...in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary. Many of the elements...
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...Belmont Report: Informed Consent and Subject Selection In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general principles of research. Informed consent is broken down into three checkpoints: information, comprehension, and voluntariness. Assessment of Risks and Benefits has two similar components: identifying the nature and scope of the risks and benefits, and then the systematic assessment. Then there is the selection of subjects which is just an evaluation of the appropriateness of a group used in a research study. I will discuss these concepts as they apply to the infamous artificial heart case study. Informed consent is the application of the general principle of respect for persons. Remember, respect for persons requires that subjects be given the opportunity to choose what will or will not happen to them (Belmont Report, 1979). The first tier...
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...in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary. Many of the elements...
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...7/1/2011 Contents Introduction 2 What is clinical research? 2 The state of health in India 2 Clinical Research Market in India 3 Factors that Continue to Make India Attractive for Future Clinical Trial Outsourcing: 4 Challenges for the Indian Clinical Research Industry 6 Cinical research profession 7 Conclusion 8 Introduction Successful persons in business are noted to be blessed with innovation, perseverance and a broad vision. Its critical to have the “big picture” in mind while we want to position and well-establish the smallest things, after all the intensity of effect that something can cause cannot be under-estimated. A tiny sim-card that provides enormous data and communication coverage, an atom bomb which caused ruthless destruction in Japan, a small silicon chip that provides powerful processing speed in our computers, a tablet of aspirin that at times saves life; none can be ignored. It is important, thus, to identify the patterns, the trends, the relationships between smaller items in the “big picture” to channelize our efforts towards a unique direction. Behind every innovation lies a unique idea, and behind every successful idea lies the large audience it will cater to. Clinical research is one such area that can help a large population with some of their grave needs through small yet life-changing discoveries. What is clinical research? As per wikipedia.com, “Clinical research is a branch of medical science that determines the...
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...Human Subjects Research (HSR) Series CITI Program’s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social-Behavioral-Educational (SBE), and a set of Additional Modules of Interest. Organizations may group these modules to form a basic Biomed or SBE course, or a course that combines the two tracks. The Additional Modules of Interest should be used in any course variation, if relevant. The basic Biomed modules have three corresponding sets of refresher modules and the basic SBE modules have two corresponding sets of refresher modules. These refresher modules are intended to provide learners with a review of what was covered in the basic level modules. It is generally recommended that organizations select refresher module requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course). Three additional standalone courses are available: Institutional/Signatory Official: Human Subject Research, and IRB Chair. The Institutional/Signatory Official: Human Subject Research course provides a general introduction to the roles and responsibilities of the institutional official at an organization holding a Federalwide Assurance (FWA). The IRB Administration course offers members of an Institutional Review Board’s (IRB)...
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...Are Controlled Clinical Trials Really Ethical? Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care treatments only work in a very small percentage of patients and are very toxic with terrible side effects. Thomas learned of a new Phase 3 clinical research trial sponsored by Roche with an unapproved yet promising drug. His doctor explained that in earlier trials, a majority of volunteer patients who took the wonder drug had seen a drastic reduction in the size of their tumors with very few side effects. The only way ill patients can get the drug is by participating in this trial. The trial is a randomized controlled trial (RCT) which means half of the volunteers will get the experimental drug while the other half will be treated with another standard of care treatment. The purpose of the standard or control arm is to allow researchers to compare the long term effects of the new drug to that of the current standard treatment and determine whether it actually shrinks tumors and prolong remissions. Participants have a 50/50 chance of being placed in either arm of the study. Arm assignments are random and cannot be changed. With limited options...
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...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings...
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...University of Maryland Case Study Analysis Eli Lilly: Developing Cymbalta Case Study AMBA 650 Section 1131 Kelvin Harris January 24, 2012 Executive Summary Eli Lilly and Company resounding success was the arrival of Prozac in 1988. By mid-1988, a new anti-depressant team was formed to find and develop a drug that would be the successor to Prozac. The strategic issues and problems they faced were developing a new drug to replace Prozac, meeting the company budget constraints to perform clinical trials, and finally launch the new drug by mid-2001. The analysis and evaluation revealed that the pharmaceutical industry is changing fast and it usually takes a long time and millions of dollars to develop a new drug. The recommendation for Eli Lilly is to take the lead in developing the new drug Cymbalta, invest a stable share of the company revenue, seek the FDA approval for the development of Cymbalta before going to market, and not change their market plan from the FDA approved Cymbalta dosage of 20 mg twice daily. Introduction Eli Lilly and Company was founded by Colonel Eli Lilly, Lilly’s namesake, in 1876 when he purchased a laboratory on Pearl Street in Indianapolis, Indiana. Eli Lilly was a pharmacist who had served in the Union Army during the Civil War. The company success included creating the process for applying gelatin-coating to pills for easier swallowing and the introduction of Iletin which was the first mass-produced insulin. Iletin...
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...by type of research conducted. Training curricula are specified as Clinical Research, Epidemiological and Social Behavioral Research, and Basic Science Research. ▪ Each type has a link associated with it that when accessed, instructions are given, required courses and Just-in-Time/optional courses are listed, and the training links to each course are provided. ▪ Just-in-Time CITI courses may be required by the IRB or PI if an investigator is conducting research involving certain specialized areas, but are otherwise optional (e.g. GCP courses are optional, for research staff who do not conduct FDA-regulated research.) IRBs or PIs may also require Key Research Personnel to complete these courses. . How do I choose between the CRT, CITI Biomedical and the NIH CC Ethics course? ▪ CITI courses offer a “test-out” option. If you achieve a score of 80%, you will not be required to take the full course. ▪ CITI also offers the option to take the full course with CMEs (fee required). ▪ The NIH CRT can be accessed without an NIH login. ▪ The Ethical and Regulatory Aspects of Clinical Research course is an in-person course offered annually by the CC Bioethics Department. It can be taken as the primary training course, as well as a refresher course in place of the CRT or the CITI Biomedical course. To receive credit, 6 of the 7 weekly classes must be attended and at least a score of 80% of the exam. How can my research staff confirm...
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...register your answers. After submitting your answers, the correct answer to each question and an explanation will be displayed. Navigational links to the next module will be provided. All quiz questions count towards your score. You should answer all questions. Question 1 Multiple Choice/Single Answer - Select only one answer A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience to the IRB only if there are several other occurrences. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Report the adverse drug experience as part of the continuing review report. Do not report the adverse drug experience to the IRB since it is a common adverse experience. Question 2 Multiple Choice/Single Answer - Select only one answer How long is an investigator required to keep consent documents, IRB correspondence, and research records? As long as the investigator is at that institution Until data analysis is complete Until the study is closed For a minimum of three years after completion of the study Question 3...
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...The Placebo Effect The activity I chose to write about was on Dr. Walter A. Brown’s article in Scientific American about placebos and their effect on the patients. His article described what a placebo is and if it is ethical for doctors to prescribe this treatment to their patients. Dr. Brown, who is a psychologist at Brown University, decided to do a study on the effects of a placebo. A placebo is any treatment or drug with no medicinal value that is given to a patient to relieve symptoms of an ailment. His hypothesis in the article focused on if the placebos had any effect on the patients who took the placebos. To test his hypothesis, Dr. Brown and his colleagues performed experiments on patients who had depression. To test his idea, he employed what is known as the double blind technique. This type of experimentation involves that neither the doctors nor the patients know if they are receiving the real stuff or simply sugar pills (placebos). Only the experimenters know who gets what. What this supposedly does is that the patient will mentally think that the doctor is giving him/her the real drug and they will soon be feeling better. When in reality, it is themselves, not the medicine, which makes them feel better. These are the findings of Dr. Brown. In his experiments on the placebos, he found that the placebo can make a person feel better, but it can also have no effect what-so-ever. In his study of the depressed patients, about 50% of the subjects...
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...protection regulations that govern the participation of human volunteers in research in the United States. Learning Objectives By end of the module you should be able to: * Describe the role, authority, and composition of the IRB. * List the IRB requirements for conducting research involving human subjects. * Describe the types of IRB review. * Describe the process of working with the IRB. * Identify other regulations and regulatory groups that require compliance based on the type of research being conducted. IRB Role, Authority, and Composition The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. To clarify when IRB review is required, let's define some terms: * Research: Federal regulations define research as: "a systematic investigation... designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)] If an investigator is unclear about whether a planned activity is research, the investigator should contact his/her IRB office. * * Human Subjects:...
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...Process New drug development process has three major steps that cost the company over $500 million. The first step starts with preclinical studies. At this stage, new drug is tested on animals with the primary aim of examining its pharmacological and therapeutic compounds as well biologically dangerous compounds. The second step is the Investigational New Drug Application (IND). At this stage, the drug is submitted to the Food and Drug Administration (FDA) for approval before testing it on humans. The company is expected to give details with regard to compound composition, protocols that will be applied in Phase 1 and the clinical research plan. More than 5000 compounds are submitted for clinical testing but only one of them is approved for marketing (Sharp, 2001). Approval is granted within a period of one month and this marks the onset of clinical testing on human beings and comprises of three phases. At first, the drug is tested on a few healthy individuals (10-30) to ascertain that the drug is safe and can be tested on patients. Phase 1 focuses on safety but not drug’s efficiency (Sharp, 2001). Phase 2 utilizes a larger population...
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...on their products. They are considering a proposal that would require drug firms to register drug tests at the outset as a prerequisite to have their results published. Discuss the implications of the above proposal. The transparency of research data from clinical trials although not necessarily the panacea, could be a step towards mitigating unnecessary deaths and suffering of patients, waste of resources in terms of redundant research, and waste of taxpayers’ money. As an example, the drug maker Merck concealed that its drug against pain, marketed as Vioxx, had a fatal side effect that causes heart attacks. The use of Vioxx has caused an estimated 100,000 incidents of heart attacks and 10,000 deaths to patients administered with the drug. The Vioxx incident is not the only example of the costs of a blanket policy of secrecy. It is evident that a policy of disclosure would not only prevent widespread public health disaster, but could also serve far-reaching consequences. It is plausible that public access to research data could potentially yield much valuable new information to aid the development of new products by independent scientists and doctors. By making drug companies liable to publish full, unadulterated data from clinical trials, it would open the door for efficacy and safety claims by drug companies to be placed under scrutiny. It allows for an open system of checks and balances to be established and hence prevent any misrepresentation of...
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...limited to the Nazi regime The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners may be used to conduct research that only benefits the larger society Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".) Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? Voluntary Consent Informed consent is considered an application of which Belmont principle? **** Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence & research records? For a minimum of three years after completion...
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