Mark A. Rothstein, Prabha Rajasekaran, Edward S. Dove
{"title":"Reconsidering Open-Ended Consent for Biospecimen and Health Record Research in the United States and Europe","authors":"Mark A. Rothstein, Prabha Rajasekaran, Edward S. Dove","doi":"10.1002/eahr.60028","DOIUrl":"https://doi.org/10.1002/eahr.60028","url":null,"abstract":"<div>\u0000 \u0000 <p>Translational and other modern forms of biomedical research often use stored biospecimens and the health records of individuals whose biospecimens will be used in research. As part of the enrollment process for biobank-based research, individuals are frequently asked to provide informed consent for access to and use of their current and future health records. Although individuals might readily agree to give researchers access to their current health records, they might not realize that their future health records could contain new stigmatizing or embarrassing information. Reasonable limits on future health record disclosures in both the U.S. and Europe can address health privacy concerns without impeding research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 4","pages":"43-50"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60028","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144624304","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}
Barbara Green-Ajufo, Deepalika Chakravarty, Andres Maiorana, Marguerita Lightfoot, John Hamiga, Greg Rebchook
{"title":"Acceptability and Feasibility of Using Educational Incentives for Research Participation to Advance Antiracism","authors":"Barbara Green-Ajufo, Deepalika Chakravarty, Andres Maiorana, Marguerita Lightfoot, John Hamiga, Greg Rebchook","doi":"10.1002/eahr.60010","DOIUrl":"https://doi.org/10.1002/eahr.60010","url":null,"abstract":"<div>\u0000 \u0000 <p>Nominal cash and gift card incentives provided to research participants have immediate financial benefits but make no lasting improvements to participants’ lives or social inequities they might experience. Our study examined the acceptability of offering a nonmonetary educational incentive as an added option to research participants as a potential to advance antiracism and address social inequities. Community members (n = 128) completed a quantitative survey; nine of whom also participated in a qualitative interview. Focus group discussions occurred with 11 researchers. Survey data were analyzed to obtain descriptive statistics. Qualitative data were analyzed using an iterative process guided by template analysis. Survey participants’ mean age was 45 years; 39% were white and 30% were Hispanic/Latinx; 80% were male; 39% had completed some college; 45% had a degree; and 71% reported previous paid participation in a research or community program. Of this group, 80% preferred cash or gift card incentives; 16% preferred an educational incentive; and 88% were likely to extremely likely to use educational incentives. Qualitative data indicated that educational incentives were acceptable but should not replace cash incentives; successful implementation would require organizational support. Noncash educational incentives may be acceptable to research participants and researchers and would help address social inequities. Successful implementation would require further research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 4","pages":"18-28"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60010","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144624301","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}
Andre M. N. Renzaho, Michael Polonsky, Julie Green
{"title":"Engaging Sub-Saharan African Migrants in Social and Health Studies in Australia: Research and Ethical Challenges","authors":"Andre M. N. Renzaho, Michael Polonsky, Julie Green","doi":"10.1002/eahr.60019","DOIUrl":"https://doi.org/10.1002/eahr.60019","url":null,"abstract":"<div>\u0000 \u0000 <p>The study summarizes and discusses challenges in engaging Sub-Saharan African migrants in Australia in social and health studies using data from 15 discrete projects co-led by the three researchers who authored this article. The projects included cross-sections of the African community, focusing on parents and their children, and were carried out over 11 years (2007 to 2018) in Australia. An African Review Panel (ARP), a community-owned steering committee whose members were drawn from the target communities, oversaw the implementation of these projects. Directed content analysis of textual data, drawing on reflective practice through ARP interactive reflective meeting sessions and bilingual workers’ reflective field notes, was undertaken. Findings and associated learnings were summarized into broad themes around lessons learned from participatory research and ethical challenges. Current guiding ethical principles in research may not cater to all cultures, and there is a need to develop ethical guidelines that are culturally responsive to account for collectivist values related to cultural expression and experiences.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 4","pages":"2-17"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144624357","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}
Katherine E. MacDuffie, Benjamin S. Wilfond, Stephanie A. Kraft
{"title":"Revisiting the Obligation to Share Aggregate Results with Research Participants in the Era of Open Science","authors":"Katherine E. MacDuffie, Benjamin S. Wilfond, Stephanie A. Kraft","doi":"10.1002/eahr.60009","DOIUrl":"https://doi.org/10.1002/eahr.60009","url":null,"abstract":"<div>\u0000 \u0000 <p>Open science initiatives, intended to democratize access to research products, have made steady progress in shifting the global science culture toward practices like preregistration and data sharing. However, current open science efforts have not yet addressed the special obligation to ensure that research results are made accessible to the portion of the general population who contribute most directly to scientific advances: research participants. In this article, we explore the ethical obligation to communicate aggregate results to research participants and consider elements of open science infrastructure that could be amended for this purpose. We consider open questions for implementation related to the methods, timing, potential harms, oversight, and incentives for communicating aggregate results and pose solutions that could, following the example of open science initiatives, succeed in nudging investigators to reciprocate the efforts of research participants by sharing the scientific findings they helped to advance.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 4","pages":"29-36"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60009","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144624302","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}
{"title":"Our Theater of Anonymity","authors":"Sara Meeder, Megan Doerr","doi":"10.1002/eahr.60027","DOIUrl":"https://doi.org/10.1002/eahr.60027","url":null,"abstract":"<div>\u0000 \u0000 <p>Ethics review boards are increasingly asked to review big health data research proposals using a regulatory framework written prior to the current era of machine learning and artificial intelligence. Traditional consideration of individual identifiability does not account for the growing recognition that almost all data can be reidentified. This leaves the research ethics community performing a “theater of anonymity”: weighing benefit versus risk on the inclusion of participant identifiers alone. The wider research community, including U.S. federal agencies, is pushing for greater transparency and data sharing, stretching the current definition of identifiability to the breaking point. Additionally, shifting attitudes on the balance between privacy and research benefit may make a project more acceptable to individuals and communities than to the ethics boards designed to serve them. Reviewing the human research community's historical and current understanding of identity in terms of research, risk, benefit, and consent may point toward a need for a change in how consent is conceived. Particularly in the context of consent for big health data research, the research ethics community may need to shift its focus from solely considering individuals toward actively considering the interests of the communities most likely to be affected by the research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 4","pages":"37-42"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60027","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144624303","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}
Pamela Andanda, Johannes Machinya, Takudzwa Mutomba
{"title":"Equitable Data Sharing in Collaborative Health Research in Sub-Saharan Africa: A Translational Bioethics Perspective","authors":"Pamela Andanda, Johannes Machinya, Takudzwa Mutomba","doi":"10.1002/eahr.60023","DOIUrl":"https://doi.org/10.1002/eahr.60023","url":null,"abstract":"<div>\u0000 \u0000 <p>Clinical research is essential for establishing the safety, efficacy, and contextualized effectiveness of medical products. Data from multiple sources such as representative target population studies and health and demographic data obtained through health surveillance systems are required for designing clinical research protocols and for recruitment of participants. In this essay, we review barriers from a complex interplay of ethical, legal, and practical challenges in data governance that hamper sharing health data from these sources in Sub-Saharan Africa. We suggest that a translational bioethics approach offers a valuable framework for addressing these challenges to bridge the gap between theory and practical application of ethical principles in data governance.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 3","pages":"40-45"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60023","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914100","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}
Kamiel Verbeke, Tomasz Krawczyk, Dieter Baeyens, Jan Piasecki, Pascal Borry
{"title":"What's in a Lie? How Researchers Judge the Justifiability of Deception","authors":"Kamiel Verbeke, Tomasz Krawczyk, Dieter Baeyens, Jan Piasecki, Pascal Borry","doi":"10.1002/eahr.60003","DOIUrl":"https://doi.org/10.1002/eahr.60003","url":null,"abstract":"<div>\u0000 \u0000 <p>Research ethics guidance on deception does not seem to provide extensive support to researchers and ethics reviewers on how to assess the justifiability of specific deceptive studies. One potential explanation for this shortcoming is that guidance does not offer precise and coherent descriptions of the ethically relevant characteristics of deceptive studies. To facilitate the development of improved guidance, we report on the findings of interviews with a diverse group of 24 researchers who use deception. Interviewees discussed how the interests of participants, society, and researchers can be affected by characteristics of the deceptive methods used. These characteristics pertained to the deceptive act (i.e., false, truthlike, or vague information; standardized or flexible deception), participants’ belief formation (i.e., credibility and suspicions), and deception-induced behaviors and experiences (i.e., consent validity, negative value, and duration of induced study behaviors and experiences). In addition, researchers described as ethically relevant the characteristics of the social context in which deceptive studies were embedded. These characteristics related to the deceiver-participant relationship and the participants’ community. Overall, our study contributes to a more coherent and precise, as well as complex and nuanced, understanding of the study characteristics that affect the justifiability of deception.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 3","pages":"13-29"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914204","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}
Kevin L. Nellis, Ronnie Lichtman, Jeffrey Birnbaum, Stanley Friedman, Elise Zwicklbauer
{"title":"Incorporating Gender-Neutral Language in IRB Materials: Perceptions of IRB Professionals","authors":"Kevin L. Nellis, Ronnie Lichtman, Jeffrey Birnbaum, Stanley Friedman, Elise Zwicklbauer","doi":"10.1002/eahr.60022","DOIUrl":"https://doi.org/10.1002/eahr.60022","url":null,"abstract":"<div>\u0000 \u0000 <p>This study investigated the perceptions of institutional review board (IRB) professionals regarding the use of gender-neutral language in IRB guidance and informed consent documents, and whether respondents’ IRBs incorporated gender-neutral language in those documents. A survey was disseminated to a diverse group of IRB professionals whose emails were generated from a list received from the Office for Human Research Protections. Responses indicated substantial endorsement of gender-neutral language, although actual usage remains limited. The findings suggest that while the willingness to adopt inclusive language is high, barriers such as resource limitations and a lack of regulatory guidelines often impede its broader application. This study underscores the importance of developing explicit guidelines and resources to facilitate the adoption of gender-neutral language, enhancing inclusivity in research settings.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 3","pages":"30-39"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914099","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}
{"title":"Undue Inducement and Disparate Impact: A Collectivist Account","authors":"Christopher Bobier","doi":"10.1002/eahr.60002","DOIUrl":"https://doi.org/10.1002/eahr.60002","url":null,"abstract":"<div>\u0000 \u0000 <p>There is consensus that an inducement to participate in clinical research is undue if it compromises individual decision-making, thereby undermining voluntariness—a would-be research participant is made an excessive offer that prevents him or her from deciding well, however that is understood. I set forth and defend a view that conceptualizes inducements as undue if they result in the disparate enrollment of a protected class of individuals. I argue that this new conception avoids the problems with the standard view, is easy to operationalize, and clarifies the relation between exploitation and undue inducement.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 3","pages":"2-12"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914203","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}