written description, that were not raised in the Supreme Court cases.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11150977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-01eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae009
[This corrects the article DOI: 10.1093/jlb/lsad032.].
[This corrects the article DOI: 10.1093/jlb/lsad032.].
{"title":"Erratum to: U.S. public perceptions of the sensitivity of brain data.","authors":"","doi":"10.1093/jlb/lsae009","DOIUrl":"https://doi.org/10.1093/jlb/lsae009","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1093/jlb/lsad032.].</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11149712/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article considers the implications of the international Human Right to Science for advances in neuroscience. First, it provides background information on both the Human Right to Science and on likely challenges arising from neuroscience in five categories: prediction, mind-reading, mind-control, mental enhancement, and “humanness.” Second, it examines the Human Right to Science, analyzing its internal contradictions in general, discussing those contradictions in reference to neuroscience, and then analyzing some practical limitations it would have. Third, it considers how human rights law might better approach neuroscience, first through strengthening the Human Right to Science and then by finding neuroscience-relevant rights in existing or novel Human Rights. The article concludes that the Human Right to Science may play a small part in neuroscience, especially in promoting freedom to do neuroscience research, but that its overall role is likely to be minor.
{"title":"Implementing the human right to science in neuroscience","authors":"H. Greely","doi":"10.1093/jlb/lsae011","DOIUrl":"https://doi.org/10.1093/jlb/lsae011","url":null,"abstract":"\u0000 This article considers the implications of the international Human Right to Science for advances in neuroscience. First, it provides background information on both the Human Right to Science and on likely challenges arising from neuroscience in five categories: prediction, mind-reading, mind-control, mental enhancement, and “humanness.” Second, it examines the Human Right to Science, analyzing its internal contradictions in general, discussing those contradictions in reference to neuroscience, and then analyzing some practical limitations it would have. Third, it considers how human rights law might better approach neuroscience, first through strengthening the Human Right to Science and then by finding neuroscience-relevant rights in existing or novel Human Rights. The article concludes that the Human Right to Science may play a small part in neuroscience, especially in promoting freedom to do neuroscience research, but that its overall role is likely to be minor.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140978426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization (‘EUA’) of the COVID-19 vaccine for children ages 5–11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.
{"title":"COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk","authors":"Joanna K Sax, Neal Doran","doi":"10.1093/jlb/lsae006","DOIUrl":"https://doi.org/10.1093/jlb/lsae006","url":null,"abstract":"Abstract Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization (‘EUA’) of the COVID-19 vaccine for children ages 5–11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140682471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Manjunath, Nathan Kahrobai, Mark A. Lemley, Ishan Kumar
Abstract Competition between life science companies is critical to ensure innovative therapies are efficiently developed. Anticompetitive behavior may harm scientific progress and, ultimately, patients. One well-established category of anticompetitive behavior is the ‘interlocking directorate’. It is illegal for companies’ directors to ‘interlock’ by also serving on the boards of competitors. We evaluated overlaps in the board membership of 2,241 public life science companies since 2000. We show that a robust network of interlocking companies is present among these firms. At any given time, 10–20 percent of board members are interlocked; the number of interlocks has more than doubled in the last two decades. Over half of these interlocked firms report over $5 million in historical revenue, exceeding a legal threshold that makes an interlocking directorate a violation of antitrust law. Those interlocks are only illegal if the companies compete, even in part. Using the disease categories for which companies have sponsored clinical trials, we discover that a few markets are responsible for a large fraction of interlocks. We show that in dozens of cases, companies share directors with the very firms they identify as their biggest competitive threats. We provide a data-driven roadmap for policymakers, regulators, and companies to further investigate the contribution of anticompetitive behavior to increased healthcare costs and to enforce the law against illegal interlocks between firms.
{"title":"Illegal interlocks among life science company boards of directors","authors":"A. Manjunath, Nathan Kahrobai, Mark A. Lemley, Ishan Kumar","doi":"10.1093/jlb/lsae005","DOIUrl":"https://doi.org/10.1093/jlb/lsae005","url":null,"abstract":"Abstract Competition between life science companies is critical to ensure innovative therapies are efficiently developed. Anticompetitive behavior may harm scientific progress and, ultimately, patients. One well-established category of anticompetitive behavior is the ‘interlocking directorate’. It is illegal for companies’ directors to ‘interlock’ by also serving on the boards of competitors. We evaluated overlaps in the board membership of 2,241 public life science companies since 2000. We show that a robust network of interlocking companies is present among these firms. At any given time, 10–20 percent of board members are interlocked; the number of interlocks has more than doubled in the last two decades. Over half of these interlocked firms report over $5 million in historical revenue, exceeding a legal threshold that makes an interlocking directorate a violation of antitrust law. Those interlocks are only illegal if the companies compete, even in part. Using the disease categories for which companies have sponsored clinical trials, we discover that a few markets are responsible for a large fraction of interlocks. We show that in dozens of cases, companies share directors with the very firms they identify as their biggest competitive threats. We provide a data-driven roadmap for policymakers, regulators, and companies to further investigate the contribution of anticompetitive behavior to increased healthcare costs and to enforce the law against illegal interlocks between firms.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140707032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-16eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae004
Fruzsina Molnár-Gábor
This paper contributes to the exploration of the potential application of duties related to the diligent anticipation of the (imminent) harms and (potential) benefits to humans that scientific innovation engenders to health-related contexts. In particular, it addresses the intersection between the human right to science and health-related data processing, which plays a key role in the production, translation and implementation of biomedical knowledge. The first part of the paper provides a brief recap of the interpretation of the right to science based on Art. 15 (1) (b) of the United Nations International Covenant on Economic, Social and Cultural Rights (hereafter ICESCR or Covenant) and the resulting obligations for States in the context of health and related data processing. The second part of the paper defines the relevance of the ICESCR for EU Member States and the European Union. In the third part, theses are put forward on how the human right to science and the obligations under Art. 15 (1) (b) ICESCR influence the interpretation and application of the General Data Protection Regulation as secondary EU law. By examining the justifications for using the right to science to interpret EU data protection law and by providing interpretation and application guidance on the main data protection principles in the area of health-related data processing, taking this right into account, the aim is to shape the EU data governance framework to meet the requirements of this human right. In doing so, the paper aims to close the gaps in the interpretation and application of the main rules of EU data protection law. Such standardization in the health-related context can contribute to a coherent interpretation and application of existing rules by referring to this emerging human right. Against this background, the paper identifies governance measures that the EU legislator could take to guide the processing of health-related data in line with the requirements of the right to science.
{"title":"Implementing the human right to science in the context of health-related data processing.","authors":"Fruzsina Molnár-Gábor","doi":"10.1093/jlb/lsae004","DOIUrl":"https://doi.org/10.1093/jlb/lsae004","url":null,"abstract":"<p><p>This paper contributes to the exploration of the potential <i>application of duties</i> related to the diligent anticipation of the (imminent) harms and (potential) benefits to humans that scientific innovation engenders to health-related contexts. In particular, it addresses the intersection between the human right to science and health-related data processing, which plays a key role in the production, translation and implementation of biomedical knowledge. The first part of the paper provides a brief recap of the interpretation of the right to science based on Art. 15 (1) (b) of the United Nations International Covenant on Economic, Social and Cultural Rights (hereafter ICESCR or Covenant) and the resulting obligations for States in the context of health and related data processing. The second part of the paper defines the relevance of the ICESCR for EU Member States and the European Union. In the third part, theses are put forward on how the human right to science and the obligations under Art. 15 (1) (b) ICESCR influence the interpretation and application of the General Data Protection Regulation as secondary EU law. By examining the justifications for using the right to science to interpret EU data protection law and by providing interpretation and application guidance on the main data protection principles in the area of health-related data processing, taking this right into account, the aim is to shape the EU data governance framework to meet the requirements of this human right. In doing so, the paper aims to close the gaps in the interpretation and application of the main rules of EU data protection law. Such standardization in the health-related context can contribute to a coherent interpretation and application of existing rules by referring to this emerging human right. Against this background, the paper identifies governance measures that the EU legislator could take to guide the processing of health-related data in line with the requirements of the right to science.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10943626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leslie E Wolf, Natalie Ram, Jorge Contreras, Laura M Beskow
Abstract With the Supreme Court’s decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress’s regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants’ data. We conclude with recommendations for stakeholders based on our analysis.
{"title":"Certificates of confidentiality: privileging research data","authors":"Leslie E Wolf, Natalie Ram, Jorge Contreras, Laura M Beskow","doi":"10.1093/jlb/lsae003","DOIUrl":"https://doi.org/10.1093/jlb/lsae003","url":null,"abstract":"Abstract With the Supreme Court’s decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress’s regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants’ data. We conclude with recommendations for stakeholders based on our analysis.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139957761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-19eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae002
Andrea Boggio
Anticipation entails contemplating the beneficial and harmful impacts of scientific and technological progress. Anticipation has a long history in science, technology, and innovation policy partly due to future impacts of scientific progress being inescapable. The link between anticipation, an undertheorized concept, and human rights law is yet to be fully explored. This paper links anticipation to the rights to science, a lesser-studied human right codified in the International Covenant on Economic, Social, and Cultural Rights. The paper argues that the normative content of the right includes anticipation entitlements and duties. Combining the entitlements and duties with anticipation typologies leads to identifying three forms of anticipation that governments (and, in some cases, scientists) must carry out: beneficial, responsible, and participatory anticipation. The paper concludes by identifying three ways in which further conceptual work can enrich human-rights-based anticipation.
{"title":"Anticipation in the biosciences and the human right to science.","authors":"Andrea Boggio","doi":"10.1093/jlb/lsae002","DOIUrl":"https://doi.org/10.1093/jlb/lsae002","url":null,"abstract":"<p><p>Anticipation entails contemplating the beneficial and harmful impacts of scientific and technological progress. Anticipation has a long history in science, technology, and innovation policy partly due to future impacts of scientific progress being inescapable. The link between anticipation, an undertheorized concept, and human rights law is yet to be fully explored. This paper links anticipation to the rights to science, a lesser-studied human right codified in the International Covenant on Economic, Social, and Cultural Rights. The paper argues that the normative content of the right includes anticipation entitlements and duties. Combining the entitlements and duties with anticipation typologies leads to identifying three forms of anticipation that governments (and, in some cases, scientists) must carry out: beneficial, responsible, and participatory anticipation. The paper concludes by identifying three ways in which further conceptual work can enrich human-rights-based anticipation.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10877312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139914151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}