Ethics & human research最新文献_第10页

Nothing about Us without Us: Inclusion and IRB Review of Mental Health Research Protocols 没有我们就没有我们:心理健康研究方案的纳入和IRB审查

Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500128

Ian Tully

引用次数: 0

Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial 充分利用同意:急性中风试验中以患者为中心的同意

Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500122

Neal W. Dickert, Kathleen Metz, S. Iris Deeds, Michael J. Linke, Andrea R. Mitchell, Candace D. Speight, Opeolu M. Adeoye

{"title":"Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial","authors":"Neal W. Dickert, Kathleen Metz, S. Iris Deeds, Michael J. Linke, Andrea R. Mitchell, Candace D. Speight, Opeolu M. Adeoye","doi":"10.1002/eahr.500122","DOIUrl":"10.1002/eahr.500122","url":null,"abstract":"<div>\u0000 \u0000 <p>Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"33-40"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78343110","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

Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding? 治疗对研究程序的误解:一个简单的信息图表能增进理解吗?

Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500120

Gavin Campbell, Margie D. Dixon, Minisha Lohani, John Cook, Rachel Hianik, Mary Catherine Thomson, Eli Abernethy, Colleen Lewis, Jeffrey Switchenko, R. Donald Harvey, Rebecca D. Pentz

{"title":"Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?","authors":"Gavin Campbell, Margie D. Dixon, Minisha Lohani, John Cook, Rachel Hianik, Mary Catherine Thomson, Eli Abernethy, Colleen Lewis, Jeffrey Switchenko, R. Donald Harvey, Rebecca D. Pentz","doi":"10.1002/eahr.500120","DOIUrl":"10.1002/eahr.500120","url":null,"abstract":"<div>\u0000 \u0000 <p>In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"18-25"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89923127","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

Evaluating the Ability to Consent to Research: A Twenty-Year Track Record 评估同意研究的能力:二十年的记录

Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500119

Mikaela Matera-Vatnick, Katherine W. Todman, Paul G. Wakim, Haley K. Sullivan, Carol Squires, Julie Brintnall-Karabelas, Samuel N. Doernberg, Marion Danis

引用次数: 0

Institutional Review Board Use of Outside Experts: What Do We Know? 机构审查委员会使用外部专家:我们知道什么?

Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500121

Kimberley Serpico, Vasiliki Rahimzadeh, Emily E. Anderson, Luke Gelinas, Holly Fernandez Lynch

引用次数: 6

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