Journal of Empirical Research on Human Research Ethics最新文献

{"title":"Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes.","authors":"Christian M Simon, Kai Wang, Laura A Shinkunas, Daniel T Stein, Paul Meissner, Maureen Smith, Rebecca Pentz, David W Klein","doi":"10.1177/15562646211038819","DOIUrl":"10.1177/15562646211038819","url":null,"abstract":"<p><p>Some individuals' understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"144-166"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8712348/pdf/nihms-1728143.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39326079","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 Systematic Literature Review of Ethical Challenges Related to Medical and Public Health Data Sharing in China.","authors":"Xiaojie Li,&nbsp;Yali Cong","doi":"10.1177/15562646211040299","DOIUrl":"https://doi.org/10.1177/15562646211040299","url":null,"abstract":"<p><p>Although stakeholders in China have begun promoting medical and public health data sharing, a large portion of data cannot flow freely across research teams and borders and be converted into \"big data.\" To identify the ethical challenges that are considered to hinder medical and public health data sharing, we performed a systematic literature review pertaining to medical and health data sharing in China. A total of 2959 unique records were retrieved through the database search, 61 of which were included in the final synthesis after full-text screening. This review provides an overview of the current ethical challenges and barriers involved in data sharing for healthcare purposes in China. Through the systematic review of evidence from peer-reviewed literature and dissertations, we identified barriers and ethical challenges grouped in a taxonomy of capacity building needs, balancing different stakeholders' interests, scientific and social value, and the data subjects' rights, public trust and engagement. Best practices and educational implications were suggested based on our findings.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"537-554"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39412810","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":"Participants' Preferences and Reasons for Wanting Feedback of Individual Genetic Research Results From an HIV-TB Genomic Study: A Case Study From Botswana.","authors":"Dimpho Ralefala,&nbsp;Mary Kasule,&nbsp;Olivia P Matshabane,&nbsp;Ambroise Wonkam,&nbsp;Mogomotsi Matshaba,&nbsp;Jantina de Vries","doi":"10.1177/15562646211043985","DOIUrl":"https://doi.org/10.1177/15562646211043985","url":null,"abstract":"<p><p>The feedback of individual results of genomics research is an ethical issue. However, which genetic results African participants would like to receive and why, remains unclear. A qualitative study was conducted to collect data from 44 adolescents and 49 parents/caregivers of adolescents enrolled in a genomic study in Botswana. Almost all the participants wanted to receive genetic results. Parents and caregivers wanted to receive results across all categories of genetic conditions discussed in the study, while adolescents were reluctant to receive results for severe, non-preventable, and unactionable conditions. Participants expressed different reasons for wanting feedback of results, including for awareness, improving lifestyle, accepting one' situation, and preparing for the future. Our findings also reveal that participants' context, relations, and empowerment are important to consider in interpreting their preferences for feedback of results.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"525-536"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/40/2a/10.1177_15562646211043985.PMC8642165.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39528079","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 Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania.","authors":"Mwifadhi Mrisho,&nbsp;Zaynab Essack","doi":"10.1177/15562646211026855","DOIUrl":"10.1177/15562646211026855","url":null,"abstract":"<p><p><b><i>Background</i></b>. Independent ethics review of research is required prior to the implementation of all health research involving human participants. However, ethics review processes are challenged by protracted turnaround times, which may negatively impact the implementation of socially valuable research. Previous research has documented delays in ethics review in developed and developing countries. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. <b><i>Methods</i></b>. This descriptive cross-sectional study employed a mixed-method approach, with qualitative and quantitative components. Seven IRBs were purposively sampled from the 15 accredited IRBs operational in Tanzania during the study period, April 2017-April 2018. Quantitative data were analysed using STATA software and qualitative data were analysed thematically. <b><i>Results</i></b>. The median time for review across all IRBs was 32 days, with a range of 1-396 days. Qualitative results identified five key themes related to turnaround time from interviews with participants. These included: (1) procedures for receiving and distribution of protocols, (2) number of reviewers assigned to protocols, (3) duration of reviewing protocols, (4) reasons for delayed feedback, and (5) training of research ethics committee members. <b><i>Conclusion.</i></b> The study showed that the median days for ethical approval in Tanzania was 32 days. We observed from this study that electronic submission systems facilitated faster turnaround times. Failure to adhere to the submission checklists and guidelines was a major obstacle to the turnaround time.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"514-524"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211026855","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39114522","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":"Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurements.","authors":"Ryan Spellecy","doi":"10.1177/15562646211043782","DOIUrl":"https://doi.org/10.1177/15562646211043782","url":null,"abstract":"Dr Tsan’s invited commentary “Improving the quality and performance of institutional review boards in the U.S. through performance measurements” should be commended for two important reasons. First, the article is based on a review of the performance measurement data literature on IRBs, thus grounding the discussion in the empirical evidence. There is a welcome trend in the IRB literature to see a focus on empirical research on IRBs (when the question being asked is empirical in nature), led by JERHRE and continued by this article. I welcome work such as this, and I would hope our field would as well. Second, the author should be commended for focusing not merely on turn-around time, but on other measures of quality as well. For too long, the single measure of IRB quality has been turn-around time. While this is certainly important, and we ought not lose sight of it, seeking to reduce turn-around time whenever possible, it is not the sole measure of quality for IRBs. The Coast IRB scandal, in which a commercial IRB was exposed by the Government Accountability Office for approving fake, risky studies with fictitious PIs, is a clear reminder that turn-around time alone cannot account for the quality of an IRB (Dove, 2009). Regardless of turn-around time, Coast IRB was far from a quality IRB in part because it failed to meet some of the very quality recommendations made in this article. Yet, turn-around time is important, and not simply to approve studies faster. It matters, and is related to the IRB mission, as it facilitates adherence to the Belmont ethical principles. If IRBs do not work to improve the time it takes to review and approve studies, we fail to live up to respect for persons and justice. If we believe that prospective research participants have the right to decide for themselves whether or not to participate in research, as respect for persons requires, delays in the review and approval of research will mean that some individuals will miss that chance because the research was approved too late. So too for justice, in that if we believe that research requires a fair distribution of the benefits and burdens of research, delays will slow efforts to address healthcare and research inequalities through research. Yet, we must emphasize that the IRB is tasked with reviewing and approving research, not simply expediting to reduce turnaround time. That is an essential point made by the author of this article, focusing on how the quality and efficiency of IRBs can be improved. The importance of looking to measures of quality beyond mere turn-around time relates to the question of what the role of an IRB is, or what is its mission. While many would say it is to protect research participants, including OHRP, FDA, and the regulations that govern research, I have argued elsewhere that this view is short-sighted and over focuses on non-maleficence, perhaps at the expense of other Belmont principles such as respect for persons and justice (Spellecy ","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"485-486"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39392687","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":"Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements.","authors":"Min-Fu Tsan","doi":"10.1177/15562646211018665","DOIUrl":"https://doi.org/10.1177/15562646211018665","url":null,"abstract":"<p><p>Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"479-484"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211018665","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38982675","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":"Corrigendum to 'Using the Emanuel Framework to Explore the Ethical Issues Raised in a Participatory Visual Research Project in Rural South Africa'.","authors":"","doi":"10.1177/15562646211040281","DOIUrl":"https://doi.org/10.1177/15562646211040281","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"555"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822184/pdf/10.1177_15562646211040281.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39363040","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":"Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study.","authors":"Hooi Y See,&nbsp;Mohd S Mohamed,&nbsp;Siti N M Nor,&nbsp;Wah Y Low","doi":"10.1177/15562646211033191","DOIUrl":"https://doi.org/10.1177/15562646211033191","url":null,"abstract":"<p><p>Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"487-500"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211033191","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39208611","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":"Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee.","authors":"Thana Khawcharoenporn,&nbsp;Wilaiwan Chimkhong,&nbsp;Varanya Roestpricha","doi":"10.1177/15562646211025470","DOIUrl":"https://doi.org/10.1177/15562646211025470","url":null,"abstract":"<p><p>A pre-post study was conducted to evaluate the utility of template documents specifically created to assist research protocol submissions to a Thai research ethics committee (REC). A total of 172 protocols during the 2014-2016 preintervention period were matched to 172 protocols during the 2017-2019 postintervention period by type of principal investigator and REC review category. The intervention was associated with a significant reduction in initial REC requirement deficiencies in the information sheet and informed consent form, resubmission turn-around time by the principal investigator, and time form protocol submission to REC approval. The most significant postintervention improvements were for information about the consent process and listed risks of study participation. In this study, utilization of a structured protocol template with guidance instructions was associated with measurable improvement in the quality of research protocol submissions and REC review process.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"501-513"},"PeriodicalIF":1.3,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211025470","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39092573","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":"Path Analysis of RCT Recruitment: Secondary Analysis of Results from a Systematic Review.","authors":"Nicole Jochym,&nbsp;Lisa Y Lin,&nbsp;Jon F Merz","doi":"10.1177/15562646211023698","DOIUrl":"https://doi.org/10.1177/15562646211023698","url":null,"abstract":"<p><p>We examine recruitment processes for 71 pragmatic and comparative effectiveness trials identified in a systematic review, using path analysis to examine rates of refusal to screen, test, and consent to trial participation. Our analysis suggests that refusal rates might be on net slightly higher if potential subjects are screened or asked to undergo physical eligibility tests, but this was not significant in our sample of trials (<i>p</i> = .11 by Mann-Whitney test). We find that rates of refusing to provide informed consent are much lower for trials in which subjects have agreed to screening or testing (odds ratio = 0.40, Wilcoxon rank-sum <i>z</i> = 2.67, <i>p</i> = .008). We also observe that the overwhelming majority of trials examined secured consent after determining eligibility, even in trials involving screening or testing activities. The ethical implications and areas for future research are discussed.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 4","pages":"418-423"},"PeriodicalIF":1.3,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211023698","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39078259","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}