Ethics & human research最新文献_第9页

Research Documents for Populations with Limited English Proficiency: Translation Approaches Matter 英语水平有限人群的研究文献:翻译方法的重要性

Ethics & human research Pub Date : 2021-12-22 DOI: 10.1002/eahr.500115

Sonia Colina, Miriam Rodríguez-Guerra, Nicole Marrone, Maia Ingram, Karla J. Navarro, Genesis Arizmendi, Laura Coco

{"title":"Research Documents for Populations with Limited English Proficiency: Translation Approaches Matter","authors":"Sonia Colina, Miriam Rodríguez-Guerra, Nicole Marrone, Maia Ingram, Karla J. Navarro, Genesis Arizmendi, Laura Coco","doi":"10.1002/eahr.500115","DOIUrl":"10.1002/eahr.500115","url":null,"abstract":"<div>\u0000 \u0000 <p>To avoid excluding individuals with limited English proficiency from participating in research, the consent form and other documents should be presented to them in their primary language and in a format that is understandable. However, evidence suggests that, when documents are translated for prospective and actual research participants with limited English proficiency, these individuals often fail to engage with the documents and the research in the same terms as their English-speaking counterparts do. We argue that this is because methodological challenges remain after a decision to translate has been made. This study investigated how translation approaches affected reader response and intelligibility. Participants were asked to review two translated versions of a survey (which reflected a functionalist and a literal approach to translation) followed by semistructured interviews. Quantitative and qualitative analysis revealed a preference for a functionalist translation and a higher number of problems raised in regard to the literal translation. The recommendations we offer here include considering the most appropriate translation approach for a specific genre and purpose.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 1","pages":"29-39"},"PeriodicalIF":0.0,"publicationDate":"2021-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500115","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39747690","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

Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent 生物样本库参与者对生物样本库同意书要求理解的态度

Ethics & human research Pub Date : 2021-12-22 DOI: 10.1002/eahr.500114

T.J. Kasperbauer, Colin Halverson, Abigail Garcia, Karen K. Schmidt, Peter H. Schwartz

{"title":"Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent","authors":"T.J. Kasperbauer, Colin Halverson, Abigail Garcia, Karen K. Schmidt, Peter H. Schwartz","doi":"10.1002/eahr.500114","DOIUrl":"10.1002/eahr.500114","url":null,"abstract":"<div>\u0000 \u0000 <p>Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent. The interviews revealed that while biobank enrollees thought the information on the knowledge test was important, they did not think that performance on the test should affect whether individuals are permitted to enroll in a biobank. Three main themes emerged from the interviews: helping others by contributing to research is more important than understanding consent forms, less understanding is required because biobank-based research is low risk, and only a small amount of information in the consent form is really essential. These perspectives should be considered in discussing the ethics and governance of biobank consent processes.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 1","pages":"18-28"},"PeriodicalIF":0.0,"publicationDate":"2021-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500114","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39747689","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

The Ethical Implications of Big Data Research in Public Health: “Big Data Ethics by Design” in the UK-REACH Study 公共卫生大数据研究的伦理意义:英国reach研究中的“设计大数据伦理”

Ethics & human research Pub Date : 2021-12-22 DOI: 10.1002/eahr.500111

Ruby Reed-Berendt, Edward S. Dove, Manish Pareek, UK-REACH Study Collaborative Group

{"title":"The Ethical Implications of Big Data Research in Public Health: “Big Data Ethics by Design” in the UK-REACH Study","authors":"Ruby Reed-Berendt, Edward S. Dove, Manish Pareek, UK-REACH Study Collaborative Group","doi":"10.1002/eahr.500111","DOIUrl":"10.1002/eahr.500111","url":null,"abstract":"<div>\u0000 \u0000 <p>In this article, we analyze legal and ethical issues raised in Big Data health research projects in the Covid-19 era and consider how these issues might be addressed in ways that advance positive values (e.g., furtherance of respect for persons and accordance with relevant legal frameworks) while mitigating or eliminating any negative aspects (e.g., exacerbation of social inequality and injustice). We apply this analysis specifically to UK-REACH (The United Kingdom Research Study into Ethnicity and Covid-19 Outcomes in Healthcare Workers), a project with which we are involved. We argue that Big Data projects like UK-REACH can be conducted in an ethically robust manner and that funders and sponsors ought to encourage similar projects to drive better evidence-based public policy in public health. As part of this, we advocate that a <i>Big Data ethics-by-design</i> approach be undertaken when such projects are constructed. This principle extends the work of those who advocate ethics by design by addressing prominent issues in Big Data health research projects; it holds that ethical values and principles in Big Data health research projects are best adhered to when they are already integrated into the project aims and methods at the design stage. In advocating this principle, we present a unique perspective regarding pressing ethical problems around large-scale, data-driven Covid-19 research, as well as legal issues associated with processing ostensibly anonymized health data.</p></div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 1","pages":"2-17"},"PeriodicalIF":0.0,"publicationDate":"2021-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500111","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9100521","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: 5

How Scientists Perceive CRISPR's Translational Promise and the Implications for Individuals with Genetic Conditions 科学家如何看待CRISPR的转化前景及其对遗传疾病个体的影响

Ethics & human research Pub Date : 2021-11-09 DOI: 10.1002/eahr.500108

Jodi Halpern, Sharon E. O'Hara, Aleksa L. Owen, David Paolo

引用次数: 0

An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB 使用单一IRB审查知情同意试验例外的本地背景的方法

Ethics & human research Pub Date : 2021-11-09 DOI: 10.1002/eahr.500109

Ann R. Johnson, Lisa M. Rigtrup, John VanBuren, Erin Rothwell, J. Michael Dean

{"title":"An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB","authors":"Ann R. Johnson, Lisa M. Rigtrup, John VanBuren, Erin Rothwell, J. Michael Dean","doi":"10.1002/eahr.500109","DOIUrl":"10.1002/eahr.500109","url":null,"abstract":"<p>In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 6","pages":"42-48"},"PeriodicalIF":0.0,"publicationDate":"2021-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9928846","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

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change 医生对将孕妇纳入新冠肺炎临床试验的看法：是时候改变范式了。

Ethics & human research Pub Date : 2021-10-26 DOI: 10.1002/eahr.500107

Marie-Julie Trahan, Annabelle Cumyn, Matthew P. Cheng, Emily G. McDonald, Stephen E. Lapinsky, Nick Daneman, Haim A. Abenhaim, Isabelle Malhamé

{"title":"Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change","authors":"Marie-Julie Trahan, Annabelle Cumyn, Matthew P. Cheng, Emily G. McDonald, Stephen E. Lapinsky, Nick Daneman, Haim A. Abenhaim, Isabelle Malhamé","doi":"10.1002/eahr.500107","DOIUrl":"10.1002/eahr.500107","url":null,"abstract":"<div>\u0000 \u0000 <p>Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general “culture of exclusion” of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 6","pages":"19-27"},"PeriodicalIF":0.0,"publicationDate":"2021-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8652879/pdf/EAHR-43-19.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39562044","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

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use 迈向IRB先例系统的步骤:总结IRB决策以供未来使用的试点方法

Ethics & human research Pub Date : 2021-10-21 DOI: 10.1002/eahr.500106

Andrea Seykora, Carl Coleman, Stephen J. Rosenfeld, Barbara E. Bierer, Holly Fernandez Lynch

{"title":"Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use","authors":"Andrea Seykora, Carl Coleman, Stephen J. Rosenfeld, Barbara E. Bierer, Holly Fernandez Lynch","doi":"10.1002/eahr.500106","DOIUrl":"10.1002/eahr.500106","url":null,"abstract":"<p>Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of <i>IRB precedent</i>, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems. In theory, an IRB faced with a review decision could look back at previous IRB decisions, either its own or those of other boards, made in similar studies or circumstances to guide the present decision. Some IRBs attempt this informally within their institution, but few examples of a structured system of IRB precedent have been described in the literature, and none has been widely adopted. This article describes a pilot project to summarize IRB decisions in a way that could facilitate their use as precedent by creating a documentation tool that meets four criteria—comprehensiveness, validity, searchability, and efficiency. Though this process turned out to be more challenging than expected, we identified key features of such a tool that holds promise for future development and could promote more consistent, robust IRB decision-making and advance discourse in human research ethics.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 6","pages":"2-18"},"PeriodicalIF":0.0,"publicationDate":"2021-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39541198","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: 3

Creating a Research Ethics Consultation Service: Issues to Consider 创建研究伦理咨询服务:需要考虑的问题

Ethics & human research Pub Date : 2021-09-08 DOI: 10.1002/eahr.500101

Holly A. Taylor, Kathryn M. Porter, Erin Talati Paquette, Jennifer B. McCormick, Emma Tumilty, Jason F. Arnold, Kayte Spector-Bagdady, Marion Danis, Debra Brandt, Jina Shah, Benjamin S. Wilfond, Lisa M. Lee

{"title":"Creating a Research Ethics Consultation Service: Issues to Consider","authors":"Holly A. Taylor, Kathryn M. Porter, Erin Talati Paquette, Jennifer B. McCormick, Emma Tumilty, Jason F. Arnold, Kayte Spector-Bagdady, Marion Danis, Debra Brandt, Jina Shah, Benjamin S. Wilfond, Lisa M. Lee","doi":"10.1002/eahr.500101","DOIUrl":"10.1002/eahr.500101","url":null,"abstract":"<p>This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.</p>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 5","pages":"18-25"},"PeriodicalIF":0.0,"publicationDate":"2021-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500101","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39395649","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

A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era 呼吁在Covid-19时代进行更好而不是更快的研究伦理委员会审查

Ethics & human research Pub Date : 2021-09-08 DOI: 10.1002/eahr.500104

Leonardo Tamariz, Fred J. Hendler, John M. Wells, Annette Anderson, Stephen Bartlett

{"title":"A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era","authors":"Leonardo Tamariz, Fred J. Hendler, John M. Wells, Annette Anderson, Stephen Bartlett","doi":"10.1002/eahr.500104","DOIUrl":"10.1002/eahr.500104","url":null,"abstract":"<div>\u0000 \u0000 <p>With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"43 5","pages":"42-44"},"PeriodicalIF":0.0,"publicationDate":"2021-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/eahr.500104","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39413351","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

Making Metrics Meaningful: How Human Research Protection Programs Can Efficiently and Effectively Use Their Data 使指标有意义:人类研究保护计划如何有效地使用他们的数据

Ethics & human research Pub Date : 2021-09-08 DOI: 10.1002/eahr.500102

Kimberley Serpico

引用次数: 2