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Journal of Empirical Research on Human Research Ethics: JERHRE

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https://www.readbyqxmd.com/read/28412874/effects-of-regulatory-support-services-on-institutional-review-board-turnaround-times
#1
Pankaja Desai, Priyanka Nasa, Jackie Soo, Cunhui Jia, Michael L Berbaum, James H Fischer, Timothy P Johnson
We evaluated how regulatory support services provided by University of Illinois at Chicago's Center for Clinical and Translational Science may reduce Institutional Review Board (IRB) turnaround times. IRB applications were categorized by receipt of any regulatory support and amount of support received. Turnaround time included total turnaround time, time for IRB review, and time for investigators to modify protocols. There were no differences in any turnaround times for supported versus nonsupported applications...
April 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28366045/equitable-selection-of-subjects
#2
(no author information available yet)
No abstract text is available yet for this article.
March 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421889/overall-assessment-of-human-research-and-ethics-committees-in-the-united-arab-emirates
#3
Mahera Abdulrahman, Satish Chandrasekhar Nair
Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421888/instructions-to-prospective-authors-by-indian-biomedical-journals-an-opportunity-to-promote-responsible-conduct-of-research
#4
Anup Bhat, Akash Shah, Swathi G Sherighar
Journals provide instructions to prospective authors to facilitate the process of manuscript publication. The information provided under such instructions could be a potential opportunity to promote responsible conduct of research (RCR). We analyzed 74 Indian biomedical journals for the type of information provided in the "instructions to authors" section and adherence to the International Committee of Medical Journal Editors (ICMJE) recommendations. Among the 71 journals that had an "instructions to authors" section, 53 journals adhered to ICMJE recommendations...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421887/preferences-for-the-return-of-individual-results-from-research-on-pediatric-biobank-samples
#5
Kurt D Christensen, Sarah K Savage, Noelle L Huntington, Elissa R Weitzman, Sonja I Ziniel, Phoebe L Bacon, Cara N Cacioppo, Robert C Green, Ingrid A Holm
Discussions about disclosing individual genetic research results include calls to consider participants' preferences. In this study, parents of Boston Children's Hospital patients set preferences for disclosure based on disease preventability and severity, and could exclude mental health, developmental, childhood degenerative, and adult-onset disorders. Participants reviewed hypothetical reports and reset preferences, if desired. Among 661 participants who initially wanted all results (64%), 1% reset preferences...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421886/book-review-balanced-ethics-review-a-guide-for-institutional-review-board-members-whitney-s-n-2016-balanced-ethics-review-a-guide-for-institutional-review-board-members-cham-germany-springer-131-pp-isbn-978-3-319-20704-9-us-59-99-paper
#6
https://www.readbyqxmd.com/read/28421885/recognizing-risk-and-vulnerability-in-research-ethics-imagining-the-what-ifs
#7
Elizabeth Peter, Judith Friedland
Research ethics committees (RECs) may misunderstand the vulnerability of participants, given their distance from the field. What RECs identify as the vulnerabilities that were not adequately recognized in protocols and how they attempt to protect the perceived vulnerability of participants and mitigate risks were examined using the response letters sent to researchers by three university-based RECs. Using a critical qualitative method informed by feminist ethics, we identified an overarching theme of recognizing and responding to cascading vulnerabilities and four subthemes: identifying vulnerable groups, recognizing potentially risky research, imagining the "what ifs," and mitigating perceived risks...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421884/children-s-decision-making-involvement-about-research-participation-associations-with-perceived-fairness-and-self-efficacy
#8
Victoria A Miller, Chris Feudtner, Abbas F Jawad
The primary objective of this study was to examine the associations of children's involvement in decisions about research participation with their perceptions of the decision-making process and self-efficacy. Participants were children (ages 8-17) who enrolled in research studies in the prior 2 months. Children completed a questionnaire that yielded three decision-making involvement subscales: Researcher Engages Child, Researcher Supports Autonomy, and Child Participates. Children reported on fairness of the decision-making process and health-related decision self-efficacy...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421883/ctsa-institution-responses-to-proposed-common-rule-changes-did-they-get-what-they-wanted
#9
Suzanne M Rivera, Lisa Nichols, Lois Brako, Genevieve Croft, Toni Russo, Tara Tran
In 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies proposed revisions to the Federal Policy for the Protection of Human Subjects. In this Notice of Proposed Rulemaking (NPRM), the departments sought to strengthen, modernize, and make more effective human subjects regulations while reducing administrative burden, delay, and ambiguity. We reviewed public comments from National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSA) institutions on key provisions of the NPRM to understand how the proposed changed were received at research-intensive institutions...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220725/european-universities-guidance-on-research-integrity-and-misconduct
#10
NoƩmie Aubert Bonn, Simon Godecharle, Kris Dierickx
Research integrity is imperative to good science. Nonetheless, many countries and institutions develop their own integrity guidance, thereby risking incompatibilities with guidance of collaborating institutions. We retrieved guidance for academic integrity and misconduct of 18 universities from 10 European countries and investigated accessibility, general content, principles endorsed, and definitions of misconduct. Accessibility and content differ substantially between institutions. There are general trends of common principles of integrity and definitions of misconduct, yet differences remain...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220724/an-observational-study-of-children-s-involvement-in-informed-consent-for-exome-sequencing-research
#11
Victoria A Miller, Allison Werner-Lin, Sarah A Walser, Sawona Biswas, Barbara A Bernhardt
The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220723/ethical-issues-surrounding-the-use-of-modern-human-remains-for-research-in-south-africa
#12
N Briers, J J Dempers
Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220722/life-after-research-misconduct
#13
Kyle L Galbraith
Research misconduct is a serious violation of a scientific community's ethical standards. Scientists who commit research misconduct typically face corrective actions from employers and funding agencies, as well as significant professional stigma. Unfortunately, there is little systematic data about the post-misconduct career of these guilty parties. Through a review of Office of Research Integrity (ORI) case summaries, I identified a pool of 284 researchers who engaged in research misconduct and were subject to ORI corrective actions...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220721/increasing-community-research-capacity-to-address-health-disparities
#14
Goldie Komaie, Christine C Ekenga, Vetta L Sanders Thompson, Melody S Goodman
The Community Research Fellows Training program is designed to enhance capacity for community-based participatory research; program participants completed a 15-week, Master of Public Health curriculum. We conducted qualitative, semistructured interviews with 81 participants from two cohorts to evaluate the learning environment and how the program improved participants' knowledge of public health research. Key areas that provided a conducive learning environment included the once-a-week schedule, faculty and participant diversity, and community-focused homework assignments...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28220720/jerhre-s-journey
#15
Joan Sieber, Douglas Wassenaar
No abstract text is available yet for this article.
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28078953/evidence-based-strategies-for-shortening-informed-consent-forms-in-clinical-research
#16
Amy Corneli, Emily Namey, Monique P Mueller, Jenae Tharaldson, Steve Sortijas, Thomas Grey, Jeremy Sugarman
Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once...
February 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28007007/to-what-extent-do-risks-need-to-be-minimized
#17
Practical Ethicist
No abstract text is available yet for this article.
December 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28007006/abstracts-from-the-prim-r-2016-advancing-ethical-research-conference
#18
Emily E Anderson
No abstract text is available yet for this article.
December 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/27646401/are-leadership-and-management-essential-for-good-research-an-interview-study-of-genetic-researchers
#19
Alison L Antes, Adelina Mart, James M DuBois
Principal investigators are responsible for a myriad of leadership and management activities in their work. The practices they use to navigate these responsibilities ultimately influence the quality and integrity of research. However, leadership and management roles in research have received scant empirical examination. Semi-structured interviews with 32 National Institutes of Health (NIH)-funded genetic researchers revealed that they considered leadership and management essential for effective research, but their scientific training inadequately prepared them...
December 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/27307420/is-safety-in-the-eye-of-the-beholder-safeguards-in-research-with-adults-with-intellectual-disability
#20
Katherine E McDonald, Nicole E Conroy, Carolyn I Kim, Emily J LoBraico, Ellis M Prather, Robert S Olick
Human subjects research has a core commitment to participant well-being. This obligation is accentuated for once exploited populations such as adults with intellectual disability. Yet we know little about the public's views on appropriate safeguards for this population. We surveyed adults with intellectual disability, family members and friends, disability service providers, researchers, and Institutional Review Board (IRB) members to compare views on safeguards. We found many points of convergence of views, particularly for decision-making and participation...
December 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
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