Indemnity And Compensation

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.

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.

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

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.

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

Our study will comply with standard ethical research procedures. We will obtain informed consent from our participants before they participate in our study. Our potential participants will be fully informed about what will happen during our study; in addition, they will understand the effects that our study will have on them and our research (Grinnell, Unrau, and Williams, 2014). We will not use bribery, deception, threats, or any other forms of coercion in order to gain participants for our study. The physical/emotional safety of the participants will come before the research; therefore, we will adhere to all ethical research procedures.

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.

Patient also feel that only allowing drugs to be used for clinical trials to encourage greater participation in testing is unfair. Being a part of a drug trial is not easy for patients. Chahal points out that tests are often conducted in major cities, requiring many patients to spend significant amounts of time away from their hometown (368). Leaving home requires extra expenses for travel, lodging, and food and extra emotional strain from being away from family and friends. However, many deem these hardships as necessary for the moment in exchange for the

 Were appropriate procedures used to safeguard the rights of study participants? Was the study subject to external review by an IRB/ethics review board?

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

Before an investigational study on a new drug may take place, research subjects must submit informed consent and informed of all possible risks and benefits of the therapy. There are four types of phases associated with investigational studies that may occur. Beginning with the first phase, a Phase I study consist of few healthy participants who do not have the disease that the certain drug is said to treat. The purpose of this phase is to determine the optimal dosage range and the pharmacokinetics of the drug and if further testing of the drug is necessary. Vital signs, blood tests, urinary analysis, and other specific monitoring exams are performed. The next phase, Phase II, also involves a relatively small number of participants who this time have the disease that the drug is designed to treat. Participants are closely monitored to determine the effects and adverse

As a provider, your involvement is to understand the risks, potential benefits and treatment protocol to the point you can answer participants questions. It is also, the responsibility of the clinical research team to obtain informed consent and answer any questions to throughout the study.

The current market for clinical research trials is evolving towards increasing productivity in clinical trials. There is a demand for cost-effective, faster, and more efficient clinical trial processes. Clinician and regulatory agencies are requiring more data from clinical trials, increasing the complexity of clinical trials. Trends towards complex clinical trials have created a demand for increasing clinical trial staffing. In addition, companies aiming for more successful clinical trials have had an impact on staffing. Since 2008,

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

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