Independent Review, Data Safety Monitoring, and Research Oversight

Author(s):  
Toby L. Schonfeld

Independent review, data monitoring, and general oversight of human subjects research provide systematic mechanisms for ensuring that investigators implement best practices to minimize risks, maximize benefits, and ensure justice in the conduct of research. This chapter describes how successful partnerships between research teams and oversight groups have focused on the shared goals and commitments of the research enterprise and how each constitutive piece combines with structure, function, and purpose to facilitate the conduct of ethical research. The author argues that collaborative work toward ensuring not just fidelity to rules and regulations but also attention to the underlying ethical foundations for these mechanisms will foster meaningful conversations about how to ensure high-quality research that places the safety of human subjects at its core.

2021 ◽  
Vol 75 (6) ◽  
Author(s):  
Stacey Reynolds

The American Journal of Occupational Therapy (AJOT) retains its ranking as the top-rated occupational therapy journal in North America by maintaining its commitment to publishing high-quality research aimed at occupational therapy professionals. As the needs and scope of the profession continue to expand, AJOT will continue to serve as a resource to practitioners, academics, and administrators to help guide best practices. Communication and engagement with readers will be facilitated through the new AJOT website as well as the new AJOT: Authors and Issues series. The journal seeks to expand its scope through its website, manuscript submission platform, and new ways to engage readers.


2021 ◽  
Vol 75 (6) ◽  
Author(s):  
Stacey Reynolds

The American Journal of Occupational Therapy (AJOT) retains its ranking as the top-rated occupational therapy journal in North America by maintaining its commitment to publishing high-quality research aimed at occupational therapy professionals. As the needs and scope of the profession continue to expand, AJOT will continue to serve as a resource to practitioners, academics, and administrators to help guide best practices. Communication and engagement with readers will be facilitated through the new AJOT website as well as the new AJOT: Authors and Issues series. The journal seeks to expand its scope through its website, manuscript submission platform, and new ways to engage readers.


2012 ◽  
Vol 40 (4) ◽  
pp. 922-929 ◽  
Author(s):  
Steven Joffe

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.


2020 ◽  
Vol 12 (17) ◽  
pp. 6846
Author(s):  
Jinyuan Ma ◽  
Fan Jiang ◽  
Liujian Gu ◽  
Xiang Zheng ◽  
Xiao Lin ◽  
...  

This study analyzes the patterns of university co-authorship networks in the Guangdong-Hong Kong-Macau Greater Bay Area. It also examines the quality and subject distribution of co-authored articles within these networks. Social network analysis is used to outline the structure and evolution of the networks that have produced co-authored articles at universities in the Greater Bay Area from 2014 to 2018, at both regional and institutional levels. Field-weighted citation impact (FWCI) is used to analyze the quality and citation impact of co-authored articles in different subject fields. The findings of the study reveal that university co-authorship networks in the Greater Bay Area are still dispersed, and their disciplinary development is unbalanced. The study also finds that, while the research areas covered by high-quality co-authored articles fit the strategic needs of technological innovation and industrial distribution in the Greater Bay Area, high-quality research collaboration in the humanities and social sciences is insufficient.


Author(s):  
Elizabeth Lerner Papautsky ◽  
Richard J. Holden ◽  
Rupa S. Valdez ◽  
Jordan Hill ◽  
Janetta Brown

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.


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