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Journal of Empirical Research on Human Research Ethics: JERHRE

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https://www.readbyqxmd.com/read/29448868/a-practical-approach-to-including-adults-unable-to-consent-in-research
#1
P Ethicist
No abstract text is available yet for this article.
February 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29390947/broad-consent-for-research-on-biospecimens-the-views-of-actual-donors-at-four-u-s-medical-centers
#2
Teddy D Warner, Carol J Weil, Christopher Andry, Howard B Degenholtz, Lisa Parker, Latarsha J Carithers, Michelle Feige, David Wendler, Rebecca D Pentz
Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Donors expressed very positive views regarding tissue donation in general and endorsed the use of their biospecimens in future research across a wide range of contexts...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29350083/from-a-fair-game-to-a-form-of-covert-research-research-ethics-committee-members-differing-notions-of-consent-and-potential-risk-to-participants-within-social-media-research
#3
R A Hibbin, G Samuel, G E Derrick
Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29347871/commentary-on-regulatory-support-improves-subsequent-irb-rec-approval-rates-in-studies-initially-deemed-not-ready-for-review-a-ctsa-institution-s-experience
#4
Stuart G Nicholls
In response to researcher concerns a number of initiatives have been developed to support individual researchers seeking ethics review and approval. In this issue, Sonne et al. (2017) outline an example of an intervention to support researchers, which they refer to as a Regulatory Knowledge Support (RKS) service. While the study points to potential benefits, other studies have not had the desired impact on key performance measures. There is a need to develop a community of practice and expand the burgeoning evidence base regarding what interventions work, for whom, and under what circumstances...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29345186/response-to-commentary-regulatory-support-improves-subsequent-irb-approval-rates-in-studies-initially-deemed-not-ready-for-review-a-ctsa-institution-s-experience
#5
Susan Sonne, Stephanie Gentilin, Royce Sampson, Leslie Bell, Toni Mauney, Summer Young, Katherine Bright, Patrick Flume
No abstract text is available yet for this article.
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29345179/regulatory-support-improves-subsequent-irb-approval-rates-in-studies-initially-deemed-not-ready-for-review-a-ctsa-institution-s-experience
#6
Susan Sonne, Stephanie Gentilin, Royce R Sampson, Leslie Bell, Toni Mauney, Summer Young, Katherine Bright, Patrick Flume
We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29345178/frequency-and-factors-associated-with-honorary-authorship-in-indian-biomedical-journals-analysis-of-papers-published-from-2012-to-2013
#7
Akash Shah, Sathish Rajasekaran, Anup Bhat, John M Solomon
Honorary authorship is the inclusion of an author on an article whose contribution does not warrant authorship. We conducted an Internet-based survey among first authors publishing in Indian biomedical journals from 2012 to 2013 to study the frequency and factors associated with honorary authorship. The response rate was 27% (245/908) with the prevalence of perceived, International Committee of Medical Journal Editors (ICMJE)-defined, and unperceived honorary authorship of 20.9% (50/239), 60% (147/245), and 46...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29226747/examining-data-repository-guidelines-for-qualitative-data-sharing
#8
Alison L Antes, Heidi A Walsh, Michelle Strait, Cynthia R Hudson-Vitale, James M DuBois
Qualitative data provide rich information on research questions in diverse fields. Recent calls for increased transparency and openness in research emphasize data sharing. However, qualitative data sharing has yet to become the norm internationally and is particularly uncommon in the United States. Guidance for archiving and secondary use of qualitative data is required for progress in this regard. In this study, we review the benefits and concerns associated with qualitative data sharing and then describe the results of a content analysis of guidelines from international repositories that archive qualitative data...
December 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29226746/what-can-irbs-learn-from-cabs-a-qualitative-analysis-of-the-experiences-of-recruitment-and-training-of-nonscientist-members-on-research-review-boards
#9
Stephanie Solomon Cargill
Governments, funders, and institutional policies increasingly encourage and even mandate the involvement of nonscientists in the ethical review of research, most famously in institutional review boards (IRBs), but also on community advisory boards (CABs) and other committees that contribute to research governance. In spite of these requirements, few have examined how different factors such as recruitment strategies, training, and different qualifications shape the contributions of nonscientists to the research enterprise...
December 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29243548/readability-of-human-subjects-training-materials-for-research
#10
Kristie B Hadden, Latrina Prince, Laura James, Jennifer Holland, Christopher R Trudeau
Institutions are required to ensure that persons involved in human subjects research receive appropriate human subjects protections training and education. Several organizations use the Collaborative Institutional Training Initiative (CITI) program to fulfill training requirements. Most researchers find the CITI program too complex for community members who collaborate with researchers. This study aimed to determine the readability of CITI modules most frequently used in community-based participatory research (CBPR)...
February 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29226745/management-of-adolescent-parent-dyads-discordance-for-willingness-to-participate-in-a-reproductive-health-clinical-trial
#11
Jenny K R Francis, Lauren Dapena Fraiz, Ariel M de Roche, Marina Catallozzi, Carmen Radecki Breitkopf, Susan L Rosenthal
The objective of this study is to understand the resolution of discordance between adolescent-parent dyads about participation in research. Adolescent (14-17 years) and parent dyads were recruited from NYC pediatric clinics to assess attitudes toward research participation. A subset of dyads participated in videotaped discussions about participation in a hypothetical study. Videos from dyads that held strongly discordant opinions about participation ( n = 30) were content-coded and analyzed using a thematic framework approach...
February 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29141519/abstracts-from-the-prim-r-2017-advancing-ethical-research-conference
#12
(no author information available yet)
No abstract text is available yet for this article.
December 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29086622/are-the-criteria-for-approval-sufficient-to-protect-research-participants
#13
P Ethicist
No abstract text is available yet for this article.
December 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28691559/ethics-and-science-in-the-participatory-era-a-vignette-based-delphi-study
#14
Elizabeth Bromley, Lisa Mikesell, Dmitry Khodyakov
Participatory researchers rely on relationship-based ethical considerations to address ethical challenges, but little is known about how these considerations shape day-to-day decision-making. We presented vignettes describing ethical dilemmas to health researchers with varying degrees of experience in participatory research in an online modified-Delphi panel. Panelists rated potential solutions to dilemmas and provided rationales for choosing solutions in text boxes and discussion boards. Panelists agreed on a preferred solution for three of five vignettes...
December 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29179626/reply-to-commentary-are-hiv-infected-candidates-for-participation-in-risky-cure-related-studies-otherwise-healthy
#15
Karine Dubé, Laurie Sylla, Lynda Dee
We respond to Eyal et al.'s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities...
November 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29179625/the-ethics-of-health-care-delivery-in-a-pediatric-malaria-vaccine-trial-the-perspectives-of-stakeholders-from-ghana-and-tanzania
#16
Claire Leonie Ward, David Shaw, Evelyn Anane-Sarpong, Osman Sankoh, Marcel Tanner, Bernice Elger
This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions...
November 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29179624/invited-commentary-on-dub%C3%A3-et-al-perceptions-of-equipoise-risk-benefit-ratios-and-otherwise-healthy-volunteers-in-the-context-of-early-phase-hiv-cure-research-in-the-united-states-a-qualitative-inquiry-are-hiv-infected-candidates-for-participation-in-risky
#17
https://www.readbyqxmd.com/read/29179623/in-defense-of-the-questionable-defining-the-basis-of-research-scientists-engagement-in-questionable-research-practices
#18
Donald F Sacco, Samuel V Bruton, Mitch Brown
National Institutes of Health principal investigators reported their perceptions of the ethical defensibility, prevalence in their field, and their personal willingness to engage in questionable research practices (QRPs). Using ethical defensibility ratings, an exploratory factor analysis yielded a two-factor solution: behaviors considered unambiguously ethically indefensible and behaviors whose ethical defensibility was more ambiguous. In addition, increasing perceptions that QRPs affect science predicted reduced acceptability of QRPs, whereas increasing beliefs that QRPs are normative or necessary for career success predicted increased acceptability of QRPs...
November 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29160115/linking-participatory-action-research-on-health-systems-to-justice-in-global-health-a-case-study-of-the-maternal-and-neonatal-implementation-for-equitable-health-systems-project-in-rural-uganda
#19
Bridget Pratt, Adnan A Hyder
An ethical framework called "research for health justice" provides initial guidance on how to link health systems research in low- and middle-income countries to health equity. To further develop the largely conceptual framework, we tested its guidance against the experience of the Maternal and Neonatal Implementation for Equitable Health Systems (Manifest) project, which was performed in rural Uganda by researchers from Makerere University. We conducted 21 in-depth interviews with investigators and research implementers, directly observed study sites, and reviewed study-related documents...
November 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29117849/seeking-ways-to-inform-the-uninformed-improving-the-informed-consent-process-in-online-social-science-research
#20
Evan K Perrault, David M Keating
Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, bolding, diagrams). Participants ( n = 547) were randomly exposed to one of seven form variations...
November 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
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