Shifting sands: the complexities and uncertainties of the evolving US regulatory,policy, and scientific landscape for biospecimen research

Human tissue biorepositories and the biospecimens they provide play a critical role in advancing research and medical care, especially in supporting research to develop precision medicine. However, advancements in genomics, informatics, and other sophisticated technologies and extensive biospecimen and data sharing have raised questions about how best to protect research participants. Complex ethical issues remain unresolved, such as the identifiability of biospecimens and associated data, the best consent models for future research, ownership and commercial use of biospecimens, and return of individual research results.This review summarizes the relevant US regulations and recent changes to them, as well as current and future ethical and policy issues related to biospecimen research. Because many issues remain unresolved, additional policy development will be needed. We discuss approaches for how researchers and other stakeholders can provide input to ensure that these policies will protect research participants while facilitating research important for scientific and medical advancements.     

医院参与全员新冠病毒核酸检测样本采集管理专家共识

目的 形成《医院参与新冠病毒核酸检测样本采集管理专家共识》,规范采样管理。方法 在查阅国内外文献,依据相关政策的基础上,综合参与采样工作的操作实践及相关专家意见建议,撰写共识初稿,并通过会议讨论及函询征求专家意见,对共识稿进行修改,形成终版共识稿。结果 专家就采样前准备,采样点、采样台设置及采样人员配置,采样操作管理,标本管理及交接,医疗废物处理,支持督导管理,采样后续管理环节形成一致意见。结论 该共识具有一定的实用性和科学性,可为全员新冠病毒核酸检测样本采集管理提供参考。     

Surgical tissue handling methods to optimize ex vivo fluorescence with the activatable optical probe γ‐glutamyl hydroxymethyl rhodamine green

Optical fluorescence imaging has been developed as an aid to intraoperative diagnosis to improve surgical and endoscopic procedures. Compared with other intraoperative imaging methods, it is lower in cost, has a high safety margin, is portable and easy to use. γ‐glutamyl hydroxymethyl rhodamine green (gGlu‐HMRG) is a recently developed activatable fluorescence probe that emits strong fluorescence in the presence of the enzyme γ‐glutamyl transpeptidase (GGT), which is overexpressed in many cancers, including ovarian cancer. Ex vivo testing is important for clinical approval of such probes. The diagnostic performance of gGlu‐HMRG in fresh excised surgical specimens has been reported; however, details of tissue handling have not been optimized. In this study, we investigated four different tissue handling procedures to optimize imaging in excised tumor specimens. The fluorescence intensity time courses after the different tissue handling methods were compared. Additionally, the fluorescence positive areas were correlated with the presence of red fluorescent protein (RFP) in an RFP positive cell line as the standard of reference for cancer location. In the ‘intact’ groups, tumors yielded quick and homogeneous activation of gGlu‐HMRG. In the ‘rinse’ and ‘cut’ groups, the fluorescence intensity of the tumor was a little lower than that in the intact group. In the ‘pressed’ groups, however, fluorescence intensity from gGlu‐HMRG was lower over the entire time course, suggesting a decrease or relocation of excreted GGT. In conclusion, we demonstrate that the method of tissue handling prior to ex vivo imaging with the activatable probe gGlu‐HMRG has a strong influence on the signal derived from the specimen. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.     

NICU新生儿喂养后采集足跟血最佳时机研究

目的探讨NICU新生儿喂养后采集足跟血的最佳时机。方法对203例NICU新生儿依据采血距末次喂养后时间的不同分为4组,即:末次喂养后￣0.5h组;0.5￣1h组;1￣1.5h组;1.5￣2h组;比较各组在不同时间段采血的难易程度。结果末次喂养后￣0.5h组优良率88.0%,0.5￣1h组优良率62.7%,1￣1.5h组优良率48.9%,1.5￣2h组优良率45.3%,末次喂养后￣0.5h组优良率最高,与其他组之间的优良率差异有统计学意义(P<0.01),其他3组相互之间的优良率差异没有统计学意义(P>0.05)。结论末次喂养后采血时间不同对采血的难易程度有很大的影响,采血距末次喂养后时间≤0.5h为最佳采血时间。     

Seroprevalence and Risk Factors of Toxoplasma gondii Infection in Buffaloes,Sheep and Goats in Yunnan Province,Southwestern China

Background:

The seroprevalence of Toxoplasma gondii infection in buffaloes, sheep and goats in Yunnan Province, southwestern China was conducted between May 2012 and December 2013.

Methods:

A total of 973 (427 buffaloes, 154 sheep and 392 goats) serum samples were collected from seven administrative regions of Yunnan Province, and examined for T. gondii antibodies by indirect hemagglutination (IHA) test. Some risk factors related to species, age, gender and geographical origin were determined using a multinomial logistic regression.

Results:

The overall seroprevalence of T. gondii in ruminant species was estimated at 11.9%. The final logistic regression model demonstrated that host species and geographical origin were the main risk factors associated with T. gondii infection (P<0.05).

Conclusion:

Taken together, the results of the present study revealed a high exposure to T. gondii in ruminant species in Yunnan Province, which has an important implication for public health.     

湖南省2013年重症监护病房血标本分离细菌耐药性监测

目的 了解湖南省ICU血标本分离细菌耐药情况.方法 监测2013年度湖南省细菌耐药监测网ICU血标本分离菌株药敏结果,采用CLSI2013年标准判读,用湖南省细菌耐药监测网直报系统在线统计分析药物敏感性.结果 共获得ICU血标本分离细菌1136株,其中革兰阳性菌739株(65.05％);革兰阴性菌397株(34.95％),排名前5位的细菌分别为凝固酶阴性葡萄球菌、大肠埃希菌、金黄色葡萄球菌、肺炎克雷伯菌、鲍曼不动杆菌.ICU血标本中耐甲氧西林的表皮葡萄球菌、人葡萄球菌、溶血葡萄球菌、金黄色葡萄球菌的检出率分别为75.84％、80.92％、90.29％和36.84％.大肠埃希菌对亚胺培南及美罗培南耐药率分别为1.82％和1.43％,肺炎克雷伯菌对亚胺培南和美罗培南耐药率分别为0和3.03％.铜绿假单胞菌对碳青霉烯类、喹诺酮类、阿米卡星、多黏菌素B、头孢哌酮/舒巴坦的敏感性高于80％.鲍曼不动杆菌对抗菌药物的耐药性普遍高于铜绿假单胞菌,对碳青霉烯类抗菌药物的敏感性均低于50％.结论 ICU血标本分离细菌耐药性较为普遍.     

Graphene supports in vitro proliferation and osteogenic differentiation of goat adult mesenchymal stem cells: potential for bone tissue engineering

Current treatments for bone loss injuries involve autologous and allogenic bone grafts, metal alloys and ceramics. Although these therapies have proved useful, they suffer from inherent challenges, and hence, an adequate bone replacement therapy has not yet been found. We hypothesize that graphene may be a useful nanoscaffold for mesenchymal stem cells and will promote proliferation and differentiation into bone progenitor cells. In this study, we evaluate graphene, a biocompatible inert nanomaterial, for its effect on in vitro growth and differentiation of goat adult mesenchymal stem cells. Cell proliferation and differentiation are compared between polystyrene‐coated tissue culture plates and graphene‐coated plates. Graphitic materials are cytocompatible and support cell adhesion and proliferation. Importantly, cells seeded on to oxidized graphene films undergo osteogenic differentiation in fetal bovine serum‐containing medium without the addition of any glucocorticoid or specific growth factors. These findings support graphene's potential to act as an osteoinducer and a vehicle to deliver mesenchymal stem cells, and suggest that the combination of graphene and goat mesenchymal stem cells provides a promising construct for bone tissue engineering. Copyright © 2014 John Wiley & Sons, Ltd.     

Social media and cadaveric dissection: A survey study

The use of social media opens content to the general public and, as a result, places images of cadaveric dissection in an open forum. This raises the question: should the general public have access to such material? A survey was conducted examining whether the general public should have access to gross cadaveric dissection images and videos for educational purposes via social media. Both medical and laypersons were queried. Questions included in the survey considered whether images were too graphic, whether online cadaveric content should be age‐restricted, and whether consent by the deceased was necessary. A link to the survey was accessible to 63,562 followers through the Seattle Science Foundation's Facebookpage for 3 weeks. Among 300 responders, 89% (267/300) agreed that portrayals of cadaveric specimens/dissection on social media should be accessible by the general public for anatomical education, and 84.67% (254/300) stated that cadaveric dissection is not too graphic for untrained eyes. There was agreement by 60.33% (181/300) that an age restriction should be in place for the viewing of cadaveric dissection on social media, and 39.33% (253/300) of responders suggested restriction to 18 years and older. No statistically significant association was noted between a prior or current history of anatomy education and the frequency of positive responses to the survey questions. Social media is an innovative tool for dispensing anatomical education. The use of cadaveric images and videos provides accessibility to the general public who wish to learn more about human anatomy and their own body. Clin. Anat. 32:1033–1041, 2019. © 2019 Wiley Periodicals, Inc.