Research EthicsPub Date : 2023-07-31DOI: 10.1177/17470161231189602
Laura Cooper, K. Johnston, Marie Williams
{"title":"Planning a ‘negligible risk’ national health service survey? Counting the cost and strategies for success: a short report","authors":"Laura Cooper, K. Johnston, Marie Williams","doi":"10.1177/17470161231189602","DOIUrl":"https://doi.org/10.1177/17470161231189602","url":null,"abstract":"Many countries, including Australia, have established a national scheme that supports the recognition of a single ethical review for multi-centre research conducted in publicly funded health services. However, local site-specific governance review processes remain decentralised and highly variable. This short report describes the ethics and governance processes required for a negligible risk national survey of physiotherapy-led airway clearance services in Australia. We detail inconsistencies in research governance document preparation and submission (platforms, processes, forms and signatories) and report the time cost and likely impact of these inconsistencies on health services research outcomes. Processes and strategies that facilitated success in this project are identified and summarised as helpful hints to other researchers looking to embark on negligible risk research in public health facilities.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76353285","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}
Research EthicsPub Date : 2023-07-27DOI: 10.1177/17470161231187099
Kimberley Serpico
{"title":"Defining institutional review board application quality: critical research gaps and future opportunities","authors":"Kimberley Serpico","doi":"10.1177/17470161231187099","DOIUrl":"https://doi.org/10.1177/17470161231187099","url":null,"abstract":"The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75122564","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}
Research EthicsPub Date : 2023-07-25DOI: 10.1177/17470161231189843
R. Zur
{"title":"Protected from harm, harmed by protection: ethical consequences of the exclusion of pregnant participants from clinical trials","authors":"R. Zur","doi":"10.1177/17470161231189843","DOIUrl":"https://doi.org/10.1177/17470161231189843","url":null,"abstract":"Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it’s own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73739519","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}
Research EthicsPub Date : 2023-07-25DOI: 10.1177/17470161231188615
E. Fernandez, Todd J. McWhorter
{"title":"Who reviews what you do at the zoo? Considerations for research ethics with captive exotic animals","authors":"E. Fernandez, Todd J. McWhorter","doi":"10.1177/17470161231188615","DOIUrl":"https://doi.org/10.1177/17470161231188615","url":null,"abstract":"Research in zoos is an important scientific endeavor that requires several complex considerations in order to occur. Among those many considerations are the ethics involved in conducting zoo research. However, it is not always clear how zoo researchers should go about resolving any research ethics matters, even determining when some type of research ethics committee should be involved in those deliberations. Our paper attempts to provide some resolutions for these issues, namely in three sections: (1) a brief history of human and animal research ethics, (2) general guidelines for zoo research ethics applications, and (3) theoretical, ethical dilemmas at the zoo. In each section, we consider pragmatic attempts to resolve any issues, as well as provide examples to illustrate our points. The primary focus of the paper is to facilitate consideration of the wide array of ethical factors any zoo researcher might encounter, as well as provide a basic set of ethical guidelines for zoo research. We also emphasize the importance of the welfare of the animals for all zoo research projects.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91387319","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}
Research EthicsPub Date : 2023-07-25DOI: 10.1177/17470161231188720
A. Lees, R. Godbold, S. Walters
{"title":"Reconceptualizing participant vulnerability in Scholarship of Teaching and Learning research: exploring the perspectives of health faculty students in Aotearoa New Zealand","authors":"A. Lees, R. Godbold, S. Walters","doi":"10.1177/17470161231188720","DOIUrl":"https://doi.org/10.1177/17470161231188720","url":null,"abstract":"While the need to protect vulnerable research participants is universal, conceptual challenges with the notion of vulnerability may result in the under or over-protection of participants. Ethics review bodies making assumptions about who is vulnerable and in what circumstance can be viewed as paternalistic if they do not consider participant viewpoints. Our study focuses on participant vulnerability in Scholarship of Teaching and Learning (SoTL) research. We aim to illuminate students’ views on participant vulnerability to contribute to critical analysis of the role and processes of ethics review. Additionally, we aim to highlight the importance of seeking the views of participant communities, especially in research environments beyond ethics review’s medical origins. Thirty-four students from a health-related faculty at a university in Aotearoa New Zealand, participated in five focus groups. Participants discussed factors affecting their potential participation in research drawing upon a series of vignettes based on examples of published SoTL projects. Themes, generated using reflexive thematic analysis, built a participant-informed picture of vulnerability. Findings indicate that students do not generally consider themselves vulnerable and instead consider participation in SoTL research through an agentic lens. Students expect that participation will be voluntary, not negatively impact their grades, and not single them out so that others could judge them. Our study also highlights the value students place on relationships with one another and teaching staff and the implications these have for SoTL research participation and future professional practice. This research challenges research ethics committees to think further about vulnerability in the context of SoTL whilst highlighting the importance of providing opportunities for research participants more broadly to explore and vocalize their views as members of participant communities.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84931430","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}
Research EthicsPub Date : 2023-07-11DOI: 10.1177/17470161231186060
Julia Henning, Ana Goncalves Costa, E. Fernandez
{"title":"Shifting attitudes on animal ‘ownership’: Ethical implications for welfare research and practice terminology","authors":"Julia Henning, Ana Goncalves Costa, E. Fernandez","doi":"10.1177/17470161231186060","DOIUrl":"https://doi.org/10.1177/17470161231186060","url":null,"abstract":"The roles companion animals have played in our lives has dramatically changed over the last few decades. At the same time, the terms we use to describe both the people and animals in these human-animal relationships have also changed. One example includes the use of the terms ‘owner’ or ‘guardian’ to refer to the human caretaker. While preferences by society appear to indicate increased interest in referring to companion animal caretakers as ‘guardians’, others have cautioned against its use or attempted to restrict it. Additionally, the use of animal welfare terminology has direct implications for how we conduct both welfare research and practice. Our paper examines the use of ‘owner’ and ‘guardian’ with respect to (1) the implications for changing terminology on the function, clarity and uniformity of their use, and (2) the ethical and welfare impact that coincides with each term’s use. Our goal is to propose terminological considerations that could influence future welfare research, as well as help guide our interactions with companion animals.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80719174","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}
Research EthicsPub Date : 2023-07-03DOI: 10.1177/17470161231181860
I. Palaiologou, Alice V. Brown
{"title":"Ethical considerations and dilemmas for the researcher and for families in home-based research: A case for situated ethics","authors":"I. Palaiologou, Alice V. Brown","doi":"10.1177/17470161231181860","DOIUrl":"https://doi.org/10.1177/17470161231181860","url":null,"abstract":"When researching with or about families in home-based research, there are numerous unexpected ethical issues that can emerge, particularly in qualitative research. This paper is based on reflective accounts of four homed-based research projects, two in the UK and two Australia, which examined ethical dilemmas identified when engaged in home-based research with young children. Using a synergy of ecocultural theory and Foucauldian ideas of Heterotopia as theoretical conceptualisations, the authors employed reflective lenses to guide their approach, and examine dilemmas and complexities when conducting research in the home. We argue that, to address ethical dilemmas, researchers need to problematise and reflect upon the nature of respectful approaches and the ethical implications of their behaviours. We conclude that, although ethical codes are valuable when researching families at home, researchers should plan for and forefront their methodological approaches in ways that are family-centred, whilst also framed by practices that are ethical, respectful and reflective to the situated contexts of family’s ecologies and heterotopias.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80122773","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}
Research EthicsPub Date : 2023-07-01DOI: 10.1177/17470161231159486
{"title":"Erratum to “Using wearable cameras to investigate health-related daily life experiences: A literature review of precautions and risks in empirical studies”","authors":"","doi":"10.1177/17470161231159486","DOIUrl":"https://doi.org/10.1177/17470161231159486","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Erratum to “Using wearable cameras to investigate health-related daily life experiences: A literature review of precautions and risks in empirical studies”","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83800183","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}
Research EthicsPub Date : 2023-06-29DOI: 10.1177/17470161231185510
Zeinab Mohammed, F. Abdelgawad, M. Ahram, M. E. Ibrahim, A. Elgamri, Ehsan B. Gamel, L. Adarmouch, K. Rhazi, S. Abd ElHafeez, H. Silverman
{"title":"Opinions and attitudes of research ethics committees in Arab countries in the Middle East and North African region toward ethical issues involving biobank research","authors":"Zeinab Mohammed, F. Abdelgawad, M. Ahram, M. E. Ibrahim, A. Elgamri, Ehsan B. Gamel, L. Adarmouch, K. Rhazi, S. Abd ElHafeez, H. Silverman","doi":"10.1177/17470161231185510","DOIUrl":"https://doi.org/10.1177/17470161231185510","url":null,"abstract":"Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89932080","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}
Research EthicsPub Date : 2023-06-29DOI: 10.1177/17470161231183100
J. Calderón-Amor, Daniela Luna, T. Tadich
{"title":"Agreement of farm animal behaviour and welfare studies with the ARRIVE Essential 10","authors":"J. Calderón-Amor, Daniela Luna, T. Tadich","doi":"10.1177/17470161231183100","DOIUrl":"https://doi.org/10.1177/17470161231183100","url":null,"abstract":"The inclusion of animals in research studies involves a great responsibility to ensure animal welfare within the relevant ethical and legal frameworks. This study aimed to review compliance with the ARRIVE Essential 10 requirements and the ethical oversight of animal behaviour and welfare studies in farm animals. Three journals and a total of 133 articles were reviewed for compliance with the ARRIVE Essential 10 items and criteria. Each article obtained a final score according to whether or not each criterion was met within each item. Likewise, ethical declaration in each article was recorded. Chi-square test and linear models were built to assess associations between the ethical statement presentation and the final ARRIVE Essential 10 score with the country, the species, and the journal. We found that 15% of the articles did not present an ethical statement. The journal with the highest impact factor and the countries of the Global South presented an ethical statement more frequently. Regarding the Essential 10, the item with the lowest agreement score was ‘Blinding’ and the one with the highest agreement was ‘Outcome Measures’. Also, significant differences were found between journals in terms of the Essential 10 score. Essential 10 provides relevant information that allows reviewers and readers to identify possible welfare risks and the validity of the results in animal welfare science publications.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74741590","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}