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Why Research Oversight Bodies Should Interview Research Subjects. 为什么研究监督机构应该采访研究对象。
IRB Pub Date : 2017-03-01
Carl Elliott
{"title":"Why Research Oversight Bodies Should Interview Research Subjects.","authors":"Carl Elliott","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36432011","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}
引用次数: 0
Pregnancy Testing of Adolescents during Clinical Research: Managing the Process. 临床研究期间的青少年妊娠检测：过程管理。
IRB Pub Date : 2017-03-01
Marilyn C Morris, Susan L Rosenthal
{"title":"Pregnancy Testing of Adolescents during Clinical Research: Managing the Process.","authors":"Marilyn C Morris, Susan L Rosenthal","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6345158/pdf/nihms-1000655.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36432015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule. 公众参与，通知和评论规则制定，和共同规则。
IRB Pub Date : 2017-01-01
Holly Fernandez Lynch, I Glenn Cohen, Barbara E Bierer
{"title":"Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule.","authors":"Holly Fernandez Lynch, I Glenn Cohen, Barbara E Bierer","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36432012","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}
引用次数: 0
Research on Medical Practices (ROMP): Attitudes of IRB Personnel about Randomization and Informed Consent. 医学实践研究:IRB人员对随机化和知情同意的态度。
IRB Pub Date : 2017-01-01
Kathryn M Porter, Mildred K Cho, Stephanie A Kraft, Diane M Korngiebel, Melissa Constantine, Sandra Soo-Jin Lee, Maureen Kelley, Cyan James, Ellen Kuwana, Adrienne Meyer, Douglas Diekema, Alexander M Capron, David Magnus, Benjamin S Wilfond
{"title":"Research on Medical Practices (ROMP): Attitudes of IRB Personnel about Randomization and Informed Consent.","authors":"Kathryn M Porter, Mildred K Cho, Stephanie A Kraft, Diane M Korngiebel, Melissa Constantine, Sandra Soo-Jin Lee, Maureen Kelley, Cyan James, Ellen Kuwana, Adrienne Meyer, Douglas Diekema, Alexander M Capron, David Magnus, Benjamin S Wilfond","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36429339","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}
引用次数: 0
Identifying Gaps in Suicide Research: A Scoping Review of Ethical Challenges and Proposed Recommendations. 确定自杀研究的差距:伦理挑战和建议的范围审查。
IRB Pub Date : 2017-01-01
Victoria Saigle, Monique Séguin, Eric Racine
{"title":"Identifying Gaps in Suicide Research: A Scoping Review of Ethical Challenges and Proposed Recommendations.","authors":"Victoria Saigle, Monique Séguin, Eric Racine","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36429337","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}
引用次数: 0
Incident Reports and Corrective Actions Received by OHRP. OHRP收到的事故报告和纠正措施。
IRB Pub Date : 2016-11-01
Kemnique Ramnath, Sarita Cheave, Lisa Buchanan, Kristina Borror, Marinna Banks-Shields
{"title":"Incident Reports and Corrective Actions Received by OHRP.","authors":"Kemnique Ramnath, Sarita Cheave, Lisa Buchanan, Kristina Borror, Marinna Banks-Shields","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36380912","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}
引用次数: 0
Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority. 当儿童研究参与者达到成年年龄时，重新联系他们征求同意。
IRB Pub Date : 2016-11-01
Bartha Maria Knoppers, Karine Sénécal, Joanne Boisjoli, Pascal Borry, Martina C Cornel, Conrad V Fernandez, Jasjote Grewal, Ingrid A Holm, Erin Nelson, Wim Pinxten, Mahsa Shabani, Anne Marie Tassé, Ma’n Zawati, Wright Clayton
{"title":"Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority.","authors":"Bartha Maria Knoppers,&nbsp;Karine Sénécal,&nbsp;Joanne Boisjoli,&nbsp;Pascal Borry,&nbsp;Martina C Cornel,&nbsp;Conrad V Fernandez,&nbsp;Jasjote Grewal,&nbsp;Ingrid A Holm,&nbsp;Erin Nelson,&nbsp;Wim Pinxten,&nbsp;Mahsa Shabani,&nbsp;Anne Marie Tassé,&nbsp;Ma’n Zawati,&nbsp;Wright Clayton","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be “recontacted” to obtain their consent to remain in the study. Using three different contexts (longitudinal studies, clinical trials, and newborn screening), we argue that distinctions should be made between the risks and benefits involved in recontacting for consent before determining the potential duties of researchers. An obligation to recontact should always be balanced with the feasibility and cost of such efforts in each particular research context and with consideration for the existence or lack of an ongoing relationship with the participant.</p>","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36380911","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}
引用次数: 0
A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research. 加强社区参与儿科研究的知情同意程序的工具包。
IRB Pub Date : 2016-09-01
William J Heerman, Richard O White, Annie Hotop, Karen Omlung, Sharelle Armstrong, Irène Mathieu, Nancy E Sherwood, Shari L Barkin
{"title":"A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research.","authors":"William J Heerman,&nbsp;Richard O White,&nbsp;Annie Hotop,&nbsp;Karen Omlung,&nbsp;Sharelle Armstrong,&nbsp;Irène Mathieu,&nbsp;Nancy E Sherwood,&nbsp;Shari L Barkin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5806528/pdf/nihms919941.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35830135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Impact of Unrealistic Optimism on Informed Consent in Early-Phase Oncology Trials. 不切实际的乐观对早期肿瘤试验知情同意的影响。
IRB Pub Date : 2016-09-01
Lynn A Jansen, Daruka Mahadevan, Paul S Appelbaum, William M P Klein, Neil D Weinstein, Motomi Mori, Racky Daffé, Daniel P Sulmasy
{"title":"The Impact of Unrealistic Optimism on Informed Consent in Early-Phase Oncology Trials.","authors":"Lynn A Jansen,&nbsp;Daruka Mahadevan,&nbsp;Paul S Appelbaum,&nbsp;William M P Klein,&nbsp;Neil D Weinstein,&nbsp;Motomi Mori,&nbsp;Racky Daffé,&nbsp;Daniel P Sulmasy","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36429333","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}
引用次数: 0
Digitizing Consent: The Food and Drug Administration’s Draft Guidance on Electronic Informed Consent. 数字化同意:食品和药物管理局关于电子知情同意的指导草案。
IRB Pub Date : 2016-09-01
Christian M Simon, David W Klein, Helen A Schartz
{"title":"Digitizing Consent: The Food and Drug Administration’s Draft Guidance on Electronic Informed Consent.","authors":"Christian M Simon,&nbsp;David W Klein,&nbsp;Helen A Schartz","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73513,"journal":{"name":"IRB","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36429334","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}
引用次数: 0
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