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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
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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
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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
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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
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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
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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

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.

由于儿童被认为没有足够的认知能力来同意参与研究,儿科研究提出了特殊的伦理和法律问题。未达到法律或政策规定的同意年龄的儿童,必须由父母(或法定监护人)授权其参加。本文探讨的问题是,为了满足研究同意的伦理和法律规范,在父母或监护人登记参加研究后达到成年年龄的儿科研究参与者是否应该“重新联系”以获得他们继续参与研究的同意。使用三种不同的背景(纵向研究、临床试验和新生儿筛查),我们认为在确定研究人员的潜在职责之前,应该区分重新联系以获得同意所涉及的风险和收益。在每个特定研究背景下,重新接触的义务应始终与这种努力的可行性和成本相平衡,并考虑到与参与者是否存在持续的关系。
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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
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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
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引用次数: 0
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