Ethics & human research最新文献_第9页

An Expanded Role for IRBs in the Oversight of Research Biopsies 审查委员会在监督研究活组织检查方面的扩大作用

Ethics & human research Pub Date : 2022-09-01 DOI: 10.1002/eahr.500141

Laura A. Levit, Julie Kaneshiro, Jeffrey Peppercorn, Mark J. Ratain

{"title":"An Expanded Role for IRBs in the Oversight of Research Biopsies","authors":"Laura A. Levit, Julie Kaneshiro, Jeffrey Peppercorn, Mark J. Ratain","doi":"10.1002/eahr.500141","DOIUrl":"10.1002/eahr.500141","url":null,"abstract":"<div>\u0000 \u0000 <p>Research biopsies included in cancer clinical trials have the goal of advancing scientific understanding of the biological bases of cancer and its treatments, but may offer no prospect of direct benefit to participants and often pose more than minimal risk. The research community is examining the ethics of research biopsies increasingly often, especially when they are mandatory for study participation but do not support primary study objectives and thus are “nonintegral” to the study. Ethical concerns center on the limited scientific justification supporting some biopsies, risks to research participants, and the potential for coercion and therapeutic misconception during the informed consent process. There is also a lack of comprehensive oversight of research biopsies by regulatory agencies and institutions. This paper reviews these ethical concerns, discusses the scope of federal oversight, and suggests that institutional review boards (IRBs) should assume a larger role in ensuring the ethical conduct of research biopsies. It concludes with guidance to IRBs on how to weigh the risks, benefits, and acceptability of such biopsies in different contexts that is based on a framework the American Society of Clinical Oncology developed for the inclusion of research biopsies in oncology clinical trials.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 5","pages":"32-41"},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40335189","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

Broad Consent—Are We Asking Enough? 广泛的同意——我们的要求够了吗?

Ethics & human research Pub Date : 2022-09-01 DOI: 10.1002/eahr.500140

Lisa E. Smilan

引用次数: 3

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions 制定和实施电子同意程序以应对Covid-19限制

Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500135

Julie R. Bromberg, Evelyn Nimaja, Andrew W. Kiragu, Karla A. Lawson, Lois Lee, Isam W. Nasr, Charles Pruitt, Stephanie M. Ruest, Michael J. Mello

{"title":"Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions","authors":"Julie R. Bromberg, Evelyn Nimaja, Andrew W. Kiragu, Karla A. Lawson, Lois Lee, Isam W. Nasr, Charles Pruitt, Stephanie M. Ruest, Michael J. Mello","doi":"10.1002/eahr.500135","DOIUrl":"10.1002/eahr.500135","url":null,"abstract":"<div>\u0000 \u0000 <p>The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 4","pages":"39-44"},"PeriodicalIF":0.0,"publicationDate":"2022-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9349659/pdf/EAHR-44-39.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40494234","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: 2

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form 以非洲裔美国人为主的社区对生物库研究和生物库同意书的看法

Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500134

Laura K. Sedig, E. Hill De Loney, Sarah B. Bailey, Kayte Spector-Bagdady, Bianca Ghita, Lydia Koh Krienke, Raymond Hutchinson

引用次数: 0

Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic 微生物组研究中的隐私风险:全球大流行之前和期间的公众观点

Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500132

Andrea Shin, Huiping Xu

{"title":"Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic","authors":"Andrea Shin, Huiping Xu","doi":"10.1002/eahr.500132","DOIUrl":"10.1002/eahr.500132","url":null,"abstract":"<div>\u0000 \u0000 <p>We assessed public perspectives of microbiome research privacy risks before and after a nationwide emergency was declared in the United States regarding the Covid-19 pandemic. From January to July of 2020, we conducted an online survey of perceived privacy risks of microbiome research among U.S. adults. Among 3,106 participants (the preemergency group), most expressed that the microbiome posed privacy risks similar to those associated with DNA (60.3%) or medical records (50.6%) and that they would prefer detailed explanations (70.2%) of risk in consent materials. Only 8.9% reported moderate to high familiarity with microbiome privacy risks. In adjusted analyses, individuals who participated in the study after the Covid-19 emergency was declared (the Covid-19 emergency group) were less likely to express that microbiome privacy risks were similar to those of DNA or medical records and more likely to report familiarity with the privacy risks of microbiomes. There was a trend toward increased concern after the Covid-19 emergency was declared (p = 0.053). Overall, the study revealed that many U.S. adults believe that microbiome privacy risks are similar to those associated with DNA or medical records, and they prefer detailed explanations in consent documents. Individuals who participated after the Covid-19 emergency was declared reported greater knowledge of microbiome privacy risks but had more concern.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 4","pages":"2-13"},"PeriodicalIF":0.0,"publicationDate":"2022-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40494774","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: 1

Big Health Data Research and Group Harm: The Scope of IRB Review 健康大数据研究与群体危害:IRB审查范围

Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500130

Megan Doerr, Sara Meeder

引用次数: 6

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials 国际临床试验中急性缺血性卒中知情同意过程中的伦理考虑

Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500133

Tiffany Bellomo, Jennifer Fokas, Noah Tsao, Clare Anderson, Christopher Becker, Rachel Gioscia-Ryan, William Meurer

{"title":"Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials","authors":"Tiffany Bellomo, Jennifer Fokas, Noah Tsao, Clare Anderson, Christopher Becker, Rachel Gioscia-Ryan, William Meurer","doi":"10.1002/eahr.500133","DOIUrl":"10.1002/eahr.500133","url":null,"abstract":"<div>\u0000 \u0000 <p>We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 4","pages":"14-25"},"PeriodicalIF":0.0,"publicationDate":"2022-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40494775","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

Influence of Dispositional Optimism on Ethically Salient Research Perspectives: A Pilot Study 性格乐观对伦理显著性研究视角的影响:一项初步研究

Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500126

Jane Paik Kim, Sangeeta Mondal, Tenzin Tsungmey, Katie Ryan, Laura B. Dunn, Laura Weiss Roberts

{"title":"Influence of Dispositional Optimism on Ethically Salient Research Perspectives: A Pilot Study","authors":"Jane Paik Kim, Sangeeta Mondal, Tenzin Tsungmey, Katie Ryan, Laura B. Dunn, Laura Weiss Roberts","doi":"10.1002/eahr.500126","DOIUrl":"10.1002/eahr.500126","url":null,"abstract":"<div>\u0000 \u0000 <p>Research participants should be drawn as fairly as possible from the potential volunteer population. Underlying personality traits are underexplored as factors influencing research decision-making. Dispositional optimism, known to affect coping, physical health, and psychological well-being, has been minimally studied with respect to research-related attitudes. We conducted an exploratory, online survey with 151 individuals (with self-reported mental illness [n = 50], physical illness [n = 51], or neither [n = 50]) recruited via MTurk. We evaluated associations between dispositional optimism (assessed with the Life Orientation Test—Revised) and general research attitudes, perceived protectiveness of five research safeguards, and willingness to participate in research using safeguards. Strongly optimistic respondents expressed more positive research attitudes and perceived four safeguards as more positively influencing willingness to participate. Optimism was positively associated with expressed willingness to participate in clinical research. Our findings add to a limited literature on the influence of individual traits on ethically salient research perspectives.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 3","pages":"12-23"},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9436640","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

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research 什么时候变化是重要的?医学和行为研究中应用程序的更新问题

Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500118

Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer

引用次数: 0

Ethical Considerations for Parent-Adolescent Dyadic Research 亲子二元研究的伦理考量

Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500127

Kemesha Gabbidon, Tiffany Chenneville, Wendy Rote

引用次数: 1