M. Scholten, A. Gieselmann, J. Gather, J. Vollmann
{"title":"德国的预先研究指令:披露标准的建议","authors":"M. Scholten, A. Gieselmann, J. Gather, J. Vollmann","doi":"10.1024/1662-9647/a000184","DOIUrl":null,"url":null,"abstract":"The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level.","PeriodicalId":45525,"journal":{"name":"GeroPsych-The Journal of Gerontopsychology and Geriatric Psychiatry","volume":"31 1","pages":"77–86"},"PeriodicalIF":0.8000,"publicationDate":"2018-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"Advance Research Directives in Germany: A Proposal for a Disclosure Standard\",\"authors\":\"M. Scholten, A. Gieselmann, J. Gather, J. Vollmann\",\"doi\":\"10.1024/1662-9647/a000184\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level.\",\"PeriodicalId\":45525,\"journal\":{\"name\":\"GeroPsych-The Journal of Gerontopsychology and Geriatric Psychiatry\",\"volume\":\"31 1\",\"pages\":\"77–86\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2018-05-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GeroPsych-The Journal of Gerontopsychology and Geriatric Psychiatry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1024/1662-9647/a000184\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PSYCHOLOGY, DEVELOPMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"GeroPsych-The Journal of Gerontopsychology and Geriatric Psychiatry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1024/1662-9647/a000184","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PSYCHOLOGY, DEVELOPMENTAL","Score":null,"Total":0}
Advance Research Directives in Germany: A Proposal for a Disclosure Standard
The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level.