A Qualitative Study of Non-Affiliated,Non-Scientist Institutional Review Board Members

In addition to outlining criteria for the approval of human subjects research, federal regulations provide guidance regarding local institutional review board (IRB) membership. IRBs are mandated to include “at least one member whose primary concerns are in nonscientific areas” and “at least one member who is not otherwise affiliated with the institution.” Often a single individual serves both of these roles simultaneously. Although there have been calls for increased representation of lay community members on IRBs, little is known regarding their experiences or their perceptions of human subject protections and the IRB process. Using an ethnographic interview approach, this study seeks to gain a perspective from non-affiliated, non-scientist (NA/NS) IRB members about the process in which they participate. Findings suggest a need for clarification regarding whom NA/NS IRB members represent. They also suggest that NA/NS IRB members’ experiences could be improved by an increased show of respect from the IRB chair, other members, and staff; efforts to make participation more convenient for these volunteer members; and training tailored specifically to NA/NS members. Further research on this important and understudied topic is needed to determine best practice and policy recommendations.     

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

Waivers of parental consent for sexual minority youth

ABSTRACT

The Society for Adolescent Health and Medicine emphasizes the need for research to focus on the health outcomes of sexual minority youth (i.e., lesbian, gay, bisexual, transgender, queer). However, sexual minority youth (SMY) are often less willing to participate in research studies where parental consent is required due to potential victimization and discrimination. This is a major concern given that more research is needed to understand the health needs of this population, especially in terms of suicide, substance use, and HIV prevention. The National Suicide Prevention Strategy classifies SMY as a high-risk group, emphasizing the need to explore suicide risks (along with other health outcomes) among this group. However, this high-risk classification also increases the safeguards necessary to conduct research with this population. Many researchers have argued for waivers of parental consent, but such waivers present with several ethical implications. This article discusses ethical principles, risks, benefits, safeguards, and potential alternative approaches to waivers of parental consent for SMY. We conclude by emphasizing the need for policy changes to allow parental consent waivers for research targeting SMY.     

内部评级法与我国商业银行信用风险管理

从上世纪九十年代中后期开始,我国商业银行的信用风险管理工作取得了一定的成绩。但是,还存在着很多的问题,诸如信用风险管理的技术还很不成熟、没有严格意义上的独立的风险管理部门和专职的风险经理来管理信用风险、并独立承担风险管理职责等,与内部评级法的要求存在较大的差距。为适应《巴塞尔新资本协议》中内部评级法的要求、加强信用风险管理能力,我国的商业银行应努力做好数据库的建设、信用风险模型的开发、加快金融改革,为信用衍生产品的推出创造良好的环境。     

《新巴塞尔资本协议》中若干焦点问题的探讨——对QIS3的总体评价及补充

第三次定量影响研究(QIS3)的研究目的是在《新巴塞尔资本协议》前几次讨论稿基础上,评估各银行资本要求的变化。QIS3的结果是与巴塞尔委员会制定的激励相容机制目标基本一致的,多数银行也对巴塞尔委员会的基本原则和新协议“三大支柱”(资本充足率、监管当局的监管检查和市场纪律)的框架表示赞同。但是由于协议的复杂性,有不少问题还是没有得到解决。在新协议中,操作风险计量方法不够精确,新型抵押担保形式不好识别,没有对零售业务进行风险集中度的调整,执行新协议的成本-收益复杂模糊,信用风险设计与激励相容相悖,流动性风险和顺周期性有所加强。这些都需要进行进一步的研究和调整。     

新巴塞尔协议信用风险度量模型的实证模拟——标准法、初级内部评级法和高级内部评级法的比较

新巴塞尔协议与旧巴塞尔协议相比,具有更多的灵活性,主要体现为在风险度量模型方面为银行提供了多种选择。巴塞尔协议的核心支柱是资本充足率要求,而风险度量模型正是计算资本充足率的基础。本文对商业银行的资产组合与风险参数进行了实证模拟,对信用风险度量的标准法、初级内部评级法与高级内部评级法进行了比较研究。研究表明：三种度量模型计算的加权风险资产,在数值上存在显著性差异,越高级别的模型所测度的加权风险资产数值越低;在商业银行的资产组合中,个人住房抵押贷款、中央政府债权、企业和个人贷款占总资产的比例对模型结果的差异性存在显著性的影响;资产组合风险水平越低,越高级的测度模型所计算的加权风险资产数值越低。     

Medical school guidelines for investigating misconduct and fraud in science

Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is “reasonable” or “proportional”. This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparable. In the last section we show that the main problem of RBR analyses is that of interpersonal incompensability. IRBs have to assume that risks to research subjects be compensated by benefits to others. The question is: To what extent? When does it become unreasonable to ask that patients accept the risks of participating in a trial for the benefit of science and/or future patients?     

Overcoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues with the Use of the “Short Form”

Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.     

Invitation to Research: Invitation to Learn

This article analyzes the process of acquiring informed consent from parents of economically disadvantaged children 7 to 12 years of age at a Boys &; Girls Club in a Midwest city. The article addresses the following question: What are the obstacles in mainstream research to including children’s voluntary participation in research that intends to benefit their lives? The lessons gained from requesting an invitation into the lives of poor children through informed-consent processes inform future social work research methods.     

巴塞尔新资本协议下的LGD测算方法研究

违约损失率(LGD)是计算监管资本的重要参数,也是实施内部评级法I(RB)高级法的银行必须自行估计的参数。文章阐述了巴塞尔新资本协议对高级法LGD计算的要求——衰退期违约损失率,分析了传统LGD测算方法的不适应之处,提出了类似于条件PD计算思想的测算方法框架,并结合我国银行业的实际针对LGD测算提出了相应的建议。