Pub Date : 2021-12-01Epub Date: 2021-06-28DOI: 10.1177/15562646211026855
Mwifadhi Mrisho, Zaynab Essack
Background. 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. Methods. 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. Results. 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. Conclusion. 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.
{"title":"Understanding Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania.","authors":"Mwifadhi Mrisho, 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}
Pub Date : 2021-12-01Epub Date: 2021-09-07DOI: 10.1177/15562646211043782
Ryan Spellecy
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
{"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}
Pub Date : 2021-12-01Epub Date: 2021-05-14DOI: 10.1177/15562646211018665
Min-Fu Tsan
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.
{"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}
Pub Date : 2021-12-01Epub Date: 2021-08-30DOI: 10.1177/15562646211040281
{"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}
Pub Date : 2021-12-01Epub Date: 2021-07-22DOI: 10.1177/15562646211033191
Hooi Y See, Mohd S Mohamed, Siti N M Nor, Wah Y Low
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.
{"title":"Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study.","authors":"Hooi Y See, Mohd S Mohamed, Siti N M Nor, 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}
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.
{"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, Wilaiwan Chimkhong, 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}
Pub Date : 2021-10-01Epub Date: 2021-06-09DOI: 10.1177/15562646211023698
Nicole Jochym, Lisa Y Lin, Jon F Merz
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 (p = .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 z = 2.67, p = .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.
我们检查了系统评价中确定的71项实用和比较有效性试验的招募过程,使用通径分析来检查拒绝筛选、测试和同意参加试验的比率。我们的分析表明,如果对潜在的受试者进行筛选或要求进行身体资格测试,拒绝率可能会略高,但这在我们的试验样本中并不显著(p =)。曼-惠特尼试验)。我们发现,在受试者同意筛查或测试的试验中,拒绝提供知情同意的比率要低得多(优势比= 0.40,Wilcoxon秩和z = 2.67, p = 0.008)。我们还观察到,即使在涉及筛选或测试活动的试验中,绝大多数试验在确定资格后审查了获得同意的情况。讨论了未来研究的伦理意义和领域。
{"title":"Path Analysis of RCT Recruitment: Secondary Analysis of Results from a Systematic Review.","authors":"Nicole Jochym, Lisa Y Lin, 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}
Pub Date : 2021-10-01Epub Date: 2021-07-26DOI: 10.1177/15562646211033727
Ana Marija Ljubenković, Ana Borovečki, Marko Ćurković, Bjørn Hofmann, Søren Holm
This cross-sectional study evaluates the knowledge, attitudes, experiences, and behavior of final year medical students, PhD students, and supervisors at the School of Medicine of the University of Zagreb in relation to research misconduct, questionable research practices, and the research environment. The overall response rate was 36.4% (68%-100% for the paper survey and 8%-15% for the online surveys). The analysis reveals statistically significant differences in attitude scores between PhD students and supervisors, the latter having attitudes more in concordance with accepted norms. The results overall show a nonnegligible incidence of self-reported misconduct and questionable research practices, as well as some problematic attitudes towards misconduct and questionable research practices. The incidence of problematic authorship practices was particularly high. The research environment was evaluated as being mostly supportive of research integrity.
{"title":"Survey on the Research Misconduct and Questionable Research Practices of Medical Students, PhD Students, and Supervisors at the Zagreb School of Medicine in Croatia.","authors":"Ana Marija Ljubenković, Ana Borovečki, Marko Ćurković, Bjørn Hofmann, Søren Holm","doi":"10.1177/15562646211033727","DOIUrl":"https://doi.org/10.1177/15562646211033727","url":null,"abstract":"<p><p>This cross-sectional study evaluates the knowledge, attitudes, experiences, and behavior of final year medical students, PhD students, and supervisors at the School of Medicine of the University of Zagreb in relation to research misconduct, questionable research practices, and the research environment. The overall response rate was 36.4% (68%-100% for the paper survey and 8%-15% for the online surveys). The analysis reveals statistically significant differences in attitude scores between PhD students and supervisors, the latter having attitudes more in concordance with accepted norms. The results overall show a nonnegligible incidence of self-reported misconduct and questionable research practices, as well as some problematic attitudes towards misconduct and questionable research practices. The incidence of problematic authorship practices was particularly high. The research environment was evaluated as being mostly supportive of research integrity.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 4","pages":"435-449"},"PeriodicalIF":1.3,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211033727","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39223266","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}
Pub Date : 2021-10-01Epub Date: 2021-09-09DOI: 10.1177/15562646211041492
Jessica Bell, Megan Prictor, Lauren Davenport, Lynda O'Brien, Melissa Wake
'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas-data, participation, trust-to support future high-quality, large-scale digital research in health.
{"title":"Digital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future.","authors":"Jessica Bell, Megan Prictor, Lauren Davenport, Lynda O'Brien, Melissa Wake","doi":"10.1177/15562646211041492","DOIUrl":"https://doi.org/10.1177/15562646211041492","url":null,"abstract":"<p><p>'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas-data, participation, trust-to support future high-quality, large-scale digital research in health.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 4","pages":"344-355"},"PeriodicalIF":1.3,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39398407","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}
Pub Date : 2021-10-01Epub Date: 2021-09-17DOI: 10.1177/15562646211039701
Christopher A Rodriguez, Lakshmi Gopalakrishnan, Margareth Del Cid, Johanna B Folk, Juliet Yonek, Marina Tolou-Shams
Given its popularity among youth ages 13-17, social media is a promising avenue for engaging and retaining historically hard-to-reach youth in longitudinal research. Social media use in longitudinal research involving youth, however, has preceded development of best practices for ethical use. This article describes the ethical challenges and considerations of using social media to engage and retain youth within the context of a randomized controlled trial of a group-based adolescent substance use intervention. Best practices for addressing ethical challenges are also provided using the Belmont Principle as a guiding framework. As social media becomes more commonly used to engage and retain youth in clinical research studies, researchers must address emerging ethical concerns within project protocols.
{"title":"The Ethical Implications of Using Social Media to Engage and Retain Justice-Involved Youth in Behavioral Health Research.","authors":"Christopher A Rodriguez, Lakshmi Gopalakrishnan, Margareth Del Cid, Johanna B Folk, Juliet Yonek, Marina Tolou-Shams","doi":"10.1177/15562646211039701","DOIUrl":"https://doi.org/10.1177/15562646211039701","url":null,"abstract":"<p><p>Given its popularity among youth ages 13-17, social media is a promising avenue for engaging and retaining historically hard-to-reach youth in longitudinal research. Social media use in longitudinal research involving youth, however, has preceded development of best practices for ethical use. This article describes the ethical challenges and considerations of using social media to engage and retain youth within the context of a randomized controlled trial of a group-based adolescent substance use intervention. Best practices for addressing ethical challenges are also provided using the Belmont Principle as a guiding framework. As social media becomes more commonly used to engage and retain youth in clinical research studies, researchers must address emerging ethical concerns within project protocols.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 4","pages":"356-363"},"PeriodicalIF":1.3,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8800377/pdf/nihms-1766309.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39427586","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}