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Journal of Empirical Research on Human Research Ethics: JERHRE

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https://www.readbyqxmd.com/read/30406711/the-psychological-risk-of-minimal-risk-activities-a-pre-and-posttest-study-using-the-self-assessment-manikin
#1
Maureen Murdoch, Melissa Ruth Partin, Derek Vang, Shannon Marie Kehle-Forbes
It is difficult to apply U.S. Federal Code of Regulation's criterion for "minimal risk," because benchmarks of minimal risk have not been quantified. Our goal was to examine the psychological risks of several day-to-day activities. Using the Self-Assessment Manikin (SAM), we assessed the state valence and arousal of 432 patients and employees at a large Midwestern Department of Veterans Affairs medical facility before and after they had their blood drawn, saw their primary care physician or mental health provider, or took part in an exercise class...
November 8, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30382789/trolley-dilemmas-fail-to-predict-ethical-judgment-in-a-hypothetical-vaccination-context
#2
Fredrik Andreas Dahl, Gry Oftedal
We investigated whether the responses of 68 ethics committee members and staff to trolley dilemmas could predict their responses to research ethics problems concerning vaccine trials. Trolley dilemmas deal with the issue of sacrificing some for the benefit of many, which is also a core issue in the vaccination trial dilemmas. The subjects' responses to trolley dilemmas showed no statistically significant correlation with their responses to our vaccination trial dilemmas. We concluded that, if there is a component of transferable intuition between the contexts, it must be small and dominated by other factors...
November 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30358480/risk-perceptions-for-trauma-related-research-an-exploratory-study-of-undergraduate-student-researchers-in-psychology
#3
Melissa S Atkins, Christopher LeGrow
The purpose of this study was to examine student researchers' perceptions of risks associated with trauma-related research. The participants were 92 students enrolled in an introductory Research Methods course. Students evaluated (a) trauma-exposed participants' ability to provide informed consent and (b) the potential consequences of participating in trauma-focused research. Risk perceptions were assessed at the beginning of the course, after completion of the Collaborative Institutional Training Initiative (CITI) ethics education, and at the end of the course...
October 25, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30358478/genomic-literacy-and-awareness-of-ethical-guidance-for-genomic-research-in-sub-saharan-africa-how-prepared-are-biomedical-researchers
#4
Olubunmi Ogunrin, Funmilola Taiwo, Lucy Frith
Achieving the objectives of rolling out genomic research programs in sub-Saharan Africa depends on how prepared indigenous biomedical researchers are for this type of research. We explored the level of preparedness of biomedical researchers in a sub-Saharan African country using in-depth interviews to obtain data on their understanding of genomics and genomic research and assess their awareness of the scope of the country's code of health research ethics. Thirty biomedical researchers were interviewed. Only eight were familiar with concepts of genomics, a form of "genomic health literacy...
October 25, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30353779/privacy-of-clinical-research-subjects-an-integrative-literature-review
#5
Sanna-Maria Nurmi, Mari Kangasniemi, Arja Halkoaho, Anna-Maija Pietilä
With changes in clinical research practice, the importance of a study-subject's privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl's work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy...
October 24, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30296898/impact-of-a-clinical-trial-in-two-district-hospitals-in-ghana-perspectives-of-ghanaian-researchers
#6
Patrick T Wilson, Katie Giessler, Marilyn C Morris
Conducting clinical trials in resource-poor settings may contribute to local capacity building. We describe the perspectives of local research personnel regarding the impact of collaborating in a clinical trial in rural Ghana. Forty-six Ghanaian research personnel were eligible to complete an anonymous survey, and 35 (76%) participated. Of the 35 respondents, 32 (91%) agreed that future patients will benefit because the hospital was part of the study. All 35 respondents reported a personal benefit derived from study involvement, most commonly citing skills or knowledge gained...
October 8, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30296884/measuring-the-quality-and-performance-of-institutional-review-boards
#7
Min-Fu Tsan
Despite the importance of institutional review boards (IRBs) in protecting human subjects participating in research and the well-known benefits of performance measurements, there has been no systematic assessment of the quality and performance of IRBs. The IRB community has frequently cited the lack of credible metrics for measuring human subject protections and the quality of IRB ethics reviews as reasons for not measuring the quality and performance of IRBs. However, the IRB, with its well-defined missions, functions, structure, and procedures, should be readily amendable to performance measurements...
October 8, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30296882/healthy-volunteers-perceptions-of-the-benefits-of-their-participation-in-phase-i-clinical-trials
#8
Jill A Fisher, Lisa McManus, Megan M Wood, Marci D Cottingham, Julianne M Kalbaugh, Torin Monahan, Rebecca L Walker
Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants' sociodemographic characteristics and clinical trial history...
October 8, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30232925/heuristic-patterns-of-ethical-decision-making
#9
David J Hartmann, Olivia McLaughlin
This article describes the context of ethical decision making in research and suggests that direct attention to the ways in which decisions are actually made in such environments is needed. A decision-making model based on the literature on heuristic processing is proposed and is followed by a review of the method, data, and results of the authors' research on this model. The implications of the research are developed, and a research agenda is outlined. Key findings were that competent actors do indeed process ethics problems heuristically and in ways that interweave intuitive, affective, and more rational phases...
September 20, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30183457/perceived-risks-and-benefits-in-ipv-and-hiv-research-listening-to-the-voices-of-hiv-positive-african-american-women
#10
Nicole M Overstreet, Mukadder Okuyan, Celia B Fisher
African American women living with HIV were asked to reflect on the perceived risks and benefits of research participation after completing a study examining socially sensitive issues in their lives, including intimate partner violence (IPV) and HIV. Administration of standardized quantitative instruments yielded positive responses to the research experience. However, qualitative assessments of perceived risks and benefits revealed more nuanced responses. For example, confidentiality concerns were more prominent in open-ended responses as was participants' positive attitudes toward monetary compensation...
September 5, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30229705/commentary-on-a-framework-for-community-and-stakeholder-engagement-experiences-from-a-multicenter-study-in-southern-africa
#11
Peter A Newman, Catherine M Slack, Graham Lindegger
Community and stakeholder engagement (CSE) is increasingly acknowledged as foundational to global health research. This commentary builds on the multisite framework for CSE described in an eco-health study conducted in Southern Africa. We acknowledge the context-specific nature of some of the challenges for CSE and draw attention to significant issues and concerns that arose from our studies of CSE in the context of multisite HIV prevention trials in South Africa, India, and Canada: (a) Pretrial-historically based mistrust, identification of appropriate gatekeepers, and considering the breadth of community; (b) Trial implementation-impact of early trial cessations, appropriate community roles and responsibilities, and multifaceted stigma; and (c) Posttrial-supporting and sustaining CSE mechanisms independent of particular trials...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30141738/is-it-time-to-re-evaluate-the-ethics-governance-of-social-media-research
#12
G Samuel, W Ahmed, H Kara, C Jessop, S Quinton, S Sanger
This article reports on a U.K. workshop on social media research ethics held in May 2018. There were 10 expert speakers and an audience of researchers, research ethics committee members, and research institution representatives. Participants reviewed the current state of social media ethics, discussing well-rehearsed questions such as what needs consent in social media research, and how the public/private divide differs between virtual and real-life environments. The lack of answers to such questions was noted, along with the difficulties posed for ethical governance structures in general and the work of research ethics committees in particular...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30124102/an-analysis-of-informed-consent-form-readability-of-oncology-research-protocols
#13
Benjamin Munley, Amy T Buser, Stephanie Gaudreau, Joseph L Breault, Lydia A Bazzano
Twenty-two percent of adults in the United States have only basic health literacy skills. We used a multiple linear regression model to identify associations between readability of informed consent documents with study sponsor, study phase, and approval year using a sample of 143 oncology studies at Ochsner Medical Center. The M ± SD Flesh-Kincaid Reading Grade Level (RGL) was 10.33 ± 0.85 and Flesh Reading Ease (FRE) was 52.89 ± 5.49. National Cancer Institute studies had a significantly lower mean RGL and FRE as compared with other sponsors (RGL 9...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30103655/adolescents-and-parents-attitudes-toward-adolescent-clinical-trial-participation-changes-over-one-year
#14
Rebecca K Tsevat, Carmen Radecki Breitkopf, Sara E Landers, Ariel M de Roche, Christine Mauro, Lisa S Ipp, Marina Catallozzi, Susan L Rosenthal
Little is known about how adolescents' and parents' thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)-parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30091400/academic-and-scientific-authorship-practices-a-survey-among-south-african-researchers
#15
Elsie Breet, Jan Botha, Lyn Horn, Leslie Swartz
Empirical studies of authorship practices in high-income countries have been conducted, while research on this issue is scarce in low- and middle-income countries. A survey was conducted among South African researchers who have published in peer-reviewed journals, to explore their understanding of and ability to apply academic authorship criteria. A total of 967 researchers participated in the survey; 88% of respondents had knowledge of academic authorship criteria, while only 52% found it easy to apply the criteria...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30084320/-hope-for-the-best-plan-for-the-worst-understanding-institutional-inertia-in-developing-confidentiality-protection-policies
#16
Ted Palys, Aaren Ivers
When legal challenges to research confidentiality arise, researchers are expected to resist while the institutions that approve their research provide legal support to enable that resistance. Although researchers have done their part, university administrators have been much less consistent doing theirs. Canada's federal policy now affirms university administrations "must" provide independent legal representation and "encourages" them to develop policies that articulate how they will do so...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29998787/women-s-views-about-a-paternal-consent-requirement-for-biomedical-research-in-pregnancy
#17
Kristen A Sullivan, Maggie Little, Nora E Rosenberg, Tiwonge Mtande, Chifundo Zimba, Elana Jaffe, Jean Anderson, Jenell S Coleman, Sappho Gilbert, Marielle S Gross Wolf, Irving Hoffman, Lisa Rahangdale, Ruth Faden, Anne Drapkin Lyerly
Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth interviews with 140 pregnant women living with or at risk of HIV-70 in Malawi, 70 in the United States-exploring their views on requiring paternal consent for pregnant women's participation in trials offering the prospect of direct benefit solely to the fetus...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29902956/the-real-time-irb-a-collaborative-innovation-to-decrease-irb-review-time
#18
Ryan Spellecy, Ann Marie Eve, Emily R Connors, Reza Shaker, David C Clark
Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised "Real-Time IRB," a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29902953/irb-oversight-of-patient-centered-outcomes-research-a-national-survey-of-irb-chairpersons
#19
Joel S Weissman, Eric G Campbell, I Glenn Cohen, Holly Fernandez Lynch, Emily A Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spikes, Maureen Fagan, Martie Carnie
Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29900801/biobanking-in-the-pediatric-critical-care-setting-adolescent-young-adult-perspectives
#20
Erin D Paquette, Sabrina F Derrington, Avani Shukla, Neha Sinha, Sarah Oswald, Lauren Sorce, Kelly N Michelson
Biorepository research in children raises numerous ethical questions that are heightened in the pediatric intensive care unit (PICU) setting. We conducted a cross-sectional, interview-based study of 20 adolescent/young adult (A/YA) PICU patients and 75 parents of PICU patients to elucidate perspectives on biorepository research. A/YAs had a positive attitude toward biobanking. In young adults, comprehension was higher for knowledge of a choice to withdraw and participate in the research and lower for purpose, procedures, risks, and benefits of participation...
October 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
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