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Journal of Empirical Research on Human Research Ethics: JERHRE

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https://www.readbyqxmd.com/read/30616432/japanese-students-do-see-the-value-of-asking-about-child-abuse-and-trauma-in-the-research-setting
#1
Carolyn B Allard, Elizabeth Straus, Mai I Ra, Katie B Thomas, Reiko Kawamura, Yukari Tosaka
Despite evidence regarding the impact of childhood abuse perpetrated by close others, or high betrayal trauma, a number of barriers continue to impede research efforts, including concerns that research may do more harm than good. Research conducted with Western samples has indicated that contrary to such concerns, participants rate the benefit of participating in trauma research as outweighing costs, even when they have a history of high betrayal trauma. Certain non-Western values, such as interpersonal harmony, could play a role in perceptions regarding trauma research participation...
January 7, 2019: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30585505/exploring-ethical-concerns-about-human-challenge-studies-a-qualitative-study-of-controlled-human-malaria-infection-study-participants-motivations-and-attitudes
#2
Stephanie A Kraft, Devan M Duenas, James G Kublin, Kelly J Shipman, Sean C Murphy, Seema K Shah
Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-making tension with friends and family, mixed motivations for participating, low study risks but high burdens, fair compensation, sacrificing values, deceiving researchers, and perceived benefits...
December 26, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30541368/of-parachutes-and-participant-protection-moving-beyond-quality-to-advance-effective-research-ethics-oversight
#3
Holly Fernandez Lynch, Stuart Nicholls, Michelle N Meyer, Holly A Taylor
There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures...
December 12, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30522382/reviewing-student-research-can-we-consider-bad-science-to-be-ethical
#4
P Ethicist
No abstract text is available yet for this article.
December 7, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30486713/experts-perspectives-on-key-ethical-issues-associated-with-hiv-phylogenetics-as-applied-in-hiv-transmission-dynamics-research
#5
Farirai Mutenherwa, Douglas R Wassenaar, Tulio de Oliveira
The use of phylogenetics in HIV molecular epidemiology has considerably increased our ability to understand the origin, spread, and characteristics of HIV epidemics. Despite its potential to advance knowledge on HIV transmission dynamics, the ethical issues associated with HIV molecular epidemiology have received minimal attention. In-depth interviews were conducted with scientists from diverse backgrounds to explore their perspectives on ethical issues associated with phylogenetic analysis of HIV genetic data as applied to HIV transmission dynamics studies...
November 28, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30406711/the-psychological-risk-of-minimal-risk-activities-a-pre-and-posttest-study-using-the-self-assessment-manikin
#6
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
#7
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
#8
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
#9
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/30417754/-why-don-t-you-go-into-suburbs-why-are-you-targeting-us-trust-and-mistrust-in-hiv-vaccine-trials-in-south-africa
#10
Siyabonga Thabethe, Catherine Slack, Graham Lindegger, Abigail Wilkinson, Douglas Wassenaar, Philippa Kerr, Linda-Gail Bekker, Kathy Mngadi, Peter A Newman
Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members' experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites...
December 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/30417753/shifting-perspectives-on-research-integrity
#11
Melissa S Anderson
No abstract text is available yet for this article.
December 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
#12
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...
December 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
#13
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...
December 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
#14
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
#15
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
#16
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/30229705/commentary-on-a-framework-for-community-and-stakeholder-engagement-experiences-from-a-multicenter-study-in-southern-africa
#17
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
#18
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
#19
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
#20
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
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