Gene Therapy Research
The National Institute of Health and the Food and Drug Administration are the government bodies responsible for the regulation of gene therapy experimentation. The NIH oversees gene therapy clinical trials through the NIH Guidelines for Research Involving Recombinant DNA Molecules and the Recombinant DNA Advisory Committee (RAC). The Food and Drug Administration (FDA) also oversees the trials through such regulatory measures as scientific review, testing, and inspection.10
Following the death of Jesse Gelsinger, the Advisory Committee to the Working Group on NIH Oversight of Clinical Gene Therapy Research was established to examine the purpose and role of the NIH in gene therapy regulation. It made several recommendations, many of which were adopted by the NIH as amendments to its research guidelines.12
In March of 2000, two initiatives by the FDA and the NIH were announced by the Department of Health and Human Services to increase protection for individuals involved in gene therapy experiments. The first initiative, the Gene Therapy Clinical Trial Monitoring Plan, requires that the sponsors of gene therapy studies regularly submit their monitoring plans to the FDA for review. The FDA will also inspect clinical trials to insure that the plans are being followed, and any problems are managed. In addition, scientists experienced in gene therapy will be gathered to discuss monitoring practices at conferences of the inspectors. The second initiative, the Gene Transfer Safety Symposia, includes a series of symposia that take place four times a year to discuss gene therapy data, inviting some of the most experienced authorities in their respective fields. The NIH and FDA are also providing support for other organizations interested in holding safety conferences on the topic of gene therapy.12
Proposed Review Process3
The guidelines of the NIH for gene therapy research have also changed since 2000. In one amendment to the guidelines governing gene transfer research, the NIH altered the way research subjects are enrolled for gene therapy experiments. Under the amendment, clinical trial protocols must be submitted to the NIH Office of Biotechnological Activities (OBA) for RAC review, and the RAC must finish its review before the local Institutional Biosafety Committee (IBC) gives its approval to the trial. Subjects for research can only be accepted once the IBC and the International Review Board, IRB, approve the trial.
Harris, Carol. "Women Under Fire in World War Two". BBC News. BBC, 17 Feb. 2011. Web. 19 Apr. 2014
Never before this time had women across the country been given the chance to express themselves and hold responsibilities outside their own households. They felt that they were needed and enjoyed their ability to contribute to the war effort. They were given opportunities to prove to the male society that they could be independent and financially secure on their own. These new opportunities were not only for the white women of the population but also the blacks. World War Two acted as a catalyst for change for the women of the United States. Many feel that it was the beginning of a whole new era for the Women of America.
Various socioeconomic classes of women were targeted by wartime propaganda mobilizing them to “do their part”. Customarily, single women of the lower and middle classes were recruited into the...
World War II, the most destructive and devastating conflict that the globe would ever would be weighed upon, was a threat to eliminate the balance of the nations. Germany, Japan, and Italy utilized their military power, placing the world at peril in 1939 through 1945. However, the period beckoned for opportunity, also. Women desired the chance to serve for their country. They wanted others to recognize that they weren’t going to be idle during this mass era. Women to have rights and responsibilities in World War II would affect their view of their roles in history forever.
Putnam, Robert D. 1993b. The Prosperous Community: Social Capital and Public Life. American Prospect 13: 35-42.
Many factors affected the changes in women’s employment. The change that occurred went through three major phases: the prewar period in the early 1940s, the war years from 1942-1944, and the post war years from around 1945-1949. The labor shortage that occurred as men entered the military propelled a large increase in women’s entrance into employment during the war. Men's return to the civilian workforce at the end of the war caused the sudden drop to prewar levels. The cause of the sudden decline during post war years of women in the paid workforce is unclear. Many questions are left unanswered: What brought women into the war industry, ...
Hawkes, Sarah. “Who was Rosie the Riveter?: The American Factory Women of World War II”. 2014. Web. 8 May 2014.
... fight the disease. It is crucial that regulation be a necessary component of gene therapy research and applications. In hopes that the government can regulate and can receive this treatment, not restricting it to people that has serious genetic diseases. Gene therapy will change the field of medicine from what it is today. As scientist discovers more genes and their functions, the potential of this treatment is limitless. Though gene therapy is an auspicious treatment choice for numerous diseases (including inherited disorders, some types of cancer, and certain viral infections), the procedure remains precarious and is still under study to make sure that it will be safe and effective. Thus government regulators and scientist must take a lead role in adopting a practical approach to address these issues and determining the correct procedures for dealing with them.
Before the World War II, many women only held jobs in the house providing for their children, husband, and the needs that came with taking care of the household, but during the war, this completely changed. Many women were given new opportunities consisting of new jobs, new skills, new challenges, and greater chances to do things that were once only of imagination to them. Women made the war especially possible with taking over the jobs that men would usually do, but could not do because of the war. One of the first things that encouraged women to take on jobs of the men who went off to war was the propaganda. Propaganda consisted of films, radio, and print. These advertisements used showed women fighting in the army and many working in factories. Often, the advertisements directed women in the direction to take on roles of the males.
The women of this era made remarkable steps forward while men fought abroad, serving as the ever crucial backbone to the war effort’s support network. Though it won’t be the focus of
During World War II, thousands of women in various nations were deeply involved in volunteer work alongside men. Before World War II, the women’s role was simply to be a wife to her husband, a mother to her children, and a caretaker to the house (Barrow). As World War II raged on, women made enormous sacrifices for their family, and also learnt new jobs and new skills. Women were needed to fill many “male jobs”, while men went off to fight in the war. Women served with distinction in The Soviet Union, Britain, Japan, United States, and Germany and were urged to join armed forces, work in factories, hospitals, and also farms to support the soldiers fighting the war. During this time, women took on the dual responsibility of managing the home and fighting actively in the battlefield.
Putnam further states that social capital is a part of social life that encourages participants to act together more effectively to achieve common goals, in which participants are the beneficiaries of the social capital.
Perhaps my expectations were poorly formed, but I found the chapter which dealt with the aftermath of World War II, “War and Peace: Fanning the Home Fires,” to be somewhat uneven. May quite thoroughly lays out the occupational and economic changes for women workers both during and after the war. Her insight on the Women’s Army Auxiliary Corps (WAACS) and the Women Appointed for Volunteer Emergency Service (WAVES) is equally pertinent to a discussion of the contribution women made to the war effort. In fact, this treatment in particular could have been expanded to examine some of the very particular non-traditional roles women performed in military service at the time - for example, women serving as test pilots - which truly stretched the boundaries
High profile adverse events resulting in disproportionate media attention have prevented a greater difficulty for the field, with the death of Jesse Gelsinger in a trial of gene therapy for ornithine transcarbamylase deficiency undermining public trust of clinical research in the US. There is a danger that the gene therapy field may have become too risk-averse in response to these adverse events, and that this could manifest as fewer trials that take longer to commence. In the context of a research environment that is increasingly turning to the developing world for the expedient conduct of clinical trials, it is imper...
In every war the women had stepped up to try to help the men who were off to fight, but the more agrarian societies of the revolution, the War of 1812, the Civil War, and even World War I meant that most stepped up to do the work on the farm. In World War II, it was just as likely that the wives and mothers were stepping up to take a place in a factory as in the fields. While America was still primarily agrarian, the factories needed for warfare had brought the women to take their husband’s and son’s and boyfriend’s places. And while some women followed their husbands to the battlefront in the Civil War, and a few even enlisted as men, World War II brought a whole new experience as a huge war machine needed the men at the fronts for ...