Journal of Empirical Research on Human Research Ethics最新文献

{"title":"\"No Country Bureaucratised its way to Excellence\": A Content Analysis of Comments on a Petition to Streamline Australian Research Ethics and Governance Processes.","authors":"Anna M Scott,&nbsp;E Ann Bryant,&nbsp;Jennifer A Byrne,&nbsp;Natalie Taylor,&nbsp;Adrian G Barnett","doi":"10.1177/15562646211048268","DOIUrl":"https://doi.org/10.1177/15562646211048268","url":null,"abstract":"<p><p>We created a petition for a national inquiry into the Australian system of research ethics and governance, to inform the politicians about the problems with the existing system. We analyzed the reasons that signatories offered for why signing the petition was important to them. A total of 409 comments (by 805 signatories) focused on five major themes: (1) views on previous changes to the system of research ethics and governance; (2) drawbacks of the existing system; (3) suggested changes to the system; (4) anticipated impacts of changing the system; and (5) miscellaneous/other comments. Comments ranged from several words to over 400 words in length, and most often focused on the procedural aspects, and commented on theme 2: drawbacks of the existing system.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"102-113"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39510075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis - A Systematic Review.","authors":"Minna Stolt,&nbsp;Emilia Kielo-Viljamaa,&nbsp;Anne-Marie Laitinen,&nbsp;Riitta Suhonen,&nbsp;Helena Leino-Kilpi","doi":"10.1177/15562646211047654","DOIUrl":"https://doi.org/10.1177/15562646211047654","url":null,"abstract":"<p><p>Research ethics is a fundamental part of the entire research. Patients with rheumatoid arthritis are sensitive group of research participants because their long-term health problems cause significant changes in their foot health. In foot health research, data are usually collected through a clinical assessment of the foot or questionnaires. However, there is limited evidence of the reported research ethics of empirical studies on foot health in patients with rheumatoid arthritis. Therefore this review aimed to analyze the reported research ethics of peer-reviewed empirical studies focusing on foot health in patients with rheumatoid arthritis as research participants. This systematic review used the Medline/PubMed, CINAHL, and Embase databases. A total of 1,653 records were identified, and 32 articles were included in the final analysis. Reporting research ethics in studies of patients with rheumatoid arthritis is fragmented, focusing predominantly on ethical approval and informed consent and lacking a broader discussion about research ethics.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"39-51"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8721538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39516556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the Operational Characteristics of Research Ethics Committees in Ghana.","authors":"Samuel Asiedu Owusu,&nbsp;Grace Addison,&nbsp;Barbara Redman,&nbsp;Lisa Kearns,&nbsp;Paul Amuna,&nbsp;Amos Laar","doi":"10.1177/15562646211051189","DOIUrl":"https://doi.org/10.1177/15562646211051189","url":null,"abstract":"<p><p>There were eighteen Research Ethics Committees (RECs) operating in Ghana as of December 2019 but no empirical assessment of their operational characteristics had been conducted. We assessed the characteristics of Ghanaian RECs using an existing Self-Assessment Tool for RECs in Developing Countries. We present results from nine RECs that participated in this nation-wide assessment. Our results indicate that the RECs are generally adherent to the recommendations in the Tool including being composed of members with diverse expertise. They also reviewed and approved research protocols as well as had access to some limited funding for their activities. There is no national policy on research human protections or an ethics authority to regulate the activities of the RECs. We recommend the establishment of this authority in Ghana while encouraging institutions to sustain efforts aimed at making their RECs operate independently.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"114-128"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8712386/pdf/nihms-1741794.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39532251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea.","authors":"Ji-Hye Seo,&nbsp;Ock-Joo Kim,&nbsp;Sang-Ho Yoo,&nbsp;Eun Kyung Choi,&nbsp;Ji-Eun Park","doi":"10.1177/15562646211034275","DOIUrl":"https://doi.org/10.1177/15562646211034275","url":null,"abstract":"<p><p>The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered \"university graduation\" and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers' participation in research was \"financial reward.\" Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"193-212"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39328960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009-2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic.","authors":"Linda Kateb,&nbsp;Sawsan El-Jayousi,&nbsp;Maysa Al-Hussaini","doi":"10.1177/15562646211053234","DOIUrl":"https://doi.org/10.1177/15562646211053234","url":null,"abstract":"<p><p><i>The problem</i>: Running an efficient institutional review board (IRB) can be challenging. <i>The research subjects</i>: To ensure an efficient committee, our IRB adopted several operational metrics. <i>Methods</i>: Analysis of retrospective data from the IRB records, database, and annual reports over 12 years. <i>Results</i>: The IRB roster comprises 11 members. The average medical to nonmedical member ratio is 5:6, and the male to female ratio is 4:7, which has not been consistent over the years. One thousand three hundred and twenty-four proposals were reviewed including 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) with a median turnaround time to approval of 4.0, 35.0, and 68.0 days, respectively. Training of the IRB members was conducted to enhance their knowledge and skills. IRB at King Hussein Cancer Center has managed to stay abreast and efficient during the COVID-19 pandemic, by working remotely. <i>Conclusion</i>: Running an efficient IRB mandates implementing a number of operational metrics.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"94-101"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39646038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Human Research Ethics Committee Experiences and Views About Children's Participation in Research: Results From the <i>MESSI</i> Study.","authors":"Stephanie Taplin,&nbsp;Jenny Chalmers,&nbsp;Judith Brown,&nbsp;Tim Moore,&nbsp;Anne Graham,&nbsp;Morag McArthur","doi":"10.1177/15562646211048294","DOIUrl":"https://doi.org/10.1177/15562646211048294","url":null,"abstract":"<p><p>As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members' confidence to judge ethical research with children.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"70-83"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39510072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceptions of HIV Research Participation Among Gay, Bisexual, and Other Men who Have Sex with Men and Transgender and Nonbinary Adults: Results From a Midwest Pride Event.","authors":"Andrea R Kaniuka, Meagan Zarwell, Robert J Cramer, Katherine Quinn, Michelle Broaddus, Alexandra Patton, Jennifer L Walsh","doi":"10.1177/15562646211062707","DOIUrl":"10.1177/15562646211062707","url":null,"abstract":"<p><p>Human immunodeficiency virus (HIV) continues to disproportionately affect gay, bisexual, and other men who have sex with men (GBM) and transgender and nonbinary (trans/NB) individuals. This study investigated attitudes toward participation in HIV survey research, guided by Emanuel's framework for ethical clinical research (e.g., risk-benefit ratio, fair participant selection, respect for participants, social value, and collaborative partnership). GBM (<i>n</i> = 294) and trans/NB (<i>n</i> = 86) persons recruited at a Pride event in Milwaukee completed a survey assessing risks and benefits of participation in, and comfort responding to, sexual health surveys. Participants reported few ethical concerns (e.g., privacy and confidentiality), with notable differences by race, sexual orientation and gender identity, and prior research experiences. Implications for HIV research with GBM and trans/NB individuals are discussed.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"15-28"},"PeriodicalIF":1.7,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11639097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39946429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.","authors":"Erin D Solomon,&nbsp;Jessica Mozersky,&nbsp;Matthew P Wroblewski,&nbsp;Kari Baldwin,&nbsp;Meredith V Parsons,&nbsp;Melody Goodman,&nbsp;James M DuBois","doi":"10.1177/15562646211037546","DOIUrl":"10.1177/15562646211037546","url":null,"abstract":"<p><p>Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"177-192"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8712347/pdf/nihms-1726503.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39326069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Social Researchers' Approaches to Research Ethics During the COVID-19 Pandemic: An Exploratory Study.","authors":"Adrianna Surmiak,&nbsp;Beata Bielska,&nbsp;Katarzyna Kalinowska","doi":"10.1177/15562646211055056","DOIUrl":"https://doi.org/10.1177/15562646211055056","url":null,"abstract":"<p><p>The global COVID-19 pandemic and quarantine/distancing measures have forced researchers to cope with a new situation. This paper aimed to analyze how the pandemic and its associated constraints have affected social researchers' approach to research ethics. Drawing on an online qualitative survey with 193 Polish social researchers conducted in April and May 2020, we distinguished three approaches: <i>nothing has changed</i>, <i>opportunity-oriented</i>, and <i>precautionary</i>. According to the first, the pandemic was not regarded as a situation that required additional reflection on ethical issues or changes in research approaches. By contrast, the other two were based on the assumption that the pandemic affected research project ethics. The difference was in the assessment of changes in the area of ethics. The pandemic presented an opportunity and a threat to the ethicality of research, respectively. We discuss the implications of all three approaches for research and education.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"213-222"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39878294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biobank Participants' Attitudes Toward Data Sharing and Privacy: The Role of Trust in Reducing Perceived Risks.","authors":"T J Kasperbauer,&nbsp;Colin Halverson,&nbsp;Abby Garcia,&nbsp;Peter H Schwartz","doi":"10.1177/15562646211055282","DOIUrl":"https://doi.org/10.1177/15562646211055282","url":null,"abstract":"<p><p>Biobank participants are often unaware of possible uses of their genetic and health information, despite explicit descriptions of those uses in consent forms. To explore why this misunderstanding persists, we conducted semi-structured interviews and knowledge tests with 22 participants who had recently enrolled in a research biobank. Results indicated that participants lacked understanding of privacy and data-sharing topics but were mostly unconcerned about associated risks. Participants described their answers on the knowledge test as largely driven by their trust in the healthcare system, not by a close reading of the information presented to them. This finding may help explain the difficulties in increasing participant understanding of privacy-related topics, even when such information is clearly presented in biobank consent forms.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"167-176"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39878297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}