{"title":"“An Official Conscience and Warranting Agency”: Institutional Isomorphism and the Rise of Dutch Ethics Review in the 1970s and 1980s","authors":"N. Jacobs","doi":"10.1163/26667711-bja10009","DOIUrl":"https://doi.org/10.1163/26667711-bja10009","url":null,"abstract":"\u0000Why did medical research involving human subjects, a practice that is arguably as old as medicine itself, come to be regulated by research ethics committees in the late twentieth century? In this essay, I answer this question for the Netherlands, by querying the rise of ethics review in the 1970s and 1980s through the lens of “institutional isomorphism”. Drawing on the classic work of Paul Dimaggio and Walter Powell, I argue that extra-national changes to funding and publishing requirements in this period were identifiably more important for the emergence of ethics review in the Netherlands than were ethical concerns for research misconduct – a process that was marked by definitive elements of internationally coercive, and perhaps also of mimetic isomorphism. In addition, I detail how, as a consequence of these developments, those involved in Dutch ethics review came to consider “variation and inconsistency” as one of the system’s biggest problems in the late 1980s. To remedy this, numerous normative isomorphic attempts were undertaken in the late twentieth century to make all Dutch research ethics committees act in the same way. This emphasis on institutional homogeneity has been borne out in the Netherlands, even though it has repeatedly been criticized for hampering democratic and ethical decision-making.","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"200 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75912998","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":"The Genesis and Development of Research Ethics Committees in Canada, 1960–1978","authors":"Fedir V. Razumenko","doi":"10.1163/26667711-BJA10008","DOIUrl":"https://doi.org/10.1163/26667711-BJA10008","url":null,"abstract":"\u0000Following World War ii, many medical investigators continued their ambitious experimental interventions as rationalized, rather than justified, trials. In Canada, there were hardly any legally proscriptive or prescriptive instruments to regulate clinical experimentation until the 1960s. What was ethical could rightly be established only in the course of devising clinical research protocols and undertaking the procedures thereof. This paper examines an historical trajectory shaping human-subject research and its regulation in Canada. I argue that public disclosures of human experimentation, court litigation resulting from clinical research, international standardization of regulations on biomedical investigation, and the proliferation of clinical trials induced the evolution of human research ethics and the elaboration of guidelines to regulate it. In this process, Canadian physician-investigators adopted British and American guidelines on the conduct of ethically acceptable clinical research and modified them according to local circumstances. The first research ethics committees emerged at the Canadian university-affiliated teaching hospitals, where the investigative practices revealed and clarified the changing meanings of human research ethics.","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79774721","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":"The Missing Committees: Research Ethics in the Making in Switzerland","authors":"Magaly Tornay","doi":"10.1163/26667711-bja10007","DOIUrl":"https://doi.org/10.1163/26667711-bja10007","url":null,"abstract":"\u0000This article analyzes the formation of research ethics and particularly of ethics committees in Switzerland by tracing their early history along distinct phases: (1) the first guidelines on human experimentation issued by the Swiss Academy of Medical Sciences in 1970; (2) conceptual struggles in establishing these norms; (3) the emergence of a central medical-ethical committee in 1979; and (4) the first local ethics committee established in the rural canton of Thurgau in 1987. It analyzes the interplay between local practices, industrial standards, and a neoliberal, low-key, soft regulation by negotiation among peers. Key actors are the Swiss Academy of Medical Sciences, the pharmaceutical industry, and the canton of Thurgau. In this context, ‘research’ and ‘experiments’ for a long time remained disputed, unclear and risky notions. rec s were encouraged mainly as a way of distributing responsibility, of managing a wide array of risks and, crucially, as part of a wider strategy to avoid juridical and political regulation. The article asks, on a more general level, how and why ‘ethics’ entered this field and what becomes visible or obscured when issues are transposed into an ethical language.","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88605161","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":"Regulating Research: The Origins and Institutionalization of Research Ethics Committees in Sweden","authors":"Helena Tinnerholm Ljungberg","doi":"10.1163/26667711-bja10006","DOIUrl":"https://doi.org/10.1163/26667711-bja10006","url":null,"abstract":"\u0000The year 1966 saw the birth of Sweden’s first formal Research Ethics Committee (rec) at the medical university Karolinska Institute (ki). In the following years other ethical committees were institutionalized, coordinated by a working group steered by the Swedish Medical Research Council (smrc). Research ethical issues of a principled nature were also discussed by the Ethics Delegation of the Swedish Society of Medicine (ssm). Between 1966 and 1975, around 500 research proposals were assessed by rec s in Sweden, and the medical community started to follow certain protocols when preparing applications for ethical review. This paper traces the origins and early development of the rec system in Sweden and offers an analysis of their practices, discussions, and assessments through the reading of meeting protocols and correspondence between central actors. The aim is to sketch out how and why the system of research ethics committees emerged, became institutionalized, and developed in Sweden from the 1960s to the early 1980s. This paper connects to the recent empirical turn in historical research on medical research ethics and regulations, by focusing on how the insiders, i.e., the medical community, reacted to new demands of ethical review. The analysis illustrates how the medical researchers interacted with transnational funders, the Patients Association, a broader public, governmental authorities, and parliamentary politics when developing the Swedish rec system.","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75879088","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":"Europe as a Community of Values","authors":"J. Moscoso","doi":"10.1163/26667711-78010024","DOIUrl":"https://doi.org/10.1163/26667711-78010024","url":null,"abstract":"","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82529366","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":"Transcending the Language Barrier","authors":"F. Huisman","doi":"10.1163/26667711-78010021","DOIUrl":"https://doi.org/10.1163/26667711-78010021","url":null,"abstract":"","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75027520","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}
V. Barras, H. Fangerau, Vasia Lekka, J. Nieznanowska, H. Steinke
{"title":"A New Medical History Journal","authors":"V. Barras, H. Fangerau, Vasia Lekka, J. Nieznanowska, H. Steinke","doi":"10.1163/26667711-78010027","DOIUrl":"https://doi.org/10.1163/26667711-78010027","url":null,"abstract":"","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79123212","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":"History of Medicine: European Perspectives","authors":"B. Majerus","doi":"10.1163/26667711-78010020","DOIUrl":"https://doi.org/10.1163/26667711-78010020","url":null,"abstract":"In mid-January 2020, a German biotechnology company started working on a potential covid-19 vaccine based on a new technology that uses messenger rna to trigger an immune response – a technology initially developed to fight cancer – rather than inserting a weakened or inactivated virus into the body.1 “Project LightSpeed” was backed by Pfizer, an American multinational pharmaceutical corporation, and Fosun, a Chinese conglomerate and investment company. On 10 March 2020, Austria issued an entry ban for non-Austrians coming from Italy. Over the following days, several European Union Member States independently imposed border closures or border controls, thus suspending the Schengen Agreement, considered as one of the cornerstones of the European integration process. On 21 December of the same year, the European Medicines Agency (ema) approved the Pfizer and BioNTech covid19 vaccine for use in the EU, 18 days after the vaccine was approved by the United Kingdom. This allowed the EU Member States to start vaccination just days later. The EU negotiated vaccine orders from the various laboratories for","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"2 3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78653224","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":"The Place of EHMH in a Changing Scholarly Landscape","authors":"H. Hakosalo","doi":"10.1163/26667711-78010022","DOIUrl":"https://doi.org/10.1163/26667711-78010022","url":null,"abstract":"","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78753055","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":"Medicine and the Senses: Towards Integrative Practices","authors":"L. Jordanova","doi":"10.1163/26667711-78010028","DOIUrl":"https://doi.org/10.1163/26667711-78010028","url":null,"abstract":"\u0000Paying attention to the senses has been part of historical practice for some decades and has special resonance in the history of medicine since the senses play a central role in all aspects of health care and medical sciences. Both practitioners and patients rely upon them in complex ways. Using a range of primary and secondary sources, this article reflects on what is gained by a focus on the senses, for our understanding of both medicine and our own historical practices. It advocates a generous, expanded understanding of the senses to include, for example, somatic affinity.","PeriodicalId":72967,"journal":{"name":"European journal for the history of medicine and health","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81513148","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}