Neurobiological research involving human subjects: Perspectives from the office for protection from research risks

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that all human subjects research supported by HHS be reviewed and approved by a local Institutional Review Board (IRB). Investigators may not involve human subjects in research without their informed consent, and additional safeguards are required when subjects are likely to be vulnerable to coercion or undue influence. Application of the regulations to neurobiological research is discussed.     

Human Embryonic Stem Cell Research: An Argument for National Research Review

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. At the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.     

Defining the Research Category in Pediatric Phase I Oncology Trials

Clinical research studies in children are classified by risk into three major categories. These are as follows: a) minimal risk studies, b) more than minimal risk studies but with benefit, and c) studies with minor increase over minimal risk but with no benefit.

Pediatric Phase I oncology trials, which are conducted in a highly vulnerable population of severely ill children with cancer, are designed to establish safety and to determine the maximum tolerated dose (MTD), as well as establish dose limiting toxicity (DLT). These types of studies can be associated with significant risk. The research design of such high- risk studies, which comprise short-term treatments with varying doses, is generally not associated with any clinical benefit. Classification of the research category in these pediatric studies poses a special problem for the Institutional Review Board (IRB) with major implications for the consenting process. The challenges associated with the classification of such studies are discussed in this article.     

我国银行业离实施新巴塞尔资本协议有多远

新巴塞尔资本协议的主要创新之一,就是提出了计算信用风险的内部评级法(Internalratings-basedapproaches)。该法以银行自己内部评级为基础,有可能大幅度提高资本监管的风险敏感度,代表了未来银行业风险管理的一种趋势。但在目前,我国银行业要实行内部评级法是不现实的,因为在缺乏风险管理内在激励、外部监管和评级系统尚不健全的情况下实施新巴塞尔资本协议存在不少障碍,要尽早达到新巴塞尔资本协议的要求,必须先在改善实施新资本协议的外部环境方面做准备,特别要通过强化外部监管力量如完善外部评级体系、加快银行业信息披露制度建设、加强市场监管等措施来推动我国银行业风险管理水平的提高,在此基础上,才谈得上实施新巴塞尔资本协议的问题。