Indemnity And Compensation

Our country is one where every day, new medical treatments and medicines are being discovered and being approved to help Americans battle all of the different diseases and conditions that affect us. In order for us to be able to get access to those medications and treatments, many people agree to become part of clinical trials, they are the first to receive the treatments, this helps to understand how the body will be affected and if the medication will be effective. People who are part of these clinical trials, go through extensive medical testing, and they must be of sound mind and

Instead of the trials being conducted by a anonymous group of people only one specific person is treated. The treatment is meant to make that individual patient and is paid for by the patient and their family, however they choose to pay. The decision to follow through with the treatment is made by the patient when it is decided that they need it, and they do not directly need consent. The treatments can be available to the public through product labeling, although the patients medical records cannot be released to the public as they are

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

People should participate in clinical trials because they are safe, a way to earn money, a positive impact on the medical field, easy to perform in, and highly successful. A clinical trial is similar to a research study that is conducted for many reasons.

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

Typically, there is a small number of people used in these Phase I trials, between 20 and 80. Phase II trials have more participants(100-300) who have the condition or disease that the product may be able to treat. Researchers want to gather further safety data and preliminary evidence of the drug’s beneficial effects, and they develop and refine research methods for future trials with this drug. If the drug is indicated to possibly be effective during Phase II, given the observed severity of the disease, the drug will progress to Phase III. In Phase III, the drug is studied in a larger number of people with the disease, between 1,000-3,000 usually. The phase further tests the product’s effectiveness, monitors side effects and, in can compare the product’s effects to a standard treatment, if one is available already. Having more participants reveals the less common side effects. Phase II and Phase III clinical trials typically involve a “control” standard. One group is given the drug and the control group is given either a standard treatment for the illness or a placebo. Phase IV is the part of the trial that is sometimes conducted after a product is already approved and on the market. The purpose is to find out more about the treatment’s long-term risks, optimal use, and benefits, or to test the product in different demographics, such as children. Informed consent is the process by which potential participants for a study are given complete information about the study. The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients are invited to enter a trial but are not forced to do so. They can consent to participate if they find the potential risks and benefits acceptable. A participant must sign a consent form prior to enrolling in a study before

There are several issues faced in this study case. All three principles (respect for persons, beneficence, and justice) that researchers are supposed to abide by are questioned in this study. Were the participates consider to have autonomy, if not did the researchers still continue? Was proper informed consent giving? If so, was the information fully comprehended? Was their agreement to participate coerced or voluntary? These questions help determine if the researchers had respect for person. In the case of beneficence, were the benefits of the experiment maximized and were the risk minimized? Was there any harm caused to the men? Were they aware of the potential harm? Was it justified why a vulnerable population was chosen to conduct the

The trial is first investigator-initiated; a steering committee will be the responsible to design, execute and conduct the study. The monitoring board (professional of the health system) will review the intern results, monitor the safety of the patients, and examine the efficacy of the therapies. Local ethic committee and FAMHP have to approve the study before initiating it.

Research groups that utilize clinical trials for the “Research that includes treatment of an individual must obtain the patients authorization to disclose any protected heath information to all health care providers other than those involved in the direct care of the patient” (Axia College, 2007). For example, Jan participates in a clinical trial at CEDRA Clinical Research for the study of a new pain medication sponsored by ABC Labs. After the trial, Jan sees her primary care physician in regards to ongoing headaches. Jan informs her doctor that she participated in a clinical study but stated that the medicine give did not contain this side effect, the next day, her physician called CEDRA to obtain information regarding the treatment and information on the outcome of the patient’s results. CEDRA advised the doctor that that patient did not provide authorization to release any information to other healthcare providers other than those involved in the clinical trial. According to

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

Interestingly, IRBs are set up mainly to confirm that a clinical trial is ethical and that the process will not harm patients. Whether or not the clinical trial is constructed properly or not is commented upon, but may not be a major focus of the review. For this reason, many institutions also require a concurrent review by an institutional “Office of Clinical Research” and a regular meeting of supervising clinicians during the

Who Enrolls in Drug Trials? Healthy experienced testers are used during Phase I where the side effects and safety of a potential new drug are tested. Phase II trials find dosing requirements and therapeutic efficiency. Phase III trials are on a much larger scale so they can compare the results with other medications on the market. Experimental drugs, biologics, and devices are just a few of the studies these “guinea pigs” can participate done.

Participants were also given the right to withdraw before and during the research, therefore the participants were not pressured to take part or complete the study if they were not comfortable with the terms of the research or what the data was being used for. However, there may be ethical issues regarding the wellbeing of the participants during the research as the study may have caused stress or anxiety in the participants when completing the memory or millionaire tests because they may feel the pressure to do well in each test, although the research was anonymous and so this may have reduced the amount of stress caused by the study.

Clinical trials are research based studies that are performed to determine whether a drug, device, or medical procedure (depending on the stage of the study) is safe and effective. A complete set of trials that would include all phases may cost hundreds of millions of dollars which is usually paid for by a sponsor such as a government agency or a for-profit company. Increasingly, clinical trial activities are contracted out to service providers such as an academic medical center (AMC), a contract research organization (CRO), or a physician’s practice and this outsourcing requires negotiation and execution of CTAs. Therefore, a clinical trial agreement (CTA) is required between the sponsor and the organization to conduct the

Take Elliott Sharp for example, he pursued a career in freelance journalism and ended up making three dollars for an article here, fifty dollars for a weeks-worth of blogs there. He ended up needing to pick up supplemental jobs, and the most profitable one he found was doing medical research studies (Sharp, 2012). Elliott is not alone. Immigrants have been another group that have been targeted. They are especially vulnerable because many do not speak English or have little if any skills. Testing centers, especially for Phase I trials, are simply looking for healthy bodies. They are willing to provide translators and pay a “reasonable” amount of money to reimburse participants for their time (Smith, 2005). The large payouts and minimal requirements make drug trials very appealing. Those who fall into drug trial testing as a full-time job, become dependent on the manipulation of their body for an income. The University of Miami bioethicist Ken Goodman says that “the line between compensation and coercion [has become] a very fine line “(Smith, 2005). There comes a point when the need of the money negates the fact that they are consenting freely. Free consent is an essential part ensuring the ethicality of human subject research. Another issue that “career guinea pigs” present in relation to the Belmont reports in the area of application of general ethical human