浅议研究机构伦理评审委员会的建设

通过阐述研究机构伦理审查制度建设中各个方面的一般原则及存在的问题,就现有伦理评审委员会进行的伦理审查项目中涉及的两个难点问题进行了初步探讨,对加强研究机构伦理评审委员会的建设提出建议。     

浅议研究机构伦理评审委员会的建设

通过阐述研究机构伦理审查制度建设中各个方面的一般原则及存在的问题,就现有伦理评审委员会进行的伦理审查项目中涉及的两个难点问题进行了初步探讨,对加强研究机构伦理评审委员会的建设提出建议.     

新时代医院伦理审查机构建设存在问题及对策

伦理审查机构建设是加强医学科技伦理治理的基础性保障。通过对广东省部分三级甲等医院伦理机构建设及工作情况的现状调查,分析当前医院伦理审查工作变化趋势及存在问题。指出当前医院普遍存在机构能级偏低、工作创新不足、信息化建设滞后、人员配置缺口大等问题。提出：新时代要坚持党建引领,健全和完善伦理审查体制机制;通过管理创新,驱动伦理审查工作新突破;加大基础设施投入,推动伦理信息化管理;加快专业队伍培育,提升伦理治理能力。     

新时期医疗机构伦理委员会建设需厘清的一些问题

当前,医疗机构伦理委员会建设已取得了明显进步,但为取得高质量发展,尚需要厘清一些关键性问题：甄别生物医学研究和医疗技术临床应用、始终坚持伦理审查的基本原则、建立具备独立行政建制的伦理委员会办公室、根据专业不同大型医疗机构应设立多个相互独立的伦理审查委员会以及加强对机构内部医务群体和科学研究人员的伦理培训。     

单位制下伦理委员会审查能力建设

受单位制社会意识的影响,伦理委员会的工作也带有许多单位制的明显特征,制约了伦理审查质量的提高.分析机构伦理委员会建设现状,提出垂直管理机制、资质准入、项目交叉审查、统一标准作业程序、技术性与伦理性审查相对分开等建议.     

临床医学研究伦理审查分析

为总结中山大学附属第三医院临床医学研究伦理审查工作,提高伦理审查能力,分析2004--2007年中山大学附属第三医院医学伦理委员会受理的临床医学研究项目的伦理审查档案,归纳统计申请项目的类型、不同审查结论的构成比和计算审查一次通过率,分析审查结论为“作必要修正后同意”的项目存在的伦理问题。加强伦理委员会的建设,是提高伦理审查能力的关键所在。     

我国伦理委员会建设现状分析

目的了解我国伦理委员会的建设现状, 为推进符合我国社会现状的伦理委员会建设提供借鉴。方法 2022年7—8月, 采用自行设计的问卷, 面向全国的二级及以上医院和疾病预防控制中心/传染病防治院调查伦理委员会的建设情况, 采用多阶段分层抽样法进行抽样, 对问卷数据进行描述性分析。2022年, 依据东中西部经济带分区, 分层抽样选取22家伦理委员会, 对其秘书进行深度访谈, 访谈内容包括伦理审查中遇到的主要问题、针对医学伦理培训工作的具体建议、伦理委员会设立独立的社会第三方评估机构的必要性等。采用扎根理论对访谈资料进行三级编码, 并应用NVivo 11.0软件进行覆盖率、情感识别及词频分析。结果有效回收问卷107份, 覆盖23个省级行政区。其中, 63家伦理委员会实行独立办公室建制;委员中包含1名伦理专家的有49家, 以行政领导身份兼任主任委员者80人;107家均完成了伦理审查章程和制度建设;21家尚未建立跟踪审查机制;33家未开展面向社会公众的教育培训活动, 仅有25家机构通过国内外相关伦理认证体系认证。扎根理论分析结果显示, 伦理委员会建设中存在的问题可归纳为伦理审查效率与质量、伦理培训...     

医学科研伦理审查的几点思考

通过医学科研伦理审查薄弱现象,分析困扰研究和管理人员的科研伦理审查不力因素。我院科研伦理审查质量仍有提升空间。伦理管理符合科研管理和现代医院管理的内在要求。伦理审查质量提升的管理要素包括加强伦理委员会的建设监督,建立统一规范的审查制度和体系,加强监管,增加培训建立稳定的专家队伍,把控重点审查内容,重视伦理审查的过程管理和质量控制等。     

提高伦理定期跟踪审查监管的实践经验分享

目的改变定期跟踪审查管理相对薄弱的现状, 进一步提高伦理委员会持续跟踪审查能力。方法通过梳理分析定期跟踪审查中存在的问题, 采取相应的解决措施。细化管理要求, 加强日常监督。专项伦理培训并加强沟通以增强研究者的伦理意识。优化伦理办公室人员分工提高工作效率和委员定期跟踪审查质量。信息化审查系统助力加强定期跟踪提醒等。结果在实践工作中, 定期跟踪的迟报、漏报情况明显减少, 提高了伦理委员会对定期跟踪审查的监管能力。结论定期跟踪审查中, 只有研究机构、伦理委员会、研究者各方足够重视, 各尽其责, 积极配合才能有效提高定期跟踪审查质量。     

医院科研项目伦理审查现状分析与对策

科研项目的伦理审查用伦理学的原则审视科学研究的社会价值,指导科研活动。我国科研伦理审查机构多下设在医院职能部门,存在伦理审查缺乏独立性、规范性、知识体系缺乏完整性的特点。针对上述情况,本文提出建立监察机制、规范审查程序、建立培训机制及电子信息系统等措施,为医院科研项目伦理审查的规范化建设提供参考。     

HIV risk profile and prostitution among female street youths

The objective of this study was to compare human immunodeficiency virus (HIV) risk factors among female street youths involved in prostitution and those with no history of prostitution. Youths aged 14 to 25 years were recruited into the Montreal Street Youth Cohort. Semiannually, youths completed an interviewer-administered questionnaire. Statistical analyses comparing characteristics and HIV risk factors for girls involved in prostitution and those never involved were carried out using parametric and nonparametric methods. Of the girls, 88 (27%) reported involvement in prostitution, and 177 girls reported no history of prostitution at the baseline interview. Girls involved in prostitution were two times and five times more likely to have reported bingeing on alcohol and on drugs, respectively. A history of injection drug use was four times more likely to have been reported by girls involved in prostitution. Further, these girls were 2.5 times more likely to have reported injected cocaine as their drug of choice. Girls involved in prostitution were younger the first time they had consensual sex and were twice as likely to have reported anal sex. Consistent condom use for anal, vaginal, and oral sex was low for all girls. Girls involved in prostitution reported more risky sexual partners. In conclusion, girls involved in prostitution may be at increased risk of HIV infection due to their injection drug use and risky sexual behaviors. Unique intervention strategies are necessary for reducing HIV infection among female street youths involved in prostitution.     

Central mechanisms for thermoregulation in a hot environment

Homeothermic animals regulate body temperature by autonomic and behavioral thermoeffector responses. The regulation is conducted mainly in the brain. Especially, the preoptic area (PO) in the hypothalamus plays a key role. The PO has abundant warm-sensitive neurons, sending excitatory signals to the brain regions involved in heat loss mechanisms, and inhibitory signals to those involved in heat production mechanisms. The sympathetic fibers determine tail blood flow in rats, which is an effective heat loss process. Some areas in the midbrain and medulla are involved in the control of tail blood flow. Recent study also showed that the hypothalamus is involved in heat escape behavior in rats. However, our knowledge about behavioral regulation is limited. The central mechanism for thermal comfort and discomfort, which induce various behavioral responses, should be clarified. In the heat, dehydration affects both autonomic and behavioral thermoregulation by non-thermoregulatory factors such as high Na+ concentration. The PO seems to be closely involved in these responses. The knowledge about the central mechanisms involved in thermoregulation is important to improve industrial health, e.g. preventing accidents associated with the heat or organizing more comfortable working environment.     

The regulation of body weight: lessons from the seasonal animal

The hypothalamus is a major regulatory centre involved in the control of many important physiological axes. One of these axes is the regulation of ingestive behaviour. Recent work using a combination of genetic-mutant mouse models together with targeted gene deletions has contributed much to our understanding of how neural pathways of the hypothalamus are involved in the regulation of energy balance in animals. These pathways are also relevant to human energy homeostasis. as mutations in key genes are correlated with obesity. Many of the genes identified mediate the effects of leptin, and are therefore primarily involved in sensing and responding to peripheral signals. In seasonal animals, such as the Siberian hamster (Phodopus sungorus), there is evidence for a higher level of regulation. The systems involved regulate body weight around an apparent 'set-point' through the action of photoperiod via the neurohormone, melatonin. The ability to manipulate energy balance through photoperiod (and melatonin) in the seasonal-animal model offers novel opportunities to identify further fundamental aspects of the control mechanisms involved in the central control of energy homeostasis and body weight.     

The non-medical use of antibiotics and the risk of causing microbial drug-resistance

One of the hazards involved in the use of antibiotics in animal feeds is that it may lead to the development of bacterial drug-resistance. An analysis of the phenomenon shows that this possibility largely depends on the size of the bacterial populations involved and on the possibility of selective multiplication of the resistant mutants that may be present. Additional factors involved in the development of resistance are the type of drug applied and the time during which the bacteria are in contact with it.     

An outbreak of Salmonella gastroenteritis in an urban jail

An outbreak of gastroenteritis in New York City's largest jail involved 145 cases over a two-month period. The outbreak was unusual in that two Salmonella strains (serogroups B and D) were involved. Management of the outbreak involved screening kitchen workers by culture of stool samples, and education regarding personal hygiene. Obstacles to investigation and management of the outbreak arose out of the special nature of the jail environment; these included jurisdictional problems and high turnover of the inmate population.     

International Study of Chaplains’ Attitudes About Research

An online survey was conducted by twelve professional chaplain organizations to assess chaplains’ attitudes about and involvement in research. A total of 2,092 chaplains from 23 countries responded to the survey. Over 80% thought research was definitely important and nearly 70% thought chaplains should definitely be research literate. Just over 40% said they regularly read research articles and almost 60% said they occasionally did. The respondents rated their own research literacy as 6.5 on a 0–10 scale. Significant positive inter-correlations were found among all four measures: importance of (a) research and (b) research literacy; (c) frequency of reading articles; and (d) research literacy rating. Approximately 35% were never involved, 37% had been involved, 17% were currently involved, and 11% expected to be involved in research. The last three groups were significantly more likely to think research and research literacy were important and to read research articles than chaplains who were never involved in research. Given chaplains’ interest in research, actions should be undertaken to facilitate further research engagement.     

Training primary health care workers in Upper Volta

In collaboration with aid agencies and government health workers, Save the Children Fund medical staff have been involved in the training of primary health care workers in the Sahel region of Upper Volta. This report deals specifically with the problems involved in training illiterate health workers.