Columbia College Social Media in Politics Discussion

Ethical Justification: Involving Human Volunteers in Trials

Share this: Facebook Twitter Reddit LinkedIn WhatsApp Ethical Justification of Involving Human Volunteers in Phase 1 Trials Zoheb Rafique INTRODUCTION Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for the potential unfavorable effects. These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. DISCUSSION It is now widely accepted that medical research designed for the benefit of populations in developed countries should not be conducted with subjects recruited from populations in economically underdeveloped countries. Indeed, it is ethically objectionable to recruit from populations in resource-poor settings, even in developed countries, unless those populations are particularly susceptible to the condition the research is designed to relieve. In one study, there was proposal to conduct a phase-1 vaccine study recruiting subjects from the United States when the purpose is to assist the population of Mali, in Sub-Saharan Africa, to overcome the pervasive local consequences of Malaria. The ethical principle of justice, which requires a fair allocation of the risks and benefits of medical research, provides that the risk of research should not be planned to affect subjects from one population when benefits of the research are primarily directed to another population. It may accordingly appear, at first assessment, that the Malian government’s requirement that all phase-1 testing of the antimalarial vaccine be conducted in the United States is as unethical as it would be for the United States government to require that all phase-1 testing of a vaccine or other product intended primarily to benefit the population of the United States be conducted in Mali. Yet codes of ethical conduct are less consistent on this point than commentators usually require being. The World Medical Association’s much-cited Declaration of Helsinki: Ethical principles for Medical Research Involving Human subjects provides that “Medical research is only justified if there is a reasonable likelihood that the population in which the research is carried out stand to benefit from the results of the research.” By this criterion, conduct of the phase-1 study in the United States appears unethical. In the context of HIV/AIDS, however, the WHO’S Global program on AIDS (1989) provided that, “in general, initial phase-1 trials should be conducted in the country of origin of the vaccine”. By this criterion, phase-1 testing in the United States is appropriate, if a vaccine would originate and initially be governmentally approved in the United States. The situation would be otherwise, of course, if the NIH was funding the study for production of the vaccine in Mali. The ethical remains of where the initial phase-1 vaccine trials can be conducted most equitably, with least risk of exploitation and most protection of the interests of study subjects (3). Most clinical research trials today require the informed consent. Concern however is raised that subjects of phase 1 trial studies might not provide valid consent. In particular, few commentators worry that subjects of phase 1 oncology trials have an exaggerated idea of any chance of the therapeutic benefit. The Empirical studies tells that phase 1 trial participants are highly optimistic and hopeful about their chance of personal benefit and also are motivated by hope for the clinical improvement. Altruism, on other hand is much less often identified as driving the decision to enroll, when quoted as motivating factor; and it typically is not the prime reason for the participation. In one research study, sixty one (61 %) of phase 1 oncology participants were doubtful about altruism would motivate the advanced cancer patients to enroll in the non beneficial research and several phase 1 volunteers in another study showed “Surprise” at idea of research participation based exclusively on altruism. Some studies find, however that the individuals in some other types of research trials often participate in the hope of helping others. As an example, schaeffer and colleagues describe that “hope others benefit” is one of the two most common motivational factors for the healthy volunteers (4). The research participants should be fully informed about the difference between research and therapy and also risk-benefit ratio. The researcher should offer patients substitutes other than participation in the trials and also vulnerable population should not be included in the trials at any cost and especially in the phase-1 trials. CIOMS guideline 7 talks about inducement of participation in research. According to the guideline the research subjects can be reimbursed for their needs such as transport and other expenses, and also lost earnings, that is associated with participation in the research. Those persons who receive no any direct benefit from research may also get a small amount of money for their inconvenience due to the participation in research. All volunteers may get the medical services unrelated to research and could have tests and procedures performed free of cost. Payments in terms of money or in kind to the research subjects may not be so huge as to carry them to take unwarranted risks or volunteer against the better judgment. Incompetent persons are vulnerable to the exploitation for financial gain by the guardians. A subject who withdraws himself/herself from the research for various reasons related to research study, such as unacceptable side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if full participation had taken place. For all biomedical research involving human subjects, the investigator must ensure that potential benefits and risks are reasonably balanced and risks are minimized. The Declaration of Helsinki deals with the wellbeing of research subjects and the avoidance of risk. Thus, considerations related to the well-being of the human subject should take precedence over the interests of science and society, clinical testing must be preceded by adequate laboratory or animal experimentation to demonstrate a reasonable probability of success without undue risk, every project should be preceded by careful judgment of predictable burden and risks in comparison with the foreseeable benefits to research subjects or to others; physician-researchers must be confident that the risks involved have been adequately assessed and can be satisfactorily managed; and the risks and burdens to the subject must be minimized, and reasonable in relation to the importance of the objective or the knowledge to be gained (5). CONCLUSION The first basic principle of the Declaration of Helsinki requires biomedical research involving human subjects to be based on “adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.” This implies that human subjects should not be used unless and until successful experiments in animals, as well as in vitro, have been completed. The Declaration, like most consensus documents formulated by representatives of different nations and medical traditions, is often vague and difficult to interpret in specific cases. It might allow proceeding to clinical trials if adequate animal studies demonstrated the inapplicability irrelevance, or absence of a useful animal model. If animals died immediately after receiving a vaccine, this would undoubtedly prohibit using the vaccine in human subjects (6). I will conclude this paper by saying that research is the only way of getting rid of various diseases through proper treatment and also benefiting future patients from those diseases which have no cure at present or any medical treatment available, so research should not be stopped. In my opinion, human volunteers can be involved in phase-1 trials but following all international guidelines and all other aspects of biomedical ethics. REFERENCES Inayat Ullah Memon. JUSTIFICATION OF PARTICIPATION OF HUMAN SUBJECTS IN PHASE 1 CLINICAL TRIALS: AN ETHICAL ANALYSIS. Bangladesh Journal of Bioethics 2011; 2(2):26-29 Franklin G Miller and Steven Joffe. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clinical Trials. 2008; 5: 617-623. Bernard Dickens. Reverse Exploitation in the Baltimore Malaria Vaccine Study. Emily Abdoler, Holly Taylor, and David Wendler. The Ethics of Phase 0 Oncology Trials. Clin cancer Res. 2008; 14(12): 3692-3697. International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS 2002; 1-113. Wendy K. Mariner. Why Clinical Trials of AIDS Vaccines Are Premature. Public Health and the Law. AJPH. 1989; Vol. 79, No. 1: 86-91. Share this: Facebook Twitter Reddit LinkedIn WhatsApp

Strayer Impact of The Covid 19 Pandemic on The US Economy Discussion Questions

nursing essay writing service Strayer Impact of The Covid 19 Pandemic on The US Economy Discussion Questions.

5: Find an online article (news, magazine, journal, etc.) of interest that uses statistics to make its conclusionShare a link in this thread, and answer these questions about that articleWhat is the premise and conclusion of the argument based on statistics?Determine whether or not the argument uses any deceptive statistics.Give your opinion on whether the argument has persuaded you. Explain why or not. Determine the primary ways in which statistics or authority are used in your current position in developing persuasive arguments and provide examples. 6. On the Internet or Strayer Library find one of each of the following:A reliable sourceAn unreliable sourceA source that reveals biasA source that uses emotional language2. For each source, document:What you foundWhere you found itThe category the example fits (unreliable, bias, emotional language) and explain why you think it is an example of that category.7: Imagine you are interviewing for a job you really want and the interviewer asks you the following: “Explain a specific example in which you used critical thinking problem-solving strategies to solve a problem in the real world.”What will be your answer to the question?Choose one classmate’s own response to the interviewer’s question. If you are a job coach, what suggestions would you make to maximize your classmate’s answer to the interview question?Be sure to respond to at least one of your classmates’ posts.8: Consider the following quote by the philosopher Ludwig Wittgenstein, who believed that thought without language was impossible: “The limits of my language are the limits of my life.” For more information on Wittgenstein and his analysis on the importance of language, watch the video Ludwig Wittgenstein (1889 – 1951) The Limits of Language.Please respond to the following:Examine whether it is possible to think without using language.If you believe it is possible, describe the primary ways in which a person might enact so-called languageless thinking.If you believe it is not possible, describe what you foresee as major problems with “languageless” thinking.9: Using what you’ve read about ethics in the webtext, examine the world around you. Search online for your local news website and locate a story where you believe an ethical dilemma is going on. Please keep this story local and not national news.Please respond to the following:Briefly explain the story, the ethical dilemma you identified, and how you think it can be resolved. Include a link to your story in your initial post.
Strayer Impact of The Covid 19 Pandemic on The US Economy Discussion Questions

Implementing a Cloud-based Collaborative Solution

As an organization grows, it’ll come to a point where it must contemplate whether or not a cloud-based solution will meet their needs and attain the required level of support needed to help the corporation continue to grow. For this assignment, I will be discussing the implementation of a cloud-based collaborative solution for businesses. By definition, a cloud collaboration permits staff to work along together on documents and different information that is kept off-site. This is often done employing a cloud-based collaboration platform used to share, edit and work on comes along (Rouse, 2015). For a business to contemplate cloud-based collaborative solution they must consider a number of things before move ahead to implementation. They have to be ready to firmly store and share the information within the cloud. They’re going to need to be able to set permissions and accessibility perimeters for restricted access based on job roles and need to understand data information to ensure security of potentially sensitive information and to guard their clients. It’s necessary to make certain that end users have a clear understanding of the goals of the platform and the way they will gain the foremost out of using the platform. There will need to be coaching given and constant support throughout the conversion. A business must have a backup arranged for just in case of an emergency or system failure, they’re going to need to have a thorough understanding of the disaster recovery aspects of the service that they choose to be able to recover any information from the cloud service that they use. Having the ability to possess confidence within the cloud service to maintain the safety of the data from potential attacks and outside intrusion into the system is one of the primary things an organization ought to consider once considering their choices. For most corporations looking into the cloud based collaborative, it’s invariably a priority as to how seamless the transition can go from their current system to a replacement one. “In a survey of 2,438 IT executives and technology decision makers in the United States, Canada, France, Germany, and also the UK, Forrester found that fifty six have moved or plan to move a number of their enterprise collaboration systems to the cloud.” (C. 2017) The potential cloud solution will have to offer constant support throughout the modification for both the IT department handling the migration and supporting the users. This concern ought to be met with a rigorously planned infrastructure to facilitate modification management and control the variables that come in conjunction with migrating from the present system to a cloud-based one. Azendoo designed to help companies reduce the bulk of maintaining “to-do” lists and monitoring active projects. It is a characteristic corporate solution that highlights the importance of efficient team work synchronization, file sharing and project planning as well as communication. With Azendoo, you can share files from desktop, Gmail drive, DropBox and Evernote and also allows real time discussions. Without doubt, this cloud based collaboration solution organizes your work environment and makes optimizes team work activities. Monday.com is actually an app designed for smart business communication. It allows team members to work on projects and share information in a central place through streamlined discussions and contributions. Monday.com uses very efficient user navigation reminiscent of modern social media platforms where each team member creates a profile and shares project files and information with one another. Prominent clients include Uber and Universal like NBC. Both iPhone and Android applications, platforms are appropriate for companies that range from small businesses to large enterprises. Both companies also offer support for online, training, phone and live support. Both of these platforms offer a large variety of features, there are a few that a business owner needs to be aware of before they subscribe to one or the other. There are many cloud collaboration solutions in the market and finding one is as effortless as looking up businesses on your favorite browser. However, not all perform exceptionally well. Although no single solution can be identified as the best for every business, since each industry has its unique set of requirements, some offers have attributes that distinguish them from the rest. References C. (2017, April 19). CloudTweaks Technology Services. Retrieved August 06, 2017, from https://cloudtweaks.com/2013/12/5-best-practices-for-implementing-cloud-collaboration-in-2014/ Rouse, M. (2015, February 2). cloud collaboration . Retrieved from TechTarget: http://searchcloudapplications.techtarget.com/definition/cloud-collaboration Azendoo vs dapulse 2019 Comparison: FinancesOnline. (n.d.). Retrieved from https://comparisons.financesonline.com/azendoo-vs-dapulse Top 5 Cloud Collaboration Solutions. (n.d.). Retrieved from https://www.eztalks.com/telecommuting/cloud-collaboration-solutions.html

Case Study Assignment

Case Study Assignment. I’m studying for my Health & Medical class and need an explanation.

As part of his internship, Trey is working night intake at a psychiatric hospital in a medium-sized college town. It’s been pretty quiet all evening until a little after 1 a.m., when he hears shouting in the outer hallway.
Trey looks at Lisa, his fellow student intern, who says, “What’s going on out there?” A moment later the doors burst open, and a young man, who looks about 18 years old, is escorted in to the intake desk. He is agitated and has tears on his face, but he is not showing signs of violence or aggression, beyond the brief shouting he did out in the hallway. He plunks himself down in the chair across from the intake desk and buries his face in his hands, rocking slightly and moaning. He has a slight body odor and is perspiring heavily. “He’s all yours,” Lisa whispers. Trey ignores her and moves quickly to the intake desk. Lisa runs off to find the supervising nurse, who has gone on break. “Hey there,” Trey says calmly, bending over to look into the patient’s eyes. “I’m Trey. What’s up?” He is almost surprised when the patient stops rocking, sits up, and lowers his hands. “Hey,” he says quietly. “I’m Matt, and this is hell, dude.” “Not quite,” Trey smiles. “I’m here to help. Can you tell me what’s happened?” “I’m going all to pieces,” Matt says, “little screws and bolts and debris flying off everywhere.” Trey says nothing; he just waits. “I had kind of a breakdown in my dorm,” Matt says. “I threw my laptop out the window.” “Ooh, that’s rough. Bad night, huh?” “Bad week, bad month, bad year, bad bad life. Bad bad bad bad bad bad bad bad BA-A-A-AD.” “What happened?” “Where you wanna start?” In fits and starts, Matt conveys small clues that hint at his story. Matt has always been a “nerd,” he says, according to his older brothers. As a child he often withdrew from play groups at school to play on his own. In isolation, he has always managed to perform well academically, but in group work or group assignments, he has tended to resort to outbursts and a refusal to participate. He says he has always been awkward in social situations and has always found it hard to carry on “a good, rewarding conversation.” “And I’m freakin’ clumsy. Klutzy. A klutz,” he says, looking everywhere but at Trey. “I’m the opposite of an athlete, the opposite of my brothers.” Although his speech is frequently eccentric, Matt manages to convey a very brief picture of how, because of his withdrawal, negative thoughts, and social awkwardness, people tend to leave him on his own, both at large extended family gatherings or social functions in his family’s community and place of worship. In his senior year of high school, Matt’s grades and SAT scores gained him entrance to a leading Midwest university-despite his disruptive problems. Matt had been looking forward to going away to school, hoping that part of his problems “fitting in” had to do with his family’s “obscenely proper prominence” in the community, and his older brothers’ “super-dude images, which,” he says, “I will never live up to.” “At the same time,” he says during intake, “I was also pretty nervous, pretty stressed, pretty freaked out, pretty freaky.” In his first week of college, Matt found orientation week “disorienting,” he jokes with a slight smile. “Orientation disoriented me. It dissed me. I got dissed. There were people everywhere, like climbing-the-walls-and-on-top-of-you everywhere.” Except when Trey first initiated conversation, Matt, for the most part, has worked to avoid eye contact and continually bounces his left leg nervously. He is gripping the arms of his chair and looks as if he’s about to fly right out of it. “My roommate is a jock,” he says. “Jocular jock. Oh, Jocularity, wouldn’t you know they’d put me with a jocular-not-so-very-jocular-jock. They plan that stuff, you know. Just to keep me from escaping, from making a fresh start. Guy’s a jerk, and now, here I am.” He grins and expands his arms, gesturing the psychiatric ward around him. “And now here I am, just 8 weeks into my first semester away from home, and I’ve just been admitted for totally breaking down, shooting laptop missiles from the second freakin’ floor. They win.”

If Matt is truly suspected of having newly diagnosed or recent-onset schizophrenia, should Trey be letting the conversation focus so much on Matt’s childhood? Where might intake or assessment be best focused?
Based on this initial phase of Matt’s intake interview alone, what symptoms are already suggested in his behavior that would be significant in terms of potential psychosis or schizophrenia?

Case Study Assignment