The value the ICH Guidelines bring to the field of clinical research Essay

The value the ICH Guidelines bring to the field of clinical research - Essay Example The quality guidelines ensure maintenance of high quality in clinical research at all times. The guidelines provide harmonization procedures that are crucial for standardization of clinical research. The presence of standardization means it is easy to monitor factors that point to low quality. The quality guidelines provide the thresholds for testing and a relatively flexible approach to research that includes the use of pharmaceutical products (ICH, 2005). Quality guidelines ensure good manufacturing practices are implemented in the production of all pharmaceutical products. ICH guidelines support clinical research by availing detailed safety guidelines that increases the chances of success and limits injuries (ICH, 2005). The guidelines aid in identifying or unearthing potential risks, which include carcinogenicity, reprotoxicity, and genotoxicity. Recently, there was a breakthrough in a non-clinical testing strategy that is used to assess the QT internal prolongation liability. It is a signification contribution to the field of clinical research. The carcinogenicity studies provide safety guidelines on the use of rodents, the importance of carcinogenicity pharmaceuticals, prices, and any relevant issues that affect the performance of the drug. Safety guidelines help in maximizing success and minimizing failure and losses. Safety is among the foundational issues in matters concerning clinical research. Efficacy guidelines are all about conduct, design, safety and the reporting guidelines for clinical trials (ICH, 2005). They provide a benchmark that can be used to measure success or efficiency in the clinical research. The guidelines also touch on new drugs that have been made biotechnological procedures and the use of genomic techniques. These processes aid in the development of improved medicines. These guidelines have a huge impact on the safety of clinical

Sexual Assault Research Paper Example | Topics and Well Written Essays - 1750 words

Sexual Assault - Research Paper Example The attempt to or assaults to commit rape through threat or force are included. It excludes statutory rape. As of 2009, reports of forcible rape annually have reached 88,097. Of all the reported rape cases in 2009, 93% were rapes of force (URC). B. Rape by Fraud   Rape by fraud is a form of rape or sexual assault wherein the woman is made to believe that it is her husband whom she has sex with. Rape, as mentioned, is a woman’s the carnal knowledge in the absence of her consent and is obtained by threats, fraud, force, etc. The fraud here should be consist of certain strategies by which the woman is made to believe that the offender is her spouse (Lee v. State, 1902). C. Marital Rape   Marital rape, also referred to as intimate partner sexual assault, is one that is done or committed by the current or the past partner, whether boyfriend or spouse. It happens when there is forced intercourse within the marriage or the partnership. However, there are still many countries that do not consider marital rape as a crime. In the United States for instance, rape is defined as sexual conduct forced on an individual other than a wife since the wife sexual consent is presumed. D. Date Rape In acquaintance rape, the offender is usually somebody who the victim knows casually or by sight, such as a colleague or a neighbour. In date rape, the offender is somebody who the victim knows and who the victim has consented to spend time with. Somebody who commits acquaintance rape or date rape can make use of various tactics, such as seeing to it that she is isolated, locking the door, making promises of taking her home from an event or party but taking her someplace else instead; he may threaten the victim with public humiliation, telling her that he will tell their friends that they sexually romantic regardless of what might actually take place; he may pressure her emotionally, saying that if she doesn’t agree, he will leave her; or he may use economic pressure, sa ying that he deserves sexual intimacy because he paid for their dinner (Huff, 2009). II. Who are the offenders and their characteristics?   A. Age of Offenders According to Holmes (1991), sex offenders and rapists are likely to be young men below the age of 30 during the time of the assault. In a study conducted by Quinsey and Upfold (1985) involving 72 rape offenders, the average age of these offenders was 24 years old. The relationship between age and offense is seldom taken into consideration in the literature on rape beyond its descriptive qualities in the methodology. It was suggested that hormonal factors existing in young men were linked with sexual offense (Marshall and Barabee, 1984). B. Gender of Offenders According to researchers (e.g. Lievore, 2003; Avakame, 1999), between 97% and 99% of alleged sex offenders are male. While physiologically and legally females are also capable of committing rape, for example, by digitally or orally penetrating victims (both male and fe male), such instances seldom reach the criminal justice system (Matthews et al 1991). C. Class of Offenders According to Holmes (1991), overwhelmingly, convicted rape offenders are from lower socio-economic backgrounds. Usually, they have inconsistent employment history in unskilled works, have high academic failure rates, and come from unstable backgrounds (Bard et al, 1987). The underrepresentation of males from upper and middle class backgrounds may indicate a higher involvement in marital and date rapes, which have lower conviction and