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Huang, David T.; Hadian, Mehrnaz

doi:10.1186/cc5114

Cited by 6 publications

(1 citation statement)

References 54 publications

(49 reference statements)

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“…For effective vaccine development, it is essential to understand the mechanisms underlying the acquisition of malaria immunity in humans [ 36 - 39 ]. However, studies in humans are complex and beyond ethical limitations [ 40 , 41 ], and many other limitations, such as the lack of access to relevant organ and tissue samples and the difficulty to manipulate the immune response, make the use of experimental models necessary. Therefore, the use of experimental models phylogenetically related to humans is ideal.…”

Section: Discussionmentioning

confidence: 99%

Molecular and immunological tools for the evaluation of the cellular immune response in the neotropical monkey Saimiri sciureus, a non-human primate model for malaria research

Riccio

Pratt-Riccio

Bianco‐Júnior

et al. 2015

Malar J

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BackgroundThe neotropical, non-human primates (NHP) of the genus Saimiri and Aotus are recommended by the World Health Organization as experimental models for the study of human malaria because these animals can be infected with the same Plasmodium that cause malaria in humans. However, one limitation is the lack of immunological tools to assess the immune response in these models. The present study focuses on the development and comparative use of molecular and immunological methods to evaluate the cellular immune response in Saimiri sciureus.MethodsBlood samples were obtained from nineteen uninfected Saimiri. Peripheral blood mononuclear cells (PBMC) from these animals and splenocytes from one splenectomized animal were cultured for 6, 12, 18, 24, 48, 72 and 96 hrs in the presence of phorbol-12-myristate-13-acetate and ionomycin. The cytokine levels in the supernatant were detected using human and NHP cytometric bead array Th1/Th2 cytokine kits, the Bio-Plex Pro Human Cytokine Th1/Th2 Assay, enzyme-linked immunosorbent assay, enzyme-linked immunospot assays and intracellular cytokine secretion assays. Cytokine gene expression was examined through TaqMan® Gene Expression Real-Time PCR using predesigned human gene-specific primers and probes or primers and probes designed based on published S. sciureus cytokine sequences.ResultsThe use of five assays based on monoclonal antibodies specific for human cytokines facilitated the detection of IL-2, IL-4 and/or IFN-γ. TaqMan array plates facilitated the detection of 12 of the 28 cytokines assayed. However, only seven cytokines (IL-1A, IL-2, IL-10, IL-12B, IL-17, IFN-β, and TNF) presented relative expression levels of at least 70% of the gene expression observed in human PBMC. The use of primers and probes specific for S. sciureus cytokines facilitated the detection of transcripts that showed relative expression below the threshold of 70%. The most efficient evaluation of cytokine gene expression, in PBMC and splenocytes, was observed after 6–12 hrs of culture, except for LTA in PBMC, whose expression was best analysed after 24 hrs of culture.ConclusionsReal-time PCR facilitates the analysis of a large number of cytokines altered during malaria infection, and this technique is considered the best tool for the evaluation of the cellular immune response in S. sciureus.

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Section: Discussionmentioning

confidence: 99%

Molecular and immunological tools for the evaluation of the cellular immune response in the neotropical monkey Saimiri sciureus, a non-human primate model for malaria research

Riccio

Pratt-Riccio

Bianco‐Júnior

et al. 2015

Malar J

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Challenges and Opportunities in Pain Management Disparities Research: Implications for Clinical Practice, Advocacy, and Policy

Campbell

Robinson

Meghani

et al. 2012

The Journal of Pain

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Due to high profile initiatives at the national level, awareness of inadequate pain care affecting many groups in our society has never been greater. Nevertheless, increased awareness of pain disparities and the initiatives to address these disparities have yielded only modest progress, most notably in the form of growing appreciation that pain disparities likely result from multiple factors, including biological, psychological, environmental, health system, and cultural factors. Much less progress has been made in developing interventions that target these multiple determinants to reduce pain management disparities. In this paper we discuss key ethical and methodological challenges that undermine our capacity to investigate and develop meaningful interventions to improve pain outcomes among vulnerable populations. Key challenges in the areas of research engagement, recruitment, design, and measurement are discussed from both scientific and normative standpoints. Specific opportunities within emerging research paradigms to improve designs and measures are also discussed. Finally, we conclude with identifying potential synergies between the pain management disparities research agenda and the broader areas of clinical practice, advocacy, and policy that could help to move the field forward. Perspective Researchers studying disparities in pain care face a number of ethical and methodological challenges that must be addressed to advance the field towards eliminating disparities. We discuss these ethical and methodological challenges and propose opportunities for paradigmatic revisions in areas of research engagement, design, measurement, advocacy, and policy.

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Changes in the institutional review board submission process for multicenter research over 6 years

Pogorzelska

Cohn²,

Larson³

2010

Nursing Outlook

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While collaborative research across sites is essential to increase the statistical power and generalizability of research findings, the need to undergo multiple IRB reviews is a challenge. The purposes of this paper are to describe changes in the IRB submission process in two national multisite studies before and after the implementation of the Health Information Portability and Accountability Act (HIPAA) Privacy rule (2002 and 2008), and to discuss implications for policy and practice related to human subjects research. In the second study there was a shorter mean approval time and reduced variability in the decision about the level of review, the mean number of pages per application doubled, and an increased proportion of IRBs required conflict of interest and data use agreements. Possible approaches to further enhance the efficiency and streamlining of the research review process are suggested. Keywords human subjects; Institutional review boards; research ethics; clinical researchOversight of human subjects research is an ethical as well as a legal imperative. Such oversight is generally delegated to local institutional review boards (IRBs), whose mandate is to assure that regulatory and ethical standards are upheld in research protocols.1 , 2 Although federal regulations regarding research are mandated only for protocols receiving federal funding, these same standards are generally applied to all research, regardless of whether a project receives external funding or is unfunded. Several recent reviews have reported wide variation and substantial challenges in how IRBs handle multisite studies.3 -5 To encourage standardization of human subject protections in research, IRBs or independent ethics committees must be registered through the Office of Human Research Protections (OHRP). There are currently thousands of such registered boards. In California alone, for example, there are >2,000 registered IRBs and in New York there are >1, 400. 6 In addition to OHRP oversight, the Health Information Portability and Accountability Act (HIPAA) Privacy Rule 7 enacted in 2003, has resulted in major changes in how personal health information is handled. The IRB is charged with the responsibility of monitoring © 2010 Mosby, Inc. All rights reserved. mp2422@columbia.edu . Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. adherence to HIPAA regulations as part of the approval process for research protocols. In order to better understand the current status of the review of human subjects research and the impact of HIPAA on the IRB process, we examined our experiences in two na...

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Untitled

Cited by 6 publications

References 54 publications

Molecular and immunological tools for the evaluation of the cellular immune response in the neotropical monkey Saimiri sciureus, a non-human primate model for malaria research

Molecular and immunological tools for the evaluation of the cellular immune response in the neotropical monkey Saimiri sciureus, a non-human primate model for malaria research

Challenges and Opportunities in Pain Management Disparities Research: Implications for Clinical Practice, Advocacy, and Policy

Changes in the institutional review board submission process for multicenter research over 6 years

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