Ethics & human research最新文献_第10页

IRB Decision-Making about Minimal Risk Research with Pregnant Participants IRB对孕妇最小风险研究的决策

Ethics & human research Pub Date : 2021-09-08 DOI: 10.1002/eahr.500100

Amina White, Christine Grady, Margaret Little, Kristen Sullivan, Katie Clark, Monalisa Ngwu, Anne Drapkin Lyerly

{"title":"IRB Decision-Making about Minimal Risk Research with Pregnant Participants","authors":"Amina White, Christine Grady, Margaret Little, Kristen Sullivan, Katie Clark, Monalisa Ngwu, Anne Drapkin Lyerly","doi":"10.1002/eahr.500100","DOIUrl":"10.1002/eahr.500100","url":null,"abstract":"<p>Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States to elicit their interpretations of “minimal risk”—a formal regulatory category—and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant people in research.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 5","pages":"2-17"},"PeriodicalIF":0.0,"publicationDate":"2021-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500100","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39413349","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: 2

Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event 一项观察性毒理学研究的选择退出设计，涉及在舞蹈音乐活动中醉酒的患者

Ethics & human research Pub Date : 2021-09-08 DOI: 10.1002/eahr.500103

Paul Calle, Peter Blanckaert, Sabine Lemoyne, Robert Rubens

{"title":"Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event","authors":"Paul Calle, Peter Blanckaert, Sabine Lemoyne, Robert Rubens","doi":"10.1002/eahr.500103","DOIUrl":"10.1002/eahr.500103","url":null,"abstract":"<p>At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatment with an intravenous line. All included patients received an information letter inviting them to contact the principal investigator (PI) to obtain more information about the study and/or to inform the PI that they wanted to be excluded from it. Overall, 238 patients were included in the study. Nine participants (4%) responded to the information letter, either on their own or through their parent; none of them asked to be excluded from the study. All respondents expressed their gratitude for the information they received. The opt-out study design seemed to be acceptable to the patient-participants, and it provided a fuller picture of the drug-related medical incidents at such music events than what could likely be achieved through a study that includes only people who explicitly choose to participate. These findings may help institutional review boards when evaluating study designs involving recreational drug use, especially at electronic dance music events. Nevertheless, we warn against extrapolation to other settings where informed consent is difficult to obtain.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 5","pages":"36-41"},"PeriodicalIF":0.0,"publicationDate":"2021-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500103","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39413350","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

The Inevitability and Ethics of Inaccurate Screening in Clinical Trials: A Call for Research and Guidance 临床试验中不准确筛选的必然性和伦理:对研究和指导的呼吁

Ethics & human research Pub Date : 2021-07-01 DOI: 10.1002/eahr.500098

David Wendler

引用次数: 0

Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children's Identities 招收儿童参加遗传神经发育条件的临床试验:伦理、父母的决定和儿童的身份

Ethics & human research Pub Date : 2021-07-01 DOI: 10.1002/eahr.500097

Erin Turbitt, Ainsley J. Newson, Barbara B. Biesecker, Benjamin S. Wilfond

{"title":"Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children's Identities","authors":"Erin Turbitt, Ainsley J. Newson, Barbara B. Biesecker, Benjamin S. Wilfond","doi":"10.1002/eahr.500097","DOIUrl":"10.1002/eahr.500097","url":null,"abstract":"<p>Knowledge of genetic mechanisms contributing to neurodevelopmental conditions is advancing. This is informing development of new drugs to treat or ameliorate these conditions, through targeting underlying genetic pathways. Drugs are tested in clinical trials, necessitating parents to engage with decisions about whether to enroll their child. In this article, we consider important ethical issues to anticipate as clinical research opportunities in genetic neurodevelopmental conditions arise. For example, genetic pathways targeted by the drugs may interact with valued character and personality traits. It is essential that recruitment and consent processes are optimized for families who will grapple with whether these novel drug treatments interact with their child's personality and authentic identity. We call for focused social science research and further normative analysis so that parents are better supported to make informed choices. Additionally, clinical research regulators should have a sound understanding of the contextual experiences regarding how this population of parents engages with decisions.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 4","pages":"27-36"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500097","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39125428","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

Developing Biopsychosocial Research on Maternal Mental Health in Malawi: Community Perspectives and Concerns 开展马拉维孕产妇心理健康的生物心理社会研究:社区观点和关切

Ethics & human research Pub Date : 2021-07-01 DOI: 10.1002/eahr.500095

Lucinda Manda-Taylor, Eric Umar, Robert C. Stewart, Macdonald Kufankomwe, Genesis Chorwe-Sungani, Owen C. Mwale, Demoubly Kokota, Joyce Nyirenda, Kazione Kulisewa, Martyn Pickersgill

{"title":"Developing Biopsychosocial Research on Maternal Mental Health in Malawi: Community Perspectives and Concerns","authors":"Lucinda Manda-Taylor, Eric Umar, Robert C. Stewart, Macdonald Kufankomwe, Genesis Chorwe-Sungani, Owen C. Mwale, Demoubly Kokota, Joyce Nyirenda, Kazione Kulisewa, Martyn Pickersgill","doi":"10.1002/eahr.500095","DOIUrl":"10.1002/eahr.500095","url":null,"abstract":"<div>\u0000 \u0000 <p>Interest in maternal mental health research is growing around the world. Maternal mental health research studies in Malawi have, for instance, sought to determine and establish the incidence and prevalence of depression and anxiety in pregnant people and the factors that contribute to experiences of these states. This article reports stakeholder perspectives on potential community concerns with biopsychosocial mental health research (which might include collecting blood samples) in Malawi. These perspectives were generated through a town hall event that featured five focus group discussions with various participants. In this article, we reflect on key themes from these discussions, demonstrating the endurance of long-standing concerns and practices around autonomy, consent, and the drawing of blood. We conclude by arguing that, while maternal mental health research conducted in Malawi could benefit Malawian women and children, consultation with community stakeholders is necessary to inform whether and how such research should be conducted.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 4","pages":"11-19"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500095","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39125429","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: 6

Online Research Participant Communication: Balancing Benefits and Risks 在线研究参与者沟通:平衡利益与风险

Ethics & human research Pub Date : 2021-07-01 DOI: 10.1002/eahr.500094

Luke Gelinas, Walker Morrell, Sarah A. White, Barbara E. Bierer

引用次数: 0

An Argument for Reinterpreting the Benign Behavioral Intervention Exemption 重新解读良性行为干预豁免的争论

Ethics & human research Pub Date : 2021-07-01 DOI: 10.1002/eahr.500096

Ian Tully

引用次数: 0

Advance Research Directives: Dementia Researchers' Views on a Prototype Directive and Implementation Strategies 前期研究指令:痴呆研究者对原型指令和实施策略的看法

Ethics & human research Pub Date : 2021-05-21 DOI: 10.1002/eahr.500091

Nola Ries, Elise Mansfield

引用次数: 3

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance 利益相关者在单一IRB审查过程中的经验和食品药品监督管理局指导建议。

Ethics & human research Pub Date : 2021-05-21 DOI: 10.1002/eahr.500092

Amy Corneli, Carrie B. Dombeck, Kevin McKenna, Sara B. Calvert

{"title":"Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance","authors":"Amy Corneli, Carrie B. Dombeck, Kevin McKenna, Sara B. Calvert","doi":"10.1002/eahr.500092","DOIUrl":"10.1002/eahr.500092","url":null,"abstract":"<div>\u0000 \u0000 <p>The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA-regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 3","pages":"26-36"},"PeriodicalIF":0.0,"publicationDate":"2021-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500092","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39004198","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: 8

American Indian and Alaska Native Enrollment in Clinical Studies in the National Institutes of Health's Intramural Research Program 美国印第安人和阿拉斯加原住民在美国国立卫生研究院校内研究项目临床研究中的注册

Ethics & human research Pub Date : 2021-05-21 DOI: 10.1002/eahr.500090

Deionna Vigil, Ninet Sinaii, Barbara Karp

{"title":"American Indian and Alaska Native Enrollment in Clinical Studies in the National Institutes of Health's Intramural Research Program","authors":"Deionna Vigil, Ninet Sinaii, Barbara Karp","doi":"10.1002/eahr.500090","DOIUrl":"10.1002/eahr.500090","url":null,"abstract":"<div>\u0000 \u0000 <p>Clinical studies conducted by the National Institutes of Health's Intramural Research Program (NIH-IRP) provide eligible individuals with access to innovative research treatments that may not otherwise be available. The NIH-IRP's mission is to include all Americans, including American Indians and Alaska Natives, in its clinical research. This study is the first to provide data about inclusion of American Indians/Alaska Natives in NIH-IRP clinical studies. We analyzed data from the more than 1,800 NIH-IRP protocols active in 2014 and 2017. We found that the absolute number of American Indian/Alaska Native enrollees increased between 2014 and 2017 but remained at 1% of all participants, a disproportionately low level. The number of clinical studies that enrolled American Indian/Alaska Native individuals similarly did not change. NIH efforts to expand participation of American Indians/Alaska Natives in clinical studies has often focused on research within their communities or on health needs specific to these groups. Those efforts should expand to include processes and protections for the proportionate and ethical inclusion of American Indians and Alaska Natives who individually enroll in studies that are not specific to American Indians, Alaska Natives, or their tribal nations.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 3","pages":"2-9"},"PeriodicalIF":0.0,"publicationDate":"2021-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500090","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38935328","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: 8